JP2016517601A - Apparatus, system, and method associated with sample monitoring apparatus and apparatus incorporating them - Google Patents

Abstract

Specimen monitoring systems, specimen monitoring devices, methods associated with specimen monitoring devices, and devices incorporating them are provided. Various graphical user interfaces (GUIs) and navigation flows are provided for various features, activities, functions, etc. associated with the analyte monitoring device or system. Intuitive navigation is provided to improve the interpretation of analyte measurements.

Description

Priority claim

  This application is based on the provisions of 35 USC 119 (e), “Devices, Systems, and Methods Associated with Analyte Monitoring Devices and Devices Incorporating the Same” filed on March 15, 2013. US Patent Provisional Application No. 61 / 801,518 entitled "Associated Devices, Systems, and Methods, and Devices Incorporating They," the disclosure of which is incorporated by reference for all purposes. Are incorporated herein.

  The present disclosure relates to devices, systems, and methods associated with analyte monitoring devices and devices incorporating them.

  A sample monitoring device is used as a medical diagnostic device for determining a sample level from a sample. One common application is glucose measurement. In order to perform sample measurement, for example, a sample monitoring device is used together with a remote sensor. The sensor can be configured to be implanted in a patient (eg, implanted subcutaneously, vein, or artery). The analyte monitoring device may process the signal from the remote sensor to determine the concentration or level of the analyte in the subcutaneous tissue and display the current analyte level.

  Embodiments of the present disclosure are best understood when the following detailed description is read in conjunction with the accompanying drawings. In accordance with common practice, the various features of the drawings are not to scale. Rather, the dimensions of the various features are arbitrarily expanded or reduced for clarity.

1 illustrates an in vivo analyte monitoring system according to certain embodiments of the present disclosure FIG. 4 shows a block diagram of a system that includes an analyte monitoring device and a remote data processing device, according to certain embodiments of the present disclosure. FIG. 6 illustrates an analyte monitoring device for use with a remote sensor, according to certain embodiments of the present disclosure. 6 illustrates a method for powering on an analyte monitoring device, such as a glucose monitoring device, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method of turning on an analyte monitoring device, such as a glucose monitoring device, according to certain embodiments of the present disclosure (continuation of FIG. 4-1). FIG. 5A illustrates a method for navigating from another screen of a sample monitoring device to a home screen according to certain embodiments of the present disclosure. 5B, 5C, and 5D illustrate a method for powering off an analyte monitoring device according to certain embodiments of the present disclosure. FIG. 5E illustrates a low battery screen indicating that the device battery is low for an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 5F illustrates a method for linking an analyte monitoring device to a PC and transferring data between the two according to certain embodiments of the present disclosure. FIG. 5G illustrates a method for charging a battery of an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for performing a sensor scan or system check according to certain embodiments of the present disclosure. FIG. 4 illustrates a method of activating a sensor according to certain embodiments of the present disclosure. FIG. 4 illustrates a method of activating a sensor according to certain embodiments of the present disclosure. 6 illustrates a method of scanning a sensor when the sensor is about to expire, according to certain embodiments of the present disclosure. FIG. 4 illustrates an exemplary graphical user interface that displays sensor lifetime in increments according to certain embodiments of the present disclosure. FIG. 6 illustrates a method for activating a sensor after a device is powered on according to certain embodiments of the present disclosure. FIG. 7 illustrates a method for activating a sensor after a device is powered on according to certain embodiments of the present disclosure (continuation of FIG. 7-1). FIG. 7 illustrates a method of activating a sensor after the device is powered on according to certain embodiments of the present disclosure (continuation of FIG. 7-2). 6 illustrates a method of scanning a sensor using an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 8 illustrates a method of scanning a sensor using an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 8-1). FIG. 8 illustrates a method of scanning a sensor using an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 8-2). FIG. 6 illustrates a method for performing two scans within a predetermined period using an analyte reader, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for recording dose calculations according to certain embodiments of the present disclosure. FIG. 6 illustrates a method that allows two consecutive scans according to certain embodiments of the present disclosure. FIG. 10A illustrates an example of a sensor result screen, according to certain embodiments of the present disclosure, FIG. 10B illustrates an example of a result unavailable screen, according to certain embodiments of the present disclosure, and FIG. 10C illustrates the present disclosure. Shows an example of a screen with results masked, according to certain embodiments of FIG. 10D illustrates an interface that indicates that the temperature of the sensor is too high, according to certain embodiments of the present disclosure, and FIG. 10E illustrates an interface that indicates that the temperature of the sensor is too low, according to certain embodiments of the present disclosure. Show 10F and 10G illustrate an interface that indicates that a sensor measurement is out of range, according to certain embodiments of the present disclosure. FIG. 10H illustrates an interface indicating high sensor readings according to certain embodiments of the present disclosure, and FIG. 10I illustrates an interface indicating low sensor readings according to certain embodiments of the present disclosure. FIG. 10J illustrates an interface indicating that high analyte levels are predicted according to certain embodiments of the present disclosure, and FIG. 10K illustrates that low analyte levels are predicted according to certain embodiments of the present disclosure. Show interface FIG. 10L illustrates an example of a sensor result screen according to a particular embodiment of the present disclosure, and FIG. 10M illustrates an example of a result unavailable screen according to a particular embodiment of the present disclosure. 7 illustrates an example of a method for performing a blood glucose test using a test strip, according to certain embodiments of the present disclosure. FIG. 11 illustrates an example of a method for performing a blood glucose test using a test strip, according to certain embodiments of the present disclosure (continuation of FIG. 11-1). FIG. 11 illustrates an example of a method for performing a blood glucose test using a test strip, according to certain embodiments of the present disclosure (continuation of FIG. 11-2). FIG. 12A shows an example of a blood glucose results screen according to certain embodiments of the present disclosure. FIG. 12B illustrates an example interface showing the results of a blood glucose control solution test according to certain embodiments of the present disclosure. FIG. 12C illustrates an example interface indicating that the temperature of the analyte monitoring device is too high or too low, according to certain embodiments of the present disclosure. 12D and 12E illustrate an interface that indicates that a measurement value is out of range, according to certain embodiments of the present disclosure. FIG. 12F illustrates an interface indicating a high measurement value according to a specific embodiment of the present disclosure, and FIG. 12G illustrates an interface indicating a low measurement value according to a specific embodiment of the present disclosure. FIGS. 12H and 12I show display screens with results masked, respectively, for blood glucose control solution test and blood glucose test strip results, according to certain embodiments of the present disclosure. 6 illustrates an example method for performing a ketone test using a ketone test strip, according to certain embodiments of the present disclosure. FIG. 13 shows an example of a method for performing a ketone test using a ketone test strip according to certain embodiments of the present disclosure (continuation of FIG. 13-1). FIG. 13 illustrates an example of a method for performing a ketone test using a ketone test strip, according to certain embodiments of the present disclosure (continuation of FIG. 13-2). FIG. 14A shows an example of a ketone results screen according to certain embodiments of the present disclosure. FIG. 14B illustrates an example interface showing the results of a ketone control solution test, according to certain embodiments of the present disclosure. FIG. 14C illustrates an example interface indicating that the temperature of the analyte monitoring device is too high or too low, according to certain embodiments of the present disclosure. FIG. 14D illustrates an interface indicating that a measurement value is out of range, according to certain embodiments of the present disclosure. FIG. 14E illustrates an interface indicating high ketone readings according to certain embodiments of the present disclosure. 14F and 14G show display screens with results masked, respectively, for the results of a ketone control solution test and a ketone test strip, according to certain embodiments of the present disclosure. FIG. 15A illustrates a note interface for entering notes on a reader, according to certain embodiments of the present disclosure. 15B and 15C illustrate a note interface for entering notes on a reader according to certain embodiments of the present disclosure. FIG. 15D illustrates a note interface for entering notes on a reader, according to certain embodiments of the present disclosure. FIG. 15E illustrates a note interface for entering notes on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a residual insulin interface for entering residual insulin information on a reader, according to certain embodiments of the present disclosure FIG. 6 illustrates a residual insulin interface for entering residual insulin information on a reader, according to certain embodiments of the present disclosure FIG. 6 illustrates a residual insulin interface for entering residual insulin information on a reader, according to certain embodiments of the present disclosure FIG. 6 illustrates an insulin calculator interface for using an insulin calculator on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator interface for using an insulin calculator on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator interface for using an insulin calculator on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator interface for using an insulin calculator on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator interface for using an insulin calculator on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a dose details interface for displaying details of insulin dose on a reader according to certain embodiments of the present disclosure. FIG. 6 illustrates a dose details interface for displaying details of insulin dose on a reader according to certain embodiments of the present disclosure. FIG. 6 illustrates a reminder interface for setting reminders on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a reminder interface for setting reminders on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a reminder interface for setting reminders on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a reminder interface for setting reminders on a reader, according to certain embodiments of the present disclosure. 6 illustrates a reminder receiving interface for receiving a reminder on a reader, according to certain embodiments of the present disclosure. 6 illustrates a reminder receiving interface for receiving a reminder on a reader, according to certain embodiments of the present disclosure. FIG. 21A illustrates an exemplary interface for providing a summary menu on an analyte monitoring device, according to certain embodiments of the present disclosure, and FIG. 21G illustrates a sample in masking mode, according to certain embodiments of the present disclosure. Shows an example interface for providing a summary menu on a monitoring device FIG. 21B shows a daily graph screen showing a daily graph of sensor readings taken over a single day, ie, a 24-hour period, according to certain embodiments of the present disclosure, FIG. 21E illustrates an exemplary screen showing the percentage of time that a sensor measurement was within a target zone, according to certain embodiments of the present disclosure, and FIG. 21E is obtained over a period of time, according to certain embodiments of the present disclosure. FIG. 21F illustrates an exemplary screen showing a graph of the number of events associated with a measured sensor value summarized for a given time period, and FIG. 21F illustrates a time period according to certain embodiments of the present disclosure. Shows an exemplary screen showing information associated with the use of various sensors FIG. 21C illustrates an exemplary average glucose summary interface that provides a graph of sensor measurements obtained over a period of time and summarized for a given period, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. 6 illustrates a registry interface for displaying, adding, and / or editing a registry entry on a reader, according to certain embodiments of the present disclosure. FIG. 6 illustrates a strip / hardware error interface displaying error messages on a reader according to certain embodiments of the present disclosure. FIG. 6 illustrates a strip / hardware error interface displaying error messages on a reader according to certain embodiments of the present disclosure. FIG. 5 illustrates recovering a date and time after a time loss according to certain embodiments of the present disclosure FIG. 6 illustrates a method for initial start of an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 7 illustrates a method for initial start of an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 24-1). FIG. 7 illustrates a method for initial start of an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 24-2). FIG. 4 illustrates a method for entering settings on an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 25 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 25-1). FIG. 25 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 25-2). FIG. 25 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 25-3). FIG. 4 illustrates a method for entering settings on an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 6 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 26-1). FIG. 6 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 26-2). FIG. 26 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 26-3). FIG. 26 illustrates a method for entering settings on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 26-4). 6 illustrates a method for checking system status of an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 7 illustrates a method for checking the system status of an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 27-1). FIG. 4 illustrates a method for setting a masking mode of an analyte monitoring device according to certain embodiments of the present disclosure. FIG. 28 illustrates a method for setting a masking mode of an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 28-1). FIG. 6 illustrates a method for activating a computer function on an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for activating a computer function on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 29-1). FIG. 29 illustrates a method of activating a computer function on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 29-2). FIG. 6 illustrates a method for activating a computer function on an analyte monitoring device (continuation of FIG. 29-3), according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for configuring a computer on an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for configuring a computer on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 30-1). FIG. 4 illustrates a method for configuring a computer on an analyte monitoring device, according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for configuring a calculator on an analyte monitoring device according to certain embodiments of the present disclosure (continuation of FIG. 31-1). FIG. 4 illustrates a method for setting correction according to certain embodiments of the present disclosure. FIG. 32 illustrates a correction setting method according to certain embodiments of the present disclosure (continuation of FIG. 32-1). FIG. 4 illustrates a correction setting method according to certain embodiments of the present disclosure (continuation of FIG. 32-2). FIG. 6 illustrates a residual insulin setting method and a storage setting method according to certain embodiments of the present disclosure. FIG. 3B illustrates a residual insulin setting method and a storage setting method according to certain embodiments of the present disclosure (continuation of FIG. 33-1). FIG. 33 illustrates a residual insulin setting method and a preservation setting method according to certain embodiments of the present disclosure (continuation of FIG. 33-2). FIG. 6 illustrates an example of an animation interface according to certain embodiments of the present disclosure. FIG. 3B illustrates an example of an animation interface according to certain embodiments of the present disclosure (continuation of FIG. 34-1). FIG. 6 illustrates an example of an animation interface according to certain embodiments of the present disclosure. 6 illustrates a method for initiating remote device (RD) software on a remote data processing device, according to certain embodiments of the present disclosure. FIG. 6 illustrates a flowchart of data management software start processing according to certain embodiments of the present disclosure. FIG. 6 illustrates an example of a welcome screen, according to certain embodiments of the present disclosure FIG. 6 illustrates a flowchart of a method for navigating in reader mode to access settings and functions used to configure and control a reader device, according to certain embodiments of the present disclosure. FIG. 4 shows a flowchart of a method for navigating in reader mode to access settings and functions used to configure and control a reader device according to certain embodiments of the present disclosure (continuation of FIG. 39-1). FIG. 4 shows a flowchart of a method for navigating in reader mode to access settings and functions used to configure and control a reader device according to certain embodiments of the present disclosure (continuation of FIG. 39-2). FIG. 6 illustrates an example of a reader landing screen according to certain embodiments of the present disclosure. FIG. 6 shows a screen indicating that the reader is not synchronized, according to certain embodiments of the present disclosure FIG. 6 shows a profile screen according to certain embodiments of the present disclosure. FIG. 7 illustrates an insulin calculator setting interface of health management software configured for a simple insulin calculator, according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator settings interface of health care software configured for an advanced insulin calculator configured to calculate carbohydrates in grams of carbohydrates according to certain embodiments of the present disclosure. FIG. 7 illustrates an insulin calculator setting interface of health care software configured for an advanced insulin calculator configured to calculate carbohydrates in grams of carbohydrate by time of day according to certain embodiments of the present disclosure. FIG. 7 illustrates an insulin calculator setting interface of health care software configured for an advanced insulin calculator configured to calculate carbohydrates in grams of carbohydrate by time of day according to certain embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator setting interface of health care software configured for an advanced insulin calculator configured to calculate carbohydrates by the number of servings of carbohydrates by time of day according to embodiments of the present disclosure. FIG. 6 illustrates an insulin calculator setting interface of health care software configured for an advanced insulin calculator configured to calculate carbohydrates by the number of servings of carbohydrates by time of day according to embodiments of the present disclosure. FIG. 6 illustrates a masking mode setting screen according to certain embodiments of the present disclosure. 6 illustrates a method of synchronizing a reader device with a remote device, according to certain embodiments of the present disclosure. 6 illustrates a method for a guided reader configuration interface, according to certain embodiments of the present disclosure. FIG. 6 illustrates a single screen of a guided reader configuration interface according to certain embodiments of the present disclosure FIG. 6 illustrates a flowchart for navigating through a report mode of RD software, in accordance with certain embodiments of the present disclosure. FIG. 5 illustrates a flowchart of navigating through report mode of RD software according to certain embodiments of the present disclosure (continuation of FIG. 51-1). FIG. 6 illustrates an example of a report landing screen according to certain embodiments of the present disclosure. FIG. 6 illustrates an example report creation screen according to certain embodiments of the present disclosure. FIG. 9 illustrates an example of a record book report screen when viewed from report mode, according to certain embodiments of the present disclosure. FIG. 6 shows a flow chart of a guided report configuration interface according to certain embodiments of the present disclosure. FIG. 4 illustrates a method for exporting reader data according to certain embodiments of the present disclosure. FIG. 6 illustrates an example snapshot report for a particular time frame, according to certain embodiments of the present disclosure FIG. 5B illustrates an example snapshot report for a particular time frame according to certain embodiments of the present disclosure (continuation of FIG. 57-1). FIG. 6 illustrates a calendar report according to certain embodiments of the present disclosure. FIG. 5B shows a calendar report according to certain embodiments of the present disclosure (continuation of FIG. 58-1). FIG. 6 shows daily pattern reports according to certain embodiments of the present disclosure FIG. 5C shows daily pattern reports according to certain embodiments of the present disclosure (continuation of FIG. 59-1). FIG. 6 illustrates a meal pattern report according to certain embodiments of the present disclosure FIG. 6 shows the first page of a daily statistical report for a given time period according to certain embodiments of the present disclosure FIG. 6B shows the first page of a daily statistical report for a given time period according to certain embodiments of the present disclosure (continuation of FIG. 61-1). FIG. 4 illustrates an exemplary register report according to certain embodiments of the present disclosure. FIG. 4 illustrates an exemplary register report according to certain embodiments of the present disclosure. FIG. 6 illustrates an exemplary registry report according to certain embodiments of the present disclosure (continuation of FIG. 63-1). FIG. 6 illustrates an example of a reader settings report according to certain embodiments of the present disclosure. FIG. 6 illustrates a reader settings report in accordance with certain embodiments of the present disclosure. FIG. 5 shows a data management software home screen when the reader device is not connected to a PC on which the data management software resides, according to certain embodiments of the present disclosure. FIG. 4 shows a home screen of data management software when an unconfigured reader device is connected to a PC on which the data management software resides, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when an unconfigured reader device is connected to a PC on which the data management software resides, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when the reader device is connected to a PC on which the data management software resides, according to certain embodiments of the present disclosure. FIG. 5 shows a home screen of data management software when the date and time of a connected reader device is not synchronized with the time of the computer on which the software is loaded, according to certain embodiments of the present disclosure FIG. 5 shows a home screen of data management software when the date and time of a connected reader device is not synchronized with the time of the computer on which the software is loaded, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when a software update is available, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when a software update is available, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when a software update is available, according to certain embodiments of the present disclosure FIG. 4 shows a home screen of data management software when a software update is available, according to certain embodiments of the present disclosure FIG. 6 illustrates a report creation screen for data management software, in accordance with certain embodiments of the present disclosure. FIG. 4 illustrates an example snapshot report, according to certain embodiments of the present disclosure FIG. 6 illustrates an exemplary daily pattern report according to certain embodiments of the present disclosure. FIG. 6 illustrates an exemplary daily pattern report according to certain embodiments of the present disclosure. FIG. 4 illustrates an exemplary advanced daily pattern report according to certain embodiments of the present disclosure FIG. 4 illustrates an exemplary advanced daily pattern report according to certain embodiments of the present disclosure FIG. 6 illustrates an exemplary meal pattern report according to certain embodiments of the present disclosure. FIG. 4 illustrates an exemplary monthly summary report according to certain embodiments of the present disclosure. FIG. 6 illustrates an exemplary weekly summary report according to certain embodiments of the present disclosure FIG. 4 illustrates an exemplary daily recording report according to certain embodiments of the present disclosure FIG. 4 illustrates an exemplary reader detail report in accordance with certain embodiments of the present disclosure. FIG. 4 illustrates an exemplary reader detail report in accordance with certain embodiments of the present disclosure. FIG. 7 illustrates an exemplary frame of a report creation menu for setting report parameters, according to certain embodiments of the present disclosure. FIG. 5 illustrates an advanced daily pattern report configuration screen according to certain embodiments of the present disclosure. FIG. 5 illustrates an advanced daily pattern report configuration screen according to certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. 6 illustrates an exemplary screen for adjusting settings of a reader device, in accordance with certain embodiments of the present disclosure. FIG. 6 shows a screen associated with a reader device expert option in accordance with certain embodiments of the present disclosure. FIG. 6 shows a screen associated with a reader device expert option in accordance with certain embodiments of the present disclosure. FIG. 6 shows a screen associated with a reader device expert option in accordance with certain embodiments of the present disclosure. FIG. 6 shows a screen associated with a reader device expert option in accordance with certain embodiments of the present disclosure. FIG. 6 shows a screen associated with a reader device expert option in accordance with certain embodiments of the present disclosure. Shows options available in the main system menu of the data management software, according to certain embodiments of the present disclosure FIG. 6 illustrates an auto-save choice screen according to certain embodiments of the present disclosure

  Before describing embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the particular aspects described and may be varied in many ways. Also, since the scope of the present disclosure is limited only by the appended claims, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. I want you to understand.

  Where a range of values is given, each value between the upper and lower limits of the range is specifically disclosed to the tenth of the lower limit unit unless otherwise stated. I want you to understand. Each smaller range between any stated value or value within the stated range and any other stated value or value within the stated range is also included in this disclosure. Is done. The upper and lower limits of these smaller ranges can each independently be included or excluded from the range, and each range in which the lower range does not include the upper and / or lower limits is also disclosed in this disclosure. And is subject to the limits specifically excluded within the stated ranges. Where the stated range includes one or both of the upper and lower limits, ranges excluding either or both of the included upper and lower limits are also included in the disclosure.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or experimentation of the present disclosure, some possible preferred methods and materials are described below. To do. All publications mentioned in this specification are herein incorporated by reference to disclose and explain the methods and / or materials of interest for which the publication is cited. In case of conflict, it is to be understood that the present disclosure has priority over any disclosure of incorporated publications.

  Note that the singular forms “a”, “an”, and “the” used in the present specification and claims include a plurality of meanings unless otherwise specified. Thus, for example, reference to “program update” includes a plurality of such program updates, and reference to “program update” includes one or more program updates and equivalents known to those skilled in the art. Etc.

  Embodiments of the present disclosure generally relate to in vivo methods and devices for detecting at least one analyte, such as glucose in body fluids. Thus, embodiments provide that at least a portion of a sensor is placed within a user's body (eg, within an ISF) (eg, percutaneously within the user's body) to obtain information about at least one analyte of the body. An in vivo analyte sensor configured to be disposed). In certain embodiments, the in vivo analyte sensor is connected to an electronic device unit that is maintained on the user's body (eg, the skin surface), thereby connecting the in vivo analyte sensor electronics assembly for body wear. Is provided.

  In certain embodiments, sample information is communicated from a first device, such as a body-worn electronic device unit, to a second sample monitoring device that may include a user interface function (including a display or the like).

  In many embodiments of this system, the sensor / body-worn electronic device (eg, body-worn electronic device assembly) was obtained only when the user requested, such as by selecting the timing of data communication. Specimen information is made available in a form that is available or viewable by the user. The body-worn electronic device may periodically measure and record such data until on-demand measurement is performed by the user (eg, bringing the display device closer to the body-worn electronic device and sensor). Good. During communication, the body-worn electronic device may communicate data recorded for a set period. For example, the body-worn electronic device may have an 8 hour memory that stores periodic measurements taken every 15 minutes. Once on-demand measurements are obtained, a total of 8 hours is transferred to the device. If the user does not perform on-demand measurement for a period longer than 8 hours, part of the data may be lost.

  Thus, in certain embodiments, once the sensor electronics assembly is placed on the body and the sensor is electrically connected to the electronics unit such that at least some of the in vivo sensors are in contact with bodily fluids such as ISF, Turn on the display device and execute a software algorithm stored and accessed in the memory of the display device to generate and send one or more request commands, control signals, or data packets to the body-worn electronic device Thus, the specimen information obtained by the sensor may be communicated on demand from the body-mounted electronic device to the display device. For example, a software algorithm executed under the control of the display's microprocessor or application specific integrated circuit (ASIC) may display a generated request command, control signal, and / or data packet to initiate transmission. A routine for detecting the relative position of the body-worn electronic device relative to the device may be included.

  The display device memory is responsive to the activation of an input mechanism on the display device by the user (eg, pressing a button on the display device associated with the data communication function, triggering a soft button, etc.). Also stored may be programming executed by one or more microprocessors and / or ASICs to generate and send one or more request commands, control signals, or data packets to be sent to the device. Alternatively, or in addition, an input mechanism may be provided that may be configured to be activated by a user on or in the body-worn electronic device. In certain embodiments, a voice command or audible signal is used to generate one or more request commands, control signals, or data packets in a microprocessor or ASIC and stored in memory for transmission to the wearable device. You may be prompted or instructed to execute a software routine that is running. In embodiments that are voice activated, i.e. responsive to voice commands or audible signals, the body-worn electronic device and / or display device are each a microphone, speaker, and body-worn electronic device and / or display device. It includes processing routines for processing voice commands and / or audible signals stored in these memories. In certain embodiments, when the body-worn device and the display device are placed within a predetermined distance (eg, in close proximity) to each other, the display device can be configured to generate and send a request command, control signal, or data packet. One or more software routines stored in memory are initiated.

  For each on-demand measurement, the current sample level information (ie, real-time or most recently obtained sample level information corresponding in time to the time at which the measurement was started), the rate of change of the sample over a predetermined period, Rate of change (acceleration of rate of change), including, but not limited to, one or more of the history of specimen information corresponding to the specimen information obtained prior to a given measurement and stored in the memory of the assembly Type and / or form and / or quantity information may be transmitted. Some or all of the real-time information, historical information, rate of change information, rate of change rate (eg, acceleration or deceleration) information for a given measurement may be transmitted to the display device. In certain embodiments, the type and / or form and / or amount of information transmitted to the display device may be pre-programmed and / or immutable (eg, a manufacturing preset). Alternatively, it may not be pre-programmed and / or unchangeable so that it can be selected and / or changed more than once in the field (eg, by activating a switch in the system). . Thus, in certain embodiments, for each on-demand measurement, the display device displays the current (real-time) analyte value (eg, numeric format) obtained by the sensor, the rate of change of the current analyte (eg, current rate). And sample trend history data based on sensor measurements acquired and stored in the memory of the body-worn electronic device (eg in the form of a graphical trace) ) Is output. In addition, skin temperature or sensor temperature measurements, or measurements associated with each on-demand measurement, may be communicated from the body-worn electronic device to the display device. However, temperature readings may not be output or displayed on the display device, but with software routines executed by the display device to correct or compensate for analyte measurement values output to the user on the display device. May be used.

  As described, embodiments include an in-vivo analyte sensor and a body-worn electronic device that combine to form a body-worn sensor electronics assembly (also referred to herein as a “patch”). Provided. In certain embodiments, in-vivo analyte sensors are fully integrated into the body-worn electronic device (fixed connection at the time of manufacture), while in other embodiments they are separate and after manufacture (e.g., It can be connected before, during or after insertion of the sensor into the body. Body-worn electronic device includes an in vivo glucose sensor, electronic device, battery, and antenna encapsulated in a water resistant housing that includes or is attachable to the adhesive pad (except for the portion of the sensor disposed in vivo) May be included.

  Embodiments include a sensor insertion device, also referred to herein as a sensor delivery unit or the like. The insertion device may hold the body-worn electronic device assembly completely within its internal compartment. That is, during the manufacturing process, the insertion device may be preloaded with a body-worn electronic device assembly (eg, the body-worn electronic device may be enclosed in a sterilized internal compartment of the insertion device). In such an embodiment, the insertion device is a sensor of a pre-use or new body-worn electronic device assembly and an insertion device configured to apply the body-worn electronic device assembly to the recipient's body. An assembly package (including a sterilized package) may be constructed.

  Embodiments include a portable display device for collecting information from the assembly and providing analyte measurements obtained by the sensor to a user as a separate device spatially separate from the body-worn electronic device assembly including. Such a device may also be referred to as a meter, reader, monitor, receiver, human interface device, companion, etc. Certain embodiments may include an integrated in vitro analyte meter. In certain embodiments, the display device is configured to establish communication between the display device and another device (eg, a body-worn electronic device, a power supply for recharging the battery, a PC, etc.). It includes one or more wired or wireless communication ports such as a USB port, a serial port, and a parallel port.

  In certain embodiments, suitable information software is, for example, data analysis, charting, data storage, data archiving, and data communication residing on or executed on a display device, personal computer, server terminal, As well as, but not limited to, a data management software program that can be used in a stand-alone or network connection to perform data synchronization. In certain embodiments, the information software upgrades the display device and / or body wearable electronics unit firmware (eg, additional functionality) to upgrade the resident software of the display device and / or the wearable electronic device unit. And / or software that performs field-upgradable functions to upgrade to a firmware version that includes software bugs, error corrections, and the like.

  Embodiments include a haptic feedback function, such as a vibration motor, configured such that a corresponding notification (eg, the display device has received a good on-demand measurement) can be provided in the form of haptic feedback. But you can.

  Embodiments include programming embedded in a computer-readable medium, ie, computer-based application software (herein) for processing specimen information obtained from the system and / or data reported by the user himself. Then, it is also referred to as information software or programming. The application software may be installed on a host computer of a mobile phone, a PC, an Internet-compatible human interface device (for example, an Internet-compatible phone, PDA, etc.) by a display device or a body-mounted electronic device unit. Information programming may transform data obtained and stored on a display device or body-worn unit for use by a user.

  Although embodiments of the present disclosure are described primarily with respect to glucose monitoring devices and systems and glucose monitoring methods for convenience, such descriptions are not intended to limit the scope of the present disclosure. It should be understood that the analyte monitoring system can be configured to monitor various analytes simultaneously or at different times.

  For example, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (eg CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone, lactic acid, oxygen , Peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. For example, the concentration of drugs such as antibiotics (eg, gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, warfarin, etc. may be monitored. In these embodiments for monitoring two or more analytes, a single sensor is used, or multiple sensors using the same body-worn electronic device (eg, simultaneously), or different body-worn electronic devices. In use, the analytes may be monitored simultaneously or at different times.

  As described in detail below, embodiments may include one or more physiological parameters such as, but not limited to, analyte level, temperature level, heart rate, user activity level over a predetermined monitoring period. Includes devices, systems, kits, and / or methods for monitoring. A manufacturing method is also provided. The predetermined monitoring period may be less than about 1 hour, or about 1 hour or more (eg, several hours or more, days or more, about 3 days or more, about 5 days or more, about 7 days or more, about 10 days As mentioned above, it may include about 14 days or more, several weeks, about 1 month or more). In certain embodiments, one or more functions of the system may be automatically disabled or disabled in the body-worn electronic device assembly and / or display device after a predetermined monitoring period has expired.

  For example, the predetermined monitoring period may begin with the sensor being placed in vivo to contact a bodily fluid such as ISF, and / or the start (or power on) of the body-worn electronic device. It may start with a full operating mode). The initialization of the body-worn electronic device is generated and transmitted by the display device in response to the activation of the switch and / or the placement of the display device within a predetermined distance (eg in close proximity) from the body-worn electronic device. Or by a user manually actuating a switch on the body-worn electronic device unit (eg, pressing a button). Alternatively, for example, US patent application Ser. No. 12 / 698,129 filed on Feb. 1, 2010, and provisional patent applications 61 / 238,646 and 61 / 246,825. 61 / 247,516, 61 / 249,535, 61 / 317,243, 61 / 345,562, and 61 / 361,374 As described in the document (incorporated herein for all purposes with reference to the respective disclosure), the insertion device may cause such an operation.

  Once the body-worn electronic device is initialized in response to a command received from the display device, the body-worn electronic device uses its memory to fully power on the body-worn electronic device components. A software routine is retrieved and executed to actually put the body-worn electronic device into a fully operational mode in response to receiving an activation command from the display device. For example, before receiving a command from the display device, power may be supplied to some of the components of the body-worn electronic device from an internal power source such as a battery, while the components of the body-worn electronic device Another part of may be a power down mode or a low power mode (no power supplied, including inactive mode). Alternatively, all the components may be in a non-operation mode or a low power mode. Upon receipt of the command, the rest (or all) of the body-worn electronic device components are switched to the active full mode of operation.

  Embodiments include transcutaneous sensors, fully implantable sensors, and fully implantable assemblies (such as sealed housings (e.g., sealed housings) that are implanted in a user's body to monitor one or more physiological parameters. A single assembly comprising an analyte sensor and an electronic device provided in a sealed biocompatible housing).

  Exemplary analyte monitoring systems that may be used in connection with the present disclosure and in connection with the disclosed analyte measurement systems include those described in the following references. US Pat. No. 7,041,468, US Pat. No. 5,356,786, US Pat. No. 6,175,752, US Pat. No. 6,560,471, US patent US Pat. No. 5,262,035, US Pat. No. 6,881,551, US Pat. No. 6,121,009, US Pat. No. 7,167,818, US Pat. , 270,455, US Pat. No. 6,161,095, US Pat. No. 5,918,603, US Pat. No. 6,144,837, US Pat. No. 5,601. , 435, U.S. Pat. No. 5,822,715, U.S. Pat. No. 5,899,855, U.S. Pat. No. 6,071,391, U.S. Pat. No. 6,120,676. Specification, US Pat. No. 6,143 No. 164, US Pat. No. 6,299,757, US Pat. No. 6,338,790, US Pat. No. 6,377,894, US Pat. No. 6,600,997 Specification, US Pat. No. 6,773,671, US Pat. No. 6,514,460, US Pat. No. 6,592,745, US Pat. No. 5,628,890 US Pat. No. 5,820,551, US Pat. No. 6,736,957, US Pat. No. 4,545,382, US Pat. No. 4,711,245, US US Pat. No. 5,509,410, US Pat. No. 6,540,891, US Pat. No. 6,730,200, US Pat. No. 6,764,581, US Pat. 6,299,757, rice US Pat. No. 6,461,496, US Pat. No. 6,503,381, US Pat. No. 6,591,125, US Pat. No. 6,616,819, US Pat. US Pat. No. 6,618,934, US Pat. No. 6,676,816, US Pat. No. 6,749,740, US Pat. No. 6,893,545, US Pat. 942,518, US Pat. No. 6,514,718, US Pat. No. 5,264,014, US Pat. No. 5,262,305, US Pat. No. 5,320, No. 715, US Pat. No. 5,593,852, US Pat. No. 6,746,582, US Pat. No. 6,284,478, US Pat. No. 7,299,082 Description, “Compact On-Body Physiological Mon US Patent Application No. 61 / 149,639 entitled “Itoring Device and Methods Thereof”, “Analyte Sensors” filed on Aug. 1, 2006. and US Patent Application No. 11 / 461,725 entitled “Extruded Electrode Structures and Methods of Using Same” filed June 30, 2009. US Patent Application No. 12 / 495,709, US Patent Application Publication No. 2004/0186365, US Patent Application Publication No. 2007/0095661, US Patent Application Publication No. 2006/0091006, US Patent Application Publication No. 2006/0025662, US Patent Application Publication 2008/0267823, US Patent Application Publication No. 2007/0108048, US Patent Application Publication No. 2008/0104441, US Patent Application Publication No. 2008/0066305, US Patent Application Publication No. 2007 / No. 0998818, U.S. Patent Application Publication No. 2008/0148873, U.S. Patent Application Publication No. 2007/0068807, U.S. Patent Application Publication No. 2010/0198034, and “Compact On-Body Physiological Monitoring Device”. No. 61 / 149,639, entitled “and Methods Thereof”. The entire disclosure of each of the above documents is incorporated herein by reference.

  Further related subject matter is provided in the following disclosure. Patent Provisional Application No. 61 / 498,142 filed on June 17, 2011, US Patent Application Nos. 13 / 071,461, 13 / 071,487 filed on March 24, 2011 No. 13 / 071,497, U.S. Patent Application No. 13 / 091,557 filed on April 21, 2011, U.S. Patent Application Publication No. 2010/0081905, No. 2011. / 0021889, 2010/0230285, and 2011/0021889, and US Pat. Nos. 6,736,957, 7,501,053, and 7, 754,093. The entire disclosure of each of the above references is incorporated herein for all purposes.

  FIG. 1 illustrates an exemplary embodiment of an in vivo analyte monitoring system and is described below. FIG. 1 illustrates an exemplary in vivo-based analyte monitoring system 1100 according to an embodiment of the present disclosure. As shown, in certain embodiments, the analyte monitoring system 1100 is electrically connected to an in vivo analyte sensor 1101 (the proximal portion is shown in FIG. 1) and the skin surface of the user's body. A body-worn electronic device 1110 attached to an adhesive layer 1140 for attachment to the body. Body-worn electronic device 1110 includes a body-worn housing 1119 that defines an internal compartment. Also shown in FIG. 1 is an insertion device 1150 that, in operation, places a portion of the analyte sensor 1101 percutaneously in fluid contact with the ISF through the skin surface and for body wear. An electronic device 1110 and an adhesive layer 1140 are placed on the skin surface. In certain embodiments, the body-worn electronic device 1110, analyte sensor 1101, and adhesive layer 1140 are sealed within the housing of the insertion device 1150 prior to use, and in certain embodiments, the adhesive layer 1140 is also included. It is sealed in the housing or the adhesive layer 1140 itself seals the terminal portion of the insertion device 1150. Apparatus, systems, and methods that can be used with the embodiments herein are described, for example, in US patent application Ser. No. 12 / 698,129, and provisional application 61 / 238,646, 61 / 246,825, 61 / 247,516, 61 / 249,535, 61 / 317,243, 61 / 345,562, and 61 / 361,374, incorporated herein by reference for all purposes with reference to the respective disclosures.

  Referring again to FIG. 1, the analyte monitoring system 100 includes a display device 1120, which includes a display 1122 for outputting information to a user, and for inputting data or commands to the display device 1120 or otherwise. In this manner, input elements 1121 such as buttons, actuators, touch sensor type switches, capacitance type switches, pressure sensitive switches, and jog wheels for controlling the operation of the display device 1120 are included. Note that some embodiments may include devices that do not include a display or devices that do not have user interface elements. These devices store data as a data logger and / or provide a communication path for transferring data from a device that does not have a body-worn electronic device or display to another device or location You may have. In the present specification, for the purpose of illustration, a plurality of embodiments as a display device will be described, but it is not intended to limit the embodiments of the present disclosure thereby. It will be appreciated that devices that do not include a display may be used in certain embodiments.

  In certain embodiments, display 1122 and input element 1121 are integrated as a single component, such as a display capable of detecting the presence and location of physical contact to the display, such as a touch screen user interface. May be. In such embodiments, the user can single or double tap on the display, drag a finger or tool on the display, bring multiple fingers or tools close to each other, move multiple fingers or tools away from each other, etc. The operation of display device 1120 may be controlled using a set of pre-programmed motion commands including, but not limited to. In certain embodiments, the display includes a touch screen having a pixel area with single or dual function capacitive elements that serve as LCD elements and touch sensors.

  Display device 1120 may be a dynamic color LCD display. In certain embodiments, display device 1120 may have preset customizable options including display resolution, image quality, and backlight options. In one embodiment, the display device may have a dynamic color palette of at most 65,000 colors and may have a graphical display consisting of a 256-color subset of a 65,000-color dynamic display. In other embodiments, the LCD display may include a backlight that may be an LED backlight. The LCD backlight may be pre-programmed so that the screen dims or disappears after a certain period of time when no operation is performed. For example, in certain embodiments, the default time before the display disappears may be 1 minute on most screens, including the ability to turn off the backlight after 15 seconds. In some embodiments, the time before the display disappears or the display goes dark may vary based on the current screen or device mode. For example, as will be described in more detail later in this specification, on the “Apply blood to test strip” screen, the timeout may be longer than the default one minute (eg, two minutes). In other embodiments, the display does not darken or disappear unless the user manually instructs the device to turn off the display.

  The display device 1120 also includes a data communication port 1123 for wired data communication with an external device such as a remote terminal (personal computer) 1170, for example. Exemplary embodiments of data communication port 1123 include a USB port, mini USB port, RS-232 port, Ethernet port, FireWire port, or other similar data communication port configured to connect to a corresponding data cable. Including. Display device 1120 may also include an integrated in vitro glucose meter that includes an in vitro test strip port 1124 that receives an in vitro glucose test strip for performing in vitro blood glucose measurements.

  With continued reference to FIG. 1, in certain embodiments, display 1122 is configured to display a variety of information, and some or all of the information may be displayed on display 1122 at the same time or at different times. The display 1122 can be, for example, a graphical display 1138 that provides a graphical output of glucose values over a monitored period (may show important markers such as diet, exercise, sleep, heart rate, blood pressure, etc.), for example (information A numerical display 1132 that provides a monitored glucose value (obtained or received in response to the request) and, for example, the rate of change of the analyte and / or the rate of change of the analyte by moving a location on the display 1122 It may include, but is not limited to, an arrow display 1131 indicating a trend or direction indicating speed.

  As further shown in FIG. 1, the display 1122 includes, for example, a date display 1135 that provides date information to the user, a time information display 1139 that provides time information to the user, and a display device 1120 (rechargeable or disposable). A battery level indicator display 1133 that graphically indicates the status of the battery, for example, in a monitoring system that requires periodic, routine or predetermined number of user calibration events, informs the user that the analyte sensor needs to be calibrated Sensor calibration status icon display 1134, audio / vibration output status or alarm status icon display 1136 for displaying alarm status, and body-worn electronic device, data processing module 1160, and / or remote terminal 1170 Etc. with other equipment Providing an indication of the line communication connection may also include wireless connectivity status icon display 1137. As further shown in FIG. 1, display 1122 is a simulated touch screen button 1125 for accessing menus, changing the graphical display output configuration, or otherwise controlling the operation of display device 1120, 1126 may further be included.

  Referring again to FIG. 1, in certain embodiments, the display 1122 of the display device 1120 may be audible, tactile, or any combination thereof in addition to or instead of a visual display. Or you may be comprised so that alarm notifications, such as a warning notification and a glucose level, may be output. In one aspect, the display device 1120 may include a speaker, a vibration output element, etc. for providing the user with an audible and / or vibration output display in addition to the visual output display provided on the display 1122. Output elements. Further details and other display embodiments are described, for example, in U.S. Patent Application No. 12 / 871,901, U.S. Provisional Applications 61 / 238,672, 61 / 247,541, 61 / No. 297,625, which is hereby incorporated by reference for all purposes with reference to the respective disclosures.

  Once the body-worn electronic device 1110 is placed on the skin surface and the analyte sensor 1101 is placed to establish fluid contact with the ISF (or other suitable body fluid) in vivo, the body-worn electronic device in certain embodiments. 1110 refers to specimen-related data (eg, data corresponding to monitored analyte level and / or monitored temperature data, and / or when the wearable electronic device 1110 receives a command or request signal from the display device 120. Or a history of stored sample-related data). In certain embodiments, the body-worn electronic device 1110 may be configured to at least periodically broadcast real-time data associated with the monitored analyte level, the data being displayed by the display device 1120 on the body-worn. When it is within the communication range of the data broadcast from the electronic device 1110, it is received by the display device 1120. That is, there is no need to issue a command or request for information transmission from the display device.

  For example, the display device 1120 may be configured to send one or more commands to the body-worn electronic device 1110 to initiate data transfer, the body-worn electronic device 1110 responsive to the monitoring The sample-related data collected and stored during the period may be wirelessly transmitted to the display device 1120. The display device 1120 may be further connected to a remote terminal 1170 such as a personal computer, and functions as a data communication path for transferring stored specimen level information from the body-mounted electronic device 1110 to the remote terminal 1170. In certain embodiments, data received from the body-worn electronic device 1110 may be stored (permanently or temporarily) in one or more memories of the display device 1120. In another particular embodiment, the display device 1120 is configured as a data communication path for passing data received from the body-worn electronic device 1110 to a remote terminal 1170 connected to the display device 1120.

  With continued reference to FIG. 1, the sample monitoring system 1100 also shows a data processing module 1160 and a remote terminal 1170. Remote terminal 1170 may include a personal computer, server terminal, laptop computer, or other suitable data processing device that includes software for data management, data analysis, and communication with components of analyte monitoring system 1100. . For example, the remote terminal 1170 may include a local area network (LAN), a wide area network (WAN), a one-way or two-way data communication between the remote terminal 1170 and the display device 1120 and / or the data processing module 1160. Alternatively, it may be connected to another data network.

  In certain embodiments, the remote terminal 1170 may include one or more computer terminals located in a doctor's office or hospital. For example, the remote terminal 1170 may be arranged at a place other than the place where the display device 1120 is located. The remote terminal 1170 and the display device 1120 may be in different rooms or different buildings. Remote terminal 1170 and display device 1120 may be at least about 1 mile away (eg, at least about 110 miles), eg, at least about 1100 miles. It may be (about 1770 kilometers) away. For example, the remote terminal 1170 may be in the same city as the display device 1120, the remote terminal 1170 may be in a different city from the display device 1120, and the remote terminal 1170 may be in the same state as the display device 1120. The remote terminal 1170 may be in a different state than the display device 1120, the remote terminal 1170 may be in the same country as the display device 1120, or the remote terminal 1170 may be in a different country than the display device 1120. Also good. In certain embodiments, the specimen monitoring system 1100 may be provided with a separate data communication / processing device provided as needed, such as a data processing module 1160. The data processing module 1160 is, for example, an infrared (IR) protocol, a Bluetooth (registered trademark) protocol, a Zigbee (registered trademark) protocol, an 802.11 wireless LAN protocol, or the like, but is not limited thereto. Components for communicating using the protocol may be included. A further description of communication protocols, including those based on the Bluetooth® protocol and / or the Zigbee® protocol, can be found in US Patent Publication No. 2006/0193375, with reference to that content Incorporated herein for all purposes. The data processing module 1160 may establish a wired communication with one or more of the display device 1120, the body-worn electronic device 1110, or the remote terminal 1170, for example, a USB connector and / or a USB port, an Ethernet connector and / or a port. , A FireWire connector and / or port, or an RS-232 port and / or connector may further include a communication port, driver or connector.

  In certain embodiments, the control logic or microprocessor of the body-worn electronic device 1110 may include information obtained from the analyte sensor 1101 (eg, current analyte level, rate of change in analyte level, acceleration of change in analyte level, and Based on stored monitoring specimen data and / or future trend based on specimen trend information providing a trend or direction history of specimen level variation as a function of time during the monitoring period) Includes a software program to determine the expected specimen level. Predictive alarm parameters may be programmed or programmable in the display device 1120 or in the body-worn electronic device 1110 or both, and the user's analyte level reaches a future level. This may be predicted and output to the user in advance. This provides the user with an opportunity to take corrective action in a timely manner.

  One or more control logics or microprocessors of display device 1120, data processing module 160, and / or remote terminal 1170, and / or body-worn electronic device 1110, for example, providing analyte trend information over time Information such as monitored analyte level variations as a function may be determined. Such information may be displayed, for example, as a graph (such as a line graph) that shows the user current and / or historical and / or predicted future analyte levels measured and predicted by the analyte monitoring system 1100. Good. Such information can include direction arrows (see, eg, arrow displays 1131 indicating trends or directions) and, for example, the position of the icon relative to a reference point on the screen when the sample level is increased or decreased. As well as other icons indicating acceleration or deceleration of the increase or decrease of the analyte level. This information can be used by the user to determine any necessary corrective actions to ensure that the analyte level remains in an acceptable and / or clinically safe range. Other visual indicators including color, flash, fading, etc., as well as audio indicators including changes in the pitch, volume, or tone of the audio output, and / or vibration or other tactile indicators are also available at the monitored analyte level. It may be incorporated into the trend data display as a means of notifying the user of the current level and / or direction and / or rate of change. For example, the system 1100 can determine the rate of change of glucose, programmed clinically significant glucose threshold levels (eg, high and / or low blood glucose levels), and current obtained by in vivo analyte sensors. May include an algorithm stored in a computer readable medium to determine the time taken to reach a clinically significant level based on the analyte level of the 30 minutes before and / or 20 minutes before and / or 10 minutes before and / or 5 minutes before and / or 3 minutes before and / or 1 minute before clinically significant levels are expected ) To output a notification while increasing the intensity of the output.

  Returning again to FIG. 1, in certain embodiments, the software algorithms executed by the data processing module 1160 are each connected to one or more of the body-worn electronic device 1110, the remote terminal 1170, or the display device 1120, respectively. It may be stored in an external memory device such as an SD card, micro SD card, compact flash card, XD card, memory stick card, memory stick Duo card, or USB memory stick / device that stores executable programs to be executed . In yet another aspect, the software algorithm executed by the data processing module 1160 is executed by a communication device that downloads an application to a communication device including a mobile phone such as a smartphone or PDA that supports WiFi or the Internet, for example. It may be provided as a downloadable application.

  Examples of smartphones include Windows (registered trademark), Android (trademark), and iPhone (registered trademark) operating systems having a data network connection function for data communication via an Internet connection and / or a local area network (LAN). , Palm (R) WebOS (TM), Blackberry (R) operating system, or mobile phone based on the Symbian (R) operating system. The PDA described above has, for example, one or more microprocessors and a data communication function with a user interface (for example, display / output unit and / or input unit), for example, data processing, data via the Internet. A portable electronic device configured to perform upload / download. In such embodiments, the remote terminal 1170 may be configured to provide executable application software to one or more of the communication devices described above when communication between the remote terminal 1170 and the device is established.

  In yet another embodiment, the executable software application may be provided over-the-air as an OTA download, in which case no wired connection to the remote terminal 1170 is required. For example, the executable application may be automatically downloaded to the communication device as a software download and automatically installed and used on the device depending on the configuration of the communication device, or based on user confirmation Alternatively, it may be installed in the device based on notifying execution of application installation on the communication device. Software OTA download and installation may include software applications and / or routines that are updates or upgrades to existing functionality of data processing module 1160 and / or display device 1120.

  Referring back to the remote terminal 1170 of FIG. 1, in certain embodiments, when communication between the remote terminal 1170 and the display device 1120 and / or the data processing module 1160 is established, the remote terminal 1170, among other things, displays the display device. New software and / or software updates, such as software patches or modifications, firmware updates, or software driver upgrades of 1120 and / or body-worn electronic device 1110 and / or data processing module 1160 may be provided. . For example, a software upgrade of the wearable electronic device 1110 or an executable program change or modification may be received from the remote terminal 1170 by one or more of the display device 1120 or the data processing module 1160 and then the wearable device. The software and programmable functions of the electronic device 1110 for body wearing may be updated by being provided to the electronic device 1110 for the body. For example, in certain embodiments, the software received and installed on the body-worn electronic device 1110 can be used to fix software bugs or to change previously installed software parameters (especially the storage time of specimen related data). Change of interval, time reference of body-worn electronic device 1110 and reset or adjustment of information, change of transmitted data type, data transmission sequence, or data storage period). Further details of software field upgradeability and data processing of portable electronic devices are described in US patent application Ser. Nos. 12 / 698,124, 12/794721, 12 / 699,653. , And 12 / 699,844, as well as provisional patent applications 61,359,265 and 61 / 325,155, which are incorporated herein by reference for their purposes. Are incorporated herein.

  In some aspects, the display device (also referred to herein as “analyte monitoring device” or simply “device”) is configured to receive a signal from a remote sensor using radio frequency identification (RFID) technology. .

  This configuration may be used, for example, to provide a glucose on demand function, in which case the analyte monitoring device is placed in close proximity to the implantable sensor when a measurement is desired. In other embodiments, the wireless communication unit may communicate with the sensor using a wireless communication technique different from RFID. When the device is in range, the device may be configured to verify that the sensor is a suitable sensor configured to operate with the device. If it is not a suitable sensor, the device ignores the sensor and does not begin operation with that sensor. If it is a suitable sensor, the device begins operation with that sensor.

  The analyte monitoring device may, for example, correct the signal from the sensor using calibration data and / or measurements from a temperature probe (not shown), determine the analyte level in the interstitial fluid, sensor measurements of the interstitial fluid Determination of analyte level in the bloodstream based on, determination of analyte level, rate of change and / or acceleration of rate of change exceeds or reaches one or more thresholds, alarm when threshold is reached or exceeded Activation of the system, assessment of analyte level trends based on a series of sensor signals, therapy management (eg, determination of drug dose, etc.), and (eg, averaging or comparing signals of measurements from multiple electrodes) ) Various functions can be performed, including reducing noise and error contributions. The analyte monitoring device may be simple that performs only one or a few of these functions, or the analyte monitoring device may perform all or most of these functions.

Remote Device Software In some embodiments, the analyte monitoring device may be communicatively connected to a remote data processing device for management purposes. Remote devices may include, for example, personal computers, laptop computers, PDAs, mobile phones, smartphones, set top boxes, and the like. The remote device may include a controller including, for example, various processors, microprocessors, microcontrollers, and the like. The remote device may also include a storage unit including non-volatile memory and volatile memory.

  As used herein, the term “remote device” refers to any device that is external to the analyte monitoring device. The remote device needs software to communicate well with the sample monitoring device, manage data from the sample monitoring device, change the settings of the sample monitoring device, or otherwise work with the sample monitoring device It can be. This automatic support user interface software is referred to herein as “remote device software”, “RD software” or “data management software”, and is distinguished from user interface software executed on the sample monitoring device. The RD software can be obtained by one or more methods such as download from the web, CD-ROM, memory stick, etc. Here, an overview of the RD software is described, and further details regarding the various flows and screens are described below.

  In some embodiments, the analyte monitoring device includes an RD software program and / or application running on a remote device. In some examples, the RD software may be configured to automatically start when the analyte monitoring device is connected to a computer. For example, the sample monitoring device may include an installer program that is stored in a non-volatile memory and executed when the sample monitoring device is connected to a remote device. The installer program may be executed when the user connects the sample monitoring device to the remote device. Next, the installer program may start activation of the RD software on the remote device.

  In some embodiments, the RD software is not stored in the non-volatile memory of the remote device. The RD software is stored in the sample monitoring device and used to activate the RD software on a remote device connected to the sample monitoring device.

  In some embodiments, the RD software may be downloaded and stored in the non-volatile memory of the remote device. For example, the RD software may be downloaded via a network connection (eg, Internet connection), by a storage device (eg, CD-ROM, memory stick, etc.) and / or from an analyte monitoring device. In some examples, the RD software can be executed even when the device is not connected to a computer.

  Note that the RD software may correspond to various hardware systems (for example, PC, MAC) and various operating systems (for example, Windows, MAC OS, Linux).

  The sample monitoring device may be communicably connected to the remote device via wired technology. Examples of wired technology include, but are not limited to, technologies such as USB, FireWire, SPI, SDIO, and RS-232 port, or technologies of those systems.

  The sample monitoring device may include, for example, a communication connector unit that enables wired communication and connection to a remote device. The communication connector portion provides a function of communicating with a remote device having an appropriate interface for operative connection with the communication connector. In some embodiments, the communication connector is configured to communicate with a smartphone such as iPhone or Blackberry.

  The communication connector unit may be any of various connection interfaces such as a male / female connection interface. As an example, when USB is used, the communication connector may be any of a variety of USB plugs or USB receptacles / ports. Since computers and other devices generally have a USB receptacle, the sample monitoring device can be directly connected to the USB receptacle by a corresponding USB plug used as a communication connector, and the use of a cable can be avoided. In other examples, the specimen monitoring device may use a suitable USB receptacle that enables communication using a USB cable (as in many other devices such as digital cameras, cell phones, smartphones, etc.).

  Note that in some embodiments, the sample monitoring device may be communicably connected to a remote device via wireless technology. In such examples, the analyte monitoring device may include a corresponding transmitter, receiver, and / or transceiver. The sample monitoring device includes radio frequency (RF) communication, Zigbee (registered trademark) communication protocol, WiFi, infrared, wireless universal serial bus (USB), ultra wide band (UWB), Bluetooth (registered trademark) communication protocol, and cellular communication. (Including code division multiple access (CDMA), GSM (Global System for Mobile Communication), etc.), etc., but may be configured to perform wireless communication using techniques not limited thereto.

  The functions of the RD software activated on the remote device include, for example, data acquisition, data management, sample monitoring device functions, settings, configuration management, report creation, storage, transmission, and / or printing, update management. It may include various functions related to (e.g., field updates to device firmware and RD software), training content, content on the Internet, access to marketing on the Internet, and the like.

  The RD software may be activated on a remote device and used by a user (eg, patient) and / or a health care provider (HCP) (eg, doctor, hospital staff, etc.). For example, the HCP and / or patient can use the remote device to analyze patient data, view and print reports, view and change device settings, update device firmware and application software, etc. Software can be used.

  In some examples, the RD software compares the date and time of the analyte monitoring device with the date and time of the remote device and / or the date and time of the remote time server accessed from the remote device via the Internet connection. You may start. The RD software may understand the discrepancy and take action accordingly. For example, a threshold (e.g., a 5 minute difference) may be set, and when the threshold is reached, the analyte monitoring device will prompt the user for misalignment and / or misalignment correction (e.g., adjust the time of one device). Indicates warnings, questions, indicators, etc. In some examples, the RD software causes other discrepancies between the analyte monitoring device and the remote device (eg, data recording, data values, stored files, devices and / or user interface configurations, settings, etc.) A similar comparison may be performed to ascertain). Appropriate action can be taken or required.

  Various default configurations and settings and customized configurations and settings may be defined for creating, printing, saving, exporting, etc. reports. For example, various report formats (eg, layout, style, theme, color, etc.) and various file types (eg, PDF, Word document, Excel spreadsheet, etc.) for saving the report may be defined. In some examples, for example, the RD software allows the user to export a tab-delimited text file of instrument data (eg, including blood glucose, ketones, carbohydrates, insulin, event tags, etc.), or XML An ability to export may be provided. In some examples, the RD software saves the user's choices including favorite reports, target blood glucose range, autosave, autoprint, color / black and white print, device / software update settings for multiple devices, It may be possible to print and / or export.

  In some aspects, RD software is used to control device configuration and data from the device. This control may be used by the user and / or HCP. In some examples, the RD software provides access to one or more explanatory documents, training, tutorials, etc. For example, the RD software application may provide a link to a website provided by the manufacturer and intended for any of a variety of purposes, such as marketing and training content.

  In some aspects, the RD software includes an update management function that assists in facilitating detection, download, and installation of analyte measurement device and / or RD software updates (eg, firmware, information application updates, etc.). May be included. In some examples, updates may be detected and downloaded automatically (eg, when an internet connection is active) and / or detected and downloaded if the user confirms or requests. . In some examples, an update to the software also updates the software installation file stored on the device. Further, in some examples, when the device firmware is updated, the labeling / user documentation required on the device is also updated. In some examples, when the device firmware is updated, existing device settings and test history (eg, blood glucose, insulin, carbohydrate data, etc.) are saved.

  In some aspects of the present disclosure, data management software loaded and activated on a remote data processing device may operate with a connected sample monitoring device. The data management software may include one or more GUIs for communicating with the analyte monitoring device. It should be noted that the GUI can be used to represent one or more of the graphical elements that are displayed on the display of the remote device for user interface purposes. Thus, a “graphical user interface” or “GUI” may encompass the entire display, application windows, pop-up windows, menus, progress and status bars, buttons, and the like.

  In some aspects of the present disclosure, the data management software provides an instrument mode to provide access to settings and functions used to configure and control the analyte monitoring device. The data management software may also provide a meter setting mode for guiding the user in the initial setting of the sample monitoring device. The data management software may provide a report mode to provide access to settings and functions for creating, viewing, saving, and / or printing various reports. Further, the data management software may provide a report setting mode for guiding the user in the initial report setting and creation process. The data management software may also provide the user with the ability to export data from the sample monitoring device, for example, as a tab-delimited file or other spreadsheet compatible format. In some examples, the data management software may provide functionality for providing help documents, tutorials, etc. to the user. The data management software may provide a function of checking for software updates and acquiring the updates. For example, the check may be initiated automatically and / or initiated by the user. In some examples, software updates may be checked and obtained via a network connection on a remote device.

Exemplary Apparatus and System FIG. 2 shows a block diagram of a system that includes an analyte monitoring device and a remote data processing device, according to some embodiments. The illustrated system 1500 includes a sample monitoring device 1501 communicatively connected to a remote device 1505. As shown, in some examples, remote device 1505 may have network access to network 1510 to which the illustrated second remote device 1515 is connected. Note that the network 1510 may include one or more networks including a LAN, a WAN, and / or the Internet.

  The illustrated sample monitoring device 1501 is detachably connected to a remote device 1505 via a communication connector unit 1422. For example, the communication connector unit includes a USB plug that connects to the USB receptacle 1507 of the remote device 1505. The remote device 1505 may include peripheral devices such as a printer, a keyboard, a monitor, and a CD drive. As shown, the remote device 1505 may also include a network interface 1530 that connects the remote device 1505 to the network 1510. A remote device 1515 is also connected to the network 1510 and may communicate with the remote device 1505 via the network 1510.

  The following paragraphs describe an operating system 1500 according to some embodiments. In some examples, the analyte monitoring device described is a glucose monitoring device that measures the glucose concentration level of a blood sample. It should be understood that this description applies equally to other analytes and other forms of samples.

  In use, the sample monitoring device 1501 receives the test strip 1525 in order to measure the sample level of the sample applied to the test strip 1525. Test strip 1525 is received at strip port portion 1520. The sample monitoring apparatus 1501 performs measurement calculation on the sample, and the user can view the measurement value on, for example, a touch screen display (not shown). The user may also be presented with a menu for viewing and selection (eg, a menu for storing data, downloading data, calculating boluses based on measurements, etc.) on the touch screen display.

  The user may connect the sample monitoring device 1501 to a remote device 1505 (for example, a personal computer) via a communication connector unit. For example, the user may decide to store measurement data and then choose to download stored test data (including stored measurements) to the remote device 1505.

  The sample monitoring device 1501 may be connected to the remote device 1505 via the communication connector unit 1422. The communication connector unit 1422 may include, for example, a USB plug that connects to the USB receptacle 1507 of the remote device 1505.

  In some examples, when the sample monitoring device 1501 is connected to the remote device 1505 via the communication connector unit 1422, the remote device 1505 may supply power to the sample monitoring device 1501. In such a case, the user connects the analyte monitoring device 1501 to the remote device 1505 and then inserts a test strip 1525 into the strip port 1520 to obtain measurements. In some examples, the analyte monitoring device includes its own power source (eg, button cell or AAA battery) and is not powered by the remote device 1505.

  In some examples, the analyte monitoring device may be “locked” or prevented from performing the test while connected to the remote device 1505. For example, if the specimen monitoring device is configured to perform a test while connected to a remote device, a restriction on a medical device such as a high voltage insulation test may be required. Thus, if desired, the sample monitoring device can be excluded from further testing by “locking” or preventing the execution of the test while the sample monitoring device is connected to the remote device.

  In some aspects, the analyte monitoring device 1501 executes a user interface application (eg, RD software) on the analyte monitoring device and / or on the remote device 1505 when connected to the remote device 1505. May start. The user interface application may be stored in the storage unit of the sample monitoring device 1501, for example. In some aspects, the user does not need to run previously loaded software on the remote device 1505 with the analyte monitoring device 1501. In some aspects, the analyte monitoring device may be configured to automatically start a user interface application when connected to a remote device. Note that the user interface application may be configured to support various hardware systems (eg, PC, MAC) and various operating systems (eg, Windows, MAC OS, Linux).

  User interface applications may include, for example, applications related to diabetes management. The user interface application may provide various menus, options, charts, alarms, reminders, visual indicators, and the like. For example, a menu for a user to obtain a measurement value, view a stored measurement value, store data, download data, perform a bolus calculation based on the measurement, and so on. Options can be presented.

  The user interface program includes, for example, (1) generation of a copy of test data stored in the sample monitoring device 1501 or the remote device 1505, and (2) test data from the sample monitoring device 1501 and the remote device 1505. Allows you to perform a step of synchronization with the database. Instrument settings and / or user settings / selections from the analyte monitoring device may also be included in the test data and synchronized with the remote device. The date and time of the remote device 1505 and the date and time of the sample monitoring device 1501 may be synchronized.

  In this specification, in order to read out test data from the sample monitoring device 1501 and write it into the remote device 1505, the data of the remote device may be configured as a table, or they may be configured as a record. May be divided into predefined fields. Similarly, a certain amount of data is configured as a record having a consistent field structure on the sample monitoring apparatus 1501. The user interface application may read test data from the sample monitoring device and write it to a table on the remote device 1505. The user interface application may read data from the table of the remote device 1505 and write them to the sample monitoring device 1501. Various types of data conversion may be used. For example, the data in the field of the sample monitoring device may be converted from a format that exists in the sample monitoring device to a format that corresponds to the remote device, and vice versa. The logical structure of records in both systems may be different.

  The remote device 1505 may include peripheral devices such as a printer, a keyboard, a monitor, and a CD drive. The remote device 1505 includes a network interface that connects the remote device 1505 to a network 1510 (eg, the Internet). The user interface application allows the user to view the inspection data on a monitor, store the inspection data on a storage medium (eg, CD-ROM, memory card, etc.), and further analyze and / or manipulate the inspection data. Options may be provided such as sending data to another device and / or printing inspection data such as charts and reports on a printer.

  As shown, remote device 1505 may also include a network interface 1530 (eg, a network interface card (NIC), modem, router, RF front end, etc.) used to connect remote device 1505 to network 1510. For example, in some aspects, the analyte monitoring device 1501 may be connected via a USB connection to a remote device that may be a personal computer or laptop computer connected to the Internet using a wireless modem and / or router. Good. In some aspects, the analyte monitoring device 1501 may be connected via a micro USB connection to a remote device 1505 that is a smartphone having an RF front end for accessing a mobile network. The user interface application may be connected to the remote device 1505 to transfer test data to a physician, hospital, health care provider, and / or other third party at the location of the second remote device 1515 on the network 1510, for example. A user interface for using a network connection may be provided. Appropriate action can then be taken by the recipient at the second remote device 1515.

  Referring to FIG. 2 again, the sample monitoring device may include, for example, a wireless communication unit, which includes, for example, a remote device 1505, a drug delivery device, and / or a patient monitoring device (eg, a continuous glucose monitoring device, A receiver and / or transmitter for communicating with another device, such as a health care system such as the CoPilot ™ system available from Abbott Diabetes Care, Inc., Alameda, California, USA. The wireless communication unit includes radio frequency (RF) communication, Zigbee (registered trademark) communication protocol, WiFi, infrared, wireless universal serial bus (USB), ultra wide band (UWB), Bluetooth (registered trademark) communication protocol, and cellular communication. It may be configured to perform wireless communication using techniques including but not limited to (Code Division Multiple Access (CDMA), GSM (Global System for Mobile Communication), and the like). In some aspects, the wireless communication unit is configured to perform bidirectional radio frequency (RF) communication with another device for data transmission and reception with the sample monitoring device 1501.

  In some aspects, the wireless communication unit may be used to communicate with a remote device, as described above for the communication connector unit. In some aspects in which the sample monitoring device includes a communication connector unit, the wireless communication unit may replace the functions provided by the communication connector unit described above, or may provide an optional communication channel. Referring back to FIG. 2, the analyte monitoring device 1501 may be connected to the remote device 1505 via a wireless communication unit and may provide an optional alternative communication channel with the remote device 1505. In some aspects, the sample monitoring device 1501 may not include the communication connector unit 1422, but instead may only communicate with the remote device 1505 via a wireless communication unit present in the sample monitoring device 1501. Good. In some aspects, the analyte monitoring device is configured to receive program updates from a remote device via a wireless communication unit.

  In some aspects, the wireless communication module may be configured to communicate with a smartphone (eg, iPhone, Blackberry, etc.). Smartphones typically include various wireless technologies such as Wi-Fi, infrared, and Bluetooth (registered trademark).

  In some aspects, the analyte monitoring device wirelessly communicates with the server device via the wireless communication unit using a common standard such as, for example, 802.11, Bluetooth® RF protocol, or IrDA infrared protocol. It may be configured. The server device can be another portable device such as a PDA or notebook computer, or a larger device such as a desktop computer or appliance. In some aspects, the server device includes a display such as a liquid crystal display (LCD) and an input device such as a button, a keyboard, a mouse, or a touch screen. In such a configuration, the user can indirectly control the measuring instrument by interacting with the user interface of the server device that communicates with the measuring instrument via a wireless link.

  In some aspects, the wireless communication module is used to communicate with a remote sensor, such as a sensor configured to be implanted in a patient or user, for example. Examples of sensors used in the analyte monitoring system of the present disclosure are described in US Pat. No. 6,175,752 and US application Ser. No. 09 / 034,372, with reference to them. Incorporated herein. Further information regarding sensors and continuous analyte monitoring systems and devices is described in the following references. US Pat. No. 5,356,786, US Pat. No. 6,175,752, US Pat. No. 6,560,471, US Pat. No. 5,262,035, US Pat. US Pat. No. 6,881,551, US Pat. No. 6,121,009, US Pat. No. 7,167,818, US Pat. No. 6,270,455, US Pat. No. 6, , 161,095, US Pat. No. 5,918,603, US Pat. No. 6,144,837, US Pat. No. 5,601,435, US Pat. No. 5,822. No. 5,715, US Pat. No. 5,899,855, US Pat. No. 6,071,391, US Pat. No. 6,120,676, US Pat. No. 6,143,164 Specification, US Pat. No. 6,299 No. 757, US Pat. No. 6,338,790, US Pat. No. 6,377,894, US Pat. No. 6,600,997, US Pat. No. 6,773,671 Specification, US Pat. No. 6,514,460, US Pat. No. 6,592,745, US Pat. No. 5,628,890, US Pat. No. 5,820,551 US Pat. No. 6,736,957, US Pat. No. 4,545,382, US Pat. No. 4,711,245, US Pat. No. 5,509,410, US US Pat. No. 6,540,891, US Pat. No. 6,730,100, US Pat. No. 6,764,581, US Pat. No. 6,299,757, US Pat. No. 6,461,496, rice US Pat. No. 6,503,381, US Pat. No. 6,591,125, US Pat. No. 6,616,819, US Pat. No. 6,618,934, US Pat. US Pat. No. 6,676,816, US Pat. No. 6,749,740, US Pat. No. 6,893,545, US Pat. No. 6,942,518, US Pat. No. 514,718, US Pat. No. 5,264,014, US Pat. No. 5,262,305, US Pat. No. 5,320,715, US Pat. No. 5,593, No. 852, US Pat. No. 6,746,582, US Pat. No. 6,284,478, US Pat. No. 7,299,082, filed on Dec. 26, 2003 “Continuous Glucose Monitoring System an US patent application Ser. No. 10 / 745,878 entitled “Methods of Use” and “Compact On-Body Physiological Monitoring Device and Methods Thereof” No. 61 / 149,639, entitled “Monitoring Device and Method”. The disclosures of each of the above references are incorporated herein by reference.

  FIG. 3 illustrates an analyte monitoring device for use with a remote sensor, according to some embodiments. The sensor 1605 may be configured to be implanted in a patient (eg, implanted subcutaneously, vein, or artery). The sensor 1605 is connected to a sensor controller 1610 that is typically attached to the patient's skin. The sensor control unit 1610 operates the sensor 1605 and includes, for example, supplying a voltage to the electrode of the sensor 1605 and collecting a signal from the sensor 1605. The sensor control unit 1610 may evaluate the signal from the sensor 1605 and / or transmit the signal to the wireless communication unit 1423 of the sample monitoring device 1501 for evaluation.

  In some aspects, the wireless communicator 1423 is configured to receive a signal from a remote sensor using radio frequency identification (RFID) technology. This configuration may be used to provide glucose on-demand functionality, in which case the analyte monitoring device is placed in close proximity to the implantable sensor when a measurement is desired. In some examples, RFID technology may be used in continuous glucose monitoring (CGM) applications.

  The sample monitoring device 1501 processes the signal from the sensor control unit 1610 attached to the skin and displays the current sample level via the display unit 1421 in order to determine the concentration or level of the sample in the subcutaneous tissue. May be. In addition, the sensor controller 1610 and / or the analyte monitoring device 1501 may detect when the analyte level is at or near the threshold level, for example by an alarm that stimulates audible, visual, or other sensations. That may be shown to the patient. For example, when monitoring glucose, an alarm may be used to alert the patient to hypoglycemic or hyperglycemic glucose levels, or near future hypoglycemia or hyperglycemia.

  The sample monitoring device 1501 can change the signal from the sensor 1605 using calibration data and / or measurement values from a temperature probe (not shown), determine the sample level in the interstitial fluid, and the interstitial fluid sensor. Determination of specimen level in the bloodstream based on measurements, determination of specimen level, rate of change and / or whether rate of change acceleration has exceeded or reached one or more thresholds, if the threshold has been reached or exceeded Activation of an alarm system, assessment of analyte level trends based on a series of sensor signals, therapy management (eg, determination of drug dosage, etc.), and (eg, averaging of signals of measurements from multiple electrodes or Various functions can be performed, including reducing noise and error contributions (by comparison). The analyte monitoring device may be simple that performs only one or a few of these functions, or the analyte monitoring device may perform all or most of these functions.

As described above, the sample monitoring device 1501 communicates with the remote device 1505 via the communication connector unit 1422 and / or the wireless communication unit 1423 and / or the second wireless communication unit (not shown). Also good. Moreover, the sample monitoring apparatus may be configured to have one or more wireless communication units.
User Interface of Specimen Monitoring Device In some embodiments, the specimen monitoring device includes software used to perform various processes and functions using the device (eg, but not limited to the functions described above). The device is stored, for example, in a machine readable storage medium (eg, flash memory or other non-volatile memory) and is one or more general purpose or dedicated programmable microprocessors and / or microcontrollers or other types. Software instructions executed by the processing device may be included. Note that a machine-readable storage medium may include any of a variety of non-volatile memory (eg, flash memory) or volatile memory (eg, random access memory (RAM)) that includes one or more memory components. May be included.

  In some aspects, the analyte monitoring device may include an overall user interface for operation of the device and software used to provide a general user experience with the device. The user interface is a graphical user interface (GUI) displayed for various functions that can be provided by the device (eg, home screen, glucose measurement screen, record book screen, reader summary screen, reader usage screen, etc.) Can be included. The user interface provides various processes that can be performed by the device (eg, on-demand measurement, patch activation, patch replacement, patch status provisioning, patch expiration notification, record book, summary screen, usage reports, etc. This includes the navigation / flow of the screen for the creation of a report for starting, displaying, communicating, printing, etc.

  As used herein, the terms “sensor” and “patch” generally refer to both implantable sensors and body-worn electronic devices.

  In some aspects of the present disclosure, the analyte monitoring device may be configured with various graphical user interfaces (displayed on the analyte monitoring device display) to assist the user in operating the device or to provide information to the user. GUI) or screen. In this specification, the terms “graphical user interface”, “GUI”, “interface” and “screen” are used in a broad sense and represent any graphical interface element displayed on the display and are not distinguished from each other. Used for. For example, the graphical user interface may include graphical icons, elements, pictures, videos, text boxes, pop-up windows, application windows, home screens, and the like.

  Furthermore, it is noted that the terms “graphical user interface”, “GUI”, “interface” and “screen” are used in a broad sense in this specification and may include a plurality of instructions unless otherwise specified. I want. Thus, for example, the term “setting screen” can include one or more screens in the setting process, and the term “setting screen” refers to one or more program updates and is known to those skilled in the art. Or its equivalent.

  Further, it should be understood that one or more GUIs may be implemented for various features, functions and / or settings. Further, in some examples, different GUIs can be combined without compromising the underlying nature of the present disclosure.

  The user may navigate through the various screen branches via trigger elements on the device. The trigger element may be any of a variety of trigger elements such as buttons, keys, toggle switches, wheels, arrows, etc. The trigger element may be a physically tactile trigger element (eg, a hardware button or key on a housing or keyboard) located on the device and / or a non-tactable trigger element displayed on the device. (Eg, a graphical user interface element). A navigation branch may also be displayed on the home screen (eg, as an icon on the display) and triggered by a corresponding physical tactile trigger element on the keyboard housing.

  In some embodiments, a touch screen display is implemented and the trigger element is an icon displayed on the touch screen. A trigger element is activated by a user touching a corresponding trigger element (eg, an icon). As used herein, “icon” is used in a broad sense and should be understood to represent any text, image, video, graphic, etc. For example, a trigger element may have its gear image, arrow keys, checkboxes, toggle switches, buttons (for example, text or images for identification) etc. representing the trigger element to access the settings menu, etc. It may suggest a function or feature.

Home Screen In some aspects of the present disclosure, a home screen is provided. A home screen, that is, a landing screen, is displayed on the display of the sample monitoring apparatus, and functions as a reference point or a relative reference point when executing various functions and features of the apparatus. From the home screen, the user can navigate to any of various GUIs for performing or accessing various functions and features of the device. For example, the user can navigate to a screen that allows the user to access records, settings menus, reminders, and the like. From there, the user can access additional features and functions associated with the selected item.

Active Screen In some aspects of the present disclosure, an active screen is provided. An active screen (eg, a scan prompt screen) waits for the user to perform an on-demand measurement or otherwise “ping”, “scan”, or “swipe” the sensor. Note that the terms “ping”, “scan”, and “swipe” are used interchangeably in this specification, and communicate in a broad sense (eg, on-demand measurement, sensor activation, etc.). Therefore, it refers to making the sample monitoring device sufficiently close to the sensor.

On-Demand Reader Screen In some aspects of the present disclosure, an on-demand reader screen is provided for providing information regarding analyte measurements (eg, glucose levels). In addition, although embodiment is described regarding an on-demand glucose measurement value, other specimens may be mounted in other embodiments.

  In some examples, the on-demand reader screen is a measured value, a trend symbol, an insulin calculation trigger element, a food intake trigger element, an additional note trigger element, a screen switching trigger element, patch status information, trail information , Current time, battery status, etc. The measurement provides the glucose level for the current measurement. The trend symbol provides trend information regarding an increasing or decreasing pattern of glucose level. When the trigger element for the insulin calculation is activated, a screen is displayed, for example, to provide the user with an insulin calculation based on the current glucose measurement. When the food intake trigger element is activated, a screen for entering food intake and / or a screen for displaying food intake is displayed. When the note display trigger element is activated, a screen for entering a note and / or a screen for displaying a previously entered note is displayed. The trail information displays the measured values up to the current measured value.

  Some embodiments have a single screen layout in which all information regarding on-demand glucose measurements is displayed on a single screen. Other embodiments have a dual screen layout that provides information on on-demand glucose measurements across two screens. The user may switch between the two screens using a trigger element such as an icon or box on the screen. In some examples, the user may be able to switch screens by sliding a finger on the device display.

Reader Summary / Report Screen In some aspects of the present disclosure, the analyte monitoring device displays a summary screen that collects information associated with the measurements made.

Event Summary View The event summary screen displays summarized information about the user's measurement history.

Event Detail View The event detail screen displays a detailed view of the user's measurements associated with an event (eg, a hypoglycemia event, etc.).

Record Book Screen The record book screen displays recorded measurement values and related data relating to user measurement values.

Usage report The usage report screen displays the usage of the instrument to show how the user is involved. If there is a time gap (eg, a long period when the user did not make a measurement), it is recorded and shown in the usage report.

Personalized Image In some embodiments, the analyte monitoring device includes a personalized screen that displays a personalized image, for example, selected or uploaded by a user. Personalized screens may be displayed at specific times. For example, a personalized screen may be displayed after the device is turned on. When the process of turning on the power is completed, the sample monitoring apparatus displays another screen such as an active screen. In another embodiment, the home screen is displayed after the process of turning on the power.

Screen Quality Note that the sample monitoring device may be mounted to have different screen qualities such as gray scale and higher resolution. In some embodiments, the analyte monitoring device may be operable with different screen quality. For example, the analyte monitoring device may have a color touch screen and be capable of color mode or grayscale mode operation.

  The following paragraphs describe various navigation flows between user screens for performing various functions and features of the device.

Navigation Flow The following paragraphs describe various navigation flows between user screens for executing various functions and features of the sample monitoring device. For example, software or firmware that implements the flows introduced herein may be stored on a machine-readable storage medium and executed by one or more general purpose or special purpose programmable microprocessors.

Hardware Provided is an exemplary embodiment of a graphical user interface that functions to perform various hardware related operations that may be used in connection with the analyte monitoring device (eg, analyte reader device) described herein. Is done.

“Hardware Power On” Interface FIG. 4 illustrates a method 100 for powering on an analyte monitoring device, such as a glucose monitoring device, according to one embodiment. In this specification, the sample monitoring apparatus is also referred to as a “reader” that acquires a measurement value from a sample sensor. From the off state represented by block 102, the device can be powered on by pressing the power button (eg, "short press" or "long press"), as represented by block 104. At block 106, a test is performed to determine if the battery is exhausted. If the battery is depleted, the device is turned off as indicated by block 107. In some examples, when the device recovers from a lack of power, the device reads the stored “sensor” status information and the sensor has not expired (eg, a 14-day period or other predetermined time period). If it has not yet elapsed), the use of the same sensor can be resumed. If it is determined that the battery is not exhausted, the device is turned on, as indicated by block 108.

  In block 110, the processor of the device determines whether there is an error in the hardware function of the device. If the device's processor determines that there is a hardware failure, such as the device not operating correctly, when powered on, the device will be described later herein, as indicated by block 111. Displays a hardware error message such as If no hardware error is detected, at block 112 it is determined whether it is the first time that the device is configured. If this is the first time, as indicated at block 114, an initial start procedure is initiated to begin setting up the device. If it is determined that the setting is not the first time, it is determined whether the sensor is already activated. If not, the home screen is displayed as indicated by block 118. If already activated, it is determined whether the sensor has expired, as indicated by block 120. If the sensor has expired, it is determined whether a sensor expiration message has been previously displayed, as indicated by block 130. If so, the home screen is displayed as indicated by block 134. If not previously displayed, a sensor expiration screen is displayed, as indicated by block 132. In some examples, an audible notification may also be provided. The sensor expiration screen may also inform the user that a new sensor must be started to make a glucose measurement. If the user confirms, for example, by pressing “OK”, the home screen is displayed on the device.

  Referring back to block 120, if the sensor has not expired, it is determined whether the sensor is warming up, as indicated by block 122. If it is not warming up, a prompt for scanning the sensor is displayed. If the sensor is warming up, a warm up message screen is displayed to inform the user that the sensor is warming up, as indicated by block 126. In some examples as shown, the warm-up message screen indicates the time remaining before the sensor can be used. As shown, an audible reminder may also be present. If the user confirms, for example, by pressing “OK”, the home screen is displayed on the device.

“Return to Home” / “Off” Interface FIG. 5A illustrates a method 140 for navigating from another screen of the sample monitoring device to the home screen, according to one embodiment. In block 141, the device displays a screen other than the home screen. At block 142, the home trigger button is pressed (eg, short pressed). When the home trigger button is pressed, as indicated by block 143, the device's processor checks whether the sensor has expired (eg, 14 days have passed). If the sensor has expired, a “Sensor Expired” screen is displayed, as indicated by block 144. In some examples, an audible notification may also be provided. The sensor expiration screen may also inform the user that a new sensor must be started to make a glucose measurement. If the user confirms, for example, by pressing “OK”, the home screen is displayed on the device, as indicated by block 145. If the sensor has not expired, the home screen is displayed, as indicated by block 146. Another home screen 148 that does not include a reminder is shown. In some examples, if a test strip has been inserted into the device and it is before receiving results, a short press on the trigger button to the home screen will not work. There may be a screen in which the home trigger button does not lead to the display of the home screen. In some embodiments, from some screens, pressing the home trigger button does not navigate to the home screen. Such exceptions will be described later in this specification.

  FIG. 5B illustrates a method 150 for turning off an analyte monitoring device, according to one embodiment. At block 152, the current screen is displayed on the device. If the screen is displayed for a predetermined period (eg, 45 seconds or other period), the screen may be dimmed to save power, as indicated by block 154. When the user touches the darkened screen, the display returns to a completely bright state and the timeout timer is reset. After the screen goes dark, the device is turned off if another predetermined period (eg, 15 seconds or other period) has passed without any operation being performed. There may be a specific screen to which such a method is not applied.

  FIG. 5C illustrates a method 160 for turning off the analyte monitoring device, according to one embodiment. When a home trigger button is pressed (eg, short or long press) as shown at block 164 from the home screen shown at block 162, a screen display is displayed indicating that the device is powered off. Triggered. An option for canceling the power-off process may be provided to the user. If no selection is detected, as indicated by block 168, the device is powered off after a predetermined period of time (eg, 5 seconds or other period), as represented by block 172. Also good. If the trigger button is pressed at block 166, as indicated at block 170, the device is powered off, as represented at block 172.

  FIG. 5D illustrates a method 180 for turning off the analyte monitoring device, according to one embodiment. From the current screen shown at block 182, pressing the trigger button (eg, long press) triggers the display of the power off screen shown at block 186. An option for canceling the power-off process may be provided to the user. If no selection is detected, as indicated by block 188, the device is powered off after a predetermined period of time (eg, 5 seconds or other period), as represented by block 192. Also good. If the trigger button is pressed at block 186, as indicated at block 190, the device is powered off, as represented at block 192.

“Battery Low” Interface FIG. 5E illustrates a “Battery Low” screen 196 that indicates that the battery of the device of the specimen monitoring device is low, according to one embodiment. For example, in one embodiment, this screen may appear after a sensor scan or strip test and before the results are displayed. In some examples, this screen begins to appear when the battery capacity reaches a level equivalent to typical daily use. This may be a predetermined value or may be based on the user's history. In some examples, when this screen is displayed, the only signal broadcast is the reminder audible / vibration signal. The standard confirmation signal is omitted. A user confirmation element may be displayed, and once the user confirms, the user goes to the scan result. In some examples, from the battery low screen, if the charger is plugged in, the device transitions to the results screen.

PC Link / Data Transfer Interface FIG. 5F illustrates a method 200 for linking an analyte monitoring device to a PC and transferring data between them according to one embodiment. In block 202, the device is connected to the PC via a wired or wireless connection, and data is transferred between the device and the PC. During data transfer, a data transfer screen is displayed to indicate that data transfer is being processed. In the example shown, the user is also instructed not to unplug the device from the computer. When the data transfer is completed or the connection between the apparatus and the PC (for example, USB connection) is released, the home screen is displayed. In one embodiment, if the reader's initial settings have not been saved, the reader proceeds to the initial start procedure after attempting data transfer. Note that in other embodiments, these screens may be changed by engineering implementation. In some examples, if the device is plugged into the computer prior to initialization, the language defaults to English until the initialization is set by the PC application.

Battery Charging Interface FIG. 5G illustrates a method 210 for charging a battery of an analyte monitoring device, according to one embodiment. The device is charged, for example, by connecting the device to a PC or other device (eg, via a USB connection etc.), or by connecting the device to an AC adapter that is plugged into an AC power source. May be. When the charger is plugged in from the off state, the home screen is displayed and the device is being charged, for example by a “charging” icon or symbol (eg, battery symbol, etc.), as indicated by block 212. It is shown that there is. In one embodiment, during charging, all screens follow a standard timeout period (eg, a 60 second timeout period).

  As indicated at 216, when the device is disconnected from the charger (eg, USB connection port), a home screen without a charging symbol or icon is subsequently displayed. This may be replaced with an icon or symbol indicating the current state of battery life. In one embodiment, if the device displays any screen (including the home screen), the device will continue to display that screen when the charger is disconnected, and the charger connection When released, the predetermined timeout period is reset.

Home Screen An exemplary embodiment of a graphical user interface that can be used in connection with the reader described herein and that functions to navigate the device with respect to the home screen is provided.

Sensor Scan or System Check Interface FIG. 6A illustrates a method 220 for performing a sensor scan or system check, according to one embodiment. From the home screen of block 222, if a glucose check is initiated, it is determined whether a system check is required, as indicated by block 230. If so, a system check is performed as indicated by block 223. If a system check is not required, a sensor scan prompt is displayed as indicated at block 234. The home screen may allow other functions to be started. For example, if a corresponding icon is triggered on the home screen, a reader summary menu screen may be displayed, as indicated by block 224. Alternatively, a setting screen may be displayed as indicated by block 226 when the corresponding icon is triggered on the home screen.

  Further, when the corresponding icon is triggered on the home screen, a residual insulin (IOB) screen may be displayed, as indicated by block 236. The remaining insulin screen provides information regarding remaining insulin remaining in the user's body estimated according to previously entered insulin data. Further details may be provided once the corresponding icon is started from the remaining insulin screen. In one embodiment, the timer counts down from the administration time for the insulin duration set in the computer settings. In one embodiment, if residual insulin is enabled in the computer settings and the remaining insulin is calculated and presented, a residual insulin screen with an active countdown appears. The icon shown provides a visual indication that reflects the estimated amount of fast-acting insulin remaining in the body (for example, the proportion of body shape icons that are buried in the body remains Corresponding to the proportion of residual insulin that is).

  Also, a reminder screen may be displayed when the corresponding icon is triggered on the home screen, as indicated by block 228. In one embodiment, when a reminder is set, the time at which the alarm sounds appears next to the reminder icon. For example, when a plurality of reminders are active, the time of the earliest reminder is shown.

“Expired” / “No Sensor” Interface FIG. 6B illustrates a method of activating a sensor according to one embodiment. In the illustrated embodiment, a home screen 242 is displayed on the device indicating that no sensor is currently paired with the sample monitoring device. For example, a sensor may have never been paired with a device, or a previously paired sensor may have expired. From the home screen 242, the user may trigger the activation of the sensor by pressing or otherwise selecting a corresponding icon or other trigger element displayed on the device display.

“Sensor Warming Up” Interface FIG. 6C illustrates a method 246 of activating a sensor according to one embodiment. For example, as represented by block 250, if the user begins to activate the sensor, the device may indicate whether the sensor is warming up. As shown, during the warm-up period, the home screen 248 indicates that the sensor is warming up. For example, as shown on the screen 248, the home screen 248 indicates the remaining time until the sensor preparation is completed (for example, “ready for 60 minutes”).

“Sensor Expiration Approach” Interface FIG. 6D illustrates a method 252 for scanning a sensor when the sensor is about to expire, according to one embodiment. In the illustrated embodiment, screen 254 shows the time remaining (e.g., 16 hours) before the currently paired sensor expires. Since the sensor has not yet expired, the user can trigger the activation of the sensor from the home screen 254 by pressing or otherwise selecting the corresponding icon or other trigger element displayed on the device display. May be.
Displaying Sensor Life in Title Bar FIG. 6E illustrates an exemplary embodiment of a graphical user interface that displays sensor life in increments. In the illustrated embodiment, the lifetime of the sensor is displayed in three ranges: days, hours, and minutes, as shown on screens 257, 258, and 259, respectively. In certain embodiments, the sensor lifetime is rounded (eg, 2 days and 1 hour are displayed as 3 days, 1 day and 20 hours are displayed as 2 days, and 1 hour and 10 minutes are displayed as 2 hours. ) In embodiments, the sensor lifetime indication is independent of the user adjustable date and time.

Sensor Activation An exemplary embodiment of a graphical user interface that functions to activate a sensor is provided that can be used in connection with the reader described herein.

  FIG. 7 illustrates a method 260 for activating a sensor after the device is turned on, according to one embodiment. At block 261, the device is powered on. When the power is turned on, a home screen 262 is displayed. Home screen 262 indicates that there are no active sensors and further includes an icon or other trigger element that allows a new sensor to be started. As represented by block 263, when an icon is selected by the user, a “Start New Sensor” screen 264 is displayed to start the sensor. The “Start New Sensor” screen 264 allows the user to start a new sensor, for example, by informing the user to scan the sensor to start the sensor. Once the scan has started, the device waits for the scan to complete (eg, 15 seconds), as indicated by blocks 265 and 266. If the scan is not completed after the waiting period has elapsed, the device may display a screen 267 informing the user that the scan has timed out.

  Once the scan is complete, the device may perform a sensor error check, including a scan consistency check 268, a sensor diagnostic 270, and a sensor expiration check 272, in order to begin pairing the device with the sensor. . If the device determines that the scan has failed, as indicated by block 269, the device may display a screen indicating that a scan error has occurred. If the device determines that the sensor is not functioning properly, the device may display a screen 271 indicating that the sensor is to be replaced with a new sensor. If the scan is successful and the sensor is found to be functioning, the device may check the sensor expiration information. If expired, for example, if the user attempts to continue using an expired sensor, the device may display a sensor expiration screen 273. If “OK” is selected from any of the scan error screen, sensor replacement screen, and sensor expiration screen, the device may be navigated back to the home screen 262 to start a new sensor again. Good.

  Referring to block 275, if the sensor has already been activated by another device, a screen 276 is displayed indicating that the sensor is already paired with another device. If the user confirms, the home screen is displayed as indicated by block 277. In certain embodiments, if a sensor is already paired with another reader device, that sensor is not allowed to be used with a new reader device.

  In some examples, the device does not display the result measurement to the user or otherwise restricts the result data to the user so that the user can measure the paired sensor measurement. It may also include a masking mode that allows acquisition. After successfully scanning non-expired sensors, the device may display a masking mode screen indicating that masking mode is currently enabled. For example, the masking mode screen 279 indicates that the device will operate in the masking mode unless otherwise changed. In some examples, an initial configuration may be set for a patient by a physician or other medical professional. In certain configurations, the masking mode can be released only by a medical professional. If the device is not operating in the masking mode, or after the user confirms the masking mode, a warm-up message screen 280 is displayed indicating that the sensor is warming up. The remaining time for warming up may also be displayed. If the user confirms the message, for example by selecting the “OK” icon, the device may navigate back to the home screen 281, for example by indicating the time remaining until the sensor is ready. A home screen indicating that warming up is in progress is displayed. As indicated by block 282, if the user attempts to scan the sensor, for example, by selecting a glucose check icon, the warm-up message screen 281 is displayed again. In some examples, the home screen may be displayed after a predetermined time for the warm-up message to be displayed, or the device automatically navigates to the home screen 283 when the sensor is ready. In certain embodiments, the device does not display a message screen indicating that the remaining time is “0 minutes”.

Sensor Scanning and Results An exemplary embodiment of a graphical user interface that can be used in connection with the reader described herein and that functions to perform scanning and provide results is provided.

Sensor Scan Interface FIG. 8 illustrates a method 300 for scanning a sensor using an analyte monitoring device, according to one embodiment. At block 301, the device is powered on. A scan prompt screen 302 is displayed, which indicates to the user to scan the sensor to check the analyte level (eg, glucose level).

  In the illustrated embodiment, an icon or trigger element is provided on screen 302 to navigate to home screen 303. If selected by the user, the home screen 303 is displayed. From home screen 303, the user may then start scanning the sensor and return to scan prompt screen 302.

  Once the scan has started, the device waits for the scan to complete (eg, 15 seconds), as indicated by blocks 304 and 305. If the scan is not completed after the waiting period has elapsed, the device may display a screen 306 that informs the user that the scan has timed out. Once the scan is complete, the device may perform a scan 307 consistency check. If the device determines that the scan has failed, as indicated by block 308, the device displays a screen indicating that a scan error has occurred and instructs the user to scan the sensor again. Also good.

  If the sensor is a new inactive sensor, as indicated by block 309, a “New Sensor Detection” screen 310 is displayed indicating that the sensor is a new sensor. Screen 310 provides the user with an option to start a new sensor. If the user chooses to start a new sensor, the device starts the sensor activation process, as indicated by block 312. If the user chooses not to start a new sensor, the device displays a home screen, as indicated by block 311.

  As indicated by block 313, if the device determines that the current sensor is not active, a “Sensor Confirmation” screen 314 is displayed indicating that there may be a problem with the sensor. In some embodiments, the sensor confirmation screen 314 may suggest that the user confirm whether the sensor is about to come off or not. If the sensor is coming off, it should be paired with the new sensor removed. If the sensor is applied correctly, the sensor is scanned again.

  Referring to block 315, if the sensor is already being operated by another device, a screen 316 is displayed indicating that the sensor is already paired with another device. When the user confirms, the home screen is displayed. In certain embodiments, if a sensor is already paired with another reader device, that sensor is not allowed to be used with a new reader device.

  As indicated by block 317, the device may check sensor expiration information. If it has expired (eg, the user has attempted to reuse an expired sensor), the device may display a sensor expiration screen 318. If “OK” is selected from any of the scan error screen, sensor replacement screen, and sensor expiration screen, the device may be navigated back to the home screen to start a new sensor again.

  If the device determines that the sensor is not functioning properly, the device may display a screen 271 indicating that the sensor is to be replaced with a new sensor. If the scan is successful and the sensor is found to be functioning, then the device will expire within a predetermined time (eg, within the next three days), as indicated by block 321. Decide whether or not. It should be noted that in other embodiments, the amount of time may vary, and in one embodiment, it is determined whether the sensor has expired. The predetermined time may be programmed in advance at the time of manufacture and / or may be set by setting or the like. If at block 321 it is determined that the sensor will expire within a predetermined time, a “sensor expiration approach” screen 322 is displayed indicating that the sensor is about to expire. For example, the remaining time until the sensor expires may be displayed. In a particular embodiment, the last 3 days of the sensor's life are displayed with a message of remaining time after the first scan of each day, and the last 8 hours before the sensor expires is displayed on this screen after every scan. Is shown. The screen showing the remaining time until the sensor expires may be displayed as the remaining number of days when the remaining time is 2 days or more. If the remaining time is 2 hours to 1 day, If the remaining time is less than 1 hour, it may be displayed as the remaining number of minutes. In this case, the remaining time is rounded as described above with respect to FIG. 6E. If the remaining time screen is still active when the remaining time reaches zero, the device will return a sensor result with a “no sensor active” screen, as described later in this specification. You may navigate automatically.

  If it is determined at block 321 that the sensor does not expire within a predetermined time, it is determined whether the sensor battery is low, as indicated at block 325. If the battery is low, at block 326, the device indicates that the battery is low, eg, by a “Battery Low” screen or a “Battery Low icon. Results are not displayed.

  If the battery is not low, at block 327 it is determined whether the skin temperature is too high or too low, for example using a “safe” temperature range. The sensor may provide temperature data to the device. If it is determined that the temperature is too high or too low, as indicated at block 328, the device displays the resulting measurement to indicate that the temperature of the sensor was too high or too low, respectively. . If the skin temperature is not too high or too low, it is determined whether the quality of the data is acceptable, as indicated by block 329. If the data quality check fails, the device may display a sensor error screen 330 to inform the user that glucose measurement cannot be performed. In certain embodiments, the device may suggest to the user to rescan after a predetermined waiting period (eg, 10 minutes). If the “OK” confirmation element is selected by the user, the device may navigate back to the home screen 331.

  As indicated by block 332, it is determined whether the resulting measurement is out of range. If the sensor is out of range, it is determined whether a high glucose state or a low glucose state has occurred. For example, the target range or acceptable range may be preset by the manufacturer or may be customizable by the user. If a high or low state exists, a sensor result screen is presented to the user, as indicated by block 333, and the sensor result screen indicates whether the high or low state (e.g., by a message, icon, etc.) It may be shown with the results.

  Referring again to block 332, if it is determined that the sensor is not out of range, it is determined whether the glucose level was a high glucose level or a low glucose level (334). For example, the high or low glucose level may be preset by the manufacturer or may be customizable by the user. If a high glucose level or a low glucose level is present, the sensor result screen may be presented to the user and the sensor result may be displayed, as indicated by block 335. If no high or low state exists, it is determined whether a high or low state is expected, as indicated by block 336. A high state or a low state may be predicted by, for example, a trend in measured values. If a high or low state is predicted, the sensor result screen is presented to the user, as shown at block 337, and the predicted high or low state is shown along with the sensor result on the sensor result screen.

  In some examples, the device may allow skin temperature testing to be more than other concurrent testing conditions (eg, out-of-range testing, high / low glucose testing, predicted high / low glucose testing, etc.). Programmed to be preferred.

Continuous Scan Interface An exemplary embodiment of a graphical user interface that serves to provide navigation when a continuous scan is present that can be used in connection with the reader described herein is provided.

Two scans within a predetermined period In some embodiments, the specimen reader device is programmed to perform a specific navigation when the device is scanned multiple times within a predetermined period.

  FIG. 9A illustrates a method 350 for performing two scans using an analyte reader within a predetermined time period, according to one embodiment. After the first scan is performed, a sensor result screen is displayed as indicated by block 352. If the power is turned off or moved from the sensor result screen to another screen before a predetermined period of time (eg, 3 minutes in the illustrated embodiment example), as represented by block 354, The result of the first scan is saved. As indicated by blocks 356 and 358, if the device is turned on again within a predetermined period of time or if the next scan is attempted, the device will allow the user to perform a new scan. Prevent and display a “NO NEW SCAN” screen indicating that no new sensor measurements can be taken at this time. The new no-scan screen may also indicate the time remaining until the next scan, and if desired, allow the user to view the last sensor result screen as represented by the sensor result screen 362. Good.

Device timeout in “Suggested Dose” screen from BG (Blood Glucose) results In some embodiments, when the dose is calculated but not yet recorded, the reader is turned off. Or if the “Calculator / Suggested Dose” (CALC SGTD) screen is moved to another screen and the device is turned on again within a predetermined period of time or the next scan If attempted, the specimen reader device is programmed to return to the stored “suggested dose” screen.

  FIG. 9B illustrates a method 364 for recording dose calculations according to one embodiment. After the glucose measurement is taken, a “Calculator / Suggested Dose” (CALC SGTD) screen 366 may be displayed for calculating and recording the suggested insulin dose. If desired, the user can adjust the suggested dose and record the dose from screen 366. However, as indicated by block 368, when the suggested dose has been calculated and has not yet been recorded, the device power supply within a predetermined period of time (eg, 3 minutes in the illustrated embodiment). If is turned off or moved from screen 366 to another screen, suggested dose data is saved. As indicated by block 370, if the reader is turned on again within a predetermined period of time, or if the next glucose scan is attempted, the user will be prompted for a stored suggested dose. The “Calculator / Suggested Dose” screen 372 having the following data is returned. From here, the user may continue to calculate the dose and record the calculated dose. If the dose is recorded at this time, the dose is stored in the record book together with the test result. In one embodiment, the dose is recorded as being acquired at the time the test was performed, not the time at which the dose was actually recorded. However, the countdown of body insulin starts from the time when the dose was actually recorded.

Suggested Dose from Recorded BG Results In some aspects of the disclosure, after the first scan has been performed and the calculated insulin dose has been recorded, the device is pre-determined from the first scan. During this period, it is programmed to prevent the second scan. The user cannot perform the second scan, but can browse the record book.

  FIG. 9C illustrates a method 374 that allows two consecutive scans according to one embodiment. In block 376, the reader is turned off within a predetermined period of time (eg, 3 minutes in the illustrated embodiment) after the first scan has been performed, or other from the sensor results screen. Move to the screen. As indicated by block 378, if the reader is turned on again within a predetermined period of time from the first scan, or if the next scan is attempted, until the predetermined period has elapsed, The second scan is prevented. A “NO NEW SACN” screen 380 is displayed indicating that the next scan is not permitted at this time. In some examples, as shown, screen 380 provides the time remaining until the next scan can be performed. In the illustrated embodiment, when the user confirms from screen 380, the home screen is presented to the user, as indicated by block 382. As indicated by block 384, the screen 380 may also provide an option that allows the user to view the last measurement in the record book.

Sensor Results Interface Some aspects of the present disclosure provide a graphical user interface that generally functions to provide sensor results that can be used in connection with the readers described herein.

Results FIG. 10A shows an example of a sensor results screen 388, according to one embodiment. The screen 388 can be provided, for example, after a successful scan. The example sensor results screen 388 shown includes a sensor reading 389a, a graph 389b of acquired glucose readings, and various reader / sensor related information such as trending arrows, current time, battery life Including sensor expiration. In certain embodiments, the time may be displayed in a 24-hour format or a 12-hour (am / pm) format. In certain embodiments, numerical glucose results are displayed in selectable units (eg, mg / dL shown in FIG. 10A, mmol / L shown in FIG. 10L, or other units). Also good. As shown at block 390, a trigger element 389c is also provided for navigating to the note interface for presenting the note screen to the user. In other embodiments, other combinations of the above and other functions and trigger elements may be included.

  In one embodiment, if the current glucose value is not available, the graph 389b is not displayed. Instead, a screen is displayed indicating that glucose results are not available.

  In one embodiment, graph 389b displays past result measurements for a given time period. The entire period may be divided into a first predetermined period 389d and a second predetermined period 389f. The second predetermined period 389f is a period following the first predetermined period 389d and includes a measurement value more recent than the first predetermined period 389d. For example, in the illustrated embodiment, at 10:23 pm, the graph 389b displays measurements for eight hours (eg, 2:00 pm to 10:00 pm) in the first predetermined period 389d. In addition, more recent measurement values for one hour (for example, 10 pm to 11 pm) within the second predetermined period 389 f are also displayed. When the graph 389b is displayed at 10:23 pm, the measurement value of the last 23 minutes (for example, 10 pm to 10:23 pm) is shown in the second predetermined period 389f. As subsequent measurements are acquired, graph 389b tracks the measurements within a second predetermined time period 389f. Once subsequent measurements are taken for the entire second predetermined period 389f, the entire measurement plot is shifted by the time of the second predetermined period 389f (eg, 1 hour). In other words, if subsequent measurements are obtained until 11:00 pm, the plot of the measurements from 3 pm to 11:00 pm is shifted to the first predetermined period 389d and the second no measurement value is obtained. A predetermined period 389f starts and tracking of the measured values from 11:00 pm to 12:00 pm is started. When the subsequent measurement values up to 12:00 are obtained, the entire measurement value plot is again shifted by the time of the second predetermined period 389f (for example, 1 hour), and the above processing is repeated.

  In one embodiment, if a scan is initiated for the first time and no data is obtained for graph 389b, until the device obtains sensor measurements for at least a first predetermined time period 389d (eg, 8 hours). The graph 389b is not displayed.

  Thus, the started graph 389b has at least a measurement of the entire first predetermined period 389d. For example, in one embodiment, this threshold period is equal to the first predetermined period 389d. In another embodiment, the threshold period is longer than the first predetermined period so that sensor measurements for some or all of the second predetermined period are obtained.

  Note that in other embodiments, a graph template may initially be displayed, but the graph does not show sensor measurements until the device obtains sensor measurements for at least the first predetermined time period 389d.

Unusable Measurements FIG. 10B shows an example of a “RESULTS NON ACTIONABLE” screen 394 according to one embodiment. If a scan is performed and the resulting measurement is not available, the “Result Unavailable” screen 394 informs the user that the result is unusable and that the result should be confirmed. Show. Unusable results are measurements that are determined to be too high or too low to be treated, determined or recommended (eg, insulin calculation), for example. Screen 394 includes a trigger element to provide the user with further information regarding unavailable measurements. When selected by the user, a “NON ACTIONABLE MESSAGE” screen 396 with further details, recommendations, etc., such as recommending the user to take a test strip measurement before making a therapeutic decision. Is provided. If the user confirms (eg, by touching an “OK” button 396a), the user is returned to the previously displayed results screen. In certain embodiments, the “result unavailable” screen may also include additional icons, such as the high glucose icon shown in FIG. 10M, as described below. FIG. 10M shows a display screen 394a that includes a result unavailable icon and a high glucose icon.

Results Masking Mode FIG. 10C illustrates an example of a screen 398 with results masked, according to one embodiment. If a scan is performed when the device is set to masking mode, a screen 398 with the results masked is displayed to indicate to the user that the measurement was successful. Screen 398 does not provide the resulting measurement to the user. The resulting measurements are stored in the device along with other scan results measurements. These stored measurements can later be accessed by a physician or other medical professional (HCP). For example, the physician or HCP may download the data at the next visit of the patient (eg, via a wired or wireless connection between the reader and the physician or HCP computer), or the data may be Alternatively, it may be transferred from a patient's PC) to a doctor or HCP computer or server via the Internet.

Sensor temperature (too high / too low)
FIG. 10D illustrates an interface indicating that the temperature of the sensor is too high, according to one embodiment. For example, a “RESULT SNSR TEMP HIGH” screen 402 is displayed to indicate to the user that the temperature of the sensor is too high for a predetermined “safe” temperature range. For example, the screen 402 may have a warning message and / or icon indicating high sensor temperature, as shown, and may further indicate that a glucose measurement cannot be made. Screen 402 provides a trigger element 402a for providing further information regarding high sensor temperature. For example, if the user touches the touch sensor button 402a, another screen 404 is displayed to provide further details or information such as the sensor temperature is too high and the user should try again later. .

  FIG. 10E illustrates an interface indicating that the temperature of the sensor is too low, according to one embodiment. For example, a “RESULT SNSR TEMP LOW” screen 406 is displayed to indicate to the user that the temperature of the sensor is too low for a predetermined “safe” temperature range. For example, the screen 406 may have a warning message and / or icon indicating a low sensor temperature, as shown, and may further indicate that a glucose measurement cannot be made. Screen 406 provides a trigger element 406a for providing further information regarding low sensor temperatures. For example, if the user touches the touch sensor button 406a, another screen 408 is displayed to provide further details or information such as the sensor temperature is too low and the user should try again later. .

High / Low Measurements Out of Range FIG. 10F shows an interface that indicates that a sensor measurement is out of range, according to one embodiment. A “Results Sensor High” (RESULTS SNSR HI) screen 412 is displayed to indicate to the user that the sensor measurement is too high and out of the range of the measurement. Screen 412 displays indicator elements 412a such as messages, icons, symbols, etc. instead of displaying sensor measurements. For example, in the illustrated embodiment, the term “HI” 412a is shown instead of a sensor measurement to indicate that the measurement is out of range and too high.

  The measurement value of the predetermined upper threshold may be determined based on a predetermined numerical value (eg, 500 mg / dL) or for a predetermined “acceptable” range of displayed measurement values (eg, , 40 mg / dL to 500 mg / dL) or a target range or the like (for example, 350 mg / dL higher than the target range).

  The screen 412 may also include a sensor measurement graph 412B that also shows the target range 412D. Screen 412 provides a trigger element 412C for providing further information, warnings, instructions, etc. regarding high sensor readings that are out of range. For example, if the user touches touch sensor button 412C, the glucose level is out of range and high, the high glucose level may be dangerous, the user should check again later, and each user's medical Another screen 414 is displayed that provides further details or information, such as the treatment recommended by the expert, etc. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 412.

  FIG. 10G illustrates an interface that indicates that a sensor measurement is out of range, according to one embodiment. A “RESULTS SNSR LO” screen 416 is displayed to indicate to the user that the sensor reading is out of range and too low. Screen 416 displays indicator elements 416a such as messages, icons, symbols, etc. instead of displaying sensor measurements. For example, in the illustrated embodiment, the term “LO” 416a is shown instead of a sensor measurement to indicate that the measurement is out of range and too low.

  The measurement value of the predetermined lower threshold may be determined based on a predetermined numerical value (eg, 40 mg / dL) or for a predetermined “acceptable” range of displayed measurement values (eg, , 40 mg / dL to 500 mg / dL), or a target range or the like (for example, 20 mg / dL lower than the target range).

  The screen 416 may also include a sensor measurement graph 416b that also indicates the target range 416D. Screen 416 provides a trigger element 416c for providing further information, warnings, instructions, etc. regarding low sensor readings that are out of range. For example, if the user touches the touch sensor button 416c, the glucose level is out of range and low, the low glucose level may be dangerous, the user should check again later, and each user's medical Another screen 418 is displayed that provides further details or information, such as a treatment recommended by an expert, etc. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 416.

High / Low Sensor Measurements FIG. 10H illustrates an interface that indicates high sensor measurements, according to one embodiment. For example, a message, icon, symbol, etc. 422c displays a “RESULTS SNSR HIGH” screen 422 that indicates to the user that the sensor measurement value is a high measurement value. For example, in the illustrated embodiment, after a high measurement value is obtained, the screen 422 is displayed to show the sensor measurement value 422a. In addition to displaying sensor measurement 422a, screen 422 includes a trigger element 422c that indicates that the measurement is high and provides access to further information such as warnings, instructions, etc. regarding the high sensor measurement. For example, if the user touches the touch sensor button 422c, the glucose level is high, the high glucose level may be dangerous, the user should check again later, and each user's medical professional recommends Another screen 424 is displayed that provides further details or information regarding the high measurement value, such as that a treatment to be performed should be performed. In certain embodiments, the high measurement screen may include a reminder option. When a reminder is selected on the high measurement value screen, the reminder appears in the reminder list as will be described later. The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 422.

  The measurement value of the predetermined upper threshold may be determined based on a predetermined numerical value (for example, 240 mg / dL), or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range or the like may be determined (for example, 120 mg / dL higher than the target range).

  The screen 422 may also include a sensor measurement graph 422b that also indicates the target range 422d. Further, the screen 422 may include a distinguishing element 422f (eg, a circled point 422f in the illustrated embodiment) for identifying high measurements on the graph 422b. Screen 422 may also include other trigger elements such as trigger element 422e for initiating the note interface.

  FIG. 10I illustrates an interface that indicates low sensor readings, according to one embodiment. For example, a message, icon, symbol, etc. 426c indicates to the user “RESULTS SNSR LOW” that the sensor reading is a low reading (eg, for a given “acceptable” reading range). A screen 426 is displayed. For example, in the illustrated embodiment, after a low measurement value is obtained, the screen 426 is displayed, indicating the sensor measurement value 426a. In addition to displaying sensor measurements 426a, screen 426 includes a trigger element 426c that indicates that the measurement is low and provides access to further information such as warnings, instructions, etc. regarding the low sensor measurement. For example, if the user touches the touch sensor button 426c, the glucose level is low, the low glucose level can be dangerous, the user should check again later, and each user's medical professional recommends Another screen 428 is displayed that provides further details or information regarding the low measurement values, such as the treatment to be performed, etc. In certain embodiments, the low measurement screen may include a reminder option. When a reminder is selected on the low measurement value screen, the reminder appears in the reminder list, as will be described later. The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 426. In certain embodiments, the reminder time for low glucose levels and the reminder time for high glucose levels may each be different (eg, 20 minutes for low glucose and 2 hours for high glucose). Of course, within the scope of this disclosure, the low glucose reminder time may include other suitable times, such as 15 minutes, 10 minutes, or 30 minutes, and the high glucose reminder time is 1 hour, 1.5 hours. , Other suitable times, such as 30 minutes.

  The measurement value of the predetermined lower threshold may be determined based on a predetermined numerical value (for example, 70 mg / dL), or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range may be determined (for example, 10 mg / dL lower than the target range).

  The screen 426 may also include a sensor measurement graph 426b that also indicates the target range 426d. Further, the screen 426 may include a distinguishing element 426f (eg, a circled point 426f in the illustrated embodiment) for identifying low measurements on the graph 426b. Screen 426 may also include other trigger elements, such as trigger element 426e for initiating the note interface.

Predicted High / Low Sensor Measurements FIG. 10J illustrates an interface indicating that high analyte levels are predicted according to one embodiment. For example, a message, icon, symbol, etc. 432c displays a “RESULTS SNSR PROJ HIGH” screen 432 that indicates to the user that a high analyte level is predicted based on current sensor measurements and trends. The For example, in the illustrated embodiment, after sensor measurements are obtained, screen 432 is displayed, indicating sensor measurements 432a. In addition to displaying sensor measurements 432a, screen 432 includes a trigger element 432c that indicates that a high analyte level is predicted and provides access to further information such as warnings, instructions, etc. regarding the predicted high analyte level. . For example, if the user touches the touch sensor button 432c, the glucose level is high, the high glucose level can be dangerous, the user should check again later, and each user's medical professional recommends Another screen 434 is displayed that provides further details or information regarding the anticipated high analyte level, such as a treatment to be performed. In certain embodiments, the predicted high measurement screen may include a reminder option. When a reminder is selected on the predicted high measurement value screen, the reminder appears in the reminder list, as will be described later. The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 432.

  The predicted high glucose measurement may be based on the user's predicted glucose level within a predetermined next time period (eg, within the next 15 minutes). The measurement value of the predetermined upper threshold may be determined based on a predetermined numerical value (for example, 240 mg / dL) or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range may be determined (for example, 120 mg / dL higher than the target range).

  The screen 432 may also include a sensor measurement graph 432b that also shows the target range 432d. Further, the screen 432 may include a distinguishing element 432f (eg, a circled point 432f in the illustrated embodiment) for identifying the predicted high measurement value on the graph 432b. Screen 432 may also include other trigger elements, such as trigger element 432e for initiating the note interface.

  FIG. 10K illustrates an interface indicating that low analyte levels are predicted according to one embodiment. For example, a message, icon, symbol, etc. 436c displays a “RESULTS SNSR PROJ LOW” screen 436 that indicates to the user that a low analyte level is predicted based on current sensor measurements and trends. The For example, in the illustrated embodiment, after sensor measurements are obtained, screen 426 is displayed, indicating sensor measurements 436a. Screen 436 includes, in addition to displaying sensor measurements 436a, a trigger element 436c that indicates that a low analyte level is predicted and provides access to further information such as warnings, instructions, etc. regarding the predicted low analyte level. . For example, if the user touches the touch sensor button 436c, the glucose level is low, the low glucose level can be dangerous, the user should check again later, and each user's medical professional recommends Another screen 438 is provided that provides further details or information regarding the expected low analyte level, such as the treatment to be performed. In certain embodiments, the predicted low measurement screen may include a reminder option. When a reminder is selected on the predicted low measurement value screen, the reminder appears in the reminder list, as will be described later. The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 436.

  The predicted low glucose measurement may be based on the user's predicted glucose level within a predetermined next time period (eg, within the next 15 minutes). The measurement value of the predetermined lower threshold may be determined based on a predetermined numerical value (for example, 70 mg / dL), or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range may be determined (for example, 10 mg / dL lower than the target range).

  The screen 436 may also include a sensor measurement graph 436b that also shows the target range 436d. In addition, the screen 436 may include a distinguishing element 436f (eg, in the illustrated embodiment, a circled point 436f) for identifying the predicted low measurement on the graph 436b. Screen 436 may also include other trigger elements such as trigger element 436e for initiating the note interface.

Blood Glucose Tests and Results In some aspects of the present disclosure, a graphical function that can be used in connection with the reader described herein, generally functioning to perform an analyte test and provide test results. A user interface is provided.

Blood Glucose Strip Test Interface FIG. 11 illustrates an example of a method 440 for performing a blood glucose test using a test strip, according to one embodiment. At block 442, a test strip is inserted into the analyte monitoring device that is powered off. Once inserted into the device, the device is turned on as indicated by block 444. As indicated by block 446, a strip port light, such as a light emitting diode, is turned on to provide illumination to the strip port. At block 448, it is determined whether a universal serial bus (USB) connection is established with the device. In other embodiments, other communication technologies such as micro USB, mini USB, RS-232, Ethernet, Firewire, or other data communication connections may be implemented. If a USB connection is established, the strip test is prevented and indicates that the strip test cannot be performed and that the user should unplug the device to perform the glucose test. A STRIP TEST DISABLED screen 450 is displayed. If the test strip is removed or the USB connection is released, the reader displays a home screen.

  If it is determined at block 448 that a USB connection has not been established, whether the inserted test strip is a blood glucose test strip or a ketone test strip, as indicated at block 452. It is determined. The test strip may include an identification element such as a specific contact configuration that allows the device to identify what type of test strip it is. If it is determined that the test strip is a ketone test strip, the device initiates a ketone test interface to perform a ketone test measurement, as indicated by block 454. On the other hand, if it is determined that the test strip is a blood glucose test strip, it is determined whether the device temperature is outside the operating range of the device, as represented by block 456 and reference path F. .

  If the temperature is determined to be higher or lower than the operating range of the device, in certain embodiments, the port light is turned off and a strip / hardware error screen 458 is displayed indicating that the operating temperature is too high or too low. Is done.

  If block 456 determines that the temperature is within the operating range of the device, the strip is checked for errors (checking the strip for damage or incompatibility as indicated by block 460). , Including ascertaining whether blood has not been applied to the strip too early or the strip has been used, as indicated by block 464). If the device determines that the strip is damaged, incompatible, or already used, the display may navigate to strip / hardware error screens 462,466.

  If it is determined that there are no strip errors, an “add blood” interface 468 is displayed indicating that blood may be applied to the test strip. If the test strip is removed at this point, as indicated by block 470, the port light is turned off and the home screen is displayed as represented by block 471. As shown at block 472, if blood is applied to the test strip on screen 468, whether or not sufficient blood has been applied to accurately perform the test measurement, as shown at block 474. It is determined. Note that the timing of this determination can vary. If there is not enough blood, a strip / hardware error interface is displayed indicating that not enough blood was applied or there was an error, as indicated at block 476.

  If it is determined that sufficient blood has been applied to the test strip, the port light is turned off and a test measurement is performed, as indicated by block 478. While performing a test measurement, a standby interface 480 may be displayed. At block 482, it is determined whether the result is ready. When ready, a strip test result screen 486 showing the measured values of the results is displayed. If not ready (eg, after a predetermined timeout period), a strip / hardware error screen 484 is displayed indicating that there was an error in the measurement. In certain embodiments, the device may also perform a low battery test as described above with respect to FIG. 8 before displaying the results.

  Turning to FIG. 34, an example of a standby interface according to one embodiment is shown. The standby interface 2400 is animated. For example, the first screen 2402 includes a butterfly 2401 in the lower left corner. When the next screen 2404 is displayed, the butterfly 2401 is in a different position. Similarly, on the next screen 2406, the butterfly 2401 has been moved again to a different position. When displayed continuously, a series of animations are displayed.

  FIG. 34 also shows an example of an animation interface 2408 for instructing the user to add blood, according to one embodiment. Screens 2410, 2412, and 2414 display images of the finger with blood and the sample monitoring device with the test strip inserted into the strip port. As the series of screens 2410, 2412, and 2414 progress, the finger and test strip move closer together and the blood application process is animated. The animation interface 2408 may be displayed, for example, when the sample monitoring device is ready to accept blood.

  FIG. 34 also illustrates an example of an animation interface 2415 for instructing the user to add blood during a ketone test, according to one embodiment. Similar to the animation interface 2408, the screens 2416, 2418, and 2420 display images of the finger with blood and the sample monitoring device with the test strip inserted into the strip port. As the series of screens 2416, 2418, and 2420 progress, the finger and test strip move closer together and the blood application process is animated. However, the animation interface 2408 includes an indication that the ketone inspection is being executed (for example, an indication of the word “ketone inspection”).

Blood glucose strip test result interface In some aspects of the present disclosure, a graphical that generally functions to provide blood glucose strip test results that may be used in connection with the reader described herein. A user interface is provided.

Results Screen FIG. 12A shows an example of a blood glucose results (RESULTS BG) screen 490, according to one embodiment. Screen 490 may be provided, for example, after a test strip measurement has been successfully performed. The example blood glucose results screen 490 shown includes various specimens such as test strip measurements 490a, blood glucose strip test indicator elements 490b, current time indicator elements 490d, battery life indicator elements 490e, etc. And related and device related information. As shown at block 494, a trigger element 490c is also provided for navigating to the note interface to present the note screen to the user. In other embodiments, other combinations of the above and other functions and trigger elements may be included.

  In a sample monitoring device with a residual insulin calculator, the screen 492 may be provided, for example, after a test strip measurement has been successfully performed. The example blood glucose results screen 492 shown is for various specimens such as test strip measurements 492a, blood glucose strip test indicator elements 492b, current time indicator elements 492d, battery life indicator elements 492e, etc. And related and device related information. A trigger element 492c is also provided for navigating to the note interface to present the note screen to the user, as indicated by block 494. As indicated by block 496, a trigger element 492f is also provided for navigating to an insulin calculation interface to provide an insulin dose calculated based on the test measurement 492a. In certain embodiments, the insulin calculation interface may be an advanced calculator interface or a simple calculator interface, based on the current configuration device, as described in detail below. In other embodiments, other combinations of the above and other functions and trigger elements may be included.

Control Solution Screen FIG. 12B illustrates an example interface showing the results of a blood glucose control solution test, according to one embodiment. RESULTS CTRL SLTN screen 498 includes blood glucose control solution test results 498a, blood glucose control solution test indicator element 498b, current time indicator element 498d, battery life indicator element 498e, etc. And various sample-related and device-related information.

Reader Temperature Warning (Too High / Too Low) Screen FIG. 12C illustrates an example interface indicating that the temperature of the analyte monitoring device is too high or too low, according to one embodiment. For example, for a given “safe” temperature range for accurately performing a test measurement, the “blood glucose result temperature high 2 / low” indicates to the user that the instrument temperature is too high or too low to provide a measurement. The 2 ″ (RESULTS BG TEMP HIGH2 / LOW2) screen 502 is displayed. For example, the screen 502 may have a warning message and / or icon 502a indicating that the temperature is too high or too low, as shown, and may further indicate that no glucose measurement is available. Screen 502 provides a trigger element 502b for providing further information regarding device temperature that is too high or too low. For example, if the user touches the touch sensor button 502b, another screen 504 to provide further details or information such as the device temperature is too low or too high and the user should try again later 506 is displayed. The user can confirm by pressing the “OK” button and return to the previously displayed result screen, for example.

  The “RESULTS BG TEMP HIGH1 / LOW1” screen 508 shows that the test measurement is available, but the device temperature is high or low for a given “safe” temperature range, for example. It is an example of the interface displayed when showing to a user. For example, the screen 508 displays the resulting test measurement 508a and also displays a warning message and / or icon 502b indicating that the device temperature is high or low. Icon 502b also functions as a trigger element to provide further information regarding high or low device temperature. For example, if the user touches the touch sensor button 502b, another screen 512 or 510 is displayed that provides further details or information such as the device temperature is too low or too high, the user should try again later, etc. Is done. In one embodiment, the device is programmed to prioritize temperature errors over other notifications that may be executed.

“Out of Range High / Low” Screen FIG. 12D illustrates an interface indicating that a measurement is out of range, according to one embodiment. A “blood glucose result high” (RESULTS BG HI) screen 516 is displayed to indicate to the user that the sensor measurement is too high and out of range of the measurement. The screen 516 displays indicator elements 516a such as messages, icons, symbols, etc. instead of displaying the measured values. For example, in the illustrated embodiment, instead of a measurement value, the term “HI” 516a is shown to indicate that the measurement value is out of range and too high.

  The measurement value of the predetermined upper threshold may be determined based on a predetermined numerical value (eg, 500 mg / dL), or for a predetermined “acceptable” range of displayed measurement values (eg, , 20 mg / dL to 500 mg / dL), or a target range or the like (for example, 350 mg / dL higher than the target range).

  Screen 516 provides a trigger element 516 to provide further information, warnings, instructions, etc. regarding high measurements outside the range. For example, if the user touches the touch sensor button 516b, the glucose level is out of range, the high glucose level can be dangerous, the user should check again later, and each user's medical expertise Another screen 518 is displayed that provides further details or information, such as the home recommended treatment, etc. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 516.

  FIG. 12E illustrates an interface indicating that a measurement value is out of range, according to one embodiment. A “RESULTS BG LO” screen 520 is displayed indicating to the user that the measured value is out of range and too low. Instead of displaying sensor measurements, the screen 520 displays indicator elements 520a such as messages, icons, symbols, and the like. For example, in the illustrated embodiment, instead of a measurement value, the term “LO” 520a is shown to indicate that the measurement value is out of range and too low.

  The measurement value of the predetermined lower threshold may be determined based on a predetermined numerical value (eg, 20 mg / dL) or for a predetermined “acceptable” range of displayed measurement values (eg, , 20 mg / dL to 500 mg / dL) or a target range or the like (for example, 40 mg / dL lower than the target range).

  Screen 520 provides a trigger element 520a for providing further information, warnings, instructions, etc. regarding low measurements that are out of range. For example, if the user touches the touch sensor button 520b, the glucose level is out of range, the low glucose level can be dangerous, the user should check again later, and each user's medical expertise Another screen 522 is provided that provides further details or information, such as the home recommended treatment should be taken. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 520.

“High / Low Glucose” Screen FIG. 12F illustrates an interface that indicates a high measurement value, according to one embodiment. For example, a message, icon, symbol, trigger element, etc. 526c displays a “RESULTS BG HIGH” screen 526 that indicates to the user that the measurement is a high measurement. For example, in the illustrated embodiment, after a high measurement value is obtained, screen 526 is displayed, showing measurement value 526a. In addition to displaying the sensor reading 526a, the screen 526 provides access to additional information, warnings, instructions, and recommendations (such as recommending that you examine the ketone) that indicate that the reading is high and that it is high. Including a trigger element 526c. For example, if the user touches the touch sensor button 422c, the glucose level is high, the high glucose level may be dangerous, the user should check again later, and each user's medical professional recommends Another screen 528 is displayed that provides further details or information regarding the high measurement value, such as that a treatment to be performed should be performed. In certain embodiments, the high glucose level screen may include a reminder option. When a reminder is selected on the high glucose level screen, the reminder appears in the reminder list as will be described later. The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 526.

  The measurement value of the predetermined upper threshold value may be determined based on a predetermined numerical value (for example, 240 mg / dL), or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range may be determined (for example, 120 mg / dL higher than the target range).

  Screen 526 may also include an indicator element (eg, icon, symbol, etc.) 526b indicating that the measurement is for a blood glucose strip test. In the illustrated embodiment, a blood drop symbol 526b is used. Screen 526 may also include other trigger elements such as trigger element 526e for initiating the annotation interface.

  FIG. 12G illustrates an interface indicating that the measurement is low, according to one embodiment. For example, a message, icon, symbol, trigger element, etc. 530c indicates to the user that the measurement is low (eg, for a given “acceptable” measurement range) “blood glucose result low” ( RESULTS BG LOW) screen 530 is displayed. For example, in the illustrated embodiment, after a low measurement value is obtained, the screen 530 is displayed, showing the measurement value 530a. In addition to displaying the measured value 530a, the screen 530 includes a trigger element 530c for indicating that the measured value is low and for accessing further information such as warnings, instructions, etc. regarding the low sensor measured value. For example, if the user touches the touch sensor button 530c, the glucose level is low, the low glucose level can be dangerous, the user should check again later, and each user's medical professional recommends Another screen 532 is displayed that provides further details or information regarding the low measurement values, such as the treatment to be performed, etc. In certain embodiments, the low glucose level screen may include a reminder option. When a reminder is selected on the low glucose level screen, the reminder appears in the reminder list as will be described later. As described above, in certain embodiments, the reminder time for low glucose results and the reminder time for high glucose results may each be configured differently (eg, 15 minutes for low glucose and high glucose For 1 hour or 2 hours). The device checks whether the reminder list is full before adding a new reminder. As will be described later, the reminder is saved only when navigating back to the home screen from the result screen or when the device times out on the result screen. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 530.

  The measurement value of the predetermined lower threshold may be determined based on a predetermined numerical value (for example, 70 mg / dL), or for a predetermined measurement value range (for example, 70 mg / dL to 240 mg / dL) Alternatively, the target range may be determined (for example, 10 mg / dL lower than the target range).

  Screen 530 may also include an indicator element (eg, icon, symbol, etc.) 530b indicating that the measurement is for a blood glucose strip test. In the illustrated embodiment, the blood drop symbol 530b is used. Screen 530 may also include other trigger elements such as trigger element 530e for initiating the annotation interface.

Masking Mode When the device is in masking mode, the blood glucose control solution test results or blood glucose test strip results may be masked on the display. FIGS. 12H and 12I show the display screens with the blood glucose control solution test results and the blood glucose test strip results masked, respectively.

Ketone Tests and Results In some aspects of the present disclosure, a graphical function that can be used in connection with the readers described herein, generally functioning to perform ketone strip test measurements and provide test results. A user interface is provided.

Ketone Strip Test Interface FIG. 13 illustrates an example method 534 for performing a ketone test using a ketone test strip, according to one embodiment. At block 536, a ketone test strip is inserted into the analyte monitoring device that is powered off. Once inserted into the device, the device is turned on as indicated by block 538. As indicated by block 540, a strip port light, such as a light emitting diode, is turned on to provide illumination to the strip port. At block 542, it is determined whether a universal serial bus (USB) connection is established with the device. In other embodiments, other communication technologies such as micro-USB, mini USB, RS-232, Ethernet, Firewire, or other data communication connections may be implemented. If a USB connection is established, the strip test is prevented, the strip test cannot be performed, and the user should unplug the device to perform a ketone test or blood glucose test A strip inspection impossible screen 544 indicating that this is displayed. If the test strip is removed or the USB connection is released, the reader displays a home screen.

  If it is determined at block 542 that a USB connection has not been established, whether the inserted test strip is a blood glucose test strip or a ketone test strip, as indicated at block 546. It is determined. The test strip may include an identification element such as a specific contact configuration that allows the device to identify what type of test strip it is. If it is determined that the test strip is a blood glucose test strip, the device initiates a blood glucose strip test interface for making a blood glucose test measurement, as indicated by block 548. On the other hand, if it is determined that the test strip is a ketone test strip, it is determined whether the device temperature is outside the operating range of the device, as represented by block 550 and reference path H. If it is determined that the temperature is above or below the operating range of the device, in certain embodiments, the port light is turned off and a strip / hardware error screen 551 is displayed indicating that the operating temperature is too high or too low. Is done.

  If block 550 determines that the temperature is within the operating range of the device, the strip is checked for errors (checking the strip for damage or incompatibility as indicated by block 552). , Including checking whether blood has been applied to the strip too early or whether the strip has been used, as indicated by block 554). If the device determines that the strip is damaged, incompatible, or already used, the display may navigate to the strip / hardware error screens 553, 555.

  If it is determined that there are no strip errors, a “PK ADD BLOOD” interface 556 is displayed indicating that blood may be applied to the test strip. If the test strip is removed at this point, as indicated by block 558, the port light is turned off and the home screen is displayed, as represented by block 560. As shown at block 564, when blood is applied to the test strip at screen 556, sufficient blood is applied to accurately perform the test measurement, as shown at block 566 and reference path I. It is determined whether or not. Note that the timing of this determination can vary. If there is not enough blood, a strip / hardware error interface is displayed indicating that not enough blood was applied or there was an error, as indicated by block 568.

  If it is determined that sufficient blood has been applied to the test strip, a standby interface 570 is displayed while performing a test measurement. At block 572, it is determined whether the result is ready. When ready, a strip test result screen 576 showing the measured value of the result is displayed. If not ready (eg, after a predetermined timeout period), a strip / hardware error screen 574 is displayed indicating that there was an error in the measurement calculation. In certain embodiments, as described above with respect to FIG. 8, the device may also perform a low battery check before displaying the results.

Ketone Strip Test Results Interface Some aspects of the present disclosure provide a graphical user interface that generally functions to provide ketone strip test results that can be used in conjunction with the reader described herein. Is done.

Results Screen FIG. 14A shows an example of a ketone results screen 580, according to one embodiment. Screen 580 may be provided, for example, after a ketone test strip measurement has been successfully performed. The example ketone result screen 580 shown includes a variety of analytes, such as a ketone test strip measurement 580a, an indicator element 580b indicating a ketone strip test, an indicator element 580d indicating the current time, an indicator element 580e indicating a battery life, etc. And related and device related information. In one embodiment, indicator element 580b for identifying a ketone test strip measurement is the same symbol as the indicator element for a blood glucose test strip measurement. In such a case, the indicator element 580b generally indicates the test strip measurement result versus the sensor measurement result. In other embodiments, different indicator elements may be used for the ketone strip test and the blood glucose strip test to distinguish between the two tests.

  As indicated by block 582, a trigger element 580c is also provided for navigating to the note interface to present the note screen to the user. In other embodiments, other combinations of the above and other functions and trigger elements may be included.

  In one embodiment, the insulin calculator is when the setting is enabled and 1) the ketone test is within a predetermined period of good strip test (eg 15 minutes) or another predetermined of good sensor test. Enabled if both of the following conditions have been met: 2) performed within a period (eg, 3 minutes) and 2) no insulin was recorded in that recent glucose test. The insulin calculator button is not provided unless both conditions are met.

Control Solution Screen FIG. 14B illustrates an example interface showing the results of a ketone control solution test, according to one embodiment. The ketone control solution result screen 584 includes a variety of analyte associations and devices such as a ketone control solution test result 584a, an indicator element 584b indicating a control solution test, an indicator element 584d indicating the current time, an indicator element 584e indicating battery life, etc. And related information. In one embodiment, the indicator element 584b for identifying the ketone control solution test is the same symbol as the indicator element for the blood glucose control solution test. In such cases, indicator element 584b generally indicates a control solution test. In other embodiments, different indicator elements may be used in the ketone control solution test and the blood glucose control solution test to distinguish between the two tests.
Reader Temperature Warning (Too High / Too Low) Screen FIG. 14C illustrates an example interface indicating that the temperature of the analyte monitoring device is too high or too low, according to one embodiment. For example, for a given “safe” temperature range for accurate ketone test measurements, the “Ketone Result Temperature High 2 / Low 2” indicates to the user that the instrument temperature is too high or too low to provide a ketone measurement. "(RESULTS KETONE TEMP HIGH2 / LOW2)" screen 588 is displayed. For example, screen 588 may have a warning message and / or icon 588a indicating that the temperature is too high or too low, as shown, and may further indicate that no ketone measurement is available. Screen 588 provides a trigger element 588b for providing further information regarding the device temperature that is too high or too low. For example, if the user touches the touch sensor button 588b, another screen 590 or 592 is displayed that provides further details or information such as the device temperature is too low or too high, the user should try again later, etc. Is done.

  The “RESULTS KETONE TEMP HIGH1 / LOW1” screen 594 shows that a ketone test measurement is available, but the instrument temperature is high or low for a given “safe” temperature range, for example. It is an example of an interface displayed when showing to a user. For example, the screen 594 displays the resulting test measurement 594a and a warning message and / or icon 594b indicating that the device temperature is high or low. Icon 502b also functions as a trigger element to provide further information regarding high or low device temperature. For example, if the user touches the touch sensor button 502b, another screen 598 or 596 is displayed that provides further details or information such as the device temperature is too low or too high, the user should try again later, etc. Is done.

“Out of Range High” Screen FIG. 14D illustrates an interface indicating that a measurement is out of range, according to one embodiment. A “KETONE RESULT-OUT OF RANGE HIGH” screen 602 is displayed that indicates to the user that the ketone measurement is too high and out of the range of the measurement. Screen 602 displays indicator elements 602a such as messages, icons, symbols, etc. instead of displaying ketone measurements. For example, in the illustrated embodiment, instead of a measurement, the term “HI” 602a is shown to indicate that the measurement is out of range and too high.

  The measurement value for the predetermined upper threshold may be determined based on a predetermined numerical value, or determined for a predetermined “acceptable” range of displayed measurement values, or with respect to a target range, etc. Also good.

  Screen 602 provides a trigger element 602b for providing further information, warnings, instructions, etc. regarding out of range high ketone readings. For example, if a user touches the touch sensor button 602b, the ketone level is out of range, the high ketone level can be dangerous, the user should check again later, and each user's medical expertise Another screen 604 is displayed that provides further details or information, such as a home recommended treatment, etc. If the user confirms (eg, by selecting an “OK” button), the user is returned to screen 602.

“High Ketone” Screen FIG. 14E illustrates an interface that indicates a high ketone reading, according to one embodiment. For example, a message, icon, symbol, trigger element, etc. 608c displays a “KETONE RESULT-HIGH KETONES” screen 608 that indicates to the user that the ketone measurement is high.

  The measurement value of the predetermined upper limit threshold value may be determined based on a predetermined numerical value, or may be determined with respect to a predetermined measurement value range, a target range, or the like.

  In the illustrated embodiment, after a high ketone measurement is obtained, screen 608 is displayed, showing measurement 608a. In addition to displaying sensor readings 608a, screen 608 includes a triggering element 608c for indicating that the ketone reading is high and accessing further information such as warnings, instructions, etc. regarding the high reading. For example, if the user touches touch sensor button 608c, the ketone level is high, the high ketone level can be dangerous, the user should check again later, and each user's medical professional recommends Another screen 610 or 612 is displayed that provides further details or information regarding the high measurement value, such as that a treatment to be performed should be performed. In the illustrated embodiment, if the ketone measurement value is within a predetermined range (eg, 0.6 to 1.5), a screen 610 is displayed and the ketone measurement value is high within a predetermined range (eg, 1 .. 6-8), the second screen 612 is displayed.

  Screen 608 may also include an indicator element (eg, icon, symbol, etc.) 608b indicating that the measurement is related to a strip test measurement (eg, a ketone test strip measurement). In the illustrated embodiment, a blood drop symbol 608b is used. Screen 608 may also include other trigger elements, such as trigger element 608e for initiating the note interface.

Masking Mode When the device is in masking mode, the results of the ketone control solution test or the results of the ketone test strip may be masked on the display. 14F and 14G show display screens for the masked ketone control solution test results and the ketone test strip results, respectively.

Annotation Interface An exemplary embodiment of a graphical user interface that facilitates an annotation procedure 3000 for entering notes in a record book that can be used in connection with the reader described herein is provided. This graphical user interface will be described in more detail with reference to FIG.

  The graphical user interface that facilitates the reader annotation procedure 3000 includes a first annotation interface of the 3002 embodiment when the insulin calculator is disabled and a second annotation interface of the 3004 embodiment when the insulin calculator is enabled. May include two different annotation interfaces. The note (insulin calculator disabled) interface 3002 shown in FIG. 15A first displays an “add to record book” screen 3006. This “Add to Record” screen 3006 includes a list of several different notes that may be entered into the record book. This list of user selectable notes may include default notes (eg, preset notes), and in some examples may include custom (eg, user defined) notes. For example, a default note may include one or more of fast-acting insulin 3008, long-acting insulin 3010, food 3012, exercise 3014, and medication 3016. Custom notes may include any notes generated by the user via the associated information software. In some cases, twelve notes may be included in the list of user selectable notes. For example, 5 default notes and 7 custom notes may be included. In certain embodiments, the touch screen displays four user selectable notes at a time. If there are four or more notes that can be selected by the user, the list of notes can be viewed by scrolling touchscreen buttons (down arrow (eg, down triangle) touch screen button 3018 and up arrow). (For example, an upward triangle) touch screen button 3020 or the like) may be scrolled as necessary. One or more user selectable notes may be selected by touching a touch screen check box next to the note that they want to select. Touching the touch screen check box switches the check box from the checked state to the unchecked state, indicating that the associated note is selected or not selected. For example, a quick action insulin note may be selected by touching the touch screen check box 3022 so that a check mark appears in the touch screen check box and the fast action insulin note is selected. Indicates. Similarly, other user selectable notes may be selected or deselected (eg, checked or unchecked) as desired.

  The note selection may be saved by touching an “OK” touch screen button 3024, which saves the user selectable note selection and returns the graphical user interface to the previous screen. If the “OK” touch screen button 3024 is pressed without changing the selection of the note that can be selected by the user, the previous selection of the note that can be selected by the user is held and saved.

  In some embodiments, touching a numeric input touch screen button (eg, a “1 2 3” touch screen button) associated with the desired selection, provides fast acting insulin, long acting insulin, food, exercise, And the amount of medicine may be entered. In some cases, if the corresponding touch screen check box is not checked, the numeric input touch screen button may not be displayed and will only be displayed if the corresponding touch screen check box is checked. May be. For example, if the fast-acting insulin check box 3008 is unchecked, the fast-acting insulin numerical value input touch screen button 3026 is not displayed. If the fast-acting insulin check box is checked (3022), a fast-acting insulin numeric input touch screen button 3026 may be displayed and selected.

  The amount of fast-acting insulin may be entered by pressing a numeric input touch screen button 3026 associated with the selection of a fast-acting insulin note. When a rapid-acting insulin numerical input touch screen button 3026 is pressed, a rapid-acting insulin numerical input screen 3028 (for example, a “fast-acting insulin input” screen) is displayed as shown in the reference path (J) (see FIG. 15B). Is done. On the rapid-acting insulin numerical value input screen 3028, the amount (for example, unit) of fast-acting insulin can be input. On the numeric entry screen, no value is initially displayed (eg, “-” is displayed instead of a numeric value), but an upward arrow is used to increase or decrease the amount of fast-acting insulin as desired. The amount of fast acting insulin may be adjusted by pressing a touch screen button of 3030 (eg, “+”) or a down arrow 3032 (eg, “−”). For example, the amount of fast-acting insulin 3034 may be adjusted in 1 unit increments by tapping the up arrow 3030 or the down arrow 3032. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. Once the desired amount of fast-acting insulin is entered, it may be saved by pressing the “OK” touch screen button 3036, which saves the amount of fast-acting insulin entered and the reference path ( As shown in J), the graphical user interface returns to the “Add to Record” screen 3006. Similarly, by pressing a numeric input touch screen button 3038 (eg, “1 2 3” touch screen button) associated with a long acting insulin selection on the “Add to Record” screen 3006, a long acting insulin. May be entered.

  The numeric value of the food may be entered by pressing a numeric input touchscreen button 3040 (eg, “1 2 3” touchscreen button) associated with the food selection on the “Add to Record” screen 3006. When the food numerical value input touch screen button 3040 is pressed, a carbohydrate numerical value input screen 3042 (for example, a “carbohydrate input” screen) is displayed as shown by the reference path (J) (see FIG. 15C). In the numerical value input screen 3042 for food, the amount of carbohydrates (for example, the number of grams) may be input. On the numeric input screen, no value is initially displayed (eg, “-” is displayed instead of a numeric value), but an upward arrow 3044 (to increase or decrease the amount of carbohydrate as desired). For example, the amount of carbohydrate may be adjusted by pressing a touch screen button of “+”) or a touch screen button of down arrow 3046 (eg, “−”). For example, by tapping the up arrow 3044 or down arrow 3046, the amount of carbohydrate 3048 may be adjusted in 1 gram increments. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. Once the desired amount of carbohydrate has been entered, it may be saved by pressing the “OK” touch screen button 3050 so that the amount of entered carbohydrate is saved and is indicated by the reference path (J). As shown, the graphical user interface returns to the “Add to Record” screen 3006.

  In certain embodiments, instead of entering the amount of food as grams of carbohydrate, the amount of food may be entered as servings of carbohydrate, as shown in FIG. 15E. In the numerical value input screen 3068 of the serving number of carbohydrates, no value is initially displayed (for example, “-” is displayed instead of the numerical value), but to increase or decrease the serving number of carbohydrates as desired. In addition, the carbohydrate serving number is adjusted in 0.5 serving increments by pressing the touchscreen button with an upward arrow 3070 (eg “+”) or the touchscreen button with a downward arrow 3072 (eg “−”). May be. For example, the number of carbohydrate servings 3074 may be adjusted by tapping the up arrow 3070 or down arrow 3072. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. In some cases, the carbohydrate serving number input screen 3068 may include a display 3076 of grams of carbohydrate corresponding to the number of servings entered. In some cases, the carbohydrate serving number input screen 3068 may include a display 3078 of carbohydrate energy (eg, kcal) corresponding to the input serving number. Once the desired carbohydrate serving number has been entered, the value may be saved by pressing the “OK” touch screen button 3080, which will save the entered carbohydrate serving number and the graphical user interface will “record” The screen returns to the “Add to Book” screen 3006.

  Referring again to the numeric input screen 3042 (see FIG. 15C) for the amount of carbohydrates (eg, grams), the numeric input screen 3042 also includes two touch screen check boxes configured to allow the user to select a glucose check reminder. . For example, the numeric input screen 3042 includes a “1 hour” touch screen check box 3052 and a “2 hour” touch screen check box 3054. If desired, neither touch screen check box may be selected, or one or both touch screen check boxes may be selected. When the “1 hour” touch screen check box 3052 is pressed, a check mark indicating that the “1 hour” touch screen check box 3052 is selected is displayed in the “1 hour” touch screen check box 3052. The reader is set to inform the user to check the glucose level. When the “2 hours” touch screen check box 3054 is pressed, a check mark indicating that the “2 hours” touch screen check box 3054 is selected is displayed in the “2 hours” touch screen check box 3054. The reader is set to inform the user to check the glucose level. The glucose check reminder check box may also be displayed on the numerical value input screen 3068 for inputting the serving number of carbohydrates described above (see FIG. 15E).

  As indicated above, in the embodiment of 3004 when the insulin calculator is enabled, a second annotation interface may be provided. The note (insulin calculator enabled) interface 3004 shown in FIG. 15D first displays an “Add to Record Book” screen 3056. This “Add to Record” screen 3056 includes a list of several different notes that may be entered into the record book, similar to the “Add to Record Book” screen 3006 of the note (insulin calculator disabled) interface 3002 described above. In the “Add to Record” screen 3056 of the note (insulin calculator enabled) interface 3004, a user selectable note (eg, default) as desired, as described above for the note (insulin calculator disabled) interface 3002. And custom notes) can be selected (eg, checked) or deselected (eg, unchecked). Further, the numeric input touch screen buttons (eg, “1 2 3” touch screen buttons) of the note (insulin calculator enabled) interface 3004 function in the same manner as described above with respect to the note (insulin calculator disabled) interface 3002.

  In the note (insulin calculator enabled) interface 3004, the remaining insulin and fast acting insulin calculator functions of the graphical user interface are enabled. For example, the note (insulin calculator enabled) interface 3004 displays a calculator touchscreen button 3058 with a choice of fast-acting insulin instead of displaying a fast-acting insulin numeric input touchscreen button. Pressing calculator touchscreen button 3058 displays a graphical user interface for residual insulin interface 3060 (see FIG. 16) and insulin calculator interface 3062 (see FIG. 17). In some embodiments, if food information (eg, amount of carbohydrates) is entered as described above, if the calculator touchscreen button 3058 is pressed, the amount of carbohydrates previously entered will be the corresponding remaining amount. Insulin and automatically displayed on the computer interface screen.

  In certain embodiments, if the “add or edit note” touchscreen button is pressed from the record entry screen, the “note-from record entry” interface 3064 may be displayed. The “note-from record book entry” interface 3064 first displays the “add to record book” screen 3066. This “Add to Record” screen 3066 includes a list of several different notes that the user can select that can be entered into the record book, similar to the notes that the user can select. In a particular embodiment, the “Add to Record” screen 3066 of the “Note-to-Record entry” interface 3064 does not include a user-selectable fast-acting insulin or food note. Other default notes (eg, long acting insulin, exercise, medication) and custom notes may still be available for the user to select as desired.

Residual insulin interface As noted above, pressing the calculator touchscreen button 3058 from the “Add to Record” screen 3056 of the note (insulin calculator enabled) interface 3004 causes the graphical user interface to display the residual insulin interface 3060 (see FIG. 16). To do. With reference to FIG. 16A, in certain embodiments, the user's residual insulin (IOB) information is used to calculate the recommended fast-acting insulin dose. For example, if the insulin dose is recorded (eg, if it is recorded as a calculated dose, or entered in the record book as a fast-acting dose), the recommended fast-acting type Insulin dosage information may be used to calculate the insulin dosage (3082).

  In certain embodiments, if the user's most recent insulin dose is administered within a period of time, the user's remaining insulin information is used to calculate the recommended fast-acting insulin dose. It is done. In some instances, if the difference between the current time and the time of the most recent fast-acting insulin administered is less than the lockout period (eg, the most recent insulin dose is within the past 2 hours, etc.) The insulin calculator may be partially locked (if administered within the previous lockout period). During the lockout period, the insulin calculator may be programmed to calculate only a meal bolus and no additional correction bolus (3084). During the lockout period, the insulin calculator may not include residual insulin in the meal bolus calculation.

  An insulin calculator is recommended if the difference between the current time and the time when the most recent insulin bolus was administered is greater than a threshold period (eg, a lockout period) and less than the duration of action of insulin. It may be programmed to include the user's IOB in the calculation of the fast acting insulin dose (3086). The insulin calculator determines a recommended fast-acting insulin dose based on the determined analyte concentration and residual insulin information during the period between the end of the lockout period and the end of the user's insulin action period May be programmed as follows. The insulin calculator, for example, during the period between the end of the lockout period and the end of the user's insulin action period, determines the recommended fast-acting insulin dose based on the current glucose concentration level. It may be programmed to subtract the user's IOB from the type insulin dose.

  In certain instances, the insulin calculator may recommend a fast-acting insulin dose if the difference between the current time and the time the most recent insulin bolus was administered is greater than the user's duration of insulin action. Do not include residual insulin in the amount calculation (3088). The insulin calculator may assume that the user's remaining insulin is zero in the period after the user's insulin action period ends (and before the next dose of insulin is administered). The insulin calculator is a fast-acting type based on the glucose concentration (without residual insulin information) during the period after the user's insulin action period ends (and before the next dose of insulin is administered). It may be programmed to determine the dose of insulin.

  With respect to FIG. 16B, the residual insulin interface is shown, and first a prompt screen 3090 is displayed asking the user whether he / she has forgotten to record fast-acting insulin taken since a previous predetermined time. . The previous predetermined time corresponds to the latest time among (a) the time when the set insulin action period is subtracted from the current time, or (b) the time of the last-recorded fast-acting insulin dose. To do. The prompt screen 3090 has a “yes” touch screen button 3092 and a “no” touch screen button 3094 to select “yes” or “no” to answer the prompt question. If the “No” touch screen button 3094 is pressed, the graphical user interface displays the insulin calculator interface 3062 (see FIG. 17). If the “yes” touch screen button is pressed, the graphical user interface displays a numeric input screen 3096 for the remaining insulin interface. On the numerical value input screen 3096, the amount of fast-acting insulin that the user forgot to record after the previous predetermined time point may be input. By increasing or decreasing the amount of fast acting insulin as desired by pressing the touch screen button with the up arrow 3098 (eg “+”) or the touch screen button with the down arrow 3100 (eg “−”) The amount (eg, units) of fast acting insulin may be adjusted. For example, the amount of fast acting insulin 3102 may be adjusted in increments of one unit by tapping the up arrow 3098 or down arrow 3100. In some embodiments, the amount of fast acting insulin may be adjusted in 0.5 unit increments (not shown) if the calculator is set to allow 0.5 unit increments. Good. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. The numeric input screen may also include a “?” Touch screen button 3104, which when pressed provides a help screen 3106 that includes further instructions for the user. For example, the help screen 3106 may instruct the user to enter the total amount of insulin units that the user has consumed during the last X hours that the user has not yet recorded (where X is the duration of the insulin action period). Is). The help screen 3106 may also inform the user that the reader will use the entered amount of fast-acting insulin to calculate the user's next fast-acting insulin dose. The help screen 3106 includes an “OK” touch screen button 3108 that, when pressed, returns the display to the numeric input screen 3096.

  On the numeric input screen 3096, once the desired amount of fast acting insulin has been entered, “Next” is displayed to advance the graphical user interface to the time input screen 3114, as shown by the reference path (M) (see FIG. 16C). “Touch screen button 3110 may be pressed. Alternatively, the “Return” touch screen button 3112 may be pressed on the numeric input screen 3096, which causes the graphical user interface to return to the prompt screen 3090.

  With respect to FIG. 16C, the time entry screen 3114 displays a question asking the user how long ago the unrecorded fast-acting insulin dose was administered. In the time entry screen 3114, the touchscreen button with the up arrow 3116 (eg, “+”) or the touchscreen button with the down arrow 3118 (eg, “−”) is pressed to increase or decrease the time as desired. Thereby, the time from the last unrecorded fast-acting insulin dose may be adjusted. For example, the time 3120 may be adjusted in 15 minute increments by tapping the up arrow 3116 or the down arrow 3118. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. In some examples, the default time is 15 minutes (eg, displayed as “15 minutes or less”). In some cases, the maximum time is the time value of the set insulin action period. If the user presses the up arrow 3116 when the time is at the maximum value, the displayed time may be shown as “[insulin duration] time or more”, and the up arrow 3116 is grayed out. The user may not be able to select.

  The time entry screen 3114 also includes a “?” Touch screen button 3122 that when pressed provides a help screen 3106 that includes further instructions to the user as described above, as indicated by the reference path (K). The time input screen includes a “return” touch screen button 3124 that, when pressed, returns the display to the numeric input screen 3096, as shown by the reference path (L). Once the desired time from the last fast-acting insulin dose that was not recorded has been entered on the time entry screen 3114, the user can proceed to the next screen of the remaining insulin interface (eg, screen 3128) by clicking “ The “Next” touch screen button 3126 may be pressed. When the “Next” touchscreen button is pressed, the entered fast-acting insulin dose is calculated based on the interval since the administration indicated by the user on the previous time entry screen 3114. Saved with the reflected time stamp. The screen 3128 indicates that the input fast-acting insulin dose is used to calculate the insulin dose suggested by the user, and that the user can input what the user intends to eat on the next screen. To inform. Screen 3128 includes a “return” touch screen button 3130 that when pressed returns the display to time entry screen 3114. Screen 3128 includes a “Next” touch screen button 3132 that, when pressed, causes the graphical user interface to display an insulin calculator interface 3062 (see FIG. 17).

Insulin Calculator Interface The insulin calculator interface 3062 first displays a “carbohydrate input” screen (see FIG. 17B). On the “Carbohydrate Input” screen, the amount of carbohydrate can be entered. The amount of carbohydrate can be entered as grams, servings, or meals, depending on the reader settings.

  For example, the amount of carbohydrates may be entered as the number of grams of carbohydrates on the “Carbohydrate Input” (grams) screen 3200. “Carbohydrate Input” (grams) screen 3200 initially displays no value (eg, “-” or “0” is displayed), but increases or decreases grams of carbohydrate as desired. To do this, a reference path (T) (see FIG. 17C) is shown by pressing the touch screen button with an upward arrow 3202 (eg “+”) or the touch screen button with a downward arrow 3204 (eg “−”). As such, the grams of carbohydrate may be adjusted. For example, by tapping the up arrow 3202 or down arrow 3204, the grams of carbohydrate 3206 may be adjusted in 1 gram increments. In some cases, the minimum number of grams of carbohydrates that can be entered is 0, and the maximum number of grams of carbohydrates that can be entered is 200. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. Once the desired amount has been entered, the amount may be saved by pressing the “Done” touch screen button 3208, thereby saving the grams of carbohydrate entered and the reference path (S and V) ( As shown in FIGS. 17B, 17C, and 17E), the graphical user interface proceeds to an insulin calculation interface 3212. The “Carbohydrate Input” (grams) screen 3200 includes a “Return” touchscreen button 3210 that, when pressed, returns the display to the results screen.

  In certain embodiments, the amount of carbohydrate may be entered as a serving number of carbohydrates on the “Carbohydrate Input” (Serving Number) screen 3216. The “Carbohydrate Input” (number of servings) screen 3216 initially does not display a value (eg, “-”, “0”, or “0.0” is displayed), but if desired, To increase or decrease the number of servings, a reference path (T) (by pressing a touch screen button with an up arrow 3218 (eg, “+”) or a touch screen button with a down arrow 3220 (eg, “−”) ( As shown in FIG. 17C), the serving number of carbohydrates may be adjusted. For example, by tapping the up arrow 3218 or down arrow 3220, the carbohydrate serving number 3222 may be adjusted in 0.5 serving number increments. In some cases, the minimum carbohydrate serving number that can be entered is zero. In some examples, the serving number magnitude may be set as 10 or 12 grams of carbohydrate per serving number and the maximum serving number of carbohydrates that can be entered is 20. In some examples, the serving number magnitude may be set as 15 grams of carbohydrate per serving number, with a maximum serving number of carbohydrates that can be entered of 15. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. In some cases, the carbohydrate input "(serving count) screen 3216 may include an indication 3228 of grams of carbohydrate corresponding to the number of servings entered (see FIG. 17C). The “input” (number of servings) screen 3216 may include a display 3230 of carbohydrate energy (eg, kcal) corresponding to the number of servings entered (see FIG. 17C). By pressing the touch screen button 3224, the amount may be saved, thereby saving the number of servings of the input carbohydrate and the reference path (S and V) (see FIGS. 17B, 17C, and 17E). As shown, the graphical user interface advances to the insulin calculation interface 3212. . "Carbohydrate Input" (number serving) screen 3216 "Back" include a touch screen button 3226, when it is pressed, the display is the result returns to the screen.

  In certain embodiments, the amount of carbohydrate may be entered by meal on the “Enter Carbohydrate” (meal) screen 3232. “Carbohydrate input” (meal) screen 3232 displays a list of meals such as breakfast, lunch, dinner, or no meal. Each option includes a corresponding touch screen radio button. For example, to select a “dinner” meal, the touchscreen radio button 3234 associated with the “dinner” option may be pressed. The “Enter Carbohydrate” (meal) screen 3232 includes a “Return” touchscreen button 3238 that, when pressed, returns the display to the results screen. The “Carbohydrate Input” (meal) screen 3232 includes a “Next” touch screen button 3236 that, when pressed, causes the graphical user interface to “double check” through the reference path (Z) as shown in FIG. 17C. "You can go to screen 3240.

  The “double check” screen 3240 (see FIG. 17C) is displayed when the user marks the same meal from midnight (12:00 am) on the current date. The “double check” screen 3240 displays a warning that indicates to the user that the user has already recorded insulin for the selected meal of the day and whether the user wants to record more insulin for the same meal of the day To the user. The “double check” screen 3240 includes a “no” touch screen button that when pressed returns the graphical user interface to the “carbohydrate input” (meal) screen 3232 through the reference path (A 1). The “double check” screen 3240 includes a “yes” touch screen button that, when pressed, advances the graphical user interface through the reference path (Q) (see FIG. 17E) to the insulin calculation interface 3212.

  Referring again to FIG. 17B, the “Carbohydrate Input” screen (eg, “Carbohydrate Input” (grams) screen 3200 and “Carbohydrate Input” (serving number) screen 3216) includes a “?” Touchscreen button 3214 that is pressed. The graphical user interface displays a help screen 3246 as shown by the reference path (O) in FIG. 17B or the reference path (N) in FIG. 17C. The help screen 3246 (see FIG. 17A) may be configured so that the reader is configured to display carbohydrates as grams, serving as carbohydrates in grams, or as carbohydrate kcal servings. Information corresponding to whether or not it is set to be displayed may be displayed to the user. For example, if the reader is set to display carbohydrates as grams, a help screen 3248 may be displayed that displays a set of help information for carbohydrates to the user. In another example, if the reader is configured to display servings in grams of carbohydrates, a different set of help information about carbohydrates as servings in grams of carbohydrates is displayed to the user. A help screen 3250 may be displayed. In another example, if the reader is configured to display the number of servings by carbohydrate kcal, a different set of help information about the carbohydrate as the number of servings by carbohydrate kcal is displayed to the user. A help screen 3252 may be displayed. In a particular example, if the help information contains more text than can be displayed on a single help screen, the help screen may include a down arrow 3254, which when pressed will cause the graphical user interface to The remaining text is displayed on the help screen 3256 on the second page. The second-page help screen 3256 includes an upward arrow 3258 that when pressed, causes the graphical user interface to appear on the first-page help screen 3248, 3250, or 3252 depending on the reader settings as described above. Return. Help screens 3248, 3250, 3252, and 3256 include an “OK” touch screen button 3260 that, when pressed, causes the graphical user interface to go through the reference path (P) and to “carbohydrate input” where the help screen was activated. Return to the screen (eg, “Carbohydrate Input” (gram number) screen 3200 or “Carbohydrate Input” (serving number) screen 3216).

  Referring to FIG. 17B, once the desired amount of carbohydrate has been entered, the amount may be saved by pressing the “Done” touchscreen button 3208 or 3224 so that the amount of entered carbohydrate (eg, The gram of carbohydrates or servings of carbohydrates) is saved and the graphical user interface proceeds to the appropriate insulin calculation interface 3212 as shown by the reference path (S) (see FIG. 17E). The insulin calculation interface 3212 may determine the suggested insulin dose based on the amount of carbohydrates entered by the user on the previous screen as described above and / or the user's remaining insulin (if any) as described above. indicate. The appearance of the insulin calculation interface 3212 looks like the reader is set to display insulin units one unit at a time, insulin is set to display every 0.5 units, or one unit of insulin and. It may vary depending on whether it is set to display a decimal point or a comma between 5 units.

  Referring to FIG. 17E, in an embodiment of the insulin calculation interface 3212 where the reader is set to display insulin units one by one, the insulin calculation interface 3212 appears as a “suggested dose” screen 3262. . The “suggested dose” screen 3262 displays the suggested insulin dose 3264 as the number of insulin units. Press the up arrow 3266 (eg “+”) touch screen button or the down arrow 3268 (eg “−”) touch screen button to increase or decrease the suggested insulin dose as desired. Thus, the suggested insulin dose may be adjusted in 1 unit increments of insulin. Suggested minimum and maximum insulin doses are 0 and 99, respectively. If the suggested insulin dose is adjusted by the user from the initial value, the number of units 3270 increased or decreased by the user is shown below the suggested insulin dose 3264. If it is calculated that the user's blood glucose, which is reduced by the suggested insulin dose adjusted by the user, will be lower than the target range, the graphical user interface will display the entered insulin dose as the user's blood A warning screen 3292 is displayed that displays a warning to the user that medium glucose can be below the user's target range and that puts the user at risk for a low glucose event (see FIG. 17D). The warning screen 3292 includes an “OK” touch screen button that when pressed returns the graphical user interface to the “suggested dose” screen 3262 through the reference path (W). The “suggested dose” screen 3262 includes a “back” touchscreen button 3272 that, when pressed, passes the reference path (R) and allows the user to enter a previous “carbohydrate input” screen (eg, “carbohydrate input”). "(Gram number) screen 3200" or "carbohydrate input" (serving number) screen 3216). The “suggested dose” screen 3262 also includes a “record dose” touch screen button 3274 that, when pressed, records the suggested insulin dose along with the associated glucose test results and the time at which the test was performed. Saved in the book (eg, insulin doses are not saved as if they were administered at the time the “Dose Record” touchscreen button was pressed) and the graphical user interface is the reference path (Y) (see FIG. 17D) To go to the record book.

  Referring to FIG. 17E, an insulin calculation interface when the reader is set to display an increment of 0.5 units of insulin and set to display a decimal point between 1 and 0.5 units. In the 3212 embodiment, the insulin calculation interface 3212 appears as a “suggested dose” screen 3276. The “suggested dose” screen 3276 displays the suggested insulin dose 3278 as the number of units of insulin in 0.5 unit increments. Press the touchscreen button with the up arrow 3280 (eg “+”) or the touchscreen button with the down arrow 3282 (eg “−”) to increase or decrease the suggested insulin dose, as desired. Thus, the suggested insulin dose may be adjusted in 0.5 unit increments of insulin. The suggested minimum and maximum insulin doses are 0 and 50, respectively. If the suggested insulin dose is adjusted by the user from the initial value, the number of units 3284 increased or decreased by the user is shown below the suggested insulin dose 3278. If it is calculated that the user's blood glucose, which is reduced by the suggested insulin dose adjusted by the user, will be lower than the target range, the graphical user interface will display the entered insulin dose as the user's blood A warning screen 3292 is displayed that displays a warning to the user that medium glucose can be below the user's target range and that puts the user at risk for a low glucose event (see FIG. 17D). Warning screen 3292 includes an “OK” touch screen button that, when pressed, returns the graphical user interface to the “suggested dose” screen 3276 through the reference path (W). The “Suggested Dose” screen 3276 includes a “Back” touchscreen button 3286 that, when pressed, passes through the reference path (R) and allows the user to enter a previous “Carbohydrate Input” screen (eg, “Carbohydrate Input”). "(Gram number) screen 3200" or "carbohydrate input" (serving number) screen 3216). The “suggested dose” screen 3276 also includes a “record dose” touchscreen button 3288 that, when pressed, records the suggested insulin dose along with the associated glucose test results and the time at which the test was performed. Saved in the book (eg, insulin doses are not saved as if they were administered at the time the “Dose Record” touchscreen button was pressed) and the graphical user interface is the reference path (Y) (see FIG. 17D) To go to the record book.

  Referring to FIG. 17E, the insulin calculation interface when the reader is set to display an increment of 0.5 units of insulin and set to display a comma between 1 and 0.5 units. In the 3212 embodiment, the insulin calculation interface 3212 appears as a “suggested dose” screen 3290. The functionality of the “suggested dose” screen 3290 is similar to that described above for the “suggested dose” screen 3276.

  If the reader's insulin calculator determines that there is no suggested insulin dose, the insulin calculation interface 3212 provides information indicating that there is no suggested fast acting insulin based on the user's current glucose level. A “no suggested dose” screen 3298 is displayed. The “No Suggested Dose” screen includes a “Back” touchscreen button 3300 that, when pressed, passes through the reference path (R) and allows the user to enter a previous “Carbohydrate Input” screen (eg, “Carbohydrate Input”). "(Gram number) screen 3200" or "carbohydrate input" (serving number) screen 3216). The “no suggested dose” screen 3298 includes a “next” touch screen button 3302 that, when pressed, advances the graphical user interface to the “suggested dose” screen 3304. The “suggested dose” screen 3304 begins by displaying the suggested insulin dose 3306 as 0 units of insulin. Press the touchscreen button with the up arrow 3308 (eg “+”) or the touchscreen button with the down arrow 3310 (eg “−”) to increase or decrease the suggested insulin dose, as desired. Depending on the reader setting, the suggested insulin dose may be adjusted in increments of 1 or 0.5 units of insulin. If the suggested insulin dose is adjusted by the user from the initial value, the amount of units increased or decreased by the user is shown below the suggested insulin dose 3306. If it is calculated that the user's blood glucose, which is reduced by the suggested insulin dose adjusted by the user, will be lower than the target range, the graphical user interface will display the entered insulin dose as the user's blood A warning screen 3292 is displayed that displays a warning to the user that medium glucose can be below the user's target range and that puts the user at risk for a low glucose event (see FIG. 17D). The warning screen 3292 includes an “OK” touch screen button that when pressed returns the graphical user interface to the “suggested dose” screen 3304 through the reference path (W). The “suggested dose” screen 3304 includes a “back” touchscreen button 3312 that, when pressed, returns the user to the previous “no suggested dose” screen 3298. The “suggested dose” screen 3304 also includes a “record dose” touchscreen button 3314 that, when pressed, records the suggested insulin dose along with the associated glucose test results and the time at which the test was performed. (Eg, insulin doses are not saved as if they were administered at the time the “Dose Record” touchscreen button was pressed), and the graphical user interface is recorded via the reference path (Y). Proceed to (see FIG. 17D).

  “Suggested Dose” screens 3262, 3276, 3290, and 3304 include “Dose Details” touchscreen buttons 3294 (eg, “i” touchscreen buttons) that, when pressed, refer to the graphical user interface. The dose detail interface is displayed through route (X) (see FIG. 17D).

  A dose detail interface 3296 is shown in FIGS. 18A and 18B. The dose details interface begins with a dose details screen (eg, 3316, 3318, and 3320) that displays a summary of the calculated insulin dose. Dosage detail screens (eg, 3316, 3318, and 3320) are configured to display the reader (eg, the reader is configured to display carbohydrates as grams of carbohydrate or as carbohydrate servings). Set to display by meals) and data entered by the user or calculated by a reader (eg, carbohydrate amount, residual insulin, suggested insulin dose user) It may have various appearances depending on the adjustment by the The dosage detail screen displays the amount of carbohydrate as meal 3322, as carbohydrates in grams 3324, or as carbohydrates serving number 3326. If insulin correction is enabled on the reader, the dose detail screen displays the suggested insulin dose 3328. If insulin correction is disabled in the reader (for example, if “No insulin correction” is set in a simple setting), the suggested insulin dose is not displayed. If the reader determines that there is residual insulin, the dose detail screen displays the amount of residual insulin 3330. If the reader determines that there is no residual insulin, the amount of residual insulin is not displayed. If the user adjusts the suggested insulin dose, the dose detail screen displays an amount 3332 that the user has adjusted the suggested insulin dose. The dosage detail screen displays the calculated insulin dosage 3334 based on the above data.

  The dose detail screen includes a down arrow touch screen button 3336 that, when pressed, advances to the second page of the dose detail screen through the reference path (B1) (see FIG. 18B). The information displayed on the second page of the dose detail screen varies depending on whether there is residual insulin and whether the suggested insulin dose considers only the carbohydrates in the user's diet. possible. If there is no residual insulin, page 3338 of the dose details screen shows that the suggested fast-acting insulin dose covers carbohydrates in the user's diet and corrects for the user's current glucose level. Display information indicating what to do. If residual insulin is present and the user has taken insulin within the past 2 hours, the dose detail screen 3340 on page 2 indicates that the user has taken insulin within the past 2 hours, and The displayed insulin dose covers the carbohydrates in the user's diet, but displays information indicating that no correction is made regarding the user's current glucose level. If there is residual insulin and the time when the user last took insulin is more than 2 hours from the current time, but is shorter than the action period of insulin, the dosage detail screen 3342 on page 2 Ingestion of fast-acting insulin within the last 4 hours, and suggested insulin doses cover carbohydrates in the user's diet and have been corrected for the user's current glucose level and have been previously recorded The information indicating that the insulin is taken into consideration is displayed. The dose detail screen on page 2 (eg, 3338, 3340, and 3342) includes an up arrow touch screen button 3344 that when pressed returns the graphical user interface to the previous dose detail screen.

Reminder Interface An exemplary embodiment of a graphical user interface is provided that facilitates a reminder procedure 3400 for setting reminders that can be used in connection with the reader described herein. Hereinafter, this graphical user interface will be described in more detail with reference to FIG.

  The reminder interface 3400 shown in FIG. 19A first displays the home screen 3402 of the reader. The home screen includes a reminder touch screen button 3404 (e.g., bell-shaped icon, alarm clock icon, clock icon, etc.) that when pressed initiates a procedure for setting and / or adjusting a reminder. If a reminder has been previously set, the next reminder time 3406 is displayed next to the reminder touch screen button 3404.

  Referring to FIG. 19A, if a reminder has not been previously set, pressing the reminder touch screen button 3404 causes the graphical user interface to go through the reference path (D1) to the “Remind” screen 3408 (FIG. 19B). reference). The “Remind” screen 3408 includes choices regarding reminder type, reminder schedule, and reminder time.

  For example, on the “Remind” screen 3408, the type of reminder may be selected by pressing a reminder type touch screen button 3410. The reminder selection touch screen button 3410 displays the type of the currently selected reminder, and the default value of this reminder is “glucose check”. When the reminder type touch screen button 3410 is pressed, the graphical user interface proceeds to the reminder type screen 3412 through the reference path (K1) (see FIG. 19D). The reminder type screen 3412 displays a list of available reminder types that can be set. The reminder type screen 3412 displays three default reminders: a “glucose check” touchscreen button 3414, an “insulin intake” touchscreen button 3416, and an “alarm” touchscreen button 3418. The default reminder type can be rearranged using the PC interface, but cannot be deleted from the reader. Each default reminder touchscreen button includes text describing the type of reminder, as described above, and an icon associated with each different default reminder type. Additional custom reminders can be set using the PC interface. If additional custom reminders have been previously set, they are displayed on the reminder type screen 3420. The custom reminder can be any type of reminder desired by the user. Further custom reminders can be displayed by pressing the down arrow touch screen button 3422 of the reminder type screen 3420. For example, the list of reminder types may be scrolled by tapping down arrow 3422 or up arrow 3424. In some embodiments, pressing the up or down arrow once scrolls the page one page at a time, and the scroll speed slows down after 2 seconds when the up or down arrow continues to be pressed. Once the reminder type is selected by pressing the desired reminder type, the graphical user interface returns to the “Remind” screen 3408 through the reference path (J1) (see FIG. 19B).

  On the “Remind” screen 3408, a reminder schedule may be selected by pressing a “Repeat” touchscreen button 3426. The repeat touch screen button 3426 displays the schedule of the currently selected reminder, and the default value of this schedule is “daily”, indicating that the reminder is repeated at the time selected every day. When the “Repeat” touch screen button 3426 is pressed, the graphical user interface proceeds to the reminder schedule screen 3428 (see FIG. 19C) through the reference path (N1). The reminder schedule screen 3428 displays a list of available schedule types that can be set for the reminder. The reminder schedule screen 3428 displays three types of reminder schedules: a “daily” touchscreen button 3430, a “once” touchscreen button 3432, and a “countdown timer” touchscreen button 3434. Pressing the “Daily” touch screen button 3430 sets the reminder schedule to “Daily” and the graphical user interface returns to the “Remind” screen 3408 through the reference path (L1). Pressing the “once” touch screen button 3432 sets the reminder schedule to “once” (eg, the reminder is not repeated) and the graphical user interface “reminds” screen 3408 through the reference path (M1). Return to. Pressing the “Countdown Timer” touch screen button 3434 sets the reminder schedule to “Countdown Timer” and the graphical user interface advances to the “Timer Length” screen 3436 (see FIG. 19C). A “timer length” screen 3436 may be used to set the countdown timer. For example, the “Timer Length” screen 3436 displays the current remaining amount of time for the countdown timer in hours and minutes. The default value for the countdown timer is 15 minutes. To increase or decrease the fraction as desired, the fraction is adjusted by pressing the touch screen button with the up arrow 3438 (eg “+”) or the touch screen button with the down arrow 3440 (eg “−”). May be. For example, the fraction may be adjusted in 1 minute increments by tapping the up arrow 3438 or the down arrow 3440. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. To increase or decrease the number of hours as desired, the number of hours by pressing the touch screen button with the up arrow 3442 (eg “+”) or the touch screen button with the down arrow 3444 (eg “−”) May be adjusted. For example, the number of hours may be adjusted in 1 hour increments by tapping the up arrow 3442 or the down arrow 3444. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow, and after 2 seconds, the amount is increased or decreased accordingly. Once the desired amount of time for the countdown timer has been entered, the amount may be saved by pressing the “OK” touch screen button 3446, thereby saving the amount of time entered and in the reference path (Q1). As shown, the graphical user interface returns to the “Remind” screen 3448 (see FIG. 19B). From the “Remind” screen 3448 (see FIG. 19B), the amount of time of the countdown timer may be adjusted by pressing the time touchscreen button 3464, and the graphical user interface is referenced when the time touchscreen button 3464 is pressed. The route (R1) is followed to the “timer length” screen 3436 (see FIG. 19C). In the “timer length” screen 3436, the time of the countdown timer may be adjusted as described above.

  On the “Remind” screen 3408, the time of the reminder may be selected by pressing the time touch screen button 3450. The time touch screen button 3450 displays the currently set reminder time. The default value of this time is 12:00 am, indicating that the reminder is activated at the selected time. When the time touch screen button 3450 is pressed, the graphical user interface proceeds to the reminder time screen 3452 through the reference path (P1) (see FIG. 19C). The reminder time screen 3452 allows the user to set the time when the reminder is activated. For example, the reminder time screen 3452 displays the time currently set for the reminder in hours and minutes. Press the touchscreen button with the minute up arrow 3454 (eg, “+”) or the minute down arrow 3456 (eg, “−”) to increase or decrease the minute value as desired. The time up arrow 3458 (eg “+”) touchscreen button or time down arrow 3460 (eg “−”) to increase or decrease the time value as desired. The reminder time may be adjusted by pressing a touch screen button. In some embodiments, when the up or down arrow continues to be pressed, the first 2 seconds is slow and faster after 2 seconds and the hour and minute values are increased or decreased accordingly. Once the desired time for the reminder has been entered, the time may be saved by pressing the “OK” touch screen button 3462 so that the entered time is saved, as indicated by the reference path (O1). The graphical user interface returns to the “Remind” screen 3408 (see FIG. 19B).

  Referring to FIG. 19B, the reminder settings may be saved by pressing the “Save” touch screen button 3466 after the desired reminder type, reminder schedule, and reminder time are selected as desired. When the “Save” touch screen button 3466 is pressed, the graphical user interface proceeds to the reminder list screen 3468 through the reference path (E1) (see FIG. 19A). Referring again to FIG. 19B, the reminder setting may be discarded by pressing the “Cancel” touch screen button 3470. If no reminder has been previously set, pressing the “Cancel” touch screen button 3470 causes the graphical user interface to return to the home screen 3402 via the reference path (C1) (see FIG. 19A). If one or more reminders have been previously set, pressing the “Cancel” touch screen button causes the graphical user interface to go to the reminder list screen 3468 through the reference path (H1) or (I1) (FIG. 19A). reference). In certain embodiments, the “Cancel” touchscreen button 3470 may be displayed as an “Erase” touchscreen button if a previously set reminder setting has been adjusted from the “Remind” screen 3408. .

  Referring to FIG. 19A, if one or more reminders have been previously set, pressing the reminder touch screen button 3404 from the home screen 3402 or, in some examples, pressing the next reminder time 3406. The graphical user interface proceeds to the reminder list screen 3468. The reminder list screen 3468 displays a list of previously set reminders. The list of previously set reminders displays a reminder time 3472 for each previously set reminder and an “On” / “Off” toggle touchscreen button 3474 corresponding to each previously set reminder. When the reminder time 3472 is pressed, the graphical user interface proceeds through the reference path (G1) to the “Remind” screen 3408, from which the reminder settings may be adjusted as described above. Pressing the “On” / “Off” toggle touch screen button 3474 turns the corresponding reminder on or off.

  The reminder list screen includes an “add new” touch screen button 3476 that when pressed, the graphical user interface proceeds through the reference path (F1) to the “remind” screen 3408, from which it is desired as described above. A new reminder may be set according to the above. The reminder list screen includes a “Done” touch screen button 3478 that, when pressed, returns the graphical user interface to the home screen 3402.

Reminder Receiving Interface An exemplary embodiment of a graphical user interface that facilitates a reminder receiving procedure 3500 for receiving reminders that may be used in connection with the reader described herein is provided. Hereinafter, this graphical user interface will be described in more detail with reference to FIG.

  The reminder receipt interface 3500 shown in FIG. 20B has reached when a reminder (eg, a reminder set using the reminder interface 3400 described above) is activated (eg, a scheduled reminder time or trigger event). To start). Even if the reader display is off, a scheduled reminder should be displayed when the reminder time / trigger event is reached. In certain embodiments, scheduled reminders are not displayed on the reader when the reminder time / trigger event is reached in the following cases: (1) During a blood glucose test using a strip, a reminder is presented after the results are displayed. (2) When the battery is very low, a reminder is presented when the battery is fully charged and the reader is turned on. (3) In an error state, a reminder is presented the next time the reader is turned on. (4) When the reader is connected to the computer and data transfer is in progress, a reminder is presented when the data transfer is completed.

  When the reminder time / trigger event is reached, a reminder screen 3502 is displayed (FIG. 20B). The reminder screen 3502 includes a reminder display having a reminder icon 3504 representing the type of reminder. For example, the reminder icon may be an “alarm” reminder icon 3504 (eg, a picture of a bell or an alarm clock) indicating that the reminder type is an alarm. In some examples, the reminder icon is an “insulin intake” reminder icon 3506 (eg, a syringe picture) (see FIG. 20A) indicating that the reminder type is an insulin intake reminder for the user. In some examples, the reminder icon is a “glucose check” reminder icon 3508 (eg, a picture of a glucose reader) (see FIG. 20A) indicating that the type of reminder is a reminder to check the glucose level for the user. . Other types of icons and reminders are possible.

  If the reminder sound is set to ON, an optional reminder screen appears and a buzzer sounds. If the reminder is ignored, it will appear on the screen the next time it is turned on (by hardware button or strip insertion). If multiple reminders are active, the reminder screen is overlaid and the most recent reminder is shown first. The reminder screen needs to be finished one by one. If a reminder that repeats every day is not displayed and a reminder for a new day is currently displayed, the reminder for the day before that time is not activated and is not superimposed on the reminder screen.

  The reminder screen 3502 includes a “snooze 15 minutes” touchscreen button 3510 that, when pressed, sets the active reminder to be reactivated after 15 minutes, and the graphical user interface is set to the next activated reminder. Return or if there is no other active reminder, return to the screen that was displayed before the reminder was activated. The reminder screen 3502 also includes an “OK” touch screen button 3512 that when pressed, cancels the active reminder and the graphical user interface returns to the next active reminder, or any other active reminder is displayed. If not, the graphical user interface returns to the home screen. If the reader is automatically turned off due to a timeout while the reminder screen is displayed, the reminder that was active when the reader timed out will again be displayed the next time the reader is turned on. Is displayed.

Reader Summary In some aspects of the present disclosure, software that provides a summary of information and data regarding the obtained measurements may be programmed into the analyte monitoring device. This software provides an interface for viewing and managing features related to the generated reports. A variety of different types of summaries can be generated. For example, FIGS. 21A-21G illustrate various types of interfaces for displaying a summary on an analyte monitoring device, according to certain embodiments. The summary screen shown is exemplary and should not be construed as limiting the invention.

  FIG. 3 is an exemplary embodiment of a graphical user interface that functions to provide a user with a summary of information and data obtained about a measurement that may be used in connection with the reader described herein.

Summary Menu Interface FIG. 21A shows an exemplary interface for providing a summary menu on an analyte monitoring device. FIG. 21A shows a history menu (HISTORY MENU) 01 screen 622, which provides a menu of summary options that the user can select. Option 622a presents the user with a record book screen for viewing the recorded data, as indicated by block 626. Option 622b presents the user with a daily graph screen that provides a summary of data in daily graph format. Option 622c provides an average screen of glucose measurements obtained for a period of time. If more options are available than can fit in a single screenshot, a trigger element 622h (eg, an arrow symbol) may be selected for scrolling or otherwise viewing the remaining options. . When the arrow 622h is selected, a screen 624 on which the remaining options are displayed is presented to the user. For example, option 624 provides a summary screen of low glucose events for a period of time. Option 622d provides a screen showing a summary of the time that the obtained measurement was within the target zone. Option 622f provides a screen showing a summary of information regarding the use of the reader device. Option 622g provides a summary screen of daily patterns determined or identified based on measurements taken for a period of time. Trigger element 622 i returns the user to screen 622.

  When one of the options is selected, it is determined whether sensor data is present, as indicated by block 628. If no data is present, a “no sensor data” screen 630 is displayed to indicate to the user that no sensor data is available for summarization. In one embodiment, all summaries other than the register include only sensor data (eg, glucose data obtained from the sensor). If the device has only strip data and insufficient sensor data, a “no sensor data” screen will still be provided even if the summary option is selected.

  When sensor data is provided, a screen corresponding to the selected summary option is displayed as represented by the reference path T1. If desired, the user can navigate back from the selected summary screen to the menu option screens 622, 624 as indicated by the reference path S1 to select another menu option.

  FIG. 21B shows a daily graph screen 632 showing a daily graph of sensor measurements taken over a single day, ie, a 24-hour period. For example, the daily graph 632 shows the measured values obtained on Wednesday, February 22. The horizontal axis of the graph 632 represents the time of the day, and the vertical axis represents the sensor measurement value. The graph 632 may also be provided with a target zone 632d that represents the target zone for the measured value. The graph 632 may also include a time change icon 632a for notifying the user of the time change. Also shown is an event indicator 632b that indicates various events with symbols or icons on the graph 632. For example, an injection icon represents a recorded insulin event indicating that an insulin administration has occurred, and an apple icon represents a recorded food event indicating that food has been consumed. Further details for a given event may be stored or recorded, and in one embodiment, when the event indicator 632b is selected by the user, further details regarding that event may be provided.

  In certain embodiments, the event indicator may be applied only to the glucose value after the glucose measurement is made by a glucose sensor or test strip measurement. Event details may be entered and recorded or added as notes associated with glucose values or glucose events (eg, high or low glucose levels). In certain embodiments, event details may be imported from another source (eg, electronic diary or electronic log) and stored in a memory device.

  In the illustrated embodiment, a trigger element 632c (eg, a left-pointing arrow and a right-pointing arrow) is also provided that allows the user to navigate to another day or another 24 hour period to go back and forth. ing. For example, the user can navigate to the next day of Wednesday using a right-pointing arrow and can return to the previous day by selecting the left-pointing arrow.

  FIG. 21C provides an example of a graph of sensor measurements obtained over a period summarized for a predetermined period of time (eg, a single day or a 24-hour period as shown). Fig. 5 shows an average glucose summary interface. For example, the AVG GLUC 01 screen provides a bar graph 634a of sensor readings taken over the last 7 days. Bar graph 634a includes bars of various time increments over a single day. Each bar represents the average glucose measurement obtained in that time increment over the last 7 days. For example, the average of all sensor readings obtained from 12:00 am to 6:00 am in the last 7 days is 121 mg / dL. The average glucose measurement from 6 am to 12:00 is 152 mg / dL, etc.

  Screen 634 also includes an average glucose value 634b for the data for that period. For example, the average glucose measurement of all measurements taken over the last 7 days is 119 mg / dL. Screen 634 also includes a trigger element 634c (eg, an arrow icon) for changing the period of obtained data to a different period. For example, if the user selects the right-pointing arrow icon 634c, an average glucose (AVG GLUC) that similarly displays a bar graph 636a and an average glucose value 636b for different time periods (eg, the last 14 days as shown). ) 02 screen 636 is presented to the user. Similarly, the screen 636 includes a trigger element 634c for further increasing the period. In this way, the user can change to an average glucose (AVG GLUC) 03 screen 638 that similarly displays bar graphs 638a and average glucose values 638b for different time periods (eg, the last 30 days as shown). Similarly, the user can change to an average glucose (AVG GLUC) 04 screen 640 that also displays bar graphs 640a and average glucose values 640b for different time periods (eg, the last 90 days as shown). Trigger element 634c allows the user to navigate back and forth between screens 634, 636, 638, 640 to change the duration as desired. From either screen, if the user confirms (eg, by selecting an “OK” button), the user is returned to the options menu interface 622, 624.

  FIG. 21D shows an exemplary screen showing the percentage of time that the sensor measurements were within the target zone. The “time within target” screen 642 shows the percentage of time that the sensor readings obtained for a period of time (eg, 7 days in the illustrated embodiment) were within the target zone, A representation 642a of the percentage and the percentage of time that was lower than the target zone is displayed. For example, a trigger element 642c is provided that allows the user to change the time period, similar to that described in FIG. 21c. Representation 642a also includes an associated percentage bar graph.

Summary Menu—Masking Mode Interface FIG. 21E summarizes for a given period (eg, a single day or 24 hour period, as shown) associated with sensor measurements taken over a period of time. An exemplary screen 644 showing a graph 644a of the number of events played is shown. For example, the screen 644 shows a graph 644a of sensor measurement values obtained over the last seven days. For example, one event has occurred from 12:00 am to 6:00 am, and 0 6:00 am to 12:00 pm Events have occurred, and 3 events have occurred from 12:00 PM to 6:00 AM. In the illustrated embodiment, the event corresponds, for example, to a low glucose measurement for the target zone. Other events such as high glucose readings, insulin administration, food intake events may also be implemented. A trigger element 644c is provided that allows the user to change the time period.

  FIG. 21F shows an exemplary screen 648 showing information associated with sensor usage over a period of time. For example, screen 648 shows the average number of scans per day for sensor measurements taken over the last 7 days and the number of days with sensor data. Similarly, a trigger element 648c is provided to allow the user to change the time period.

  FIG. 21G shows an example interface for providing a summary menu on the analyte monitoring device when the device is in masking mode. A “HISTORY MENU MASKED” screen 620 is displayed that provides a menu of summary options that the user can select. The option 620a presents the user with a record book screen for browsing the recorded data. Option 620b provides a screen showing summary information regarding the use of the reader device. Since the device is in masking mode and does not allow the user to view sensor measurements, a summary screen regarding the obtained measurements is not available.

Registry Interface An exemplary graphical user interface that facilitates a registry procedure 3600 for displaying, adding, and / or editing a registry entry that may be used in connection with the reader described herein. Embodiments are provided. Hereinafter, this graphical user interface will be described in more detail with reference to FIG.

  The registry book interface 3600 shown in FIG. 22A can be accessed from a continuous scan interface (see FIG. 9), an insulin calculator interface (see FIG. 17), and a reader summary interface (see FIG. 21). Pressing the record book touchscreen button from the reader summary menu screen (see FIG. 21) advances the graphical user interface to the record book interface 3600 (see FIG. 22). If there is no entry in the record book, a “record book is empty” (LGBK EMPTY) screen 3602 (see FIG. 22A) indicating that there is no data to be reported in the record book is displayed. When there are one or more entries in the record book, the record book list screen 3604 is displayed through the reference path (V1) (see FIG. 22B). FIG. 22B shows various examples of the record list screen and the types of record entries that may be displayed. Each record book entry displays a date 3606 and a time 3608 associated with the corresponding record book entry. Three record entries may be displayed per screen. The directory list screen includes down arrows 3610, and in some embodiments also includes an upward arrow (not shown), which is used to scroll down the directory entries on the directory list screen. It may be pushed. To scroll through the record list screen as desired, the record list screen may be scrolled page by page by pressing the up arrow (not shown) touch screen button or the down arrow 3610 touch screen button. Good. For example, the record list screen may be scrolled page by page by tapping an upward arrow (not shown) or a downward arrow 3610. In some embodiments, when the up or down arrow continues to be pressed, the page scrolls slowly for the first 2 seconds and faster after 2 seconds.

  Referring to FIG. 22B, various examples of record book list screens and types of record book entries that may be displayed are shown. For example, the record list screen may display the recorded glucose level 3612. The recorded glucose level 3612 may be displayed as a numerical value corresponding to the user's glucose level in units of mg / dL. The glucose level may have an upward trending arrow or an downward trending arrow associated with the glucose level, indicating an upward trend of the glucose measurement or a downward trend of the glucose measurement, respectively. In some cases, if the recorded glucose measurement is higher than the maximum threshold level, instead of a numerical glucose level, “HI” is displayed indicating that the glucose level has exceeded the maximum threshold level. Also good. Similarly, if the recorded glucose measurement is lower than the minimum threshold level, “LO” indicating that the glucose level is lower than the minimum threshold level may be displayed instead of the numerical glucose level. . In some examples, the glucose measurement may be associated with a note icon (eg, a pencil drawing) indicating that a note has been entered with the recorded glucose level.

  In some examples, the record list screen may display the recorded ketone level 3614. The recorded ketone level 3614 may be displayed as a numerical value corresponding to the user's ketone level in units of mmol / L. In some examples, the record list screen may display a recorded glucose control solution test level 3616. The recorded glucose control solution test level 3616 may be displayed as a numerical value corresponding to the glucose control solution level in mg / dL. A glucose control solution test level 3616 may be associated with a corresponding control solution icon (eg, a picture of a control solution bottle). In some examples, the record list screen may display the recorded ketone control solution test level 3704. The recorded ketone control solution test level 3704 may be displayed as a numerical value corresponding to the ketone control solution level in mmol / L. The ketone control solution test level 3704 may be associated with a corresponding control solution icon (eg, a picture of a control solution bottle). In some examples, the record list screen may display a recorded temperature error 3618. The temperature error may be a low temperature error associated with a low temperature error icon (eg, a blue thermometer picture) or a high temperature error associated with a high temperature error icon (eg, a red thermometer picture). In some examples, the registry list screen may display the masked measurements 3620 being recorded. The recorded masked measurement may be associated with a masked measurement icon (eg, a check mark icon). The registry list screen 3604 includes an “OK” touch screen button 3622 that, when pressed, causes the graphical user interface to display the previous screen that was displayed prior to entering the registry interface 3600 (eg, a continuous scan interface (FIG. 9)). See), the insulin calculator interface (see FIG. 17), or the reader summary interface (see FIG. 21)). For example, pressing the “OK” touch screen button 3622 may return the graphical user interface to the reader summary interface (see FIG. 21) through the reference path (U1) (see FIG. 22A).

  Each record book entry on the record book list screen 3604 is a touch screen button. When a record book entry on the record list screen 3604 is pressed, the graphical user interface proceeds through the reference path (W1) to the individual record book entry screen 3624 associated with the selected record book entry (FIG. 22C and FIG. 22). 22D). 22C and 22D show various examples of the individual record book entry screen 3624. FIG.

  When a recorded glucose level is selected from the record list screen 3604, an individual record list entry screen 3626 for the glucose level is displayed. The glucose level individual record entry screen 3626 includes one or more of the following information. Recorded glucose level date and time 3628, glucose measurement 3630 (unit: mg / dL), carbohydrate amount 3632 (if any), and whether the recorded glucose measurement is before or after a meal Meal icon 3634 shown (eg, whole apple icon for pre-meal measurements, eaten apple icon for post-meal measurements), suggested insulin dose 3636 (if any) and / or suggested An insulin dose icon 3638 (eg, a syringe icon), a note 3640 (if any) associated with the recorded glucose measurement, and an arrow 3642 (eg, an upward or downward trend arrow) indicating a trend in glucose level as appropriate. ), Unavailable icon 3644 indicating that glucose readings are not available High glucose level warning 3646 (as text and / or warning icon), low glucose level warning 3648 (as text and / or warning icon), masking icon 3650 (eg, check mark icon) indicating that the glucose measurement is masked ), Suggested insulin dose details (eg, carbohydrate amount 3652, suggested insulin dose 3654, IOB 3656, suggested insulin dose adjustment 3658 by user), cold error warning 3660 (eg, text and / Or as a low temperature warning icon 3666, such as a blue thermometer icon), a high temperature error warning 3662 (eg, as a high temperature warning icon 3668, such as text and / or a red thermometer icon), glucose An icon indicating that a constant value was obtained by a test strip or by a sensor (eg, a blood drop icon 3664 for a measurement obtained by a test strip), a sensor low temperature error alert 3670 (eg, text and / or blue temperature) Sensor low temperature warning icon 3672 such as a meter) and sensor high temperature error warning 3675 (eg, as a sensor high temperature warning icon 3676 such as a text and / or blue thermometer icon).

  If notes are associated with the recorded glucose measurements and the notes do not fit on one screen, the individual record entry screen 3626 may include a down arrow 3678 (see FIG. 22C) Some embodiments may also include upward arrows 3680 (see FIG. 22D), which may be pressed to scroll the note down or up. The individual record book entry screen 3626 may include an “add or edit note” touchscreen button 3682, when pressed, the graphical user interface displays an “add to record” screen 3684. The “Add to Record” screen 3684 includes a list of several different user selectable notes that can be entered into the record book. This list of user selectable notes may include one or more of long acting insulin 3686, exercise 3688, medication 3690, and the like. In certain embodiments, three user-selectable notes are displayed on the touch screen simultaneously. If there are more than three user-selectable notes, a scrolling touchscreen button (down arrow (eg, down triangle) touch screen button 3692 and up arrow (eg, up triangle) is used to view the list. ) A list of notes may be scrolled as needed using a touch screen button (not shown). One or more user selectable notes may be selected by touching a touch screen check box next to the note that they want to select. Touching the touch screen check box switches the check box from the checked state to the unchecked state, indicating that the associated note is selected or not selected. For example, touching a touch screen check box 3694 may select a long-acting insulin note, thereby displaying a check mark in the touch screen check box and selecting a fast-acting insulin note. Indicates that Similarly, other user selectable notes can be selected or deselected (eg, checked or unchecked) as desired. The note selection may be saved by pressing an “OK” touchscreen button 3696, which saves the user selectable note selection and the graphical user interface displays the previous individual record entry screen 3626. Return to.

  When the recorded ketone level is selected from the record list screen 3604, an individual record list entry screen 3698 of the ketone level that displays the recorded ketone measurement value in units of mmol / L is displayed. . When a recorded glucose control solution test is selected from the record list screen 3604, an individual record of the glucose control solution test level that displays the recorded glucose control solution test measurement value in mg / dL as a unit A book entry screen 3700 is displayed. When a recorded ketone control solution test is selected from the record list screen 3604, the recorded ketone control solution test measurement value is displayed in units of mmol / L. A book entry screen 3702 is displayed.

  Further individual record book entry screens include unrecorded doses of fast-acting insulin (FIG. 22E) and time changes (FIG. 22F). The record entry of the fast-acting insulin dose not recorded may include dose information, administration time information, and recording time information. The record entry of the time change entry may include time change information before and after. The time change record may further include a warning that other history options may be affected by the time change. Further, in certain embodiments, a prompt is presented to the user asking whether the user has forgotten to record or has an insulin dose after a set time (eg, based on the duration of action of the insulin). May be. If the user responds positively, the user is further prompted to enter unrecorded insulin dose information so that the previously unrecorded dose is recorded in the record book.

  The individual record entry screen 3626 includes an “OK” touch screen button 3706, which when pressed returns the graphical user interface to the record list list screen 3604 through the reference path (X1).

Strip / Hardware Error Interface An exemplary embodiment of a graphical user interface that facilitates a procedure for displaying a strip / hardware error 3710 that may be used in connection with the reader described herein is provided. Is done. Hereinafter, this graphical user interface will be described in more detail with reference to FIG.

  The strip / hardware error interface 3710 shown in FIGS. 23A and 23B may display strip and / or hardware errors as needed if any associated errors occur. A variety of different error messages can be displayed. For example, if the reader detects a temperature error, an “Error 1” screen 3712 may be displayed. The “Error 1” screen indicates that the reader temperature may be too high or too low, and the user moves the reader and strip to the proper environment and checks the glucose again with a new strip. A message indicating that it should be displayed may be displayed. The “Error 1” screen may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, the strip / hardware error interface 3710 may display an “Error 2” screen 3714 if the reader may not be functioning properly. The “Error 2” screen 3714 may display a message indicating that the reader may not be functioning properly and that the user should turn off the reader and try again. The “Error 2” screen 3714 may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, if the test strip may not be functioning correctly or the user's glucose may be too low, the strip / hardware error interface 3710 may display an “Error 3” screen 3716. It may be displayed. The “Error 3” screen 3716 may display a message indicating that the test strip may not be functioning properly or the user's glucose may be too low. "Error 3" screen 3716 shows that low glucose can be dangerous, the user should check his glucose again with a new strip, and the treatment recommended by the user's medical professional A message indicating that it should be displayed may be displayed. The “Error 3” screen 3716 may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, if the test strip may not be functioning properly or the user's glucose / ketone may be too high, the strip / hardware error interface 3710 may display an “Error 4” screen. 3718 may be displayed. The “Error 4” screen 3718 may display a message indicating that the test strip may not be functioning properly or the user's glucose / ketone may be too high. "Error 4" screen 3718 shows that high glucose / ketone can be dangerous, the user should check glucose or ketone again with a new strip, and treatment recommended by the user's medical professional You may also display a message indicating that it should be done. The “Error 4” screen 3718 may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, the strip / hardware error interface 3710 may display an “error 5” screen if blood has been applied to the strip too early or the test strip may have been used. 3720 may be displayed. The “Error 5” screen 3720 may display a message indicating that blood has been applied to the strip too early or that the test strip may have been used. The “Error 5” screen 3720 may also display a message indicating that the user should check his glucose again using a new strip. The “Error 5” screen 3720 may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, the strip / hardware error interface 3710 is an “Error 7” screen 3722 if the test strip is damaged, used, or otherwise not recognizable by the reader. May be displayed. The “Error 7” screen 3722 may display a message indicating that the test strip is damaged, used, or may not be recognized by the reader. The “Error 7” screen 3722 may also display a message indicating that the user should check his glucose again using a new strip. The “Error 7” screen 3722 may also display a message indicating that the user should call customer service if this message reappears.

  In certain embodiments, the strip / hardware error interface 3710 may display an “error 9” screen 3724 if the reader is not functioning properly. The “Error 9” screen 3724 may display a message indicating that the reader is not functioning properly. The “Error 9” screen 3724 may also display a message indicating that the user should turn the reader off and try again. The “Error 9” screen 3724 may also display a message indicating that the user should call customer service if this message reappears.

  The error screen includes an “OK” touch screen button 3726 that, when pressed, returns the graphical user interface to the home screen. In certain embodiments, pressing the “OK” touch screen button 3726 from the “Error 2” screen 3714 or “Error 9” screen 3724 turns off the reader display. The reader can be activated by inserting a test strip or by pressing a hardware power button.

System Time Loss A time recovery display screen may be displayed when the device is restarted after a system time loss. FIG. 23C shows the step of recovering the date and time after a system time loss. As indicated by block 3726, after the device is turned off due to one or more errors, the user presses the home button or inserts a test strip to turn on the device (3728). When powered on, the device navigates to a time recovery flow on the display screen starting at date recovery 3730, clock style setting 3732, and time recovery 3734. The steps for recovering the date and time after a system time loss are similar to those described later for the initial setup of the device herein. After the current date and time have been entered into the device, pressing the “Next” button on the last recovery screen will cause the device to navigate back to the home screen, as indicated by block 3736.

Configuration An exemplary embodiment of a graphical user interface that facilitates the configuration procedure 2000 that can be used in connection with the reader described herein is provided. Hereinafter, this graphical user interface will be described in more detail with reference to FIGS. 24 to 27 and FIGS. 29 to 33.

Initial Start Interface A graphical user interface that facilitates the reader setup procedure 2000 may include an initial start interface 2001. The initial start interface 2001 first displays the introduction screen 2002 for about 3 seconds, for example. This introductory screen 2002 may include text and / or graphics designed to identify the reader and / or the manufacturer of the graphical user interface, for example, the introductory screen 2002 may include FreeStyle ( Registered trademark) butterfly trademark.

Following the display of the language selection introduction screen 2002, one or more language selection screens 2003 are provided. In one embodiment, there is no default choice, and the “OK” touchscreen button 2004 appears only after a language selection is made, for example, by touching an empty circle 2006 next to the language to select. Language selection options may be displayed in alphabetical order. If the list of language selection choices includes more than four languages, the list may be scrolled as needed using the scroll touchscreen button 2005 to view the list. The language list area may be minimized and the order of language selection may be changed later.

Date Selection When a language selection is made by pressing an empty circle 2006 next to the language to be selected and then pressing an “OK” touch screen button 2004, a first date selection screen 2008 is displayed. This is indicated by reference path (Y1) 2007 in FIG. At this stage, the user may return to one or more language selection screens through the reference path (Z1) 2009 by pressing a “return” touch screen button 2010 if desired. The initial date selection screen 2008 provides a prompt 2011 for entering the current date, along with a sample date 2012 that can be adjusted to the current date by the user. The initial date selection screen 2008 also includes an upward touch screen arrow 2013 and a downward touch screen arrow 2014, which the user may use to adjust the sample date 2012. For example, by tapping the up arrow 2013 or the down arrow 2014, the sample date 2012 may be adjusted in 1 day increments. In one embodiment, when the up or down arrow continues to be pressed, the date is incremented or decremented as appropriate, slowly during the first 2 seconds and faster after 2 seconds. The date format is set for each SKU for each region (FIG. 24 shows the US format), and is applied to all screens showing the date.

Clock Style Selection The user may move to the next screen of the graphical user interface setting procedure 2000 by pressing the “Next” touch screen button 2015, so that the FIRST CLOCK STYLE selection screen 2016 is displayed. Is displayed. At this stage, the user may return to the initial date selection screen 2008 by pressing a “Return” touch screen button 2018 if desired. The initial clock style selection screen 2016 is a prompt for selecting a clock style (eg, 12-hour (am / pm) display or 24-hour display) by touching an empty circle 2019 next to the selected clock style. 2017 is provided. FIG. 24 shows a state in which 12-hour (am / pm) display is selected as the watch style.

Time Selection The user may move to the next screen of the graphical user interface setting procedure 2000 by pressing the “Next” touch screen button 2020, whereby the first time (FIRST TIME) selection screen 2021 is displayed. . At this stage, the user may return to the initial clock style selection screen 2016 by pressing the “Return” touch screen button 2022 if desired. The first time selection screen 2021 provides a prompt 2023 for inputting the current time. As shown in FIG. 24, the initial time selection screen 2021 includes a first upward touch screen arrow 2024 and a first downward touch screen arrow 2025 for adjusting the time value increment at time 2026. Including. The initial time selection screen 2021 also includes a second upward touch screen arrow 2027 and a second downward touch screen arrow 2028 for adjusting the increment of the numerical value of the time 2026. As described above, the initial time format (12 hours or 24 hours) set for the appropriate region is displayed. Using the associated up and down arrows, the time is adjusted in 1 minute or 1 hour increments by clicking on the arrow. When the up arrow or down arrow continues to be pressed, the first 2 seconds is slowly and faster after 2 seconds and the time increment is scrolled accordingly.

Target Glucose Range Selection Once the current time is entered on the initial time selection screen 2021, the user can move to the next screen of the setup procedure 2000 by pressing the “Next” touch screen button 2029, thereby enabling the initial target range. A (FIRST TARGET RANGE) selection screen 2033 is displayed. This is indicated by reference path (A2) 2030 in FIG. At this stage, the user may return to the initial time selection screen 2021 through the reference route (B2) 2031 by pressing the “return” button 2032 on the touch screen if desired. The initial target range selection screen 2033 provides a first upward touch screen arrow 2034 and a first downward touch screen arrow 2035 for adjusting the lower limit (eg, 80 mg / dL) of the target glucose range 2036. The initial target range selection screen 2033 also provides a second upward touch screen arrow 2037 and a second downward touch screen arrow 2038 for adjusting the upper limit (eg, 140 mg / dL) of the target glucose range 2036. The initial target range selection screen 2033 also provides a “?” Touch screen button 2039 that provides a target range details (TARGET RANGE DTL) screen 2040 that can display additional information about the target glucose range 2036. The target range details (TARGET RANGE DTL) screen 2040 includes an “OK” touch screen button 2041 that, when pressed, returns the user to the initial target range selection screen 2033.

Initial Home Button Once the target glucose range is entered on the initial target range selection screen 2033, the user can move to the next screen of the setup procedure 2000 by pressing the “Next” touch screen button 2042, which allows the initial home button ( FIRST HOME BTTN) screen 2043 is displayed. First time home button screen 2043 includes a prompt describing the function of the home button of the reader. For example, the prompt may be a text prompt such as “Pressing this button while using the reader will return to the home screen”. This text may be provided with a graphical representation showing the location of the home button on the reader, as shown in FIG. At this stage, the user may return to the initial target range selection screen 2033 by pressing the touch screen “return” button 2044 if desired. When the user reaches the initial home button screen 2043 from the setting menu (details will be described later), the “return” button is not displayed. If the reader is turned off after this screen is viewed, the first start interface start sequence described above is not displayed in the next power-on event. If this screen is not displayed, the settings made are not retained, and the initial start interface start sequence starts from the beginning.

Arrow Description Screen When the “Next” touch screen button 2045 displayed on the initial home button screen 2043 is pressed, an arrow description including an explanation of the arrows indicating various trends used to convey glucose trend information through the graphical user interface A screen 2046 is displayed. For example, the arrow description screen 2046 may display a text prompt such as “When you scan your sensor, the arrow shows your recent glucose trend”. This text prompt may be followed by various arrows and an explanation of the information associated with them indicating the tendency conveyed by them. For example, a first arrow 2047 pointing straight up may indicate that the user's glucose level is “rapidly rising” and a second arrow 2048 pointing right up at an angle of about 45 degrees is May indicate that the user's glucose level is “rising” or the like, and a third arrow 2049 pointing straight to the right may indicate that the user's glucose level is “stable” or the like. The fourth arrow 2050 pointing to the lower right at an angle of about 45 degrees may indicate that the user's glucose level is “falling”, etc., and the fifth arrow 2051 indicates that the user's glucose level is “ It may indicate that it is “decreasing rapidly”. At this stage, the user may return to the initial home button screen 2043 by pressing a “return” button 2052 on the touch screen if desired.

Charging explanation screen When the “Next” touch screen button 2053 displayed on the arrow explanation screen 2046 is pressed, a charging explanation screen 2054 is displayed. The charge description screen 2054 provides the user with a text prompt to remind the reader to recharge the reader periodically. For example, the charging explanation screen 2054 may display a text prompt such as “Please recharge the reader periodically”. The charging instructions screen 2054 may also display a graphic that shows the user how to connect the reader to a power source for recharging purposes. At this stage, the user may return to the arrow explanation screen 2046 by pressing a “return” touch screen button 2055 if desired. The charging explanation screen 2054 also includes a “Done” touch screen button 2056 that, when pressed, completes the initial start interface 2001. At this point, a sensor activation procedure may be performed.

Settings Interface A graphical user interface that facilitates the settings procedure 2000 may include a settings interface 2057 that includes a settings menu 2058 that may be displayed on the reader. The setting menu 2058 includes a first setting screen 2059, a second setting screen 2060, and a third setting screen 2061. The first setting screen 2059 includes menu items of “Sound”, “Target range”, and “Control solution test”. Each of these menu items is represented by a corresponding touch screen button (touch screen buttons 2062, 2063, and 2064, respectively). The second setting screen 2060 includes menu items of “date and time”, “brightness of display”, and “language”. Each of these menu items is represented by a corresponding touch screen button (touch screen buttons 2065, 2066, and 2067, respectively). Finally, the third setting screen 2061 includes menu items of “System Status”, “Computer Settings”, “Reader Basic Settings”, and “Expert Options”. Each of these menu items is represented by a corresponding touch screen button (touch screen buttons 2068, 2069, 2070, and 2071, respectively). The touch screen scroll buttons 2072, 2073, 2074, and 2075 may be used as appropriate to scroll between the first, second, and third setting screens.

Sound When the touch screen button 2062 (“Sound”) is pressed, a sound setting screen 2076 is displayed. This is indicated by reference path (C2) 2077 in FIG. The sound setting screen 2076 includes touch screen switching settings of “volume” 2078, “notification sound” 2079, “notification vibration” 2080, and “button sound” 2081. With these settings, sound and vibration can be switched on or off. Button sounds include, for example, sounds when a key is pressed and interactive notification sounds (eg, ready for results). The first two options affect the screen that broadcasts notifications, confirmations, and reminder signals. The default button sound is off. The default notification sound is on and vibration is off. When scrolling with the button pressed, the sound will only sound the first time you touch it. Once the desired sound settings have been selected using the touch screen switching settings, the settings can be approved by touching the “OK” touch screen button 2082.

Target Range When a touch screen button 2063 (“target range”) is pressed, a target range setting screen 2083 is displayed. This is indicated by reference path (D2) 2084 in FIG. The target range setting screen 2083 provides a first upward touch screen arrow 2085 and a first downward touch screen arrow 2086 for adjusting the lower limit (eg, 70 mg / dL) of the target glucose range 2089. The target range setting screen 2083 also provides a second upward touch screen arrow 2087 and a second downward touch screen arrow 2088 for adjusting the upper limit (eg, 130 mg / dL) of the target glucose range 2089. At this stage, the user may return to the first setting screen 2059 through the reference path (D2) 2084 by pressing a “return” touch screen button 2093 if desired. By pressing the “Done” touch screen button 2094, the current settings can be selected. The target range setting screen 2083 also provides a “?” Touch screen button 2090 that, when pressed, provides a target range detail (TARGET RAGE DTL) screen 2091 that can display additional information about the target glucose range 2089. The target range detail screen 2091 includes an “OK” touch screen button 2092 which, when pressed, returns the user to the target range setting screen 2083.

Display Brightness When a touch screen button 2066 (“display brightness”) is pressed, a display brightness setting screen 2095 is displayed. This is indicated by reference path (G2) 2096 in FIG. The display brightness setting screen 2095 provides display brightness “high”, “medium”, and “low” settings that can be selected by touching one of the empty circles 2097. FIG. 25 shows a state in which the “high” brightness setting is selected. Once the desired display brightness has been selected by pressing one of the empty circles 2097, the setting can be accepted by touching the “OK” touch screen button 2098.

Control Solution Test Pressing the touch screen button 2064 (“Control Solution Test”) displays the “Insert Test Strip” (etc.) prompt 2099 and initiates the Control Solution Test Protocol, as shown in flow diagram 2100. This is indicated by reference path (E2) 2101 in FIG. In general, a test strip is inserted into the reader (step 2102). Depending on whether the test strip is a blood glucose (BG) test strip or a ketone test strip, a corresponding “Precision Control Solution” animation (step 2103) or a ketone control solution animation (step 2104) is displayed. . See, eg, FIG. 35 for each of the “Precision Control Solution” animation and the Ketone Control Solution animation. Once the appropriate control solution has been applied (step 2105), a wait animation is displayed during processing of the results (step 2106). See, for example, FIG. 34 above in the blood glucose strip test and ketone strip test sections. When the results are ready (step 2107), blood glucose control results (step 2108) or ketone results (step 2109) are provided. These results may be displayed or stored in a reader's registry application, for example.

  FIG. 35 illustrates an example of an animation interface 2430 that instructs the user to apply a control solution, according to one embodiment. Screens 2432, 2434, and 2436 display images of the control solution dropper and the sample monitoring device with the test strip inserted into the strip port. As a series of screens 2432, 2434, and 2436 progress, the dropper and test strip move closer together and an animation of applying the dropper to the test strip is displayed. The animation interface 2430 may be displayed, for example, when the sample monitoring device is ready to receive a control solution.

  FIG. 35 also shows an example of an animation interface 2438 that directs the user to apply a ketone control solution, according to one embodiment. Similar to interface 2430, screens 2440, 2442, and 2444 display images of the control solution dropper and the analyte monitoring device with the test strip inserted into the strip port. As the series of screens 2440, 2442, and 2444 proceed, the dropper and test strip move closer together and an animation of applying the dropper to the test strip is displayed. However, the animation interface 2438 includes an indication that a ketone test is in progress (eg, displays the word “ketone test”).

Date and Time When the touch screen button 2065 (“date and time”) is pressed, a date and time setting screen 2110 is displayed. This is indicated by reference path (F2) 2111 in FIG. The date and time setting screen 2110 provides a time touch screen button 2112 and a date touch screen button 2113.

  When the time touch screen button 2112 is pressed, a “SET TIME 12” screen 2114 or a “SET TIME 24” screen 2115 is displayed. The “time setting 12” screen 2114 includes a first upward touch screen arrow 2118 and a first downward touch screen arrow 2119 for adjusting the time value increment at time 2122. The “time setting 12” screen 2114 also includes a second upward touch screen arrow 2120 and a second downward touch screen arrow 2121 for adjusting the numerical increment of the minute at time 2122. The “time setting 24” screen 2115 includes a first upward touch screen arrow 2123 and a first downward touch screen arrow 2124 for adjusting the time increment of time 2127. The “time setting 24 screen” 2115 also includes a second upward touch screen arrow 2125 and a second downward touch screen arrow 2126 for adjusting the increment of the numerical value of the time 2127. The user can switch between “time setting 12 screen” 2114 and “time setting 24 screen” 2115 by appropriately using touch screen toggle buttons 2115 and 2116. Further, “Time Setting 12” screen 2114 and “Time Setting 24” screen 2115 include “OK” touch screen buttons 2128 and 2129 for approving the input time, respectively.

  When the date touch screen button 2113 is pressed, a date setting screen 2130 is displayed. The date setting screen 2130 includes an upward touch screen arrow button 2131 and a downward touch screen arrow button 2132 for adjusting the day value of the date 2133 set at the factory. The date setting screen 2130 also includes an “OK” touch screen button 2134 for approving the input date.

  The date and time setting screen 2110 also includes a “Done” touch screen button 2135 that, when pressed, returns the user to the settings menu 2058 through the reference path (H2) 2136.

Language Setting When a touch screen button 2067 (“language”) is pressed, one or more language setting screens 2137 are displayed. This is indicated by reference path (I2) 2138 in FIG. One or more language setting screens 2137 include language choices that can be selected by pressing an empty circle next to the corresponding language choice. FIG. 26 shows a state in which an English option is selected. The user may scroll the language setting screen using the displayed upward or downward arrow 2139 as appropriate. Language setting screen 2137 also includes an “OK” touch screen button 2140 for approving the selected language.

Computer Setting When a touch screen button 2069 (“computer setting”) is pressed, a computer setting screen 2141 is displayed. This is indicated by reference path (K2) 2142 in FIG. The computer setting screen 2141 includes, for example, an “INSULIN CALC SETTINGS-EASY” screen 2142 and an “INSULIN CALC SETTINGS-ADVANCED” screen 2143. Insulin Calculator Settings-Simple Mode Screen 2142 may include, for example, 18u insulin unit measurements associated with breakfast, 20u insulin unit measurements associated with lunch, 24u insulin unit measurements associated with dinner, 70 Includes a correction target of ~ 130 mg / dL and a correction factor of 10 mg / dL. The insulin calculator settings-advanced mode screen 2143 includes, for example, a carbohydrate ratio of 1 u for 10 g, a correction target of 70-130 mg / dL, and a correction factor of 1 u for 10 mg / dL. The calculator setting screen 2141 also includes an “OK” touch screen button 2144 for accepting the indicated calculator setting.

  When the touch screen button 2070 (“Reader Basic Settings”) is pressed, the initial home button screen 2043 of the initial start interface described earlier in this specification is displayed. This is indicated by reference path (L2) 2145 in FIG.

Expert Options As shown in FIG. 26, pressing a touch screen button 2071 (“expert options”) causes an HCP question screen 2146 to be displayed. This is indicated by reference path (J2) 2147 in FIG. The HCP question screen 2146 displays a prompt asking whether or not the user is a medical professional. This question can be answered by touching the empty circle 2148 next to the “yes” or “no” option. FIG. 26 shows a state where the “Yes” option is selected. A default selection is not provided and the “Next” touchscreen button 2149 is not displayed until an option is selected. The HCP question screen 2146 also includes a “return” touch screen button 2150 that, when pressed, returns the user to the settings menu 2058 through the reference path (J2) 2147. As shown in FIG. 26, if the “No” option is selected, for example, “Non-HCP” (“Professional option can only be used by medical professionals”) NOT HCP) screen 2151 is displayed. The “not HCP” screen 2151 also includes a “done” touch screen button 2152 which causes the user to return to the settings menu 2058, for example, through a reference path (J2) 2147. When the “Yes” option is selected, a passcode input screen 2153 that prompts the user to input a passcode is displayed. If an incorrect passcode is entered, for example, a prompt “Passcode is incorrect” is displayed. If the correct passcode is entered, the user can access the expert options screen 2154. Expert options screen 2154 includes touch screen button options for system reset 2155 options, masking mode 2156 options, dose increment 2157 options, and insulin calculator 2159 options. When the touch screen button of the system reset option is pressed, a system reset (RESET SYS) screen 2155 is displayed. Selecting the “Reset” option from this screen restores all reader settings to factory default settings and erases all patient data stored in the reader. Then, the user is returned to the initial start interface 2001.

  Pressing the masking mode option touchscreen button initiates the masking mode interface 2156 described elsewhere herein.

  Pressing the dose increment option touchscreen button initiates the dose increment interface 2157. The dose increment interface 2157 allows the HCP to change the dose increment setting. The dose increment setting applies to both fast-acting and long-acting insulin doses. In one embodiment, the default value is 0.5 units. However, other suitable increment values such as 0.1 units, 0.2 units, etc. can be used. The dose increment is the minimum amount of insulin that can be recorded, which may be displayed on the device as shown at 2158. Pressing the “Finish” button returns to the expert options screen 2154.

  Pressing the touch screen button of the insulin calculator option starts the insulin calculator start interface 2159 (details will be described later).

  The expert options screen 2154 also includes an “OK” touch screen button 2159 that, when pressed, returns the user to the settings menu 2058 through the reference path (J2) 2147.

System Status Pressing touch screen button 2068 (“System Status”) initiates system status interface 2160. Details of the graphical user interface of this aspect will be described later.

System Status Interface A graphical user interface that facilitates the setup procedure 2000 may include a system status interface 2160 that includes a system status menu 2161 that may be displayed on a reader. The system status menu 2161 includes items of “System Information”, “Self Test”, “Touch Screen Test”, and “Error Log”, which correspond to the corresponding touch screen buttons 2162, 2163, 2164, and 2165, respectively. You can select by touching. The system status menu 2161 includes an “OK” touch screen button 2169 that, when pressed, returns the user to the settings interface 2057.

  When the system information touch screen button 2162 is pressed, a system information screen 2166 is displayed, which is a reader serial number, reader software number, reader hardware number, sensor ID, sensor software number, sensor count, strip. Information such as count, date of last scan, last reset, etc. may be displayed. This is indicated by reference path (N2) 2167 in FIG. System information screen 2166 includes an “OK” touchscreen button 2168 that, when pressed, returns the user to system status menu 2161 through reference path (M2) 2170.

  When the self-test touch screen button 2163 is pressed, a self-test screen 2171 is displayed and the self-diagnosis protocol is started. This is indicated by reference path (O2) 2172 in FIG. The self-test protocol can also be initiated by pressing the power button and double-tapping anywhere on the screen. Self test screen 2171 includes an “LCD test” touch screen button 2173. When the “LCD test” touch screen button 2173 is pressed, an LCD test introduction (LCD TEST INTRO) screen 2174A is displayed. The LCD test introduction screen 2174A includes, for example, a prompt “Check for missing pixels on the next screen. Press“ Start ”to start the test”. The LCD test introduction screen 2174A also includes a “start” touch screen button 2175 and a “back” touch screen button 2176. When “return” touch screen button 2176 is pressed, the user is returned to self-test screen 2171. When the “START” touch screen button 2175 is pressed, the LCD test is started and the LCD test result screen 2174B is displayed. LCD test result screen 2174B may include a prompt indicating that the LCD test is complete. The LCD test result screen 2174B may also include a “Done” touch screen button 2177 that, when pressed, returns the user through the reference path (M2) 2170 to the self test screen 2171 or the system status menu 2161. Self test screen 2171 also includes an “OK” touch screen button 2168 that, when pressed, returns the user to system status menu 2161 through reference path (M2) 2170.

  Pressing the sound test touchscreen button displays the sound test screen. The sound test screen may display, for example, a prompt “Contact customer service if you do not hear a series of sounds and vibrations”. For example, the sound test screen may include a “Next” button that, when pressed, may navigate to the next setting test. The sound test screen may include a “return” button that, when pressed, returns the user to the system status menu 1261.

  When a touch screen button 2164 for a touch screen test is pressed, a touch sensor test screen 2178 is displayed. This is indicated by reference path (P2) 2179 in FIG. Touch sensor test screen 2178, for example, “To test the touch zone grid on the display, press the start button and test all touch zones. Press the power button on the touch sensor grid to enter the diagnostic menu. You may display the prompt “Return.” The touch sensor test screen 2178 includes a “start” touch screen button 2180 that, when pressed, displays a touch sensor grid 2181 for testing the response of various zones of the touch sensor grid 2181. Touch sensor test screen 2178 also includes a “return” touch screen button that, when pressed, returns the user to system status menu 2161 through reference path (M2) 2170.

  When the error recording touch screen button 2165 is pressed, an “error recording is empty” screen 2182 or an “error recording” screen 2184 is displayed. This is indicated in FIG. 27 by reference paths (Q2) 2183 and (R2) 2185, respectively, depending on whether or not there is an error entry in the record book. The error recording screen 2184 may include one or more downward or upward arrows for scrolling between error recording pages as required.

Masking Mode Interface An exemplary embodiment of a graphical user interface that functions to enable operation of the analyte monitoring device in a masking mode that may be used in connection with the reader described herein.

  FIG. 28 shows an expert options screen 2502 that displays a menu of options for customizing the operation of the device. For example, the menu of options may be directed to a physician or other medical professional setting up or otherwise configuring the device for the patient. In one embodiment, the expert options screen 2502 may require an encryption or password for access that is known to the physician but not the patient. In another embodiment, the expert options screen 2502 may not be restricted and the patient may change the configuration.

  Expert options screen 2502 includes masking mode options 2504 for navigating to masking mode interface 2510 that allows masking mode to be activated or deactivated. Examples of other options include an insulin calculator option 2508 for navigating to an interface for activating or deactivating the insulin calculator. A system reset option 2502 for resetting the option to the default setting may also be included.

  Masking mode interface 2510 includes activation icons, symbols, trigger elements, etc. that can be selected to activate the masking mode. The masking mode interface 2510 may also provide further information regarding the masking mode to inform the user of the use of the masking mode. Masking mode interface 2510 also includes a trigger element 2514a for navigating back to expert options screen 2502. As indicated by the reference path T2, the trigger element 2514b presents a screen for setting a reminder for performing sensor measurement to the user.

  Once trigger element 2514b is selected, a masking reminder (MASKED REM) screen 2516 is displayed that allows the device to be configured to provide the user with a reminder to take a measurement. For example, element 2518 may be selected to activate or deactivate the device's reminder function. Additional information may also be provided to inform the user of the reminder options. If the reminder is “off” and the user selects the trigger element 2520a, the user is returned to the expert options screen 2502. If the reminder is “on” and the user selects the trigger element 2520b, a masking reminder time (MASKED REM-TIME) screen 2522 is displayed that allows the user to set the time to start the reminder. The Once the time has been set, the user can select a trigger element 2522b that triggers a MASKED COMP screen 252 indicating that the masking mode has been activated. In some embodiments, the masking mode reminder is set for a predetermined period of time (eg, several hours, 8 hours, 12 hours, 24 hours, etc.). In some embodiments, the reminder timer period is automatically reset if the user manually performs a scan before the next reminder. In certain embodiments, the device includes a reminder delay option, for example, when the reminder is activated in masking mode, the user has the option to delay the reminder by a preset amount of time. If the user confirms with trigger element 2524, the device navigates back to expert options screen 2502.

Computer Start Interface The graphical user interface that facilitates the setup procedure 2000 may include a computer start interface 2186, as previously described herein. The calculator start interface 2186 may be initiated by pressing an insulin calculator 2157 option touchscreen button on the expert options screen 2154. When the insulin calculator 2157 option touch screen button is pressed, the on / off state of the calculator is determined. If the computer is on, the reference path (X2) 2187 is started, thereby displaying a “CALC EDIT” screen 2188. The calculation edit screen 2188 includes a touch screen button 2189 “Turn off calculator”. Pressing the “Turn off calculator” button 2189 displays a calculation off screen 2190 that provides a prompt indicating that the insulin calculator has been turned off. In this case, the calculator button cannot be used when checking the glucose level. The calculation off screen 2190 includes a “done” touch screen button that, when pressed, initiates a reference path (V2) 2192 and returns the user to the expert options screen 2154.

  The calculation edit screen 2188 also includes a “change computer setting” touch screen button 2193. When the “change computer setting” touch screen button 2193 is pressed, a reference path (B3) 2194 is started (details will be described later). The route (W2) 2196 is started and the user is returned to the expert options screen 2154.

  As described above, pressing the touch screen button of the insulin calculator 2157 option determines the on / off state of the calculator. If the computer is off, an “I TAKE” screen 2197 is displayed. The “I TAKE” screen 2197 includes a prompt “Does the patient take fast-acting (short-acting) insulin during a meal?”. The “I TAKE” screen 2197 also includes an empty circle 2198 that can be pressed to indicate a “yes” or “no” answer to the above prompt. FIG. 29 shows a state in which the “Yes” option is selected. The “I TAKE” screen 2197 also includes a “Next” touch screen button 2199, which starts a reference path (Z2) 2200 when the “Yes” option is selected (details will be described later).

  In the reference path (B3) 2194 and the reference path (Z2) 2200, depending on whether the “easy” setting option or the “advanced” setting option is selected using the touch screen toggle element 2203 Then, a calculation type (CALC TYPE) 01 screen 2201 or a calculation type (CALC TYPE) 02 screen 2202 is displayed. The “easy” setting option is used for patients starting with a certain amount of fast-acting insulin during a meal, while the “advanced” setting option adjusts the fast-acting insulin dose during a meal Used for patients considering carbohydrates (grams or servings). Calculation type 01 screen 2201 and calculation type 02 screen 2202 each include a “back” touch screen button 2204 and a “next” touch screen button 2205. If the previously viewed screen is “I TAKE” 2197, when the “Return” button 2204 is pressed, the user is returned to “I TAKE” 2197 through the reference path (Y2) 2206. If the previously viewed screen is the calculation edit 2188, when the “return” button 2204 is pressed, the user is returned to the calculation edit 2188 through the reference path (A3) 2207. Touching the “Next” touch screen button 2205 initiates a reference path (D3) 2208 or (E3) 2209, depending on whether a simple setting option or an advanced setting option is selected. Is done.

  In reference route (D3) 2208, a “CALC STEPS EZ” screen 2210 is displayed, which is “This setting has two parts. 2) Enter the patient correction settings. ”Prompt. The “calculation step easy” screen 2210 includes a “back” touch screen button 2211 and a “next” touch screen button 2212. When the “Return” touch screen button 2211 is pressed, the user is returned to the calculation type 01 screen 2201 and the calculation type 02 screen 2202 through the reference path (C3) 2213. When the “Next” touch screen button 2212 is pressed, a simple calculation setting interface 2214 (details will be described later) is started.

  In the reference route (E3) 2209, the “CALC STEPS ADV” screen 2215 is displayed. This screen has “two parts in this setting. 1) Enter the insulin setting at the patient's meal. 2) Enter the patient correction settings "prompt. “Calculation step altitude” screen 2215 includes “Back” touchscreen button 2216 and “Next” touchscreen button 2217. When the “Return” touch screen button 2216 is pressed, the user is returned to the calculation type 01 screen 2201 and the calculation type 02 screen 2202 through the reference path (C3) 2213. When the “Next” touch screen button 2217 is pressed, a food unit (FOOD UNITS) 01 screen 2218 is displayed. The food unit 01 screen 2218 includes a prompt “unit for entering food” and two choices of “carbohydrate grams” and “serving number” that can be selected by pressing one of the corresponding empty circles 2219. including. FIG. 29 shows a state where the option “grams of carbohydrates” is selected. The food unit 01 screen 2218 includes a “Back” touch screen button 2220 and a “Next” touch screen button 2221. Pressing the “Return” touch screen button 2220 returns the user to the “Calculation Step Altitude” screen 2215. When the “Next” touch screen button 2221 is pressed, an advanced calculation setting interface 2222 (details will be described later) is started. The food unit 01 screen 2218 also includes a “?” Touch screen button that, when pressed, initiates the reference path (F3) 2223, and displays screens H01 (2224), H02 (2225), and H03 (2226) of FIG. As indicated by reference, further information regarding the selection of “grams of carbohydrate” or “number of servings” is provided.

Simple Calculation Setting Interface With reference to FIG. 30, a simple calculation setting interface 2214 will be described. A meal calculation (MEAL CALC) screen for each of the three meals, breakfast 2227, lunch 2228, and dinner 2229, is provided. Each of these screens includes up and down arrows 2230 for adjusting the displayed units of insulin associated with each meal. Each of these screens also includes a “Back” touch screen button and a “Next” touch screen button for navigating between screens of the simple calculation settings interface 2214. Finally, each of these screens includes a “?” Touch screen button 2231 that, when pressed, starts a reference path (G3) 2232. In the reference route (G3) 2232, a screen 2233 including a prompt “Please enter the recommended number of units of fast-acting insulin to cover this meal” is displayed. When the “Next” touch screen button is pressed from the dinner 2229 screen, a correction target screen 2234 is displayed.

  The corrected target screen 2234 includes first upward and downward arrows (2235 and 2236) for adjusting the lower target of the target glucose range 2237 (eg, 70 mg / dL) and the higher of the target glucose range 2237. And second up and down arrows (2238 and 2239) to adjust the target (eg, 130 mg / dL). The correction target screen 2234 includes a “?” Touch screen button 2240, and when this is pressed, a reference path (H3) 2241 is started. In reference pathway (H3) 2241, screen 2242 is displayed that includes a prompt “The target is the desired glucose value if additional fast acting insulin is needed to correct high glucose readings”. When the “Next” touch screen button is pressed from the correction target screen 2234, a correction coefficient screen 2243 is displayed. Correction coefficient screen 2243 includes upward and downward arrows 2244 for adjusting insulin correction coefficient 2245. When the correction coefficient setting (SET CORR FCTR) is scrolled below 1, a “NO CORR” screen 2249 having a prompt “NO INSULIN CORRECTION” is displayed. The correction coefficient screen 2243 includes a “?” Touch screen button 2246, and when this is pressed, a reference path (I3) 2247 is started. In reference path (I3) 2247, a screen 2248 containing the prompt “The reader uses this value to determine the number of fast-acting insulin units needed to bring high glucose down to a target value or range”. Is displayed. When the “Next” touch screen button is pressed from the correction coefficient screen 2243, a residual insulin (IOB) setting interface 2250 (details will be described later) is started.

Advanced Calculation Setting Interface The advanced calculation setting interface 2222 will be described with reference to FIG. When “By Carbohydrate Grams” is selected on the screen 2218 and the advanced calculation setting interface 2222 is started, a carbohydrate ratio setting (SET CARB RATIO) screen 2251 is displayed. The carbohydrate ratio setting screen 2251 includes upward and downward touch screen arrows 2252 for adjusting the correction coefficient 2253. The carbohydrate ratio setting screen 2251 also includes a touch screen button 2254 “in time”.

  When the touch screen button 2254 is pressed “in a time zone”, a “CR TIME LIST” screen 2255 is displayed. Correction time list screen 2255 includes touch screen buttons 2256 that can be used to select a period of correction factor 2253 (eg, morning, noon, evening, or night). When one of the touch screen buttons 2256 is pressed, a “correction time” (CR TIME) screen 2257 including upward and downward touch screen arrows 2258 for adjusting the correction factor 2253 for each time period is displayed. The correction time screen 2257 includes an “OK” touch screen button 2259, and when pressed, the correction coefficient 2253 for each displayed time zone is selected, and the user is returned to the correction time list screen 2255. The time list screen 2255 indicates that the “Return” touch screen button 2260 for returning to the carbohydrate ratio setting screen 2251 and the setting of the correction coefficient 2253 for each time zone have been completed, and in some embodiments, the correction setting interface 2268. And a “Done” touch screen button 2261 for starting (details will be described later).

  Each of the carbohydrate ratio setting screen 2251 and the correction time list screen 2255 includes a “?” Touch screen button 2264, and when this is pressed, a carbohydrate ratio information screen 2265 is displayed. The carbohydrate ratio information screen 2265 displays a prompt “Carbohydrate ratio is the amount of carbohydrate covered by one unit of insulin”. When the “OK” touch screen button 2266 is pressed from the carbohydrate ratio information screen 2265, the user is appropriately returned to the carbohydrate ratio setting screen 2251 or the correction time list screen 2255.

  The carbohydrate ratio setting screen 2251 includes a “return” touch screen button 2262 and a “done” touch screen button 2263. Pressing the “Return” touch screen button 2262 takes the user back through the reference path (J3) 2267 to the calculation start interface 2186 described earlier in this specification. When the “Finish” touch screen button 2263 is pressed, the correction setting interface 2268 is started through the reference path (K3) 2269.

  When “By number of servings” is selected on the screen 2218 and the advanced calculation setting interface 2222 starts, a serving number definition screen 2270 is displayed. The serving number definition screen 2270 includes up and down touch screen arrows 2271 for adjusting the serving number definition 2272 (eg, 1 serving number = 10.0 grams carbohydrate). The serving number definition screen 2270 also includes a “back” touch screen button 2273 and a “next” touch screen button 2274. Pressing the “Return” touchscreen button 2273 returns the user to the start computation interface 2186 described earlier in this specification. When the “NEXT” touch screen button 2274 is pressed, a carbohydrate ratio serving number setting screen 2275 is displayed. The carbohydrate ratio serving number setting screen 2275 includes up and down touch screen arrows 2276 for adjusting the serving number ratio 2277 (eg, 1.5 units of insulin for one serving number). The carbohydrate ratio serving number setting screen 2275 also includes a touch screen button 2278 “in time”.

  When the touch screen button 2278 is pressed “in a time zone”, a corrected serving number time list (CR SVG TIME LIST) screen 2279 is displayed. The corrected serving number time list screen 2279 includes a touch screen button 2280 that may be used to select a period of the serving number ratio 2277 (eg, morning, noon, evening, or night). Pressing one of the touch screen buttons 2280 displays a corrected serving number time screen 2281 that includes upward and downward touch screen arrows 2282 for adjusting the serving number ratio 2277 for each time period. The corrected serving number time screen 2281 includes an “OK” touch screen button 2283, and when pressed, the serving number ratio 2277 for each displayed time zone is selected and the user is returned to the corrected serving number time list screen 2279. . The corrected serving number time list screen 2279 has a “return” touch screen button 2284 for returning to the carbohydrate ratio serving number setting screen 2275 and a “complete” touch screen button for starting a correction setting interface 2268 (details will be described later). 2285.

  The carbohydrate ratio serving number setting screen 2275 includes a “back” touch screen button 2286 and a “next” touch screen button 2287. When the “return” touch screen button 2286 is pressed, the user is returned to the serving number definition screen 2270. When the “Next” touch screen button 2287 is pressed, a correction setting interface 2268 (details will be described later) is started.

  Each of the serving number definition screen 2270, the carbohydrate ratio serving number setting screen 2275, and the corrected serving number time list screen 2279 includes a “?” Touch screen button 2288, and when pressed, through the reference path (L 3) 2290, A serving number ratio information screen 2289 is displayed. The serving number ratio information screen 2289 displays a prompt such as “The serving number ratio is the amount of insulin that covers one serving number”. When the “OK” touch screen button 2291 is pressed from the serving number ratio information screen 2289, the user is appropriately returned to the serving number definition screen 2270, the carbohydrate ratio serving number setting screen 2275, or the corrected serving number time list screen 2279.

Correction Setting Interface The correction setting interface 2268 will be described with reference to FIG. When the correction setting interface 2268 is started, a target type screen 2292 is displayed. The goal type screen 2292 includes a prompt such as “How does the patient correct glucose?”. The target type screen 2292 includes options such as 1) “to be a single target value” and 2) “to be a target range”, etc., and the corresponding empty circle 2293 associated with the option. By pressing one, one of them can be selected. FIG. 32 shows a state where the option “so as to have a single target value” is selected. The goal type screen 2292 also includes a “Back” touch screen button 2294 and a “Next” touch screen button 2295. When the “return” touch screen button 2294 is pressed, the user is brought to a previously viewed screen (carbohydrate ratio setting screen 2251, correction time list screen 2255, carbohydrate ratio serving number setting screen 2275, or correction serving number time list screen 2279). Returned.

  When the option “to be a single target value” is selected on the screen 2292 and the “Next” touch screen button 2295 is pressed, a correction target screen 2296 is displayed. Correction target screen 2296 includes upward and downward touch screen arrows 2297 for adjusting correction target 2298 (eg, 100 mg / dL). The correction target screen 2296 also includes a touch screen button 2299 “in time”. When the touch screen button 2299 is pressed “in a time period”, a reference path (P3) 2300 (details will be described later) is started. The correction target screen 2296 also includes a “back” touch screen button 2301 and a “next” touch screen button 2302. Pressing the “Return” touch screen button 2301 returns the user to the target type screen 2292. When the “Next” touch screen button 2302 is pressed, a reference path (O3) 2303 (details will be described later) is started.

  When the “next to” touch screen button 2295 is pressed while the option “to be in the target range” is selected on the screen 2292, the corrected target range screen 2304 is displayed. Correction target range screen 2304 includes first upward and downward touch screen arrows 2305A for adjusting the lower limit (eg, 70 mg / dL) of correction target range 2306. Correction target range screen 2304 also includes second upward and downward touch screen arrows 2305B for adjusting the upper limit (eg, 130 mg / dL) of correction target range 2306. The corrected target range screen 2304 also includes a “in time zone” touch screen button 2307. When the touch screen button 2307 is pressed “in a time zone”, a reference path (M3) 2308 (details will be described later) is started. The corrected target range screen 2304 also includes a “Back” touch screen button 2309 and a “Next” touch screen button 2310. Pressing the “Return” touch screen button 2309 returns the user to the target type screen 2292. When the “Next” touch screen button 2310 is pressed, a reference path (O3) 2303 (details will be described later) is started. The target type screen 2292 includes a “?” Touchscreen button 2311 that, when pressed, causes the calculator to determine the amount of insulin required to bring glucose to a value or range, etc. A target information screen 2312 including a prompt to be displayed is displayed. Pressing the “OK” touch screen button 2313 returns the user to the target type screen 2292.

  The corrected target screen 2296 and the corrected target range screen 2304 each include a “?” Touch screen button 2314 that, when pressed, causes the “corrected target setting to indicate that the patient's glucose reading is higher or lower than the target. A target information screen 2315 including a prompt such as “You can set a glucose target to adjust the insulin dose of” is displayed. When the “OK” touch screen button 2316 is pressed, the user is returned to the correction target screen 2296 or the correction target range screen 2304 as appropriate.

  As described above, when the touch screen button 2299 is pressed “on time” on the screen 2296, the reference path (P3) 2300 is started. When the reference route (P3) 2300 is started, a target time list (TARGET TIME LIST) screen 2317 is displayed, and this screen selects a time zone (for example, morning, noon, evening, or night) of the correction target 2298. A touch screen button 2318. When one of the touch screen buttons 2318 is pressed, a target time (TARGET TIME) screen 2319 is displayed. Target time screen 2319 includes upward and downward touch screen arrows 2320 for adjusting the correction target 2298 for the selected time zone. The target time screen 2319 also includes an “OK” touch screen button 2320 to accept the adjusted correction target 2298 for the selected time zone and return the user to the target time list screen 2317. The target time list screen 2317 includes a “return” touch screen button 2321 and a “done” touch screen button 2322. When the “return” touch screen button 2321 is pressed, a reference path (Q3) 2323 is started, and the user is returned to the correction target screen 2296. When the “Finish” touch screen button 2322 is pressed, a reference path (S3) 2324 (details will be described later) is started.

  As described above, when the touch screen button 2307 is pressed “on time” on the screen 2304, the reference path (M3) 2308 is started. When the reference route (M3) 2308 is started, a target range time list screen 2325 is displayed. This screen is used to select a time zone (for example, morning, noon, evening, or night) of the corrected target range 2306. A touch screen button 2326 is included. When one of the touch screen buttons 2326 is pressed, a target range time screen 2327 is displayed. Target range time screen 2327 includes first upward and downward touch screen arrows 2328 for adjusting the lower limit of corrected target range 2306 for the selected time period. Target range time screen 2327 includes second upward and downward touch screen arrows 2329 for adjusting the upper limit of corrected target range 2306 for the selected time period. The target range time screen 2327 also includes an “OK” touch screen button 2330 to accept the adjusted corrected target range 2306 for the selected time zone and return the user to the target range time list screen 2325. The target range time list screen 2325 includes a “return” touch screen button 2331 and a “done” touch screen button 2332. When the “return” touch screen button 2331 is pressed, a reference path (N3) 2333 is started, and the user is returned to the correction target range screen 2304. When the “Finish” touch screen button 2332 is pressed, a reference path (S3) 2324 (details will be described later) is started.

  The target time list screen 2317 and target range time list screen 2325 each include an “OK” touch screen button 2334 that, when pressed, causes the patient to have a corrected target setting when the patient's glucose reading is higher or lower than the target. A target information screen 2315 is displayed that includes a prompt such as “You can set a glucose target to adjust the insulin dose of.” Pressing the “OK” touch screen button 2316 causes the user to enter the target time list screen 2317 or target range. The time list screen 2325 is appropriately returned.

  As described above, pressing the “Next” touchscreen button 2302 or 2310 starts the reference path (O3) 2303. Similarly, when the “Done” button 2322 or 2332 is pressed, the reference path (S3) 2324 is started. In reference paths (O3) 2303 and (S3) 2324, a correction coefficient setting (SET CORR FCTR) screen 2335 is displayed. The correction factor setting screen 2335 includes upward and downward touch screen arrows 2336 for adjusting an insulin correction factor 2337 (eg, 1 u insulin for 10 mg / dL). The correction coefficient setting screen 2335 also includes a touch screen button 2338 “in time zone”, and when pressed, a correction coefficient time list (CF TIME LIST) screen 2339 is displayed. The correction coefficient time list screen 2339 includes a touch screen button 2340 for selecting a time zone (for example, morning, noon, evening, or night) of the correction coefficient 2337.

  When one of the touch screen buttons 2340 is pressed, a “timely correction coefficient” (CF BY TIME) screen 2341 is displayed. The hourly correction factor screen 2341 includes upward and downward touch screen arrows 2342 for adjusting the correction factor 2337 for the selected time period. The hourly correction factor screen 2341 also includes an “OK” touch screen button 2343 for accepting the adjusted correction factor 2337 for the selected time zone and returning the user to the correction factor time list screen 2339.

  The correction coefficient time list screen 2339 includes a “return” touch screen button 2344 and a “done” touch screen button 2345. When the “Return” touch screen button 2344 is pressed, the user is returned to the correction coefficient setting screen 2335. Pressing the “Done” touchscreen button 2345 starts a residual insulin (IOB) interface 2346 (details will be described later).

  The correction coefficient setting screen 2335 includes a “return” touch screen button 2347 and a “next” touch screen button 2348. When the “return” touch screen button 2347 is pressed, the reference path (T3) 2348 or (R3) 2347 is started depending on whether the optional “target for each time period” format is selected. Pressing the “Next” touch screen button 2348 initiates a residual insulin (IOB) interface 2346. In the reference route (R3) 2347, the user is appropriately returned to the correction target range screen 2304 or the correction target screen 2296. In the reference route (T3) 2348, the user is appropriately returned to the target range time list screen 2325 or the target time list screen 2317.

  The correction coefficient setting screen 2335 and the correction coefficient time list screen 2339 each include a “?” Touch screen button 2349, and when this is pressed, an information screen 2350 is displayed. The information screen 2350 displays a prompt such as “The reader uses this value to determine the number of fast-acting insulin units needed to bring high glucose down to the target value or range”. Information screen 2350 also includes an “OK” touch screen button 2351 for returning the user to correction coefficient setting screen 2335 or correction coefficient time list screen 2339 as appropriate.

Residual insulin (IOB) setting interface The residual insulin (IOB) setting interface 2346 will be described with reference to FIG. When the IOB setting interface 2346 is started, an insulin duration setting (SET INS DUR) screen 2352 is displayed. Insulin duration setting screen 2352 includes up and down touch screen buttons 2353 for adjusting insulin duration (eg, 4 hours 30 minutes). The insulin duration setting screen 2352 also includes a “Back” touch screen button 2355 and a “Next” touch screen button 2356. When the “RETURN” touch screen button 2355 is pressed, the user is returned to the screen viewed before the correction coefficient setting screen 2335 or the correction coefficient time list screen 2339, for example. When the “Next” touch screen button 2356 is pressed, an IOB question (IOB ASK) screen 2357 is displayed. The insulin duration setting screen 2352 also includes a “?” Touch screen button 2358, and when pressed, an insulin duration explanation screen 2359 is displayed. The insulin duration description screen 2359 may indicate that “the insulin duration is the length of time that the fast-acting insulin remains active in the patient's body”, etc. Display the prompt, such as “Use the value of and the time of the last dose of the patient”. The insulin duration description screen 2359 includes an “OK” touch screen button that, when pressed, returns the user to the insulin duration setting screen 2352.

  The IOB question screen 2357 displays a prompt indicating “Do you want to display the residual insulin symbol on the home screen?” Or the like. The IOB question screen 2357 includes “Yes” and “No” choices, one of which can be selected by pressing one of the corresponding empty circles 2361 associated with the choice. FIG. 33 shows a state where the “Yes” option is selected. The IOB question screen 2357 includes a “Back” touch screen button 2362 and a “Next” touch screen button 2363. Pressing the “Return” touchscreen button 2362 returns the user to the insulin duration setting screen 2352. When the “Next” touch screen button 2363 is pressed, a calculation completion (CALC DONE) screen 2364 is displayed. The IOB question screen 2357 also includes a “?” Touch screen button 2365 that, when pressed, displays an insulin calculator description screen 2366. Insulin calculator description screen 2366 shows that if “insulin calculator estimates the amount of fast-acting insulin remaining in the patient's body” or the like and “Yes” is selected, this estimated value is used as a symbol on the home screen. Prompt indicating “etc.” is displayed. In FIG. 33, symbol 2367 is shown. The insulin calculator description screen 2366 includes an “OK” touch screen button that, when pressed, returns the user to the IOB question screen 2357.

  The calculation completion screen 2364 includes a prompt indicating that the setting is completed, and may include a prompt indicating that “the insulin calculator can be used when glucose is checked” or the like. Calculation completion screen 2364 also includes a “back” touch screen button 2368 and a “done” touch screen button 2369. Pressing the “Return” touch screen button 2368 returns the user to the IOB question screen 2357. Pressing the “Done” touch screen button 2369 returns the user to the home screen of the reader described herein.

“Save Changes” Interface “Save Changes” interface 2370 saves changes 2371 if a strip is inserted into the reader or 2372 if the home button is pressed before the sequence is complete. Works to remind the user. If the strip is inserted into the reader, reference path (U3) 2373 is started at 2371. In the reference route (U3) 2373, a reminder prompt 2374 is displayed to the user. A “Save Changes” screen 2375 including a prompt indicating “Do you want to save changes?” Is displayed. Save Changes screen 2375 includes “Yes” touch screen button 2376 and “No” touch screen button 2377. If the “No” button 2377 is pressed or if no selection has been made within 10 seconds, the setting returns to the previous value. If the “Yes” button 2376 is pressed, the new settings are saved. In either case, based on the identification of the inserted test strip, a blood glucose strip test interface or a ketone strip test interface is initiated as appropriate.

  In the reference route (V3) 2378, a reminder prompt 2379 is displayed to the user. A “Save Changes” screen 2380 including a prompt indicating “Do you want to save changes?” Is displayed. The “Save Changes” screen 2380 includes a “Yes” touch screen button 2381 and a “No” touch screen button 2382. When the “NO” button 2382 is pressed, the setting returns to the previous value. If the “Yes” button 2381 is pressed, the new settings are saved. In either case, the user is returned to the home screen described herein.

More information on data management software In the following paragraphs and drawings, further information on automated support software is provided. Note that the exemplary interface flow is exemplary and should not be construed as limiting the invention.

Exemplary Interface Flow Application Initiation FIG. 36 illustrates a method 4000 for initiating RD software, according to one embodiment. At block 4002, the reader is connected to a remote processing device, such as a user's computer. At block 4004, it is determined whether software is installed on the remote processing device. If not, the user is prompted to execute the installer file stored in the reader, as indicated by block 4006. If the user approves, a default browser is launched that displays a data management software (RD software) installation website, as indicated by block 4008. The user may select to start installing the RD software and, as indicated by blocks 4010 and 4012, the installer application is downloaded to the remote device and installation of the installer application is completed. As indicated by blocks 4012 and 4014, a standard operating system (OS) installer application is executed and RD software is launched.

  Referring again to block 4004, if the RD software is already installed on the remote device, it is determined whether the RD software is currently running. If so, at block 4026, the reader landing screen is presented to the user.

  If the RD software is not currently running, as indicated by block 4020, whether auto-start is automatically enabled to automatically start the RD software when the sample monitoring device is connected to the remote device. It is determined. If automatic activation is enabled, the RD software is activated on the remote device. If automatic activation is not enabled, the user may manually activate the software when desired, as indicated by block 4022.

  Once the RD software is launched, as represented by block 4034, the software may automatically determine whether or not a software update is available or ask. The RD software, for example, accesses the server via the Internet to determine which updates are currently available and compares the software version with the previous update to see if there are additional updates that have not been made. You may check. If no new update is available, as indicated by block 4036, the RD software application continues data management initiation processing to allow the user to use the RD software.

  If a new update is available, a reader landing screen is displayed, as indicated by block 4026. If the user chooses not to execute the update routine at that time, as indicated by block 4036, the RD software application continues the data management initiation process to allow the user to use the RD software. If the user chooses to install the update, an update routine is executed as indicated at block 4024 before continuing the data management start process at block 4036.

  Instead of starting block 4002, if the user launches RD software that is already installed on the remote device, as shown at block 4028, the analyte monitoring device will connect to the remote device, as shown at block 4030. It is determined whether it is connected. If the reader device is not connected, a reader welcome screen is displayed to assist the user during execution of the RD software, as indicated by block 4032. If the reader is connected to a remote device, it is determined whether there is an available update, as shown and described for block 4034.

  FIG. 37 shows a flowchart of a data management start process 4036 according to one embodiment. When the RD software is started, it is determined whether there is data (eg, sensor measurements) in the reader device, as indicated by block 4042. If there is no data in the reader device, it is determined whether the reader device has already been configured, as indicated by block 4044. If not, as shown at block 4046, the user is presented with a guided reader settings-welcome screen to guide the user in the reader settings process. If the reader device has been previously set, it is determined whether the reader device and the remote device are not synchronized (eg, the time of the reader device is different from the time of the remote device). . If the reader device is not synchronized, a “Reader is not synchronized” screen is provided to inform the user and be able to synchronize, as indicated by block 4052. If the reader device is synchronized, a reader landing screen is displayed, as indicated by block 4050.

  Referring again to block 4042, if there is sensor measurement data in the reader device, the data can be downloaded to the remote device automatically or once the user confirms, as indicated by block 4054. At block 4054, it is determined whether the reader instrument and the remote device are not synchronized. If yes, the “Reader is not synchronized” screen is displayed. If so, it is determined whether this is the first time the remote device has created a report, as indicated by block 4058. If so, as shown at block 4060, a guided report settings-welcome screen is displayed to assist the user in setting up the report. If it is not the first time to create a report on a remote device, it is determined whether a quick print function is enabled that allows for the rapid display and / or printing of a given or pre-customized report. . If the quick print feature is not enabled, a report creation screen is presented to the user to allow the user to create a report, as indicated by block 4068.

  FIG. 38 shows an example of a welcome screen according to one embodiment. The welcome screen 5000 may indicate to the user that the system is not currently aware of the connected reader, for example, after connecting the reader device after the user launches the software. It may be shown to prompt you to connect. Screen 5000 includes a reader tab 5002 and a report tab 5004 corresponding to the reader mode and report mode of the RD software, respectively. Tabs 5002 and 5004 are maintained on other screens of the RD software. In one embodiment, the user cannot access reader mode and report mode if the reader is not connected to a remote device.

Reader Mode FIG. 39 shows a flowchart of a method 4080 for navigating in reader mode to access and configure functions used for reader device configuration and control. The reader settings are read directly from the reader device or stored directly in the reader device via functions initiated from a reader mode and a set of screens.

  Block 4082 represents the reader landing screen, where details regarding the reader may be accessed. FIG. 40 shows an example of a screen that is displayed when a reader device is connected, according to one embodiment. Screen 5050 includes an update notification 5056 and a summary of the profile of the connected reader. Screen 5050 also includes a trigger element menu 5058 for initiating other screens of the reader mode, such as a profile screen, settings screen, custom note screen, reminder screen, expert options screen, and backup screen, as described further below. Including.

  FIG. 41 shows an example of a screen that is displayed to indicate that the reader device is not synchronized, according to one embodiment. Screen 5050 displays a notification 5080 of “not synchronized” to inform the user that the reader device may be out of sync and allows the user to synchronize the reader device. Further details regarding synchronization (eg, reader time and remote device time) may also be provided. For example, a trigger element 5081 is provided that allows the user to choose to synchronize the reader device.

  As shown in FIG. 39, from the reader landing screen of block 4082, the user can access other screens of the reader mode that can be accessed from the reader landing screen (eg, profile screen of block 4084, settings screen of block 4086, block 4088 custom annotation screen, block 4090 reminder screen, block 4092 expert options screen, block 4094 backup screen, etc.) may be selected.

  At block 4084, a profile screen is presented to the user. FIG. 42 illustrates a profile screen 5086 according to one embodiment. As shown, the profile screen 5086 provides a section 5058 that allows, for example, a user to set a name and patient ID associated with the reader device. As shown, the profile screen 5086 maintains a menu 5058 of trigger elements for initiating various screens.

  Referring again to FIG. 39, at block 4086, a settings screen is presented to the user. The settings screen is a screen that allows the user to adjust general settings (eg, time, date, clock, style, language, sound and vibration options, synchronization settings) and target zone settings (eg, glucose target zone settings). provide.

  At block 4088, a custom note screen is presented to the user, where the user can view, edit, and / or delete the note from the reader device. These notes can be default notes or user customized notes.

  At block 4090, a reminder screen is presented to the user, where the user can view, edit, and / or delete the reminder from the reader device. A reminder may be provided that reminds the user of glucose check measurements, insulin intake, and the like.

  At block 4092, an expert options screen is presented to the user, where the user has access to limited functionality that should only be accessed by a trained medical professional (HCP). A password or passcode given only to the HCP may be required to access the settings. Examples of functions that may be limited are activation and setting of insulin calculation functions, device masking mode operation, reset of system and / or device settings, and the like.

Insulin Calculator Settings Interface An exemplary implementation of a graphical user interface that facilitates the procedure for entering insulin calculator settings via the health care software that can be used in connection with the health care software of the reader described herein. A form is provided. Hereinafter, this graphical user interface will be described in more detail with reference to FIGS.

  In some cases, the reader health care software may include programming of more than one type of dosage calculator. During health care software setup, the health care software may prompt the user and / or medical professional to select a dosage calculator type (eg, an insulin bolus calculator). The initial selection of the dosage calculator type may be changed as desired by the user or medical professional. In certain embodiments, the two or more types of dosage calculators include two types of bolus calculators. For example, two types of bolus calculators may include a simple bolus calculator and an advanced bolus calculator.

  “Simple calculator”, “Simple bolus calculator”, “Simple bolus calculator”, “Simple insulin calculator”, or “Simple insulin calculator” means a recommended dosage (eg, recommended insulin administration Means a bolus calculator with basic functions to determine the quantity etc.). For example, a simple bolus calculator may include an algorithm configured to determine a recommended dosage based on a certain dosage. In these examples, a simple bolus calculator may be suitable for users who receive a certain dosage (eg, a constant insulin dosage) for each meal. In some embodiments, a simple bolus calculator considers only certain dosages when recommending dosages to a user, and thus functions as a certain dosage reminder and / or record.

  Insulin calculator interface setting screen 3800 starts the insulin calculator setting procedure, where the user can select an insulin calculator On / Off toggle button 3802 to turn the insulin calculator on or off. When the insulin calculator On / Off toggle button is selected in the “On” position, the insulin calculator is activated and can be set as described below. By selecting an insulin calculator selection box 3804 that allows selection of “easy” to activate a simple insulin calculator and “advanced” to activate an advanced insulin calculator, the desired type of insulin calculator (eg, simple or Advanced computer) can be selected.

  When the user selects the “easy” option in the insulin calculator selection box 3804, the insulin calculator setting interface screen 3800 displays simple bolus calculator setting options. A simple bolus calculator setup is shown in FIG.

  In certain embodiments, a simple bolus calculator is, for example, information that includes, but is not limited to, a fixed dosage, a target blood glucose range (eg, a correction target), and insulin sensitivity (eg, a correction factor). Based on this, a recommended dosage (eg, a recommended fast-acting insulin dose) may be determined. In some examples, a simple bolus calculator may also include information such as the patient's remaining insulin in the recommended dosage determination. For example, a fixed dosage may be entered for each meal (eg, breakfast, lunch, and dinner).

  The insulin calculator setting interface screen 3800 includes a quantity input box for each meal. A fixed dosage may be input as a unit of insulin in the breakfast amount input box 3806, the lunch amount input box 3808, and the dinner amount input box 3810. In some embodiments, a correction target range may be input. The insulin calculator setting interface screen 3800 includes a corrected target range amount input box for inputting a target range minimum value 3812 and a target range maximum value 3814. In some embodiments, the insulin calculator settings interface screen 3800 may display an amount of correction factor that may be entered as insulin sensitivity (eg, correction factor) as 1 unit / Xmg / dL (where X is the amount of correction factor entered). Box 3816 is included. In some embodiments, the insulin calculator settings interface screen 3800 includes a radio button for enabling or disabling trend correction for the insulin calculator by selecting the trend correction enabled radio button 3818 or the trend correction disabled radio button 3820. .

  When the user selects the “advanced” option in the insulin calculator selection box 3824, the insulin calculator setting interface screen 3822 displays the advanced bolus calculator setting options. An advanced bolus calculator setting is shown in FIG. 44, showing an advanced bolus calculator setting that can be used when the insulin calculator is set to calculate carbohydrates in grams of carbohydrate.

  The description “advanced calculator”, “advanced bolus calculator” or “advanced insulin calculator” is used to determine the recommended dosage (eg, recommended insulin dosage), for example, the amount of carbohydrate consumed. Means a bolus calculator that includes, but is not limited to, carbohydrate ratio, target blood glucose range (eg, correction target), and insulin sensitivity (eg, correction factor). For example, instead of using a constant dosage for each meal as in a simple calculator, an advanced bolus calculator is used by the user to determine the recommended dosage, such as the amount of carbohydrate consumed. The input dose determination information may be used. Advanced bolus calculators determine the recommended dosage of a patient's current blood glucose level, exercise volume, target analyte concentration (eg, target blood glucose range), insulin sensitivity (eg, correction factor), insulin Duration of action, carbohydrate ratio, and residual insulin information (eg, dosage time information, dosage frequency information over a given period, and dosage), including but not limited to further dosage determination information Also good.

  The insulin calculator setting interface screen 3822 includes a “unit for entering food” selection box 3826 that, when selected, allows the user to set the insulin calculator to enter food in grams of carbohydrates or servings. When “grams of carbohydrates” is selected in the “unit for entering food” selection box 3826, the insulin calculator settings interface screen 3822 displays advanced bolus calculator setting options in grams of carbohydrates.

  In some embodiments, the carbohydrate ratio may be entered. The insulin calculator setting interface screen 3822 includes a carbohydrate ratio amount input box 3828 for entering the user's carbohydrate ratio amount as 1 unit / X gram carbohydrate (where X is the amount to be entered). In some embodiments, a correction target range may be input. The insulin calculator setting interface screen 3822 includes a correction target range amount input box for inputting a target range minimum value 3832 and a target range maximum value 3834. In some examples, the correction target may be entered as a single target value rather than a target range by selecting “single target” (not shown) from the correction target selection box 3830. In some embodiments, the insulin calculator setting interface screen 3822 is a correction factor quantity input where insulin sensitivity (eg, correction factor) can be entered as one unit of correction factor / Xmg / dL (where X is the amount that is entered). Box 3836 is included. In some embodiments, the insulin calculator setting interface screen 3822 has a radio button for enabling or disabling trend correction for the insulin calculator by selecting the trend correction enabled radio button 3838 or the trend correction disabled radio button 3840. Including.

  In a specific example, as shown in FIG. 45, a carbohydrate ratio for each time zone, a target range, and / or a correction factor may be input. To enable the carbohydrate ratio time zone setting, the carbohydrate ratio “in time zone” checkbox 3842 may be selected. In order to validate the time zone setting of the target range, the “in time zone” checkbox 3844 of the target range may be selected. In order to validate the time zone setting of the correction coefficient, the “by time zone” check box 3846 of the correction coefficient may be selected.

  If the “At time zone” check box 3842 of the carbohydrate ratio is selected, the insulin calculator setting interface screen 3848 displays the time zone setting of the carbohydrate ratio (see FIG. 45A). Carbohydrate ratios are determined in the morning (eg, 4 am to 10 am), noon (eg, 10 am to 4 pm), evening (eg, 4 pm to 10 pm), and night (eg, 10 pm It may be set to the same value or different values for four different time zones such as (hour to 4 am). The morning carbohydrate ratio is input in the morning carbohydrate ratio input box 3850, the day carbohydrate ratio is input in the day carbohydrate ratio input box 3852, and the evening carbohydrate ratio is input in the evening carbohydrate ratio amount input box 3854. And the night carbohydrate ratio may be entered in the night carbohydrate ratio amount input box 3856.

  When the “in the time zone” check box 3844 of the correction target range is selected, the insulin calculator setting interface screen 3848 displays the time zone setting of the target range (see FIG. 45B). Target ranges include morning (eg, 4 am to 10 am), noon (eg, 10 am to 4 pm), evening (eg, 4 pm to 10 pm), and night (eg, 10 pm It may be set to the same value or different values in four different time zones (hour to 4 am). The morning target range is input in the morning target range minimum value input box 3858 and the morning target range maximum value input box 3860, and the day target minimum value input box 3862 and the day target. The target range for the day is input to the amount input box 3864 for the maximum value of the range, and the target range for the evening is input to the amount input box 3866 for the minimum value of the target range for the evening and the amount input box 3868 for the maximum value of the target range for the evening. Then, the night target range may be input to the minimum amount input box 3870 of the night target range and the maximum amount input box 3872 of the night target range.

  When the correction coefficient “in time zone” check box 3846 is selected, the insulin calculator setting interface screen 3848 displays the correction factor time zone setting (see FIG. 45B). The correction factors are morning (for example, 4 am to 10 am), noon (for example, 10 am to 4 pm), evening (for example, 4 pm to 10 pm), and night (for example, 10 pm). It may be set to the same value or different values in four different time zones (hour to 4 am). The morning correction coefficient is input in the morning correction coefficient quantity input box 3874, the day correction coefficient is input in the daytime correction coefficient quantity input box 3876, and the evening correction coefficient is input in the evening correction coefficient quantity input box 3878. And a night correction factor may be entered in the night correction factor amount input box 3880.

  The insulin calculator setting interface screen 3882 includes a “unit for entering food” selection box 3882 that, when selected, allows the user to set the insulin calculator to enter food in grams of carbohydrates or servings ( (See FIG. 46A). If “Serving Number” is selected in the “Unit for Entering Food” selection box 3884, the insulin calculator setting interface screen 3882 displays advanced bolus calculator setting options for the serving number of carbohydrates.

  FIGS. 43-46 show carbohydrates by selecting the “By Time” checkbox 3886 for the carbohydrate ratio, the “By Time” checkbox 3888 for the target range, and the “By Time” checkbox 3890 for the correction factor. The insulin calculator setting interface screen 3882 is shown when the ratio, target range, and correction factor are selected to be entered for each time period.

  The insulin calculator setting interface screen 3882 displays the carbohydrate ratio time zone setting (see FIG. 46A). Carbohydrate ratios are determined in the morning (eg, 4 am to 10 am), noon (eg, 10 am to 4 pm), evening (eg, 4 pm to 10 pm), and night (eg, 10 pm It may be set to the same value or different values in four different time zones (hour to 4 am). The morning carbohydrate ratio is input in the morning carbohydrate ratio amount input box 3892, the day carbohydrate ratio amount input box 3894 is input in the day carbohydrate ratio, and the evening carbohydrate ratio amount input box 3896 is in the evening carbohydrate ratio. , And the night carbohydrate ratio may be entered in the night carbohydrate ratio amount input box 3898. From the serving number selection box 3900, grams of carbohydrate per serving number may be selected.

  The insulin computer setting interface screen 3882 displays the target range time zone setting (see FIG. 46B). Target ranges include morning (eg, 4 am to 10 am), noon (eg, 10 am to 4 pm), evening (eg, 4 pm to 10 pm), and night (eg, 10 pm It may be set to the same value or different values in four different time zones (hour to 4 am). As shown in FIG. 46B, the target range has been selected to be entered as a “single target” rather than a target range, as indicated by the corrected target selection box 3902. The morning target value is input in the morning target value amount input box 3904, the daytime target value is input in the daytime target value amount input box 3906, and the evening target value is input in the evening target value amount input box 3908. , And the night target value can be input to the night target value amount input box 3910.

  The insulin calculator setting interface screen 3882 displays the correction coefficient time zone setting (see FIG. 46B). The correction factors are morning (for example, 4 am to 10 am), noon (for example, 10 am to 4 pm), evening (for example, 4 pm to 10 pm), and night (for example, 10 pm). It may be set to the same value or different values in four different time zones (hour to 4 am). The morning correction coefficient is input in the morning correction coefficient quantity input box 3912, the daytime correction coefficient is input in the daytime correction coefficient quantity input box 3914, and the evening correction coefficient is input in the evening correction coefficient quantity input box 3916. , And the night correction coefficient amount input box 3918 may be input with the night correction coefficient.

Masking Mode Setting Interface The expert options screen also allows viewing and setting masking mode settings on the remote device. This setting screen provides the same function as the masking mode setting described above, except that the setting is performed via the RD software application.

FIG. 47 shows a masking mode setting screen 5090 according to one embodiment. As shown, the masking mode setting screen 5090 provides a section 5092 that allows the user to activate the masking mode and set a glucose check reminder at preset intervals. For example, the reminder is reset each time the sensor is scanned. As shown, the profile screen 5086 maintains a menu 5058 of trigger elements for initiating various screens.
System Reset The expert options screen also allows the user to reset the reader device settings. The system reset interface may allow all settings to be reset at once and / or allows the user to selectively reset certain settings of the device.

  Referring again to FIG. 39, at block 4094, a backup screen is presented to the user where the user can save a backup file of current reader settings. In one embodiment, the backup file does not store glucose results or other reader record entries.

  Thus, from the trigger element menu 5058 (which is maintained on the various screens of the reader mode so that they can be quickly referenced and accessed) to initiate the various screens of the reader mode. The user can navigate to the desired screen in the reader mode. Once the setting has been viewed, edited, or deleted, the user can save the setting in the reader, as shown by reference path X3. At block 4096, a reader status screen is displayed that indicates to the user that the save is in progress. At block 4098, a progress screen is shown showing saving to the reader, and after saving, a reader landing-setting save screen is presented to the user indicating that the save was successful, as shown at block 4100. Is done.

  When the change to any setting in the menu 5058 is canceled as shown by the reference route Y3, or when the user moves from the screen to another screen as shown by the reference route A4, A warning screen is presented to the user alerting the user that changes will be lost, as indicated at 4102 through reference path Z3. If the change is canceled, the user is navigated back to the reader landing screen 4082. If the user chooses to save the changes, proceed to blocks 4096 and 4098 as described above. If the user chooses not to save the settings, a reader landing-settings save screen 4100 is presented to the user.

  From the backup screen, the user can save the backup file, as indicated by block 4104. While the saving is in progress, a progress screen 4106 is displayed. If the saving is canceled before the saving is completed, the user is returned to the backup screen 4108.

  If it is determined that the save is not valid, as indicated by block 4105, a warning screen 4110 is presented to the user indicating to the user that the save is not valid. For example, if the file name already exists, the user can choose to save it and overwrite the previous file, in which case a progress screen 4106 is presented. If the user chooses not to save, the user is returned to the backup screen 4112.

  From the backup screen, as indicated by block 4114 and reference path C4, at block 4094, the user can select a backup file to restore. When a backup file is selected, a progress screen 4116 indicating that the backup file is being processed is presented to the user. If it is determined that the backup file processing is not valid, or an error has occurred in the processing, a warning screen 4120 is displayed indicating that the backup file has an error (eg, the file is damaged). The The user is then returned to the backup screen, as indicated by block 4122. When the processing of the backup file is valid, “reader setting restoration” indicating that the reader setting is restored to the backup file setting is displayed. If the restoration is canceled, the user is returned to the backup screen, as indicated by block 4126. If the restoration is not cancelled, the user is presented with a reader status screen 4128 or a progress screen 4130 and a backup screen 4132 as described above.

“Unsynchronized” Flow FIG. 48 illustrates a flow method 5100 for synchronizing a reader device when it is determined that the reader is connected to the remote device and not synchronized with the remote device. For example, when not synchronized, the reader time is different from the remote device time.

  If it is determined that the reader is connected to the remote device and is not synchronized with the remote device, then, as indicated by block 5102, the “Reader is not synchronized” screen is initiated at 5102. A warning screen is displayed warning the user about synchronization and asking the user whether to synchronize the reader with the remote device. As indicated by block 5104, a warning screen is also presented to the user at 5106 if it is determined from the reader general settings screen that the two devices are not synchronized.

  If the user chooses to synchronize both devices, the reader status screen is displayed at 5108 and the progress screen is displayed at 5110 while the update is in progress. When the update is complete, the user is returned to the reader landing-reader update screen, as indicated by block 5112.

Guided Reader Setup Flow When a new unused reader is connected to the remote device, the user is guided step by step in the initial setup of the reader. In the middle, basic reader configuration settings such as name, patient ID, date, time, and language are collected for reader initialization purposes. In one embodiment, the patient name and ID are optional settings and the date, time, and language choices must be set to complete the setting process.

  FIG. 49 illustrates a guided reader configuration interface flow method 5100 according to one embodiment. Once an unused new reader is connected to the remote device, a new reader welcome screen is displayed to begin the guided setting process, as indicated by block 5116. As shown at block 5118, a start / patient information screen for accepting patient information is initiated. As indicated by block 5120, a date / time / language confirmation screen is initiated to accept appropriate input from the user. Once entered, a save preparation complete screen is displayed that indicates to the user that the input will be saved. While saving is in progress, the reader status screen is displayed at 5130 or the progress screen is displayed at 5128. From the progress screen of block 5128, when the save is complete, a reader landing-reader ready screen is displayed at block 5132.

  If the setting process is interrupted or if any of the blocks 5118, 5120, 5122 is moved to another screen, a warning screen in block 5124 warns the user that changes will be lost if not saved. Is displayed. After the warning screen is displayed at block 5124, a new reader welcome screen is presented to the user so that the initial setup can be completed, as shown at blocks 5116 and 5126.

  FIG. 50 illustrates a single screen of a guided reader configuration interface according to one embodiment. The initial screen of the guided reader settings interface includes information about the guided settings and provides a trigger element 5136 that allows the user to initiate the guided settings.

Reader Mode Report Mode Flow FIG. 51 shows a flowchart of a method 4080 for navigating in RD software report mode, according to one embodiment. The report mode of this application provides access to settings and functions for creating, viewing, saving and printing reports. In the example shown, the report mode is provided as a tab on the interface screen of the RD software along with the reader mode tab.

  If the report tab is selected, at block 5140, a report landing screen is displayed on the remote device. The user is provided with the option to create a report or to view or edit the report settings (for example, the user can navigate to the report creation or report settings interface on the landing screen) Any of the trigger elements to be selected).

  From the report creation screen at block 5142, the user can select parameters for a particular report to create. The selection screen at block 5146 allows the user to set a directory destination for automatic saving. When a report is created, a progress screen is displayed at block 5144 while the report is being created. When complete, the report viewing screen at block 5148 displays the generated report or provides a menu for selecting from the various generated reports. The report can be saved via the save window screen at block 5152, and a progress screen is displayed at block 5154 while the save is in progress. When saving is complete, the user is returned to the report viewing screen at block 5148.

  If the report viewing screen is closed at block 5148, at block 5142, the user is returned to the report creation screen. The user may print one or more reports from the report viewing screen 5148 via the print screen at block 5150.

  From the report landing screen at block 5140, the user may choose to navigate to the report settings screen at block 5156. The report setting screen at block 5156 allows the user to pre-select a report that is created each time the user creates a report using data management software. Examples of reports include snapshots, calendars, average days, record books, daily statistics, meal averages, and reader settings, as described further below. Various reports can be selected and set as default settings for creating reports from the reader. The calendar may use a predetermined period such as three months as a default. If the user selects an average report at mealtime, they are presented with an overlay that allows default pre-meal and post-meal target ranges to be set.

  Also, from the report landing screen at block 5140, the user may choose to navigate to the following screen. Allows the user to set default settings for the time frame screen of block 5158 that allows the user to set the default time frame when the report is created, the glucose target range applied to the generated report, and the low blood glucose threshold. Allows the user to activate the glucose target screen, auto-save feature of block 5160, and allows the user to select the file name format and storage location used when creating the report (as indicated by block 5174) Block 5162 auto-save option screen, default color print option allowing user to select color print screen in block 5164, and once the reader with data is connected to the computer, the software creates a report immediately Quit to make Quick Print Screen block 5166 to the print function allows a user to enable or disable.

  Settings or changes made to screens 5156, 5158, 5160, 5162, 5164, and 5166 can be saved, at which time a progress screen is displayed at block 5172 while saving. If the user cancels, or moves from one of screens 5156, 5158, 5160, 5162, 5164, and 5166 to another screen, whether any changes have been made, as indicated by block 5168 Is determined. If not, the user can move to the desired screen. If a change has been made, a warning screen is displayed to warn the user that the change may be lost, providing the user with a save option, as represented by the progress screen at block 5172. .

  FIG. 52 illustrates an example of a report landing screen that is displayed when a user first connects a reader that stores data, according to one embodiment. As shown, the report landing screen 5220 includes trigger elements 5222 and 5224 for initiating a report creation interface and a report setting interface, respectively.

  FIG. 53 shows an example of a “Create Report” screen according to one embodiment. The illustrated “Create Report” screen 5230 provides information about the current settings for report creation and allows the user to select current settings (eg, patient information 5232, time frame 5234, print or view). Provide navigation options (e.g., trigger elements) to change the report 5236, glucose target 5238, and autosave option 5240). Screen 5230 also provides trigger elements 5240, 5242 for printing and viewing reports.

FIG. 54 shows an example of a record book report screen when viewed from report mode, according to one embodiment. As shown, the record book report screen includes a table 5252 of data for the record book report and trigger elements 5254 and 5256 for printing and saving the report.
Guided Report Setting Interface When the user first accesses the printing function of the application, the user is guided step by step in the report setting and creation process by the guided report setting interface. In the middle, the RD software collects default report settings such as patient information, time frames, report sets, glucose targets, and auto-save options, and prepares to view, save, and print the first set of reports. .

  FIG. 55 illustrates a flow chart of a guided report setting interface according to one embodiment. When the user accesses the printing function of the application for the first time, a report welcome screen at the first use for starting the guided setting is presented to the user. As indicated by block 5182, a start / patient information screen for accepting patient information is initiated. The user is then navigated through the following screens. A time frame screen at block 5186 that allows the user to set a default time frame to be used when creating the report, the user pre-selects a report to be created each time the user creates a report using data management software The report setting screen of block 5188 to allow, the glucose target screen of block 5190 to allow the user to set the default settings for the glucose target range and the hypoglycemia threshold to be applied to the generated report, the user with automatic save function , And allows the user to select the file name format and storage location used when creating the report, and the user can create and view or select the selected report. Bro which enables printing Report generation Ready screen clauses 5194.

  When printing the selected report, the progress screen of block 5196 is displayed during the creation of the report. When complete, the report viewing screen at block 5198 displays the generated report or provides a menu for selecting from the various generated reports. The report is then printed immediately via the print window screen at block 5200. If auto-save is set, once the report is created at block 5196, the selected report is automatically saved to the selected destination, as shown at block 5204. If the creation at block 5196 is interrupted or canceled, the user is returned to the report creation screen at block 5202.

  If it is selected from block 5194 to view the selected report, a progress screen is displayed at block 5206 during the creation of the report. When complete, the report viewing screen at block 5210 displays the generated report or provides a menu for selecting from the various generated reports. If auto-save is set, once the report is created at block 5206, the selected report is automatically saved to the selected destination, as shown at block 5204. If the creation at block 5206 is interrupted or canceled, the user is returned to the report creation screen at block 5208.

Reader Export Flow RD software provides the user with the ability to export data from a reader connected to a computer, for example, as a tab-delimited file or other spreadsheet compatible format. The export function can be accessed, for example, via the application's “File” menu.

  FIG. 56 illustrates a method for exporting reader data, according to one embodiment. At block 5252 of the instrument data export interface 5250, it is determined whether the reader device is connected to a remote device. If not, the data export function (eg, in the file menu) is disabled, as indicated by block 4254. If the reader device is connected to a remote device, as indicated by block 5256, it is determined whether sensor data is stored in the reader device. If there is no data stored in the reader, at block 4254, the data export function is disabled. If there is data in the reader, it is determined whether the reader is downloading the data. If so, block 4254 disables the data export function. If the reader is not downloading data, the data export function (eg, in the file menu) is enabled.

  Once enabled, the user can choose to export data from the reader, as represented by block 5262. Once selected, the instrument export file is saved, as indicated by block 5264. When it is determined that the saving is valid, a progress screen 5272 indicating that the data export process is in progress is displayed. If no error has occurred, the user is returned to the original screen as indicated by block 5276. If an error occurs, a warning screen is provided to inform the user that the export has failed, as indicated by block 5274.

  If it is determined at block 5266 that saving of the instrument export file is not valid, a warning screen is provided to inform that saving is not valid (eg, the file already exists), as indicated at block 5268. The The user is provided with the option to overwrite the existing file, which when selected will navigate the user to the progress screen at block 5272. The user is also provided with the option not to save the invalid file, in which case the user is returned to the original screen, as indicated by block 5270.

Report In some embodiments, the RD software provides a user interface for managing and / or controlling the functionality associated with the report. For example, RD software provides a report mode for performing creation, editing, viewing, printing, and any other functions associated with report creation and management.

  A variety of different types of reports may be created. For example, FIGS. 45-53 illustrate various types of reports according to particular embodiments. It should be noted that the reports shown are exemplary and should not be construed as limiting the invention. For further details regarding various reports that can be implemented in software, see US Patent Application No. 11.146,897 filed on June 6, 2005, US Patent Provisional filed on March 10, 2011. No. 61 / 451,488 and U.S. Provisional Application No. 60 / 577,064 filed Jun. 4, 2004, which are incorporated herein by reference in their entirety. Incorporate into.

  As described above, a report may be created and communicated to the remote device, eg, for display on the remote device and / or for printing on the remote device. The remote device can be, for example, a desktop computer, a laptop computer, a mobile phone, and the like. For example, the remote device may be a personal computer that is accessed by the user and allows the user to view and / or print the report. In other examples, the remote device may be a computer accessed by another party, such as a physician or medical professional. For example, the user may take the device to a doctor and the doctor may transfer the data to his computer for display and / or printing of the report.

  The sample monitoring device can be a variety of wired technologies (eg, USB, FireWire, SPI, SDIO, RS-232 port, etc.) or wireless technologies (eg, radio frequency (RF) communication, Zigbee (registered trademark) communication protocol, WiFi, infrared). , Wireless universal serial bus (USB), ultra wide band (UWB), Bluetooth (registered trademark) communication protocol, and cellular communication (such as code division multiple access (CDMA) and GSM (Global System for Mobile Communication)) You may send a report to the remote device.

  In some examples, the analyte monitoring device may include, for example, software that is loaded into the remote device when the analyte monitoring device is first connected to the remote device. In other examples, the software may be loaded onto the remote device via the Internet or a storage device (eg, CD-ROM, flash memory drive, etc.).

  In some examples, the report may be sent to a remote device and then sent to another remote device. For example, after the user downloads the data to his computer, the data may be sent to a doctor for further analysis. Once the physician receives the data, he can view and download the report to evaluate the user's activities and events.

Exemplary Reports In the following paragraphs, examples of reports are provided and described. Various reports may include general identification information of the associated patient (eg, patient name, ID number, etc.) and / or general identification information of the associated device (eg, device name, device model, etc.) ) May be included.

Snapshots In some aspects of the present disclosure, snapshot reports are provided. The snapshot report grasps the overall state of patient health management (for example, diabetes management). For example, the report may highlight key metrics about user activity over a specific period of time. In some embodiments, the snapshot report provides significant information regarding one or more of usage, glucose levels, events, and notes.

  FIG. 57 illustrates an example snapshot report for a particular time frame (eg, a two week period as shown), according to certain embodiments. Snapshot report 5300 includes key metrics associated with the user's history over a two week period. For example, the snapshot report includes a section 5302 that displays metrics 5308 for glucose, insulin, and carbohydrate intake for a user for a given two week period, and a section that displays metrics 5312 for low glucose events for a two week period. 5304 includes a section 5306 that displays a metric 5316 for glucose measurements over a two week period, and a section 5307 that displays an estimated percentage of A1c over a two week period.

  In the illustrated embodiment, the metric 5308 includes average glucose value, time above and below the target zone, average carbohydrate intake per day, average fast-acting insulin intake per day, and per day. Including the average intake of long-acting insulin. Section 5302 also includes a graph 5310 of glucose values over a two week period averaged for a particular time throughout the day. Graph 5310 also shows the range of glucose measurements for a particular time throughout the day.

  Metric 5312 includes the total number of low glucose events, the average duration of low glucose events, and a low glucose threshold. Section 5304 also includes a graph 5314 of a summary of low glucose events over a two week period averaged over a particular time throughout the day.

  Metric 5316 includes the average number of scans per day and the percentage of sensor data available. Section 5306 also includes a graph 5318 of the percentage of high glucose readings of sensor data recorded for a two week period categorized for a particular time throughout the day.

  The snapshot screen 5300 also includes a comment section 5320 that indicates the comment (if any) recorded by the user. In some embodiments, the comment section provides comments generated by analyzing sensor data by software. The snapshot screen 5300 also includes a section for identifying a report, a report application period, and a target range.

Calendar In some aspects of the present disclosure, a calendar report is provided. The calendar report provides an overview of highlight points (eg, hypoglycemia events) that are patient involvement and concerns.

  For example, FIG. 58 shows a calendar report highlighting key metrics for user activity in a calendar format, according to certain embodiments. Details of events for each day of the selected month are shown in a calendar format. A calendar report is provided for a period of one month (eg, March) showing the average glucose measurement 5352 for a given day, the number of scans 5354 for a given day, and the occurrence of a low glucose event for a given day. It is. For example, the average glucose measurement on 7 March is 171 mg / dL, 7 scans are taken, and 2 low glucose events.

Daily Pattern In some aspects of the disclosure, a daily pattern report is provided. A daily pattern report informs the trend of glucose levels over time over a given period of time.

  FIG. 59 shows a daily pattern report according to one embodiment. Daily pattern report 5360 includes a median glucose value 5364 for the time zone throughout the day, a range of glucose values 5366 associated with the 25-75th percentile value of the measured value, and a 10-90th percentile value of the measured value. Graph 5362 displaying a range of glucose values 5368 associated with the.

  Below the graph 5362, the graph shown aligned with respect to the time zone shows the ingested carbohydrates 5370 recorded above the horizontal axis and recorded below the horizontal axis. Ingested fast acting insulin 5372 is shown.

  The daily pattern report 5360 also includes sections 5374, 5376, and 5378, which are aligned with respect to the time of the day, next to the graph 5362. Section 5374 shows the daily average glucose value for each time zone throughout the day. Section 5376 shows the average daily carbohydrate intake for each time zone and the number of associated notes. Section 5378 shows the daily average of fast-acting and long-acting insulin intake for each time period throughout the day and the number of associated notes.

Meal Pattern In some aspects of the present disclosure, a meal pattern report is provided. A pattern report during a meal informs of an increase and decrease in glucose level with respect to the meal.

  FIG. 60 shows a pattern report during a meal according to one embodiment. This report includes data 5414 for a given period (eg, 2 weeks) and includes a plot of glucose values before and after a particular meal of the day.

  This report includes plots 5402, 5404, and 5406 for three different meal events (eg, meals that occur at different times of the day 5416a, 5416b, 5416c (eg, morning, noon, and evening)). Sections 5418a, 5418b, and 5418c also provide the number of notes recorded for food intake and insulin intake. In addition, recorded average carbohydrate intakes 5420a, 5420b, and 5420c for individual time zones are also shown. The recorded average insulin intakes 5422a, 5422b, and 5422c for individual time zones are also shown.

  Meal time reference points 5412a, 5412b, and 5412c indicate the time of eating. Time zones before and after the reference point are provided in 1 hour increments. Plots 5408a, 5408b, and 5408c of median glucose for each time zone are displayed. Also, plots 5402, 5404, and 5406 provide 10-90th percentile value ranges 5410a, 5410b, and 5410c, respectively. Also, below each plot, average glucose values 5426a, 5426b, and 5426c for each time zone, aligned with each plot, are provided in 1 hour increments.

Daily Statistics In some aspects of the present disclosure, a daily statistical report is provided. Daily statistical reports highlight daily glucose measurements within a given time period (eg, 2 weeks). This data can be used, for example, as an aid in identifying the cause of hypoglycemic events and other abnormalities.

  FIG. 61 shows the first page of a daily statistical report 5500 for a given period (eg, a two week period). The first page contains daily statistics for the first seven days of a given two week period. Plots of glucose values 5502, 5504, 5506, 5508, 5510, 5512, and 5514 for each day for 7 days are displayed.

  A day may be divided into an incremental period (eg, a two hour period as shown) and event information may be shown on the chart. For example, a carbohydrate intake event 5502b is shown at the corresponding incremental period in which it occurred.

  Fast-acting insulin and long-acting insulin intake events 5502c and 5502e are shown in the corresponding incremental periods in which they occurred, respectively.

  Events 5502f, 5502i associated with food intake and insulin recorded without a value are shown in the corresponding incremental periods in which they occurred, respectively.

  A user time change event 5502g is shown in the corresponding incremental period in which it occurred. For example, if the user changes the time of the reader device, this event is indicated at the appropriate time on the appropriate day.

  A sensor scan event 5502h is shown in the corresponding incremental period in which it occurred. In this way, the discontinuity (if any) of the glucose measurement is also displayed as a break in the glucose plot.

  Further, the daily total section 5516 displays the daily total of additional glucose related data. For example, section 5516 provides a daily total from the first day to March 17th. Section 5516 includes daily average glucose, daily carbohydrate count, amount of fast-acting insulin taken daily, and amount of long-acting insulin taken daily.

Record Book In some aspects of the present disclosure, a record book report is provided. Record book reports detail the obtained sensor measurements categorized by a period of time (eg, days) and, in some cases, other relevant data (eg, insulin dose, meal events, notes, Details of glucose strip measurements and ketone events).

  FIG. 62 illustrates an exemplary registry report according to one embodiment. The exemplary registry report 5520 shows the first page of the registry report 5520, where glucose related data for the first three days of a two week period is shown in Tables 5522, 5524, and 5526. ing. Glucose measurements, carbohydrate intake, and insulin data (eg, fast-acting insulin and long-acting insulin intake) are provided for each period throughout the day (eg, hourly period as shown). . The table also shows various events such as, for example, shading, symbols, icons, such as low glucose reading 5428, high glucose reading 5530, food intake 5532, and insulin intake 5534 recorded without a value. Indicated by etc. The table also includes notes, such as notes indicating exercise and other related events.

  For each day shown, graphs 5540, 5542, and 5544 of glucose values over the associated day are also provided. The daily average for each day is also shown.

  FIG. 63 illustrates another exemplary registry report according to one embodiment. The exemplary registry report 5550 is similar to the registry report 5520 of FIG. 62, and in FIG. 63 the description of similar functions will not be repeated for clarity and brevity. Record book report 5550 includes strip glucose reading 5552 and ketone reading 5554 at the associated date and time of the associated table.

Reader Settings In some aspects of the present disclosure, a reader settings report is provided. The reader settings report provides a summary of the reader device settings that are currently set.

  FIG. 64 shows an example of a reader settings report according to one embodiment. Reader settings report 5600 includes a profile section 5602 that displays profile settings such as patient name and ID. Reader settings report 5600 includes a settings section 5604 that displays general settings of the reader (eg, date, time, clock style, notification sound, button sound, vibration, target glucose range, etc.). Reader settings report 5600 also includes a notes section 5606 that displays note settings, such as available note categories. Examples of note categories may relate to fast-acting insulin, long-acting insulin, food, exercise, drugs, control solutions, stress, etc. Reader settings report 5600 also includes a reminder section 5608 that displays reminder settings such as alarms about glucose checks, insulin dose intake, and the like. Reader settings report 5600 also includes a change section 5610 that displays changes (if any) of reader settings within a given period of time (eg, the last 30 days as shown).

  If operation in the insulin calculation or masking mode is enabled on the reader device, the reader settings report may also include a summary section of those settings. For example, FIG. 65 shows insulin calculator settings (eg, whether a fast or long acting insulin calculator is on, calculator mode (eg, “advanced” or “simple” as described above), carbohydrates A reader settings report 5620 is shown that includes an insulin calculator section 5622 that displays ratios, correction goals, and correction factors. Reader settings report 5620 also includes a masking mode section 5624 that displays masking mode settings (whether masking mode is activated, glucose check reminder is activated, reminder frequency, time settings, etc.). .

Data Management Software In certain embodiments, the data management software may include a version of the data management software. Data management software information is provided in the embodiments and associated drawings described below. Note that the example interfaces and flows are exemplary and should not be construed as limiting the invention.

Home Screen FIG. 66 shows the home screen of the data management software when the reader device is not connected to the PC where the data management software resides. In a specific embodiment, before the reader device is connected, the home screen of FIG. 66, ie, the “Reader is not connected” screen 6600 is displayed and the reader device is disconnected. The software returns to this home screen. As shown, the “Reader Not Connected” screen includes an image 6610 representing the status of the reader device, ie, the reader is not connected. As shown, image 6610 shows the reader device and connection cable with the reader device not connected to the connection cable. “Reader not connected” screen 6600 also includes a textual notification of the status of the reader, as indicated by notification 6620. The home screen further includes two main menu icons: Create Report 6630 and Change Reader Settings 6640. On the “no reader connected” home screen 6600, the menus for report creation 6630 and change reader settings 6640 are disabled, and these menus are displayed as darkened output.

  FIG. 67A shows the home screen of the data management software when an unconfigured reader device is connected to the PC where the data management software resides. In certain embodiments, when an unconfigured reader is connected to the user, the home screen of FIG. 67A, ie, “Unconfigured Reader Connected” screen 6700 is displayed. . As shown, the “Unconfigured Reader Connected” screen includes an image 6710 representing the connected reader device. In certain embodiments, the data management software may support multiple different reader device models, and the image 6710 may automatically display an image of the particular model currently connected. . The “Unconfigured Reader Connected” screen 6700 also includes text information 6720 associated with the connected reader. The text information on the “Unconfigured Reader Connected” screen includes the reader serial number and date and time information for the current date and time stored in the reader.

  In certain embodiments, the text information includes a menu 6750 for adding a reader profile associated with the reader device. Selecting the “Add Reader Profile” menu 6750 launches a pop-up screen 6760 for entering the reader's user name and / or patient ID, as shown in FIG. 67B. The pop-up screen allows the reader user to associate his information including name and patient ID. After entering the name and patient ID, selecting the “Save” button saves the information associated with the connected reader. Once the reader profile information is associated with the reader, the user information is loaded into the reader device the next time the reader is connected to software.

  Returning to FIG. 67A, the home screen further includes two main menu icons: Create Report 6730 and Change Reader Settings 6740. In the “Unconfigured Reader Connected” home screen 6700, the Create Report 6730 and Change Reader Settings 6740 menu is a complete indication that the Create Report 6730 and Change Reader Settings 6740 menu is active. Appears bright. In certain embodiments, if the Create Report 6730 or Change Reader Settings 6740 menu is selected before the name and patient ID are entered and associated, a pop-up screen for entering the name and patient ID is activated and the user Reports cannot be executed or settings cannot be changed until the reader is configured using the information.

  FIG. 68 shows the home screen of the data management software when the reader device is connected to the PC where the data management software resides. In certain embodiments, when the reader is successfully connected, the home screen of FIG. 68, ie, “Reader Connected” screen 6800, is displayed. As shown, the “Reader Connected” screen includes an image 6810 that indicates the status of the reader device, ie, the reader has been successfully connected. In certain embodiments, the data management software may support multiple different reader device models, and the image 6810 representing the state of the reader device automatically represents the image of the particular model currently connected. May be displayed. The “Reader Connected” screen 6800 also includes text information 6820 for the connected reader. In certain embodiments, the information included is the reader's user name, the user's patient ID number, the reader's serial number, and date and time information about the current date and time stored in the reader. possible. The home screen further includes two main menu icons: Create Report 6830 and Change Reader Settings 6840. In the “Reader Connected” home screen 6800, both the Create Report and Change Reader Settings 6840 menus are enabled, which is indicated by the fact that these menus are displayed in a completely bright state. Is done.

  FIG. 69A shows the home screen of the data management software when the date and time of the connected reader device is not synchronized with the time of the computer where the software is loaded. In certain embodiments, a connected reader if the difference between the time stored in the reader device and the computer time exceeds a predetermined amount of time (eg, 5 minutes or more). A warning 6910 may be displayed instead of the time information. Warning 6910 includes an “Update” button that, when pressed, activates an “Update date and time” pop-up window 6920 as shown in FIG. 69B. In certain embodiments, the “Update Date and Time” pop-up window 6920 is an automatic update whereby the reader device is synchronized with the computer time or with the time obtained via the Internet. It is like that. In other embodiments, the “update date and time” pop-up window is a manual update, where the user enters a number corresponding to the hour and minute of the time, or increases or decreases the indicated time. By selecting the decreasing arrow, the time shown in the pop-up window is manually adjusted. In certain embodiments, if the time needs to be updated, the user cannot use the report creation menu and / or the reader settings change menu. In other embodiments, the report creation menu and the reader settings change menu can be used even when the clocks are not synchronized.

  70A-70D show the home screen of the data management software when a software update is available. In certain embodiments, there can be two types of software updates: a first type of update that needs immediate attention and a second type of update that can be applied when the application shuts down. FIG. 70A shows a pop-up window 7010 associated with an update that needs immediate attention. As shown, window 7010 includes a text notification that informs the user that an update is needed and that the software cannot be used until the update is applied. Window 7010 also includes two choices for the user to select: “Close” and “Update Now”. If “Close” is selected, the software may be shut down. If “update now” is selected, download of the update is started. While the download is in progress, as shown in FIG. 70B, a notification 7020 indicating that the download is in progress is displayed on the screen, preventing the user from interacting with the software while the download is in progress. Once the update download is complete, the uploader may be automatically activated to guide the user in installing the update. In certain embodiments, the update that needs to be performed immediately may include a software or firmware update of the reader device.

  FIG. 70C shows a pop-up window 7030 associated with an update that can be applied immediately or upon application shutdown. As shown, window 7030 includes a text notification informing the user that an update is available and can be applied immediately or upon application shutdown. Window 7030 also includes two options for the user to select: “Update on Shutdown” or “Update Now”. If “update now” is selected, the download of the update is started as described above and a notification that the download is in progress is shown. If “Update on Shutdown” is selected, the update is downloaded in the background of the software and, as shown in FIG. 70D, passively informs the user when the download is complete at the bottom of the home screen. A typical notification 7040 may be displayed. This passive notification 7040 displays a reminder that informs the user that the download of the update has been completed and will be applied when the software is shut down without disturbing normal use of the software. In certain embodiments, software shutdown and update installation may be triggered when the reader device is disconnected. In certain embodiments, updates that may be delayed until application shutdown may include data management software updates.

Report Creation FIG. 71 shows a report creation screen for data management software in a specific embodiment. The report creation screen 7100 can be accessed after selecting the “Create Report” menu on the home screen, as described above. Report creation screen 7100 may include a “Home” button for navigating the software back to the home screen. In certain embodiments, the report creation screen 7100 may include multiple frames. Such a frame includes a report selection section 7120, a reader profile section 7130, and a report parameter setting section 7140.

  In certain embodiments, the reader profile section 7130 may include patient information and reader information (eg, patient name, patient ID, reader serial number, reader current date and time information, etc.).

  The report parameter setting section 7140 is a setting associated with the report to be executed (eg, the time of the report to be executed, which can be set as a number of days or weeks, or can be set by selecting a specific date range) Frame). The report parameter section may further include options for setting a target glucose range for a particular report, as described below. Report parameter settings section 7140 may also include report specific settings (eg, settings applicable only to advanced daily pattern report 7150, as shown in the exemplary embodiment of FIG. 71).

  In certain embodiments, the report selection section 7120 includes multiple report types. Report types may be represented as icons, text, or a combination thereof. Multiple report types include snapshot reports, daily pattern reports, advanced daily pattern reports, meal pattern reports, monthly summary reports, weekly summary reports, daily record reports, and reading A detailed report of the vessel. In certain embodiments, multiple reports may be selected by selecting a selection box next to each report in the report section. In certain embodiments, selecting a specific report automatically triggers selection of other reports (eg, selecting an advanced daily pattern report automatically selects a daily pattern report. Triggered). In this way, multiple reports may be selected at the same time so that a single command can instruct software to execute multiple reports simultaneously. Next, the user can obtain a report and view or print it on the screen by using a “report view” 7170 button and a “report print” 7160 button. In one embodiment, the report is in a preset order (e.g., snapshots, daily patterns, advanced daily patterns, meal patterns, monthly summaries, weekly summaries, weekly summaries, daily records, and reads). Printed on the instrument details).

  FIG. 72 shows an exemplary snapshot report. As shown, the snapshot report includes information about the average glucose level (the percentage of time that the glucose level was higher than the target glucose level, the glucose level being within the target, the period during which the report is applied (eg, 14 days) Including the percentage of time spent and the percentage of time the glucose level was below the target), and the number of low (or high) glucose events during the period (including information indicating the average duration of the event) Good. The report may further include the percentage of available sensor data obtained by the reader and the number of scans per day performed during the period. In addition, the report may include carbohydrate information and insulin information (eg, the average daily intake of carbohydrates per day and the amount of insulin units consumed (fast acting and long acting) per day). A snapshot report is a comment associated with the result of the snapshot (e.g., an increase or decrease in the number of daily glucose tests for the current period compared to the previous period, possible causes of errors in the snapshot data, or (Comment regarding comparison of results between current period and past period).

  73A and 73B show an exemplary daily pattern report. FIG. 73A shows a daily pattern report including a glucose profile under the user's free behavior, and FIG. 73B shows a daily pattern report including a display of glucose measurements. As shown, the daily pattern report provides a graphical representation of one day of glucose readings over a period of days (eg 14 days), ie a 24-hour period of glucose measurements. Show. Glucose measurements may be displayed as individual points, or may be averaged and displayed as a gradient pattern that represents the density of measurements within a particular range. The graph may also include a representation of the user's target glucose range, a median over time represented by an average line, and lines representing the 10th, 25th, 75th and 90th percentile values. Good. In certain embodiments, the daily pattern report may include a numerical average over a shorter period of time throughout the day (eg, every 2 hours), as shown in FIGS. 73A and 73B. In some embodiments, the time period with the highest average glucose level may be highlighted to attract the user's attention. In certain embodiments, bins whose average glucose is higher than a predetermined threshold (eg, 240 mg / dL) or lower than a predetermined threshold (eg, 70 mg / dL) are highlighted. In other embodiments, certain levels that are outside the target range, or outside the target range or beyond the target range, are highlighted. The daily pattern report may also include an indication of the average daily glucose level. The daily pattern report may include other daily average information such as carbohydrates, fast-acting insulin, and long-acting insulin in addition to the measured glucose level. As shown, the daily information can also be displayed as a numerical daily average and as an average intake per time period.

  74A and 74B show an exemplary advanced daily pattern report. An advanced daily pattern report may include a graphical representation of glucose measurements and an average distribution of glucose measurements over a period of time, similar to a daily pattern report. The graph may further include a target median glucose level line and a lower threshold line for the glucose level. In certain embodiments, the lower threshold line of glucose levels represents a sufficiently low glucose level for the risk of a user's health problem, as described herein above. The advanced daily pattern report may further include a display system for notifying the user of variations and warnings regarding the average of the measured glucose level. As shown, an advanced daily pattern report provides an indication of the possibility of low glucose, a comparison of the median glucose level with the glucose level target, and an indication of the variation in measured glucose level below the median May be included. Glucose measurements and variability factors may be analyzed to inform the user of situations that may arise regarding control of the user's glucose level. In the example of FIGS. 74A and 74B, the fluctuation of glucose of the user lower than the median is high. In certain aspects, the notification to the user may include a warning and factors that may contribute to the determined problem.

  FIG. 75 shows an exemplary meal pattern report. As shown, the pattern report at mealtime is glucose for a particular time zone that can be associated with the meal (ie morning (breakfast), noon (lunch), evening (dinner), and night (sleeping)). It may include graphical and numerical representations of level information. As shown, a time display regarding the time before and after the corresponding meal is displayed. Further, the representation may include a numerical display of the current average glucose level and the peak glucose level at the time of ingestion of the meal. In certain embodiments, the graph shows a target glucose level line and a lower glucose level line. In another particular embodiment, the graph shows two lines representing the target range. In addition to the graph, representations of average carbohydrate intake and average insulin intake may also be displayed.

  FIG. 76 shows an exemplary monthly summary report. As shown, the monthly summary report includes a calendar display of the current month, a numerical display of average glucose levels, a number of scans per day, and a display of low glucose events. In the example shown, the fifth day of the month has an average glucose level as low as 64 mg / dL, which is scanned three times and there are multiple low glucose event notifications. In certain embodiments, days with average glucose higher than a predetermined threshold (eg, 240 mg / dL) or lower than a predetermined threshold (eg, 70 mg / dL) are highlighted. In other embodiments, certain levels that are outside or above the target range are highlighted.

  FIG. 77 shows an exemplary weekly summary report. As shown, the weekly summary report includes a representation of seven days of the week. For each day of the week, a graphical representation of the historical glucose data in 15-minute increments for that day is displayed. Each graphical representation may also include an indication of when the sensor scan was performed, and in certain embodiments also includes specific data associated with the scan, including glucose levels, carbohydrates, and current residual insulin. Good. Also, as shown, the target glucose range may be shown in a differentiated color to highlight good glucose control. In some embodiments, the graphical representation includes icons representing glucose-related events including fast-acting insulin injections, carbohydrate intake, time changes, and new sensor insertion or activation.

  With continued reference to FIG. 77, each line of daily information may include numerical and iconic representations of information including average glucose, carbohydrate intake, fast acting insulin, and long acting insulin.

  FIG. 78 shows an exemplary daily recording report. In certain embodiments, the daily recording report may consist of a combination of graphical information, numerical information, and text information regarding the user's glucose management. Referring to the drawing, the daily record includes a graphical representation of glucose levels over time on a selected day (including a specific indication of when sensor data was received and icons representing carbohydrate intake and insulin injection). May be included. Exemplary embodiments of daily recording reports include specific glucose measurements taken over a period of time, carbohydrate intake over a period of time, fast-acting insulin over a period of time and long-acting insulin. Also shown is the amount, and a numerical display of the measured ketone level over a period of time, as well as any notes (if any) associated with that period of time (e.g., information indicating the medication taken or exercise performed). In certain embodiments, low, high or dangerous glucose level measurements may be highlighted specifically to draw the user's attention. In certain embodiments, the daily recording report presents all real-time values, including sensor measurements or blood glucose test strip measurements, overlaid on historical data to the user to provide real-time results. Composed.

  79A and 79B show a detailed report of an exemplary reader. In certain embodiments, the reader detail report may include user information, configurable settings, change records, and notes. For example, as shown, the reader detail report includes user profile information including patient name and ID, date and time, clock style, sound / vibration settings, available notes, and current settings. Settings including reminders and alarms, insulin calculator settings, and masking mode settings may be included. In certain embodiments, setting changes for the past period (eg, 30 days) may be displayed in a footnote style so that setting changes are displayed for user confirmation.

  Returning again to FIG. 79A, the reader time change information is also shown, where the user can configure the reader to modify the reader time setting, and the reader time change is saved. 79A, such a change is displayed with the date and time of the reader's time change and the content of the time change (eg, “Time has been advanced by 2 hours”). Corresponding icons are also provided at positions corresponding to “Reader Date and Time” under “Settings” shown in FIG. 79A.

  FIG. 80 shows an exemplary frame of a report creation menu for setting report parameters. As shown, the report parameter setting frame 7140 includes options for setting a time frame associated with the report to be executed. The time frame may be selected as a length of time (ie, 2 weeks as shown) or may be selected by a date range. In certain embodiments, the time frame by length of time is applied to the length of time preceding the current date. The report parameter setting frame 7140 displays the target glucose range to be displayed in the report to be executed (including snapshot report, daily pattern report, meal pattern report, weekly summary report, and daily record report). Includes options to set.

  FIG. 80 also shows the settings associated with a particular report, namely the advanced daily pattern report 7150. In certain embodiments, advanced daily pattern report settings cannot be changed from the main report parameter settings frame, and an “Edit” button is entered to enter the screen to edit advanced daily pattern report settings. It is necessary to select. If the “Edit” button is selected, the data management software may launch a submenu for editing advanced daily pattern report settings as shown in FIG. 81A. As shown, the advanced daily pattern settings screen 8110 is for changing settings associated with daily events and meals (eg, breakfast time, lunch time, dinner time, and bedtime). Includes choices. Screen 8110 also includes options for changing the target median glucose level and the low glucose tolerance parameter.

  With continued reference to FIG. 81A, in certain embodiments, each section of the settings screen 8110 may include a help or detail button represented by a “?” Display as shown. The daily event settings help menu 8120 may include a daily event purpose, a definition of the daily event for calculation and suggestion purposes, and a description of the rules associated with the daily event. For example, the time between bedtime and breakfast should be less than 12 hours. The target median setting help menu 8130 may include an explanation of what the target median is and a description of the purpose for which the target median is used in advanced daily pattern reports. The low glucose tolerance help menu 8140 includes a description of the available settings. For example, menu 8140 includes instructions to the user that increasing the low glucose tolerance parameter increases the amount of acceptable low glucose readings (below a preset parameter (eg, 70 mg / dL)). In certain embodiments, a small low glucose tolerance parameter converts the tolerance to about 2% of the measurement at 50 mg / dL, 4% of the measurement at 60 mg / dL, and a moderate low glucose tolerance parameter of 50 mg / dL. / DL converts the tolerance to approximately 4% of the measured value, 60 mg / dL to 8% of the measured value, and the large low glucose tolerance parameter is approximately 10% of the measured value at 50 mg / dL and the measured value at 60 mg / dL. The allowable value is converted to 20%.

  With continued reference to FIG. 81A, the advanced daily pattern parameter menu also includes “Save” and “Cancel” buttons. When the “Save” button is selected, the changes made to the settings (if any) are retained, and when the “Cancel” button is selected, the changes made to the settings (if any) are retained. Discarded. In certain embodiments, when “Cancel” is selected, a notification may pop up on the screen requesting user confirmation to discard the changes. In certain embodiments, once a setting or parameter is configured with invalid values, the data management software prevents the user from saving changes made to the parameter and setting. In certain embodiments, when such a situation occurs, the software displays a notification 8150 that informs the user that the setting is invalid, as shown in FIG. 81B. Notification 8150 may include an explanation of which settings are invalid and a corresponding request associated with the settings, giving the user an opportunity to modify the settings. In some embodiments, an icon such as a “!” Symbol is displayed next to a particular setting that is out of range or disabled. Once all invalid settings have been corrected, the configuration may be saved by the user clicking the “Save” button.

Reader Settings FIGS. 82-86 illustrate exemplary screens for adjusting reader device settings in certain embodiments. FIG. 82 shows an example of a general setting screen. General settings include settings including date and time, clock style, sound and vibration settings, and language settings. In certain embodiments, the date and time may be updated based on the current date and time settings of the computer to which the reader is connected, or automatically via the Internet. As shown, an “Update” button is enabled, thereby updating the reader date and time to match the computer date and time. In certain embodiments, date and time updates do not affect data recorded in the reader prior to date and time changes. Another setting available in certain embodiments includes setting the clock style. The reader device may be configured to display the time in a 12 hour (am / pm) format or a 24 hour format. In addition, sound and vibration settings may be adjustable. Such settings include volume level (high / low) settings and whether to include sound / vibration for items such as notifications and touches.

  FIG. 83A is an exemplary reader profile setting screen when a reader profile is not yet stored in the reader device. As previously mentioned, the reader profile may include information including the patient name and patient ID. If the reader profile is not yet stored, the setup screen includes fields where reader profile information including name and patient ID can be entered. When complete, as shown in FIG. 83B, the settings screen includes buttons that can be used to “discard changes” or “save to reader”. Selecting “Discard Changes” cancels the input reader profile information. Selecting “Save to Reader” saves the changes to the reader and makes the reader profile information available the next time the reader is connected to the data management software. If “Save to Reader” is selected, as shown in FIG. 83C, it informs the user that the setting is being saved and prevents the user from making further changes while the save is in progress. A notification is displayed to the user that "Saving". In certain embodiments, this notification may be an animated notification. In certain embodiments, as shown in FIG. 83D, if the reader is disconnected from the data management software prior to saving the configuration change (if any), the software will display a pop-up notification informing the user of the error. It may be activated. In certain embodiments, as shown in FIG. 83E, if an error occurs between the reader and the data management software before saving the configuration change (if any), the software will prompt the user for an error. You may activate a pop-up notification to inform you. In certain embodiments, the data management software may return to the home screen once the error notification is confirmed. In other embodiments, when the reader is reconnected to the data management software, the error notification is automatically confirmed and returned to the settings screen, allowing the user to try the “Save to Reader” option again. May be.

  FIG. 84 shows a target glucose range setting screen. The target glucose setting screen allows the user to select a target glucose range associated with the glucose graph and reader calculator for managing glucose levels. The reader also uses the target glucose range to determine the percentage or amount of time that was within the target. In certain embodiments, the target glucose setting screen includes a warning to the user to consult a medical professional before determining and entering a target glucose range. In certain embodiments, if the target glucose range is changed, the software enables the “discard changes” and “save to reader” options. As described above, when the “Save to Reader” option is selected, inform the user that the setting is being saved and prevent the user from making further changes while the save is in progress. The notification “Saving” is displayed to the user.

  85A and 85B show a note screen that allows the user to configure a custom note. FIG. 85A shows the screen when a custom note has not yet been configured. As shown, in certain embodiments, several standard notes may be pre-stored in the reader device, including fast-acting insulin, long-acting insulin, food, exercise, and medication notes. Good. To add a custom note, the user can use the “Add Note” button. Selecting the “Add Note” button enables the custom note line items as shown in the screen of FIG. 85B. FIG. 85B shows a note screen ready to compose a custom note. In certain embodiments, custom annotations (if any) already stored in the reader device are displayed in the software. In certain embodiments, all custom notes can always be edited (including changing the note name and changing the note priority (top to bottom position in the list)). In addition, an “x” option is provided for erasing custom notes. If any custom note is changed, the software enables the “Discard Changes” and “Save to Reader” options. As described above, when the “Save to Reader” option is selected, inform the user that the setting is being saved and prevent the user from making further changes while the save is in progress. The notification “Saving” is displayed to the user. Changes to the notes do not apply to the reader until the “Save to Reader” option is selected.

  FIG. 86 shows a reminder screen. As shown, all configured reminders are displayed and can be edited by the user. Each reminder has an option to turn the reminder on / off, a function to change the time at which the reminder is executed, an option related to the occurrence of the reminder (repeat daily, repeat weekly, only once, etc.), and alarm type (e.g. , Glucose check alarm, insulin intake alarm, or general alarm) options. In addition, an “x” option is provided to erase the reminder. By selecting the “Add Reminder” button, a new reminder line appears, the configuration is ready, and a new reminder can be added. If any reminder is changed, the software enables the “Discard Changes” and “Save to Reader” options. As described above, when the “Save to Reader” option is selected, inform the user that the setting is being saved and prevent the user from making further changes while the save is in progress. The notification “Saving” is displayed to the user. Changes to the reminder do not apply to the reader until the “Save to Reader” option is selected.

  87A-87E show screens associated with the reader device expert options. As described above, the expert option is an option that can only be used by a health care provider or other expert associated with the reader device and is not immediately available to the user. As shown in FIG. 87A, the options in the expert options menu include a “lock” icon (represented by a padlock icon in certain embodiments). When the expert option menu is selected, a pop-up menu requesting an access code for accessing the expert option menu is initiated. If a valid access code is entered, the software navigates to the masking mode selection screen. In certain embodiments, once a valid access code is entered, the expert options menu can be used without re-entering the access code. In such an embodiment, the options in the expert options menu are displayed without a “lock” icon or with an alternative “unlock” icon.

  FIG. 87B shows a masking mode selection screen that is part of the expert options as described above. In certain embodiments, the masking mode setting screen includes two components: enabling the masking mode function and adjusting the glucose check reminder. In certain embodiments, the glucose check reminder setting cannot be used when the masking mode setting is off. Once the masking mode is enabled, as shown in FIG. 87C, the glucose check reminder settings are available, including the option to turn on / off the reminder and the option to set the time of the reminder.

  The expert options further include a system reset screen that can reset the reader to factory default settings, as shown in FIG. 87D. Activating a system reset restores the reader settings to the factory default settings, erases all patient data stored in the reader, and terminates the sensor (if any) paired with the reader Is done. In certain embodiments, a system reset can take up to 2 minutes or more to complete. In certain embodiments, selecting the system reset button activates a confirmation notification requesting confirmation before initiating a reset, as shown in FIG. 87E. This notification may include a warning to the user that all patient data has been erased, the settings have been reset to factory default settings, and the paired sensor (if any) will be terminated. The notification also includes an option to cancel the system reset before the system reset is initiated.

  FIG. 88 shows the options available on the main system menu of the data management software. Such menus include a “File” menu and a “Help” menu. The “File” menu may include options such as “Auto Start”, “Auto Save”, “Auto Save Options”, and “Exit”. When the automatic activation option is selected, the data management software is automatically activated when the computer detects the connected reader device. When the auto-save option is selected, the software automatically saves a copy of the report (eg, a PDF copy) that is running on the data management software. As shown in FIG. 89, auto-save includes user configurable settings, including an option to enable auto-save, a file name format option, and a file storage location option.

Exemplary Embodiments In some aspects of the present disclosure, a method of operating a sample monitoring device is provided, the method comprising receiving an indication to power on the sample monitoring device; Turning on the power; supplying power to the RF reader element in the specimen monitoring device; activating a scan state for scanning the specimen sensor; receiving an indication of a predetermined event; Powering off the RF reader and maintaining power to the analyte monitoring device.

  In one embodiment, the scan state includes displaying a prompt on the analyte monitoring device display prompting the analyte sensor to be scanned.

  In one embodiment, the predetermined event is that a predetermined period has elapsed without a scan being performed. In some examples, the predetermined event is the release of the scan state. In some examples, the predetermined event is a change from a scan prompt screen to a home screen initiated by the user. In some examples, the predetermined event is the occurrence of a scan error or scan failure.

  In one embodiment, the method includes receiving an indication to scan the sensor, turning the RF reader back on, and reactivating the scan state to scan the analyte sensor. including.

  In one embodiment, the method includes detecting an analyte sensor and scanning the analyte sensor to perform an analyte measurement.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a method for operating a sample monitoring device is provided, the method comprising: performing a first scan of a sample sensor; and displaying a measurement value of a result of the first scan. , Including a step of preventing the second scan over a predetermined period and a step of enabling the second scan after the predetermined period has elapsed.

  In one embodiment, the method includes turning off the sample monitoring device after the measurement value is displayed, and turning on the sample monitoring device before a predetermined period of time elapses.

  In one embodiment, the method includes receiving an indication that a second scan has been attempted before a predetermined period of time and indicating that the second scan cannot be performed. In some examples, the method includes indicating an estimated remaining time until a second scan can be performed.

  In one embodiment, the method includes exiting from a screen displaying measured values and indicating that the result displayed before the predetermined period of time has passed is the result of the first scan.

  In one embodiment, the method includes performing a second scan of the analyte sensor after a predetermined period of time.

  In one embodiment, the predetermined period is between 1 minute and 5 minutes.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a method of operating an analyte monitoring device is provided that includes performing a first scan of an analyte sensor and suggesting insulin administration based on the results of the first scan. Displaying a screen for calculating the dose, exiting the screen for calculating the suggested dose before recording the suggested dose calculation, and the suggested dose over a predetermined period of time. Allowing the dose calculation to be recorded and preventing the recording of the suggested dose calculation for the first scan after a predetermined period of time.

  In one embodiment, the method includes turning off the device and turning the device back on before displaying a screen for calculating the suggested dose and before a predetermined period of time has elapsed. When the specimen monitoring device is turned off, the screen for calculating the suggested dose appears. In some examples, when the reader is turned on again, a screen for calculating the suggested dose is displayed, and the screen for calculating the suggested dose is displayed Allow users to record quantity calculations.

  In one embodiment, the method includes receiving an indication to record the suggested dose calculation, the suggested dose calculation as a first scan, and a time at which the first scan was performed. A countdown of the estimated amount of residual insulin in the body is started when the suggested dose calculation is recorded.

  In one embodiment, the method comprises turning off the device before displaying a screen for calculating a suggested dose and before a predetermined period of time has elapsed, comprising: Turning off the power includes exiting the screen for calculating the suggested dose and turning the device back on after a predetermined period of time has elapsed.

  In one embodiment, the method includes displaying a prompt to scan the analyte sensor for a second scan when the reader is powered on again.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a step of performing a continuous scan of the sample sensor, a step of displaying a measurement value of a result of each of the continuous scans on a display of the sample monitoring device, and a display of the sample monitoring device Displaying a result measurement for one predetermined time period and displaying a graph that tracks subsequent result measurements during a second predetermined time period following the first predetermined time period; After tracking subsequent result measurements for the entire predetermined period, the subsequent result measurements are shifted to the first predetermined period to track subsequent result measurements during the second period. A method is provided that includes the steps of continuing and repeatedly shifting the measurement of subsequent results after tracking is performed for the entire second period.

  In one embodiment, the graph is displayed on a display after the resulting measurement is obtained for a first predetermined time period.

  In one embodiment, before the resulting measured value is obtained for a first predetermined period, a graph without the resulting measured value is displayed, and the measured result value for the first predetermined period is displayed. After being obtained, the resulting measured value for the first predetermined period is displayed in a graph. In some examples, the first predetermined period is a multiple of the second predetermined period. In some examples, the first predetermined period is 8 hours and the second predetermined period is 1 hour.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and instructions are stored in the memory, and the instructions include instructions for performing the above-described method.

  In some aspects of the present disclosure, a method is provided for displaying an analyte sensor measurement value on an analyte monitoring device, the method preceding the step of obtaining the sensor measurement value from the analyte sensor and the display of the analyte monitoring device. Displaying a graph of sensor measurements obtained over a period of time.

  In one embodiment, the method includes displaying a trigger element for shifting the graph forward or backward by 24 hours, receiving an indication that the trigger element has been initiated by the user, and displaying the graph for only 24 hours. Shifting before or after.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. Instructions for performing the above method are included.

  In some aspects of the present disclosure, a method for displaying an analyte sensor measurement value on an analyte monitoring device is provided, the method comprising obtaining a sensor measurement value from the analyte sensor and a display preceding the analyte monitoring device. Displaying a summary of the average sensor measurements for a plurality of segments of the day, including average sensor measurements for a plurality of segments of the day.

  In one embodiment, the preceding predetermined period is a seven day period, and the average sensor reading includes an average sensor reading for four segments of the day.

  In one embodiment, the method includes displaying a total average of each average sensor measurement for multiple segments of the day.

  In one embodiment, the method includes displaying a trigger element for shifting the graph forward or backward by a predetermined time period, receiving an indication that the trigger element has been triggered by a user, Shifting by a period before or after.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. Instructions for performing the above method are included.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. A command for obtaining a sensor measurement value from the sample sensor and an average sensor measurement value for a plurality of divisions in one day are displayed on the display of the sample monitoring device. And a command for displaying a summary of the average sensor measurements.

  In one embodiment, the preceding predetermined period is a seven day period, and the average sensor reading includes an average sensor reading for four segments of the day.

  In one embodiment, the instructions include instructions for displaying the total average of each average sensor measurement for multiple segments of the day.

  In one embodiment, the instructions include instructions for displaying a trigger element for shifting the graph forward or backward by a predetermined time period, and instructions for receiving an indication that the trigger element has been triggered by a user. And instructions for shifting the graph forward or backward by a predetermined time period.

  In some aspects of the present disclosure, a method for displaying an analyte sensor measurement value on an analyte monitoring device is provided, the method comprising obtaining a sensor measurement value from the analyte sensor and a display preceding the analyte monitoring device. Displaying a summary of the average number of events associated with sensor measurements obtained for a period of time, including an average number of events for multiple segments of the day, the summary comprising: Displayed when selected by the user.

  In one embodiment, the preceding predetermined period is a seven day period and the average event count includes an average event count for four segments of the day.

  In one embodiment, the method includes displaying a total average of each average event number for multiple segments of the day.

  In one embodiment, the method includes displaying a trigger element for shifting the summary forward or backward by a predetermined time period, receiving an indication that the trigger element has been triggered by a user, Shifting by a period before or after.

  In one embodiment, the event is a low glucose measurement.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. Instructions for performing the above method are included.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. An average number of events associated with a command for obtaining a sensor measurement value from the analyte sensor and a sensor measurement value obtained for a predetermined period preceding the display of the analyte monitoring device; And an instruction for displaying a summary of the average number of events including the average number of events for the category, the summary being displayed when selected by the user.

  In one embodiment, the preceding predetermined period is a seven day period and the average event count includes an average event count for four segments of the day.

  In one embodiment, the analyte monitoring device includes instructions for displaying the total average of each average event number for multiple segments of the day.

  In one embodiment, the analyte monitoring device includes instructions for displaying a trigger element for shifting the summary forward or backward by a predetermined time period, and instructions for receiving an indication that the trigger element has been triggered by a user. And instructions for shifting the summary forward or backward by a predetermined time period.

  In one embodiment, the event is a low glucose measurement.

  In some aspects of the present disclosure, a method for displaying an analyte sensor measurement value on an analyte monitoring device is provided, the method comprising obtaining a sensor measurement value from the analyte sensor and a display preceding the analyte monitoring device. A summary of sensor measurements obtained for a period of time, comprising: summarizing sensor measurements including one or more values or percentages of sensor measurements for a target range, the summary selected by the user Displayed.

  In one embodiment, the summary includes sensor measurements above the target range, sensor measurements below the target range, and numerical values or percentages of sensor measurements within the target range.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, obtaining sensor measurements from an analyte sensor and associated with the use of the sensor on the analyte monitoring device display, including an average number of scans per day for a predetermined period of time. Displaying a summary of the data, and a method is provided that is displayed when the summary is selected by the user.

  In one embodiment, the use of the sensor includes the number of days having sensor data within the preceding predetermined period.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. Instructions for obtaining sensor readings from the analyte sensor and display on the analyte monitoring device display a summary of data associated with sensor usage, including the average number of scans per day for a given period of time And a summary is displayed when selected by the user.

  In one embodiment, the use of the sensor includes the number of days having sensor data within the preceding predetermined period.

  In some aspects of the present disclosure, an average sensor measurement value for a plurality of sections of a day for a predetermined period preceding the step of obtaining a sensor measurement value from the analyte sensor and the display of the analyte monitoring device is displayed. Including a step of displaying a graph of the pattern for each day that is included, wherein the graph is displayed when selected by the user.

  In one embodiment, the preceding predetermined period is a seven day period, and the daily pattern graph includes average sensor measurements for four segments of the day.

  In one embodiment, the daily pattern chart shows the range of average sensor measurements for multiple sections of the day.

  In one embodiment, the method includes displaying a trigger element for shifting the graph forward or backward by a predetermined time period, instructions for receiving an indication that the trigger element has been triggered by a user, and a graph. Shifting before or after a predetermined period.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring device includes a processor and a memory operably connected to the processor, and the memory stores an instruction for displaying the sample sensor measurement value on the sample monitoring device. A graph of a pattern for each day including an average sensor measurement value for a plurality of sections of one day for a predetermined period preceding the command for obtaining the sensor measurement value from the sample sensor and the display of the sample monitoring device The graph is displayed when selected by the user.

  In one embodiment, the preceding predetermined period is a seven day period, and the daily pattern graph includes average sensor measurements for four segments of the day.

  In one embodiment, the daily pattern chart shows the range of average sensor measurements for multiple sections of the day.

  In one embodiment, the instructions include instructions for displaying a trigger element for shifting the graph forward or backward by a predetermined time period, and instructions for receiving an indication that the trigger element has been triggered by a user. And instructions for shifting the graph forward or backward by a predetermined time period.

  In one embodiment, the analyte is glucose or a ketone body.

  In some aspects of the present disclosure, a method of operating a sample monitoring device is provided, the method comprising receiving an indication of operating in a masking mode, performing a scan of a sample sensor, and Storing sensor measurement values obtained by scanning without displaying the sensor measurement values on a display.

  In one embodiment, the method includes receiving an indication of operating in a non-masking mode, performing a scan of the analyte sensor, and displaying the sensor measurement on a display of the analyte monitoring device.

  In one embodiment, the method includes transmitting stored sensor measurements to a remote device.

  In one embodiment, the method includes the analyte being glucose or a ketone body.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a method of operating a sample sensor is provided, the method comprising: communicating between the sample sensor and a first sample monitoring device; and wherein the first sample monitoring device is a sample. A step of establishing a pairing with the first sample monitoring device and receiving an identification code of the first sample monitoring device from the first sample monitoring device so that the sample measurement can be performed using the sensor; And storing a device identification code in a memory to indicate that pairing with the first sample monitoring device has been established.

  In one embodiment, the method includes receiving a request for a device ID from a second sample monitoring device and transmitting a device identification code of the first sample monitoring device to a second sample monitoring device.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a method of operating a sample monitoring device is provided, the method comprising communicating between a first sample monitoring device and a first sensor; and a first sample monitoring Using the processor of the apparatus to determine that the first sensor is not paired with any sample monitoring device; and using the processor described above, the first sample monitoring device is paired with any sample sensor. And determining that the first sample monitoring device is capable of performing sample measurement using the first sensor, pairing the first sample monitoring device with the first sensor. And transmitting an identification code of the first sample monitoring device to the first sensor to indicate pairing.

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  In some aspects of the present disclosure, a method of operating a sample monitoring device is provided, the method comprising communicating between a first sample monitoring device and a first sensor; and a first sample monitoring Using the processor of the device to determine that the first sensor is paired with the second analyte monitoring device; and using the processor, the first analyte monitoring device causes the first sensor to Using the processor to determine that the first sensor is paired, wherein the first sensor uses the processor to prevent the first sensor from performing the analyte measurement. Receiving an indication of having an identification (ID) code of a second analyte monitoring device paired with the sensor.

  In one embodiment, the method includes visually indicating that the first sensor cannot be used on the display of the first analyte monitoring device.

  In one embodiment, the method includes the step of communicating between a first analyte monitoring device and a second sensor, and the second sensor is paired with any analyte monitoring device using the processor. Determining that the first sample monitoring device is not paired with any sample sensor using the processor, and the first sample monitoring device is the second sensor. Showing the step of pairing the first sample monitoring device with the second sensor and the pairing of the first sample monitoring device with the second sensor in order to be able to perform sample measurement using Transmitting the identification code of the first analyte monitoring device to the second sensor for storage in the second sensor.

  In one embodiment, the method includes the step of communicating between a first analyte monitoring device and a third sensor, and the third sensor is paired with any sample monitoring device using the processor. Determining that the first analyte monitoring is not performed using the second sensor using the second sensor.

  Certain embodiments include a reader device that receives analyte data from an analyte sensing device, the reader device storing a housing, a display attached to the housing, a processor attached to the housing, and instructions. A memory that, when an instruction is executed by the processor, causes the processor to navigate from the current user interface screen on the display to the home screen in response to user input and from the current user interface screen to the home screen. To check whether the sample sensing device has expired, and if the sample sensing device has expired, a command to display a sensor expiration notification, the remaining time until the sample sensing device expires Command to calculate, specimen sensing Instructions for displaying a home screen including display of the remaining time until the expiration of the location, and a memory for storing instructions for displaying instructions to receive a sample information from the sample sensing device, and received the sample information on the display.

  In some embodiments, sensor expiration notifications require confirmation of sensor expiration notifications before navigating to the home screen.

  In some embodiments, the indication of the remaining time before expiration of the analyte sensing device includes an indication that no sensor is active, and the remaining time is displayed as days when the remaining time is longer than one day, and the remaining time When the time is longer than 1 hour and less than 1 day, it is displayed as the number of hours, and when the remaining time is less than 1 hour, it is displayed as the number of minutes.

  In some embodiments, the home screen includes information indicating the estimated amount of remaining insulin.

  In some embodiments, the indication of the estimated residual insulin amount includes a humanoid icon, and the estimated residual insulin amount is expressed as a percentage of the humanoid icon being filled.

  In some embodiments, the displayed specimen information includes a numerical current specimen level, a graphical representation of a past specimen level, and an arrow representing a numerical trend of the current specimen level.

  Certain embodiments allow the processor to have a current analyte level that is higher than a high analyte level threshold, lower than a low analyte level threshold, higher than an expected high analyte level threshold, or lower than an expected low analyte level. Includes instructions to determine if it is below a threshold.

  In some embodiments, the high analyte level threshold is 240 mg / dL, the low analyte level threshold is 70 mg / dL, and the expected high analyte level threshold within the next 15 minutes is 240 mg / dL. Yes, the expected low analyte level threshold within the next 15 minutes is 70 mg / dL.

  In some embodiments, the historical specimen level graphical representation includes specimen data for the past 8 hours.

  Certain embodiments include instructions that do not allow the processor to allow continuous analyte level scans within a predetermined period of time.

  Certain embodiments include instructions that do not allow the processor to allow more than one analyte level scan within a predetermined period of time.

  In some embodiments, the predetermined period is 3 minutes.

  Certain embodiments include a method of operating a reader device of an analyte monitoring system, the method using the reader device to scan for a new sensor before the new sensor scan times out. Waiting for a predetermined amount of time at the time of scanning, a step of checking whether a new sensor has been previously paired with another reader device, and a new sensor already separated When paired with another reader device, the process of not allowing pairing between the reader device and a new sensor, and waiting for a predetermined time for warming up the paired sensor Displaying a home screen including a display of a remaining time until expiration of a paired sensor after waiting for a predetermined length of time, and a pair Starting a glucose scan using the measured sensor and displaying the results of the glucose scan, the display being a numerical current glucose level, a glucose level history for a predetermined period in the past Simultaneously displaying a graphical representation of the current glucose trend and an arrow representation of the current glucose trend.

  Certain embodiments include displaying a notification that a sensor is about to expire when a new sensor expires within the next predetermined amount of time.

  In some embodiments, the next predetermined length of time includes three days.

  In some embodiments, a notification that the sensor is about to expire is displayed after the first scan of each day for the last 3 days before the sensor expires, and for the last 8 hours before the sensor expires. Is displayed after each scan.

  In some embodiments, the remaining time notification is context-dependent and the unit of display changes based on how much time remains before the sensor expires.

  In some embodiments, when the remaining time before expiration of the sensor is greater than 3 days, the remaining time is displayed in units of one day, and when the remaining time before expiration of the sensor is between 1 hour and 1 day, the remaining time Is displayed in units of one hour, and when the remaining time before expiration of the sensor is less than one hour, the remaining time is displayed in units of one minute.

  In some embodiments, the reader device automatically navigates back to the home screen when the remaining time before the sensor expires reaches zero.

  Certain embodiments include displaying an indication of high or low glucose values.

  In some embodiments, the high glucose value display is 240 mg / dL and the low glucose value display is 70 mg / dL.

  Certain embodiments include selecting to display a high or low glucose value and navigating to a high or low glucose notification screen, where the high or low glucose notification screen is the next glucose scan. Includes options for setting reminders.

  Certain embodiments include displaying an indication of a predicted high or low glucose value.

  In some embodiments, the expected high glucose value indication within the next 15 minutes is 240 mg / dL and the expected low glucose value indication within the next 15 minutes is 70 mg / dL.

  Certain embodiments include selecting an indication of a predicted high or low glucose value and navigating to a predicted high or low glucose notification screen, wherein the predicted high or low glucose The notification screen includes options for setting a reminder for the next glucose scan.

  In some embodiments, the graphical representation of the history of glucose levels includes a history of 8 hours prior to the current clock time and minutes after the current clock time.

  Certain embodiments include a method of operating a reader device in a masking mode, the method including entering a masking mode that prevents sensor data from being displayed on the display of the reader device.

  In some embodiments, the masking mode can be activated or deactivated only by a medical professional.

  In some embodiments, the display of the reader device displays a notification that the scan of the sensor is complete with no results.

  Certain embodiments include setting a reminder to scan current sensor data after a predetermined time interval.

  In some embodiments, the next reminder is reset when a manual scan is performed.

  Certain embodiments include a glucose monitoring system, wherein the glucose monitoring system is a glucose sensor, a reader device paired with the glucose sensor, and reader software executable on a personal computer, the reader device comprising: And reader software configured to configure settings associated with the reader device, the reader software being configured when the reader device is connected to a personal computer. Automatically started and the reader software is configured to automatically update the reader device firmware or the reader software when an available update is detected, the reader software being executed by the reader software Possible stored in reader device Including a plurality of reports related to the course data.

  Certain embodiments include a glucose monitoring system, the glucose monitoring system being a glucose sensor, a reader device paired with the glucose sensor and including firmware, and reader software executable on a personal computer comprising: A reader software configured to analyze data stored in the reader device and to configure settings associated with the reader device, the reader software being connected to a personal computer. The reader software is configured to automatically update the reader device firmware or the reader software when an available update is detected, the reader software Readable, executable by software Comprising a plurality of reports associated with glucose data stored devices.

  In some embodiments, the reader device must be configured prior to use, and configuring the reader device includes associating a user profile with the reader device.

  In some embodiments, the reader device software requires the user to configure the reader device prior to use of the reader device, and configuring the reader device may cause the user profile to be read by the reader device. Including associating with.

  In some embodiments, the user profile includes a patient name and a patient ID.

  In some embodiments, reader software options are not available until the reader device is associated with a user profile.

  In some embodiments, the reader software automatically discovers a user profile associated with the reader device when the reader device is connected to a personal computer.

  In some embodiments, when the reader device is connected to a personal computer, the reader software may display the date and time information stored in the reader device and the current date stored in the personal computer. And check by comparing with time information.

  In some embodiments, the reader device date and time information is synchronized automatically or manually with the current date and time information stored on the personal computer.

  In some embodiments, the reader device date and time information is synchronized with the current date and time information stored in the personal computer.

  In some embodiments, the user cannot use the reader software while a software or firmware update is in progress.

  In some embodiments, the reader software executes one or more of the multiple reports simultaneously.

  In some embodiments, the results of multiple reports that are executed are saved in PDF format.

  In some embodiments, the plurality of reports includes a snapshot report, a daily pattern report, a meal pattern report, a monthly summary report, a weekly summary report, and a daily recording report.

  In some embodiments, one or more of the plurality of reports includes graphical information and numerical information.

  In some embodiments, the reader software includes customizable notes about events associated with glucose data.

  In some embodiments, the reader software includes a customizable reminder that can be configured to run on the reader device.

  In some embodiments, the reader software includes options that allow only authorized access.

  In some embodiments, an option that allows only authorized access requires an access code for access.

  In some embodiments, the options that allow only authorized access include the option to disable or enable the masking mode that configures the reader device to not display glucose data on the reader device display. .

  In some aspects of the present disclosure, an analyte monitoring device is provided. The sample monitoring apparatus includes a processor and a memory operably connected to the processor, and the memory stores a command for operating the sample monitoring device, and the command performs the above-described method. Including instructions for.

  It should be noted that the techniques introduced herein can be implemented by programmable circuits programmed or configured by software and / or firmware, or can be implemented entirely by dedicated “hardwired” circuits, or It should be understood that it can be implemented by a combination of such forms. Such dedicated circuitry (if used) may be in the form of, for example, one or more application specific integrated circuits (ASICS), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), and the like.

  Software or firmware implementing the techniques introduced herein may be stored on a machine-readable storage medium and executed by one or more general purpose or special purpose programmable microprocessors. As used herein, the term “machine-readable medium” refers to a form accessible by a machine (eg, a computer, network device, mobile phone, PDA, manufacturing tool, any device having one or more processors, etc.). Including any mechanism that can store information. For example, the machine accessible medium is a recordable / non-recordable medium (for example, read-only memory (ROM), random access memory (RAM), magnetic disk storage medium, optical storage medium, flash memory device, etc.), etc. including. As used herein, the term “logic” may include, for example, dedicated hardwired circuitry, software and / or firmware used with programmable circuitry, or combinations thereof.

  The above description merely illustrates the principles of the present disclosure. Those skilled in the art can devise various configurations that embody the principles of the present disclosure even if not explicitly described or illustrated herein, and such configurations are within the spirit and scope of the present invention. Will be understood. In addition, all examples and conditional statements contained herein are intended primarily for the reader to understand the principles of the invention and the concepts that we contribute to advance the art. And should not be construed as limited to such specifically described examples and conditions. Moreover, all statements herein reciting principles and aspects of the present disclosure, as well as specific examples thereof, are intended to encompass their structural and functional equivalents. Furthermore, such equivalents are intended to include presently known equivalents and equivalents developed in the future (ie, any element to be developed that will perform the same function regardless of structure). Accordingly, the scope of the present disclosure is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the present disclosure is represented by the appended claims.

Claims (47)

A device for receiving sample data from a sample sensing device,
A housing;
A display attached to the housing;
A processor mounted in the housing;
A memory for storing instructions when the instructions are executed by the processor;
In response to user input, whether the analyte sensing device has expired when navigating from the current user interface screen on the display to the home screen and navigating from the current user interface screen to the home screen An instruction to display a sensor expiration notification if the analyte sensing device is expired,
A command to calculate the remaining time until expiration of the analyte sensing device;
A command to display the home screen including display of the remaining time until the specimen sensing device expires;
An apparatus comprising: a command for receiving sample information from the sample sensing device; and a memory for storing a command for displaying the received sample information on the display.   The apparatus of claim 1, wherein the sensor expiration notification requests confirmation of the sensor expiration notification before navigating to the home screen.   The display of the remaining time until expiration of the analyte sensing device includes an indication that there is no active sensor, and the remaining time is displayed as days when the remaining time is longer than one day, and the remaining time is displayed. The apparatus of claim 1, wherein the device is displayed as a number of hours when it is longer than one hour and less than one day, and as a fraction when the remaining time is less than one hour.   The apparatus of claim 1, wherein the home screen includes information indicating an estimated amount of residual insulin.   5. The apparatus of claim 4, wherein the indication of the estimated amount of remaining insulin includes a humanoid icon, and the estimated amount of remaining insulin is expressed as a percentage of the humanoid icon being filled. .   The apparatus of claim 1, wherein the displayed specimen information includes a current specimen level by a numerical value, a graphical representation of a past specimen level, and an arrow representing a trend of the current specimen level by the numerical value.   Whether the processor has a current sample level higher than a high sample level threshold, lower than a low sample level threshold, higher than an expected high sample level threshold, or lower than an expected low sample level threshold The apparatus of claim 1, further comprising instructions for determining.   The high analyte level threshold is 240 mg / dL, the low analyte level threshold is 70 mg / dL, the predicted high analyte level threshold within the next 15 minutes is 240 mg / dL, and 8. The apparatus of claim 7, wherein the predicted low analyte level threshold within 15 minutes is 70 mg / dL.   The apparatus according to claim 6, wherein the graphical representation of the past specimen level includes specimen data for the past 8 hours.   The apparatus of claim 1, further comprising an instruction that does not allow the processor to allow more than one analyte level scan within a predetermined period of time.   The apparatus of claim 10, wherein the predetermined period is 3 minutes. A method of operating a reader device of a sample monitoring system, comprising:
Scanning for a new sensor using the reader device, comprising waiting for a predetermined amount of time before the new sensor scan times out; and
Checking whether the new sensor has been previously paired with another reader device;
If the new sensor is already paired with another reader device, not allowing pairing of the reader device with the new sensor; and
Waiting for a predetermined amount of time to warm up the paired sensor;
Displaying a home screen including a display of a remaining time until expiration of the paired sensor after waiting for the predetermined time; and
Initiating a glucose scan using the paired sensor;
Displaying the results of the glucose scan, wherein the display is a numerical representation of the current glucose level, a graphical representation of a history of glucose levels for a predetermined period of time in the past, and a representation of current glucose trends by arrows. A process comprising simultaneously displaying.   The method of claim 12, further comprising displaying a notification that a sensor is about to expire when the new sensor expires within a next predetermined amount of time.   The method of claim 13, wherein the next predetermined amount of time comprises three days.   A notification that the sensor is about to expire is displayed after the first scan of each day for the last 3 days before the sensor expires, and after each scan for the last 8 hours before the sensor expires. 15. The method of claim 14, wherein the method is displayed.   14. The method of claim 13, wherein the remaining time notification is context dependent and the unit of display changes based on how much time remains before the sensor expires.   When the remaining time before expiration of the sensor is longer than 3 days, the remaining time is displayed in units of 1 day. When the remaining time before expiration of the sensor is 1 hour to 1 day, the remaining time is 1 hour. The method of claim 16, wherein the remaining time is displayed in units of one minute when displayed in units and the remaining time before expiration of the sensor is less than one hour.   18. The method of claim 17, wherein when the remaining time before expiration of the sensor reaches zero, the reader device automatically navigates back to the home screen.   13. The method of claim 12, further comprising displaying an indication of high or low glucose values.   20. The method of claim 19, wherein the high glucose value indication is 240 mg / dL and the low glucose value indication is 70 mg / dL.   Selecting a display of the high or low glucose value and navigating to a high or low glucose notification screen, wherein the high or low glucose notification screen includes a reminder for the next glucose scan. The method of claim 19, comprising options for setting.   The method of claim 12, further comprising displaying an indication of a predicted high or low glucose value.   23. The method of claim 22, wherein the indication of the predicted high glucose value within the next 15 minutes is 240 mg / dL and the indication of the expected low glucose value within the next 15 minutes is 70 mg / dL. .   Selecting a display of the predicted high or low glucose value and navigating to a predicted high or low glucose notification screen, the predicted high or low glucose notification screen comprising: 24. The method of claim 22, comprising options for setting a reminder for the next glucose scan.   The method of claim 12, wherein the graphical representation of the glucose level history comprises a history of 8 hours prior to the current clock time and minutes after the current clock time. A method of operating a reader device in a masking mode, comprising:
A method comprising the step of entering a masking mode to prevent sensor data from being displayed on the display of the reader device.   27. The method of claim 26, wherein the masking mode can be activated or deactivated only by a medical professional.   27. The method of claim 26, wherein a notification that a sensor scan is complete is displayed on the display of the reader device with no results.   27. The method of claim 26, further comprising setting a reminder to scan current sensor data after a predetermined time interval.   30. The method of claim 29, wherein a next reminder is reset when a manual scan is performed. A glucose monitoring system comprising:
A glucose sensor;
A reader device paired with the glucose sensor and including firmware;
Reader software executable on a personal computer, wherein the reader software is configured to analyze data stored in the reader device and to configure settings associated with the reader device. Prepared,
The reader software is automatically launched when the reader device is connected to the personal computer,
The reader software is configured to automatically update firmware of the reader device or the reader software when an available update is detected;
The reader software includes a plurality of reports related to glucose data stored in the reader device that can be executed by the reader software.   The reader device software requires a user to configure the reader device before using the reader device, and configuring the reader device associates a user profile with the reader device. 32. The system of claim 31, comprising.   35. The system of claim 32, wherein the user profile includes a patient name and a patient ID.   35. The system of claim 32, wherein the reader software option is not available until the reader device is associated with the user profile.   35. The system of claim 32, wherein the reader software automatically discovers a user profile associated with the reader device when the reader device is connected to the personal computer.   When the reader device is connected to the personal computer, the reader software displays the date and time information stored in the reader device and the current date and time stored in the personal computer. 32. The system of claim 31, wherein the system is checked by comparing with the information.   37. The system of claim 36, wherein the date and time information of the reader device is synchronized with the current date and time information stored in the personal computer.   32. The system of claim 31, wherein a user cannot use the reader software while a software or firmware update is in progress.   32. The system of claim 31, wherein reader software executes one or more of the plurality of reports simultaneously.   40. The system of claim 39, wherein the results of the plurality of executed reports are saved in PDF format.   40. The system of claim 39, wherein the plurality of reports includes a snapshot report, a daily pattern report, a meal pattern report, a monthly summary report, a weekly summary report, and a daily recording report.   40. The system of claim 39, wherein one or more of the plurality of reports includes graphical information and numerical information.   32. The system of claim 31, wherein the reader software includes customizable notes about events associated with the glucose data.   32. The system of claim 31, wherein the reader software includes a customizable reminder configurable to run on the reader device.   32. The system of claim 31, wherein the reader software includes options that allow only authorized access.   46. The system of claim 45, wherein the option that allows only authorized access requires an access code for access.   The option that allows only authorized access includes an option to disable or enable a masking mode that configures the reader device to not display the glucose data on a display of the reader device. 45. The system according to 45.

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