KR20130116290A - Analyte testing method and system with high and low analyte trends notification - Google Patents

Abstract

Described herein are systems and methods that use factual information based on stored analyte data to better manage diabetes in a user.

Description

ANALYTE TESTING METHOD AND SYSTEM WITH HIGH AND LOW ANALYTE TRENDS NOTIFICATION

This application claims, under 35 USC §§119, 120, 365, and / or Paris Treaty, Provisional Patent Application No. 61 / 415,598, filed November 19, 2010 (Agent No. LFS5217USPSP); 61 / 469,046 filed March 29, 2011 (Agent Control Number LFS2222USPSP); US Chairman Patent Application No. 29 / 393,126 filed May 31, 2011 (Agent No. LFS5223USDP); And claims for regular patent application No. 13 / 192,348 filed on July 27, 2011, Representative Control Number LFS5217USNP, which is incorporated herein by reference in its entirety.

Glucose monitoring is a reality of everyday life for people with diabetes. The accuracy of such monitoring can significantly affect health and ultimately the quality of life of people with diabetes. In general, diabetics measure blood glucose levels several times a day to monitor and manage blood glucose levels. Failure to check blood glucose levels accurately and regularly can lead to serious diabetes-related complications, including cardiovascular disease, kidney disease, nerve damage and vision loss. There are a number of electronic devices currently available that allow individuals to test glucose levels in small amounts of blood samples. One such glucose meter is the OneTouch® Profile ™ glucose meter, a product manufactured by LifeScan.

In addition to blood glucose monitoring, individuals with diabetes often have to maintain strict control of their lifestyle so that they are not adversely affected by, for example, irregular food intake or exercise. In addition, doctors treating certain individuals with diabetes may need detailed information about an individual's lifestyle to provide effective treatments or alterations in treatment for managing diabetes. Currently, one of the ways to monitor the lifestyle of an individual with diabetes has been for the individual to maintain a paper logbook of his lifestyle. The other way is to rely on the individual to just remember the facts about his lifestyle, and then communicate these details to his doctor at each visit.

The method of recording lifestyle information is inherently difficult, time consuming, and possibly inaccurate. Paper logbooks are not always carried by an individual and may not be accurately written when needed. Such paper logbooks are small and therefore difficult to enter detailed information requiring detailed descriptors of lifestyle events. In addition, when asked by a physician who must manually review and interpret information from a written notebook, an individual may often forget key facts about his lifestyle. There is no analysis provided by the paper logbook to refine or separate component information. In addition, there is no graphical arrangement or summary of information. Entering data into an auxiliary data storage system, such as a database or other electronic system, requires the hard marking of information, including lifestyle data, on such an auxiliary data storage device. Difficulties in recording data encourage retroactive input of relevant information, which leads to inaccurate and incomplete records.

Currently, there are a number of portable electronic devices that can measure an individual's glucose level and store that level for uploading or returning to another computer for analysis. One such device is an Accu-Check ™ Complete ™ system from Roche Diagnostics that provides limited functionality for storing lifestyle data. However, the Accu-Shock ™ Complete ™ system allows only a limited selection of lifestyle variables to be stored in the instrument. The instrument lacks intelligent feedback from previously entered values, and the user interface is not intuitive for users who do not use the instrument often. Another device is Agamatrix WaveSense. However, Wavesense does not provide for detection of high or low trends.

In a first embodiment, a mobile computing device is provided that includes a touch sensitive screen display, a memory, one or more microprocessors, and program instructions. The touch sensitive display responds to a command by finger touch, wherein at least one microprocessor is coupled to the display and the memory and is provided with program instructions stored in the memory. The program command generates at least one information screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in memory, and selects a segmented select button on the at least one information screen upon finger touch longer than a preset time. Display, overlaying a help screen on the at least one information screen upon instantaneous finger contact on one segmented select button, causing the help information to be displayed on the at least one information screen, the at least one information screen By the at least one microprocessor to overlay the shared screen on the at least one information screen upon momentary finger contact on another segmented select button that causes information related to the to be sent to different devices, including other mobile computing devices. It is executable.

In this first embodiment, the following features may be used alone or in any combination with this embodiment: The information screen has a logbook screen for the touch-sensitive display, with a high / low trend indicia. A screen selected from one of a logbook screen, a graphic screen, or a summary screen; The different device can be at least one of a desktop computer, server, printer, and combinations thereof. In this first embodiment, the at least one microprocessor stores a plurality of analyte measurements, determines whether the most recent analyte measurement is below a first threshold at a given time of day, and is best over a period of N days. Evaluate whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around a given time of recent analyte measurement is below a first threshold, and best over a period of N days. Verify that at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around a given time of recent analyte measurement are above a second threshold and upon completion of the evaluation and validation In the same time frame for at least two days over N days, the multiple analyte measurements tend to be lower than the lower threshold or higher than the second threshold. It is further programmed to notify. The notification displays at least one trend and multiple analyte measurements on the touch screen display of the mobile communication device in a table having a plurality of rows and a plurality of columns with respective row headers and column headers. Wherein the column headers represent different periods of the day, the details of each column header represent pre- or post-meal analyte measurements within each period of the day, and the row headers of each analyte measurement Numerical values representing dates and representing analyte values identified as part of one analyte trend are represented by the first label and numerical values representing analyte values identified as part of another analyte trend. Note that is represented by a different second label.

In a second embodiment, a mobile computing device is provided that includes a touch sensitive screen display, a memory, one or more microprocessors, and program instructions. The touch sensitive display responds to a command by finger touch, wherein at least one microprocessor is coupled to the display and the memory and is provided with program instructions stored in the memory. The program instruction stores a plurality of analyte measurements, determines whether the most recent analyte measurement is below the first threshold at a given time of day, and centers a given time of the most recent analyte measurement over a period of N days. Evaluating whether at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time is below a first threshold and centering on a given time of the most recent analyte measurement over a period of N days To ascertain whether at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time are above a second threshold, and upon completion of the evaluation and validation, at least two days of equality over N days A plurality of analyte measurements in the time frame indicating that they tend to be lower than the lower threshold or higher than the second threshold, Generate at least one information screen on the touch-sensitive display indicative of analyte measurements, display a segmented select button on the at least one information screen upon finger touch longer than a preset time, and display one segmented On a momentary finger contact on the select button, a mobile screen device overlaid on the at least one information screen a help screen that causes the help information to be displayed on the at least one information screen, and the information related to the at least one information screen is different. And is executable by at least one microprocessor to overlay the shared screen on the at least one information screen upon momentary finger contact on another segmented selection button that causes the device to be transmitted to a different device.

In this second embodiment, the following features may be used alone or in any combination with this embodiment: The information screen is a logbook screen for a touch sensitive display, a logbook screen with a high / low trend indication A screen selected from one of a graphic screen and a summary screen; The different device can be at least one of a desktop computer, server, printer, and combinations thereof. The microprocessor is programmed to display a plurality of analyte measurements on the display of the mobile communication device in a table having a plurality of rows and a plurality of columns with respective row headers and column headers, the column headers representing different periods of the day. An analyte in which the details of each column header represent pre- or post-meal analyte measurements within each period of the day, and the row headers represent the date of each analyte measurement and are identified as part of one analyte trend. Note that numerical values indicative of values are represented by a first label and numerical values indicative of analyte values identified as part of another analyte trend are represented by a second label different from the first label. In the alternative, the microprocessor is further configured to verify that the most recent analyte measurement has been flagged as one of certain conditions, including (a) measurements made before meals or (b) measurements taken during the fasting period. Is programmed. The microprocessor is further programmed to verify that the most recent analyte measurement is below a first threshold as a predetermined condition, N days may comprise any of about 2 days to about 14 days, and X time is about May comprise any number of hours from 0 hours to about 7 hours; X time may comprise any number of hours from about 0 hours to about 3 hours; The first threshold may comprise about 70 mg of glucose per 1 deciliter of blood and the second threshold may include about 150 mg of glucose per 1 deciliter of blood.

In a third embodiment, a method is provided for notifying a user of a trend of high or low blood sugar values. The tendency or tendencies are acquired by the analyte measurement unit and can be used in connection with a mobile communication device each having a microprocessor coupled to its respective display and memory storage device. The method comprises the steps of converting an analyte in physiological fluid into an enzymatic by-product by the analyte measuring unit, and in this process providing a measurement of the analyte in physiological fluid; Storing one or more of the analyte measurements in a memory of the analyte measurement unit; Determining, by the mobile communication device, whether the most recent analyte measurement at a given time of day is below a first threshold; By the mobile communication device, at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around a given time of the most recent analyte measurement over a period of N days results in a first threshold value. Evaluating whether it is lower; In the same time frame over N days, the plurality of analyte measurements, including at least one analyte measurement, may be achieved by notifying that the analyte trend is lower than the lower threshold, wherein the notifying is performed. Displaying an information screen indicating a water trend on a touch-sensitive display, displaying a segmented select button on at least one information screen upon finger touch longer than a preset time, one segmented select button The method may further include overlaying a help screen on the at least one information screen to cause the help information to be displayed on the at least one information screen upon a momentary finger contact on the screen.

In a third embodiment, the following features may be used alone or in any combination with this embodiment: another segment that allows information related to at least one information screen to be sent to different devices, including other mobile computing devices. Overlaying a shared screen on at least one information screen upon a momentary finger contact on a normalized selection button.

In a fourth embodiment, a method is provided for notifying a user of a trend of high or low blood sugar values. The tendency or tendencies are acquired by the analyte measurement unit and can be used in connection with a mobile communication device each having a microprocessor coupled to its respective display and memory storage device. The method comprises the steps of initiating a physical conversion of an analyte in an physiological fluid into an enzymatic by-product by the analyte measurement unit, and in this process providing a measurement of the analyte in the physiological fluid; Storing one or more of the analyte measurements in a memory of the analyte measurement unit; Determining whether the most recent analyte measurement is above a second threshold at a given time of day; Confirming that the most recent analyte measurement was flagged as (a) a measurement made before a meal or (b) a measurement made during the fasting period; By the mobile communication device, each of the at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around a given time of the most recent analyte measurement over a period of N days is generated. Evaluating whether it is higher than two thresholds; In the same time frame over N days, the plurality of analyte measurements may be accomplished by notifying that the analyte trend is higher than the second threshold, wherein the notifying step touches an information screen indicating the analyte trend. Displaying on a sensitive display, displaying a segmented select button on at least one information screen upon finger touch longer than a preset time, upon instant finger touch on one segmented select button The method may further include overlaying a help screen on the at least one information screen to display the help information on the at least one information screen.

In this fourth embodiment, the following features may be used alone or in any combination with this embodiment: another to cause information related to at least one information screen to be sent to different devices, including other mobile computing devices. Overlay a shared screen on at least one information screen upon instant finger touch on a segmented select button. The notifying may include displaying the plurality of analyte measurements on the display of the mobile communication device in a table having a plurality of rows and a plurality of columns having respective row headers and column headers, wherein the column headers of the day Represent different time periods, details of each column header represent pre- or post-meal analyte measurements within each period of the day, row headers represent the date of each analyte measurement, as part of one analyte trend Numerical values indicative of the analyte values to be identified are represented by the first label and numerical values indicative of the analyte values to be identified as part of another analyte trend can be represented by a second label different from the first label. In such embodiments, the analyte may comprise glucose, and the displaying step is analysis below the first threshold within a time frame of X time around a given time of the most recent analyte measurement over a period of N days. And showing the distribution of the first label of the stored analyte for the trend of water measurements as interconnected. Alternatively, the displaying may include a second stored analyte for the trend of analyte measurements above a second threshold within a time frame of X time around a given time of the most recent analyte measurement over a period of N days. Displaying the distribution of labels as linked to each other; The first marker may comprise at least two circles with connectors in between, the two circles comprising a first color; The second mark may comprise at least two circles, with a connector between each circle, the circle comprising a second color; The latest N days may comprise any of about 2 days to about 14 days; X time may comprise any number of hours from about 0 hours to about 7 hours; X time may comprise any number of hours from about 0 hours to about 3 hours; The first threshold may comprise about 70 mg of glucose per 1 deciliter of blood; The second threshold may comprise about 150 mg of glucose per 1 deciliter of blood.

In a fifth embodiment, a diabetes management system is provided that includes at least one glucose test strip, a measurement unit for the strip, and a mobile communication unit. The measuring unit may comprise a housing including a test strip port configured to receive a glucose test strip. The measurement microprocessor is coupled to the test strip port to provide data regarding the amount of glucose measured in the physiological fluid of the user deposited on the test strip, and the microprocessor is further coupled to the memory. The mobile communication unit includes a mobile processor coupled to the display. Either the measuring microprocessor or the mobile microprocessor measures the analyte in the physiological fluid to provide an analyte measurement, stores one or more of the analyte measurements, and at a given time of day the first analyte measurement is the first. Determining if less than the threshold, wherein at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around a given time of the most recent analyte measurement over a period of N days is the first Assess whether it is below a threshold, and wherein at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around a given time of the most recent analyte measurement over a period of N days are second; Determine if a threshold is exceeded and measure multiple analytes in the same time frame of at least two days over N days upon completion of one of the evaluation and validation Notify the user of a trend below this lower threshold or above a second threshold, and generate at least one information screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in memory and longer than a preset time Help to display a segmented selection button on at least one information screen upon finger touch, and to cause help information to be displayed on at least one information screen upon instant finger touch on one segmented selection button. Overlay the screen on at least one information screen, and at least one upon momentary finger contact on another segmented select button that causes information related to the at least one information screen to be sent to different devices, including other mobile computing devices. Overlay shared screen on info screen Lock are programmed.

In this fifth embodiment, the following features may be used alone or in any combination with this embodiment: The microprocessor is a table with multiple rows and multiple columns, each with its own row header and column header. Configured to display a plurality of analyte measurements on the display of the mobile communication device, the column headers representing different periods of the day, and details of each column header indicating pre or post-meal analyte measurements within each period of the day. Wherein the row header indicates the date of each analyte measurement, and the numerical values representing the analyte values identified as part of one analyte trend are indicated by the first label and identified as part of another analyte trend. Numerical values representing water values are represented by a second label different from the first label. In the alternative, the microprocessor may be further programmed to verify that the most recent analyte measurement has been flagged as one of certain conditions, including (a) a measurement made before a meal or (b) a measurement made during a fasting period, or The microprocessor is programmed to verify that the most recent analyte measurement is below a first threshold as a predetermined condition. The latest N days can include any number of days from about 2 days to about 14 days and the X time can include any number of hours from about 0 hours to about 7 hours; X time may comprise any number of hours from about 0 hours to about 3 hours; Note that the first threshold may comprise about 70 mg of glucose per 1 deciliter of blood and the second threshold may include about 150 mg of glucose per 1 deciliter of blood.

In a sixth embodiment, a method is provided for informing a user of a high tendency or a low tendency of blood glucose values obtained by an analyte measuring unit and used in connection with a mobile communication device. Each unit and device has a microprocessor coupled to a memory storage device. The mobile communication device includes a touch screen or a touch sensitive display. The method comprises the steps of initiating a physical conversion of an analyte in an physiological fluid into an enzymatic by-product by the analyte measurement unit, and in this process providing a measurement of the analyte in the physiological fluid; Storing one or more of the analyte measurements in a memory of the analyte measurement unit; Evaluating one or more of the analyte measurements to determine one or more of a high tendency for the blood sugar values to increase over a set time frame or a low tendency for the blood sugar values to decrease over a set time frame; Displaying an information screen on the touch screen indicative of one or more analyte measurements comprising a high trend or a low trend; Displaying a segmented button that provides at least two finger selectable options upon contact of a finger on an information screen for a duration longer than a timed threshold; Upon finger tapping on an information screen of one of the at least two finger selectable options, notifying information related to the information screen indicating one or more analyte measurements including a high or low trend; Or upon finger tapping on an information screen of another of the at least two finger selectable options, by causing the data representing the information screen to be sent to different devices, including other mobile communication devices, servers, or printers. have.

In this sixth embodiment, the following features may be used alone or in any combination with this embodiment: the at least two finger selectable options include a print option, a sharing option, or a help option; The information screen may include a screen selected from one of a logbook screen, a logbook screen having a high / low trend cover, a graphic screen, or a summary screen.

These and other embodiments, features, and advantages will become apparent to those skilled in the art upon reading with reference to the following more detailed description of various exemplary embodiments of the present invention with reference to the accompanying drawings, which are briefly described below.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate the presently preferred embodiments of the invention and, together with the general description provided above and the detailed description provided below, serve to explain the features of the invention (where Like reference numerals denote like elements).
≪ RTI ID =
1A illustrates a diabetes management system including an analyte measurement unit and a mobile communication device.
≪ RTI ID = 0.0 &
1B is a simplified schematic diagram illustrating an exemplary circuit board for each of the analyte measurement unit and the mobile communication device.
1 (c)
FIG. 1C shows an alternative to FIG. 1A as a preferred screen for a summary of a 14 day glucose report. FIG.
Fig.
FIG. 1D shows the same screen as in FIG. 1C, with the ability to share this screen with other users or healthcare providers and a mode to help explain the data on this screen. FIG.
Figure 1e
1E shows another screen in which data collected for that day can be accessed by scrolling up screen 42.
Figure 1f
1F illustrates an alternative screen with less graphics used.
Figure 1g
FIG. 1G shows a screenshot of a text-based summary screen for mean blood glucose values over a 14-day period divided by time of day.
2A and 2B.
2A and 2B illustrate two variations on the logic for determining a low tendency.
3A and 3B,
3A and 3B show two variations on the logic for determining high trends.
4A,
4A shows a pop-up message indicating a tendency to be low while the touch screen or touch sensitive display is on the summary screen.
4 (b)
FIG. 4B illustrates a detailed text screen that a user can select in response to the selection provided in the popup of FIG. 4A.
4C,
4C shows a screenshot of a pattern screen divided into two sub-screens to inform the user when the number of patterns, the type of pattern and the data for the pattern is shown.
5A)
FIG. 5A illustrates a distinctive output for a logbook display of a mobile communication device. FIG.
5B,
FIG. 5B shows the generated screen providing additional details on the low trend identified from July 25 to July 26 for the “morning” time interval.
5C)
5C shows an alternative screen of a logbook display providing a logbook of blood sugar values sorted by four different time periods.
Figure 5d
FIG. 5D illustrates another alternative screen of a logbook dividing blood sugar values by different periods of the day and patterns of low and high. FIG.
Figure 5e
FIG. 5E illustrates another function of the logbook for patterns of high and low glucose values by not considering blood glucose values that are not above or below a predefined range.
6A,
FIG. 6A illustrates a screen that allows a user to choose between obtaining help for interpretation of a trend pattern and sharing a logbook with others.
6B,
6B illustrates a subsequent screen that allows a user to share the logbook of FIG. 6A via email or text message.
6C)
FIG. 6C illustrates a screen that allows a user to choose between obtaining help for interpretation of a trend pattern, sharing a logbook with others, or printing logbook results. FIG.
7A and 7B
7A and 7B illustrate an alternative mode of notifying users of measurements over time using a graphical approach.
Figure 7c
FIG. 7C shows a graphical screenshot in which data points within a predefined normal range are unimportant so that low trend and high trend patterns are recognizable. FIG.
Figure 7d
FIG. 7D illustrates a message that may be provided once a user touches at a particular data point for one of a high trend or a low trend.
8,
8 illustrates another mode of notifying measurements over several days during the same time window using a graphical approach.

The following detailed description should be understood with reference to the drawings, wherein like elements are denoted by like reference numerals in different drawings. The drawings (which are not necessarily to scale) illustrate selected embodiments and are not intended to limit the scope of the invention. The detailed description describes by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, modifications, variations, alternatives, and uses of the invention, including what is presently considered the best embodiment for carrying out the invention.

As used herein, the term “about” or “approximately” for any numerical value or range is a suitable dimensional tolerance that allows some or a collection of components to function for their intended purpose described herein. Indicates. The term “analyte” may be read to include one or more substances in the fluid that are the subjects for determining their quantity or quality. In addition, as used herein, “patient”, “host”, “user” and “subject” refer to any human or animal subject and limit the system or method to use for humans. Although not intended, the use of the present invention in human patients represents a preferred embodiment.

1A illustrates a diabetes management system 100 that includes an analyte measurement unit 10 (“AMU”) in the form of a glucose sensor for use in a biosensor and mobile communication device 40. The biosensor is in the form of a glucose test strip 20. As shown in FIG. 1A, the glucose meter or AMU 10 may include a housing 12, a display 14, a strip port connector 16, and a data port 18. Although the buttons are not shown, a touch screen or touch sensitive display with at least one mechanical switch or virtual button can be used with the meter 10. The communication device 40 comprises a display 42, preferably a touch screen type display with a mechanical home switch 44.

FIG. 1B shows electronic components (in simplified schematic form) of the AMU 10 disposed on the top surface of the circuit board 22. Electronic components on the circuit board 22 include a strip port connector 16, a microcontroller 24, and a first wireless module 26. Electronic components also include display connectors (not shown for simplicity), nonvolatile memory (not shown for simplicity), clocks (not shown for simplicity), battery connectors (not shown) and data Port 18 may be included. Microcontroller 24 includes strip port connector 16, op amp circuit (not shown for simplicity), wireless module 26, display 14, nonvolatile memory (not shown for simplicity), It may be electrically connected to a clock (not shown for brevity), a battery (not shown for brevity), and a data port 18.

The op amp circuit (not shown for simplicity) may include two or more op amps configured to provide a portion of a potentiostat function and a current measurement function. The constant potentiometer function may refer to the application of a test voltage between at least two electrodes of a test strip. The current function may refer to the measurement of a test current due to an applied test voltage. Current measurement can be performed with a current-voltage converter. The microcontroller 24 may be in the form of a mixed signal microprocessor (MSP), such as, for example, Texas Instruments MSP 430. The MSP 430 may also be configured to perform some of the constant potentiometer function and current measurement function. In addition, the MSP 430 may also include volatile and nonvolatile memory. In other embodiments, most of the electronic components may be integrated with a microcontroller in the form of an application specific integrated circuit (ASIC).

The strip port connector 16 can be configured to form an electrical connection to the test strip. The display 14 may be in the form of a liquid crystal display that reports the measured glucose levels and facilitates entry of lifestyle related information. Display 14 may optionally include a backlight. Alternatively, display 14 may include a touch screen display that allows input of data and responses without requiring buttons and switches. The data port 18 may accept a suitable connector attached to a connecting lead, allowing the AMU 10 to be connected to an external device such as a personal computer or to recharging the rechargeable battery of the meter 10. Data port 18 may be any port that allows for the transfer of data, such as, for example, a serial, USB or parallel port. Preferably, data port 18 is in the form of a USB 2.0 port. The clock (not shown for simplicity) can be configured to maintain the current time relative to the geographic area in which the user is located and also to measure time. The AMU 10 may be configured to be electrically connected to a power source such as, for example, a battery.

The AMU 10 is designed to work well with a suitable analyte test strip (eg, electrochemical or photochemical) that provides one or more measurements of an analyte in physiological fluids such as, for example, glucose, ketones, cholesterol, and the like. In one exemplary embodiment, test strip 20 may be in the form of an electrochemical glucose test strip. Test strip 20 may include one or more working and counter electrodes. Test strip 20 may also include a plurality of electrical contact pads, where each electrode may be in electrical communication with at least one electrical contact pad. The strip port connector 16 may be configured to electrically interface with the electrical contact pads and form electrical communication with the electrodes. Test strip 20 may include a reactant layer disposed on at least one electrode. The reactant layer may comprise an enzyme and a mediator. Exemplary enzymes suitable for use in the reactant layer include glucose oxidase, glucose dehydrogenase (with pyrroloquinoline quinone cofactor "PQQ"), and glucose dehydrogenase (with flavin adenine dinucleotide cofactor "FAD") It includes. Exemplary mediators suitable for use in the reagent layer include ferricyanide in this case in oxidized form. The reagent layer may be configured to physically convert glucose into enzyme byproducts and in the process produce an amount of reduced mediator (eg, ferrocyanide) that is proportional to the glucose concentration. The working electrode can then measure the concentration of the reduced mediator in the form of a current. The AMU 10 may then convert the current magnitude into a glucose concentration. Details of preferred test strips are described in US Pat. No. 6,197,979, which is incorporated herein by reference in its entirety; US Pat. 7291256; No. 7498132.

Referring again to FIG. 1B, the circuit board 46 of the handheld computing unit 40 is shown in schematic form with certain components disposed thereon. A power amplifier chipset 48 is provided for the microprocessor 52 with the power management chipset 50, which may include a memory chipset 54, a wireless communication module 56 (eg, Bluetooth 2.0), GSM or GPRS. Coupled to chipset 58 and WiFi chipset 60. Examples of commercially available portable communication devices include BlackBerry torch smartphones, Android smartphones, iPhones, iPod touches, iPads, and others from Nokia, LG, Samsung, and Motorola. It should be noted that the portable communication device for use in the present invention does not have to be a smartphone but may include any handheld portable computing device having the ability to transfer data to and from the server. Preferably, the portable communication device includes an iPhone 4G and an iPod touch.

In operation, a patient may begin using the system 100 by performing a blood test. Specifically, a suitable test strip 20 is inserted into the AMU 10 to turn the device on. Blood or a suitable physiological fluid is extracted by a suitable device (eg, lancet) and deposited on the distal end of strip 20. Deposition of blood initiates the physical conversion of analyte (eg, glucose) to enzyme byproducts such as, for example, gluconic acid, such as glucose, such that the AMU 10 measures the current flow from the enzymatic reaction in the test chamber of the test strip. Let's do it. After the enzymatic reaction has occurred and the current from the reaction has been measured, the user is notified at 202 of the analyte results or blood glucose (“BG”) results in the exemplary embodiment. As used herein, the modifications to the term “notified” and root term indicate that the notification may be provided to the user through a combination of text, audio, visual or all communication modes.

The results from the electrochemical examination are also immediately communicated to the handheld computing unit 40 for further processing, if possible, to assist the user in the management of the user's health or disease. The delivery of test results may be via a suitable wireless protocol such as, for example, Wi-Fi, Zigbee, Bluetooth, CALM, preferably via Bluetooth 2.0. Of course, the user can always enter the value manually using the touch screen or touch sensitive display interface of the HCU 40 to enter the value using the fingertip and to store the data. Note that whenever the meter 10 is connected to the unit 40 for the transfer of data, a computer program comprising software code identified here as an "app" checks the date and time stored in the meter. . If the time difference is less than 15 minutes, the time of day in the meter is automatically updated to match the current time in unit 40.

Various functions are provided by an app in the system 100, the functions of which are US Provisional Patent Application No. 61 / 308,217 filed February 25, 2010, which is incorporated by reference in its entirety (representative control number DDI). -5194USPSP) and U.S. Patent Application No. 12 / 826,543 filed on June 9, 2010 (Agent Control Number DDI-5194USNP). It should be noted that the functions described by the aforementioned applications may be used, in part or in whole, in the AMU 10 or the HCU 40, in either or both of these devices.

Once blood glucose values are delivered to the device 40 (either manually or automatically), the user can immediately see the results and other relevant data, as shown in the information screen, which in this case is the summary screen of FIG. 1C. In this summary screen provided on the touch screen or touch sensitive display 42, a representation in the form of a bar graph is shown, where the percentage and normal or percentage of readings 42a within the "in-range" or within the normal range as defined herein are shown. The percentage of blood sugar readings 42b below the predefined range is shown on the bar graph along with the percentage of blood sugar levels 42c above the predefined range. The summary screen also provides a quick status regarding the mean blood glucose value 42d from both readings or results stored in the device 40. This screen also allows the user to determine via field 42e the number of stored results and the number of patterns collected from the results when the last data delivered was made. The summary screen also allows the user to scroll up the field 42f to see the results collected for the current day. Of particular interest to a health care provider or guardian, such as a user's parent, teacher or colleague, is the ability of a user to share a summary screen by invoking a "help sharing" function. This feature allows the user to obtain more information about the data presented on the summary screen or to share the related screen or even the entire screen with others. In particular, the data sharing feature allows the user to send his 14-day glucose report, pattern message, logbook and graph data to the destination via text or email.

The help sharing function can be invoked as follows. It is assumed that device 40 in FIG. 1D is currently displaying an information screen on touch screen 42 that represents one or more analyte measurements. When a finger or a suitable pointer touches an information screen for a duration longer than a time threshold (eg, 1 to 5 seconds), the device releases a segmented button 43 providing at least two finger selectable options. Display. Upon tapping with a finger or a suitable pointer on the information screen of one of the at least two finger selectable options 43, the device 40 indicates one or more analyte measurements including a high tendency or a low tendency. Notify you of helpful information related to the information screen. Upon tapping on the information screen of the other of the at least two finger selectable options, the device 40 is different from the data representing the information screen (or screen captured image) including different mobile communication devices, servers or printers. To be sent to the device.

As shown in FIG. 1E, the glucose test results for each of the last 14 days are displayed on the summary screen 42 ′, for example, with any tag 42g representing test results, carbohydrates ingested, activity, and drugs. Together, they are organized by date starting at the time of day of the current day. For example, in field 42h, the blood drop icon indicates that a blood test was performed at 4:20 pm and the result was an uneaten apple icon with 200 mg / dL before meals; Field 42i indicates that the meal via fork and knife was at 3:00 pm and 5 grams of carbohydrates were ingested; Field 42j shows physical exercise at light intensity for about 30 minutes at 2:30 pm; Field 42k indicates that the drug was taken in the form of 3.2 units of fast-acting insulin; Field 42f indicates that a blood test was performed, resulting in 68 mg / dL postprandial via a half-eaten apple icon.

Rather than review the details for each day within the 14-day reporting period, the user may choose to view the data at different levels of abstraction, shown here in FIG. 1G. In FIG. 1G, the 14-day averages are presented by compartment within a day, such as the night before, approximately breakfast, lunch, dinner and bedtime and whether the average is pre-meal or post-meal. Appropriate icons may be used to indicate whether average (or medium) blood glucose was taken before or after meals. In a preferred embodiment, the 42g1 uneaten apple icon represents a pre-meal state and the 42g2 eaten apple icon represents a post-meal state.

Another function is provided to the system 100 for the device 40 to alert the user of the high trend (or low trend) of recently taken analyte measurements. Two variants of the logic for low trend pattern detection are described herein in connection with FIGS. 2A and 2B, while two variants of the logic for high trend pattern detection are described in FIGS. 3A and 3B. .

In FIG. 2A, the current or most recent BG is compared at 402 to determine if such a BG result is below a lower threshold. Note that the lower threshold may also be referred to as the first threshold. If true at 402, the microprocessor, at 404, includes an X time (eg, from about 8 am) that includes the same period of time (9:30 AM) that the most recent BG measurement 602 was made at the most recent N days. It is determined whether at least one blood glucose measurement of the plurality of blood glucose measurements made within a window (approximately three hours until about 11 am) is below a lower threshold. In one example, the BG result is 65 mg / dL, which is below a predetermined lower threshold of about 70 mg / dL. BG was taken at about 9:30 am. Based on the logic described herein, microprocessor 52 may have been taken in a time frame of X time that includes the time at which the most recent blood measurement was made at the previous N days (ie, about 9:30 am). His stored blood glucose measurements will be examined to determine if at least one blood glucose measurement in such a separate time frame is lower than the lower threshold around a given time (ie, 9:30 am). If at least one previous measurement meets this condition, the microprocessor notifies a message 406 warning of the low trend (eg, FIG. 4A). In particular, as shown in FIG. 4A, on screen 604, the text message indicates that a low tendency was detected for the same time frame containing the given time when the most recent blood glucose measurement of 65 mg / dL was made. May pop up on any screen. If the user wants to see the last blood sugar result, screen 608 may be displayed, and a selection for low trend message 609 may be selected. The selection of the "view" button 609, as shown on screen 610 in Figure 4b, for example the date, time, the value of the BG result, and the BG result, for example exercise, food, or insulin drug. Have the user see details about the detection of low trends, such as a table listing other contextual information related to.

As an alternative to the logic of FIG. 2A, the logic of FIG. 2B may also be used. At 410, the logic flow begins with the transmission of one or more BG results from the AMU 10 to the handheld computing unit 40. Processor 52 of HCU 40 reads the BG results at 412 to begin the analysis for low-pattern trend detection. At 414, a determination is made as to whether the result is lower than a predetermined lower limit "LOW". If true, the logic reads the BG results collected from the previous 5 days that were not used as part of any detected pattern. At 418, the logic checks to see if any of the results read at 416 are below the LOW limit, and if true, the logic is the BG of the previous date at any time in the previous five days (“previous BG”). And a decision is made at 420 to determine if the result is below the LOW limit. If true, the process proceeds to step 422 where it is determined whether the previous BG result falls within a time window (eg, 3 hours) over the time at which the most recent BG result was taken. In this example, if the most recent BG result was taken at 9:00 am, the previous BG must be (a) below the LOW limit, and (b) between 6:00 am and 12:00 noon on one of the previous five days. Should be taken at any time. If true at 422, the program records these results as part of the low pattern 424. Returning to decision 418 again, if the most recent result is above the LOW limit, the process proceeds to 426 where the system checks to see if additional results have been sent while the logical process from 414 through 424 is running. If true at 426, the process proceeds back to the excluder 416, where steps 418 to 424 are used once more. If false at 426, the process proceeds to decision 428 to determine if the low pattern is identified and stored in the HCU 40. If true, HCU 40 notifies low pattern trending alert at 430.

Returning to process 414, if the process returns false at 414, the flow proceeds to 432 to determine if there is an update to the result. The logic ends at 434 assuming no new results are sent while steps 412-424 are executed.

The high trend detection logic 800 shown here by way of example in FIG. 3A is also provided in the system. To ensure proper operation of the high trend pattern detection, a message may be provided at the device 40 informing the user to tag or flag the BG measurement so that the high trend is detected by the unit. If the user continues to select the second empty threshold, a message is displayed that the tagging function must be enabled in order for the high trend to be detected. This is to help the user understand the relationship between pre-meal limits and tagging. In other words, unless tagging of premeal measurements is made, there is little value in providing a high trend message. Additionally, even though tagging is enabled, the user is reminded by the message that tagging should be used consistently in order for the pre-meal high trend to be valuable to the user.

In this logic flow of FIG. 3A, a logical query 802 is made as to whether the most recent BG result is above a high threshold. Note that the upper threshold may also be referred to as the second threshold. If true, a logical query 804 is made as to whether the most recent BG result is tagged as a pre-practice BG result or as a fasting BG result. If true, the logic proceeds to a query 806 that determines whether two or more previous BG measurements exceed the upper threshold over the previous N days (eg, 4 days). If true, the logic proceeds to a query 808 to determine whether the same two or more BG results are both flagged as pre-BG results or fasting BG results. If true, the logic proceeds to a query 810 to determine if both the most recent BG result and the same two or more previous BG results occur within a time frame of X time. If true, logic 800 notifies high trend warning at output 812. In queries 802-810, if the logic returns false, the routine ends at 814. In a preferred embodiment, the variable N can be any value from about 2 to 90 days, and X can be any value from about 1 hour to about 7 hours.

As an example of logic 800, as described in Table 1 below, it will be assumed that the user has made a series of measurements from Monday to Friday and the most recent BG result is 9:00 am Friday:

Referring to Table 1, the most recent BG has a logical true state for logical queries 802, 804 (i.e., it exceeds the upper threshold and is flagged as an empty fast). At least one BG for each of the last four days has a logical true state for logical queries 806 and 808. Logical query 810 must evaluate the most recent BG (from queries 802, 804) and at least three BGs (from queries 806, 808).

Based on the results collected during the previous four days, a warning message will be notified that the most recent BG is Friday 9:00 am. A three hour time group can include 7:50 AM (Monday), 9:00 AM (Friday), and 10:49 AM (Tuesday), in chronological order for the time of day, with the latest time And the earliest time difference is less than 3 hours (10:49 am-7:50 am = 2 hours 59 minutes). Thus, BGs on Monday, Friday and Tuesday belong to a three hour time group. In addition to Monday, Friday, and Tuesday, the three-hour time group also includes 7:40 AM (Wednesday), 7:50 AM (Monday), and 9:00 AM (Friday), in chronological order for the time of day. Where the difference between the latest time and the earliest time is less than 3 hours (9:00 AM-7:40 AM = 1 hour 20 minutes).

Referring back to Table 1, there is no high trend warning for Wednesday. For Wednesday, the two previous BGs and one most recent BG at 7:40 AM (Wednesday), 7:50 AM (Monday), and 10:49 AM (Tuesday) are evaluated in the logical query 810 Where the difference between the latest time and the earliest time is greater than 3 hours (10:49 AM-7:40 AM = 3 hours 9 minutes). Thus, BGs on Wednesday, Monday and Tuesday do not fall within a three hour time group.

Referring back to Table 1, there is no high trend warning for Thursday. For Thursday, the two previous BGs and one most recent BG are evaluated in the logical query 810. Monday Tuesday; Monday Wednesday; And there are three combinations of previous days that can be evaluated in logical query 810, which is Tuesday / Wednesday. Here, combining any one of the combinations of previous days with the most recent BG ensures that the three BGs do not fall within the three hour time group.

Note that in the examples described in Table 1, only one glucose concentration is shown per day that exceeds the upper threshold and is flagged on an empty stomach. In other situations, there may be more than one glucose concentration per day that is above the high threshold and flagged as fasting. In such a case, the number of combinations of three BGs that need to be evaluated by logic 800 will increase.

As a further explanation of the applicability of the logic routine 800, as described in Table 2 herein, it is assumed that the user has additionally performed the most recent BG measurement on Friday following Saturday (in Table 1).

In Table 2, logic 800 will detect a high trend warning on Saturday (at 11:50 am), which will be notified with the most recent BG. Monday Tuesday; Monday Wednesday; Monday / Thursday; Tuesday Wednesday; Tuesday / Thursday; And there are six combinations of previous days that can be evaluated in logical query 810, which is Wednesday / Thursday. A three-hour time group can include 10:49 AM Tuesday, 11:30 AM Thursday, and 11:50 AM Saturday, in chronological order for the time of day, with the latest time And the earliest time difference is less than 3 hours (11:50 am-10:49 am = 1 hour 1 minute). Thus, BG on Tuesday, Thursday and Saturday belong to a three hour time group. In the summary based on Table 2, the user will be provided with two messages, one for Friday and the other for Saturday. Alternatively, however, only one message may be generated on Saturday reporting two high trends by prioritizing the trend data. Prioritization of high or low trend reporting may be based on the following: Once glucose values are used for (high or low) trends, glucose values are no longer included in other (high / low) trends. Or not; If multiple trends are detected, the most stringent clustering of the results will be reported; If there are multiple high and low BG measurements within one hour, only the first high or low BG measurement will be included in the trend analysis (ie, if there are many high values in one hour or many low values in one hour, Only the first one will be included in the trend analysis). Alternatively, prioritization may be based on chronological proximity or clustering that may be judged by the two BG results closest in time to the most recent BG result or the three BG results closest in time to the most recent BG result. Can be based on the rigor of

The alternative logic illustrated here by way of example in FIG. 3B may also be used to detect high BG trend (s). In FIG. 3B, the logic flow begins with the transmission of one or more BG results from the AMU 10 to the handheld computing unit 40 at 500. Processor 52 of HCU 40 reads the BG results at 502 to begin the analysis for high-pattern trend detection. At 504, a determination is made as to whether the result is above a preset upper limit "HIGH". If true, the logic reads the collected BG results from the previous 5 days that were not used as part of any detected pattern at 506. At 508, the logic checks to see if the previous BG result or the most recent result at step 506 is greater than the HIGH limit, and if true, a time window (e.g., over the time at which the most recent BG result was obtained at 512). , At 510, and tagged or flagged as a “pre-meal” measurement at 514, and then at least three such results at 516 in that case. Found and a high pattern is recorded for these results. In this example, if the most recent BG result was taken at 9:00 am, the previous BG must be (a) higher than the HIGH limit; (b) be taken at any time between 6:00 AM and 12:00 noon of one of the preceding five days; (c) be flagged as pre-meal; (d) At least three such measurements (preferably within a three hour time window) must meet these thresholds. Returning to decision step 508, if the most recent result is below the HIGH limit, the process proceeds to 520 where the system checks to see if additional results have been sent while the logical process from 504-518 is running. If true at 520, the process proceeds back to exclusion step 506, where steps 508 to 518 are used once more. If it is determined to be false at 520, the process proceeds to decision 428 to determine if a high pattern is identified and stored in the HCU 40. If true, HCU 40 notifies high pattern trending alert at 524.

Returning to process 500, if the process returns false at 504, the flow proceeds to 526 to determine if there is an update to the result. The logic ends at 528 assuming no new results are sent while steps 508 to 518 are executed. In a preferred embodiment, the window of X hours comprises any numerical value of about 1 hour to about 6 hours (or minutes), and N days may range from about 2 days to about 21 days. In another preferred embodiment, the window of X hours includes about 3 hours, and N days may range from about 2 days to about 30 days, most preferably from about 2 days to about 5 days. In a further preferred embodiment, N days may range from about 2 days to about 90 days. Note that the word "day" refers to any 24-hour period that may have its start time consistent with the user's commonly understood starting point (eg, 4 am to 8 am).

The high or low pattern is stored in the HCU 40 and notified to the user in a unique manner. Specifically, as shown in FIG. 5A, the display of the HCU 40 may be controlled by its processor to evaluate whether the measurement stored in the HCU is part of one or more patterns. If the result is not part of any high or low pattern, the result (herein, result 700 indicates, for example, the value "120" in the "am" column of "July 26" as a "postprandial" measurement). Are shown such that their brightness is substantially dark relative to other indicia on the screen. If the result is part of a low trend (e.g., 702 represents a low trend in the "morning" period for both July 25 and 26), the result is, for example, between each solid member. It is indicated as a first mark, such as a circle or polygon of a first color, such as a solid circle with a connector 703. The numerical value of the measurement can also be provided as an overlay on the cover, icon or polygon. If the result is part of a high trend (eg, 704 represents a high trend in the “evening” period for July 20, 21 and 22), the result may be different from, for example, the first color. It is displayed as a second marker, such as a circle or polygon of a second color. Graphical icons, symbols, or connectors 705 may be used to indicate that these values are part of a high trend, in accordance with the logic described herein. Other labels (eg, symbols, colors, markings) can also be used to provide other contextual data related to analyte measurements. In this example, the display of HCU 40 may be configured to display an uppercase letter “I” to indicate that insulin was taken by the time 64 measurements were obtained.

Referring to FIG. 5C, an alternative display for the high or low pattern of FIG. 5A may be provided. For example, the result (here, the result 700a is shown to represent the value "120" in the "am" column for example "July 26" as a "postprandial" measurement, for example, its brightness is different on the screen. It is indicated to be substantially dark with respect to the mark. If the result is part of a low tendency (eg, reference 702a indicates a low tendency in the “morning” period for July 24, 25 and 26), the result is for example July 24, 25 And a first marker, such as, for example, a polygon of a first color, such as a series of concatenated merged squares 703a that concatenate the values of 26 days. The numerical value of the measurement can also be provided inside the polygon. If the result is part of a high trend (e.g., 704a indicates a high trend in the "night" period for July 24, 25, and 27), the result may be, for example, different from the first color. It is displayed as a second marker such as a polygon of two colors. A series of squares merged with each other forming polygon 705a may be used to indicate that these values are part of a high trend, in accordance with the logic described herein.

If the user wants more details about the trend, the user can touch the relevant marker in FIG. 5A or 5C, for example, the low trend pattern of July 25 and 26. This means that the HCU 40 has taken a measurement of 61 mg / dL, for example, on July 26, 2010, at 7:00 am before meals (represented by an icon like an uneaten apple), and for example 7: Data such as carbohydrate "C" in the amount of 5 grams to 30 and other exercise data such as injection of light exercise "E" for 30 minutes at 6:40 and about 3.2 units of fast-acting insulin "I" at 6:30 am Will be shown in more detail in FIG. 5B.

As an alternative to displaying the high trend apart from the low trend (eg, FIG. 5B), the app of the device may be configured to display a message regarding both patterns on one screen 612 of FIG. 5D. Can be. In screen 612, message field 614 indicates the number of patterns and types of patterns that can be used for review. The message field 616 shows the trend (in this case high) and when the trend occurred, along with details of the blood glucose results and dates for that trend. The message field 618 indicates the low trend and when the trend occurred, along with details of blood glucose results and dates for that trend.

The obtained blood glucose value can be indexed into various indices, for example, time, date, flag, trend, meal, and any other index suitable for the user to help manage and track diabetes. As shown in FIG. 5E, a logbook screen 620 is provided that displays more than seven days per screen, with blood glucose results, pre- or post-prandial flags and drugs for each day indexed according to the time of day. For example, in FIG. 5E, on February 10, the user's test results showed that the user's blood sugar value was 190 mg / dL before breakfast, the blood sugar value was 130 mg / dL after lunch, and the blood sugar value was 129 before dinner. Mg / dL. The icon labeled 622 indicates that there is additional information provided here, such as, for example, ingested carbohydrates, exercise or drugs. Note that the results displayed in cursive font indicate that they were entered manually, not from the meter 10 to the device 40. For example, result 624 may be configured to show a cursive like font to indicate a manually entered value. As an aid to the user in visualizing a high or low trend pattern, the results within the predefined range (in the information screen 620 of FIG. 5E) are nearly opaque but their intensity has been reduced so that they are still visible. The logbook screen 626 of FIG. 5F may be provided, and the result 628 that is part of the high trend is displayed within a circle or polygon of a particular color, for example red, while the result 630 is part of the low trend. Is displayed in blue to emphasize the trend pattern on this screen.

The example system also allows the logbook to be shared with a guardian or health care provider or to help a user interpret the logbook. This feature is shown in FIGS. 6A and 6B. In FIG. 6A, when a user wishes to share the output of the logbook or seek help with the use of the logbook, the user merely taps a suitable blank area of the touch screen or touch sensitive display 40. In another embodiment, the user keeps the finger on the screen for a predetermined time. This initiates a popup selection 708 for the user to choose between "help" and "share." Pop-up selection can be referred to as a segmented button that provides two or more selectable options.

The selection of “help” may be, for example, a video (eg, YouTube or Facebook video) regarding the effect of glucose values that tend to be lower over time or an approved article from a health care provider, a popup with explanatory text, Or activate appropriate media, such as hearing instructions. Alternatively, the selection of "help" opens a call to a pre-selected phone number or website (eg, a diabetes forum or personal Facebook website for diabetes). The selection of "Share" activates the overlay 709 with the following three choices: sending an email with a copy of the screen captured image of the logbook data or information screen to another user; Sending a text message containing a text, video or audio description of the logbook or image; Or canceling this feature. Note that the Help / Share feature is not only applicable to the logbook but can also be clearly applied to all screens of the communication device. For example, the help / share feature can be applied to the summary screen (see FIG. 1D) and the graph (see FIG. 6A). In particular, upon momentary finger contact on a segmented select button, the device overlays (eg, pops up) a help screen on the information screen, where the help screen displays the help information on at least one information screen. The device then pops up the shared screen (pop-up) on the information screen upon instantaneous finger contact on another segmented select button that causes information related to the information screen to be transferred to the other device, including other mobile computing devices. Overlay). In the embodiment of FIG. 6C, an overlay or popup with three selectable options may be provided. The three selectable options may include "help", "share", "print", or any other suitable option such as "vote" or "evaluate", for example. The print option may cause the image or data on the screen to be sent wirelessly to the printer. Details of help-sharing and related pop-ups in mobile touch-sensitive microcomputing devices are provided in WO2009 / 110941 and US Pat. No. 7,567,849 and incorporated herein by reference. Although a touch screen interface is one of the preferred embodiments, it is noted that other embodiments may use a digital assistant instead of the touch screen interface. The digital assistant can be voice-activated control and voice recognition embedded in a smartphone, such as, for example, the Siri interface built into the iPhone. In such use of the Siri interface, the user will use voice commands to allow Siri to transmit on-screen information, screen captures or basic glucose and insulin data for transmission to other devices. In particular, program instructions are provided to the memory and configured to be executed by the at least one microprocessor to generate on the touch-sensitive display at least one information screen indicative of the plurality of analyte measurements stored in the memory. The program command will display a segmented select button on at least one information screen upon voice command to the digital voice assistant to highlight a predetermined field or area of the display. Thereafter, the digital voice-activated assistant will overlay the work screen on the at least one information screen. Thereafter, the digital voice-activated assistant may be instructed to display or notify the helpful information or to send the information screen (or relevant portion of the screen) to another device.

Another feature the system also provides is the ability to display analyte measurements in graphical form. In this example, on screen 900 of FIG. 7A, the measurements are high trend, low over a numerical value referenced to 902 and a date range referenced to 906 for analyte values of 50 to 400 (units of mg / dL). Different markers representing trend, carbohydrate, exercise, or insulin are plotted on a Cartesian coordinate graph. In screen 800, the graph is overlaid with a translucent rectangle 904 representing an acceptable range for analyte measurement, for example, from 60 to 170 (suitable units such as mg / dL). Solid circles, polygons or any suitable icons or signs of the first color may indicate that the measurement belongs to a low trend pattern, solid circles, polygons or any suitable icons or signs of a second color may indicate a high trend pattern To indicate that it belongs to. In FIG. 7B, three measurements, indicated as 908a, 908b, and 908c, are shown as part of a high trend that is determined using one or more of the high trend pattern determination logic of FIGS. 3A and 3B.

). 식전 또는 식후로 태깅되어 있지 않은 결과(918)들에 대해, 아이콘은 식전 및 식후 아이콘과는 상이하다(예컨대, "▲"). 아이콘(918)에 대한 색상은 또한 높음 및 낮음 결과들의 관례와 상이할 수 있지만, 바람직하게는 혼동을 줄이기 위해 동일하다. 사용자는 또한 화면(900) 상의 "패턴 보기" 버튼을 손가락 태핑함으로써 높음 및 낮음 경향을 볼 수 있다. 여기에서 도 7d에서 일단 패턴 화면(920)이 표시되면, 사용자는 손가락을 사용하여, 추가 정보를 얻기 위해 경향을 나타내는 선 상의 아이콘(922a, 922b, 924a, 924b)들을 터치할 수 있다. 예를 들어, 도 7d에서, 높음 경향 그래프 선(924)의 아이콘(922a)의 터치는, 예를 들어 "높음 패턴 - 오전 5:00와 오전 8:00 사이에서 포도당이 높았음"과 같은 경향 선에 관한 부가 정보를 갖는 메시지를 불러온다. 유사하게, 낮음 경향 선(926)을 손가락으로 터치하하는 것은 낮음 경향에 관한 부가 정보를 불러올 것이다. 본 명세서에 사용되는 바와 같이, 손가락에 의한 동작에 관한 문구는 손가락 대신에 스타일러스를 사용하는 터치 스크린에 동등하게 적용될 것이다.Here in the preferred embodiment shown in FIG. 7C, blood sugar values are displayed, with different meanings given to different icons. On screen 14, hypoglycemia value 910 is displayed in a first color, for example blue. If an icon such as 910 is solid, this indicates that the value was obtained after a meal, while an unfilled icon such as 912 indicates that the value was obtained before a meal. Within the overlay 904 representing the preset range, the upper threshold 914 for preprandial results is displayed. Thus, whenever blood glucose results such as 916a, 916b, and 916c exceed threshold 914 before a meal, the icon is hollow rather than a solid icon (eg, "●") (eg,

). For results 918 that are not tagged before or after meals, the icon is different from the pre-meal and post-meal icon (eg, "▲"). The color for icon 918 may also be different from the convention of high and low results, but is preferably the same to reduce confusion. The user may also see high and low trends by finger tapping the “view pattern” button on the screen 900. Here, once the pattern screen 920 is displayed in FIG. 7D, the user may touch the icons 922a, 922b, 924a, and 924b on the line indicating a trend to obtain additional information by using a finger. For example, in FIG. 7D, the touch of the icon 922a of the high trend graph line 924 tends to be, for example, "high pattern-high glucose between 5:00 AM and 8:00 AM." Calls up a message with additional information about the line. Similarly, touching the low trend line 926 with a finger will bring up additional information regarding the low trend. As used herein, the phrase regarding finger motion will equally apply to a touch screen using a stylus instead of a finger.

Instead of displaying plotted measurements for the numerical range and date as in FIGS. 7A and 7B, the HCU 40 also displays the measured analyte value in the numerical range, regardless of the number of days, on screen 930 of FIG. 8. And time of day. As shown in FIG. 8, measurements 932 that are part of the low trend of approximately 5 pm over several days are also displayed as a cluster using a second marker that may include a solid polygon and a first color. Measurements 936 that are part of a high trend measured at approximately 5 pm for several days are indicated as a cluster of measurements using a solid circle or polygon and a first marker that may include a second color different from the first color. . Measurements 934 that are taken near a certain time of day but not flagged may be represented by a third marker that may include a circle having a third color.

By the systems and processes described herein, a method is provided for notifying a user of a high or low trend in blood glucose values obtained with an analyte measurement unit. The method includes performing a plurality of blood sugar measurements by a microprocessor; Storing the plurality of blood sugar measurements in a memory; Determining whether the most recent blood glucose measurement is below a first threshold or above a second threshold; Evaluating, by the microprocessor, at least one of the plurality of blood glucose measurements taken within the time frame as the most recent blood glucose measurement over a period of N days is below the first threshold or above the second threshold; And upon completion of the evaluation step, notifying that the plurality of blood glucose measurements tend to be lower than the lower threshold or higher than the second threshold in the same time frame of at least two days over N days.

Also suitable are software-development-kits, for example from Visual Studio 6.0, C or C ++ (and variants thereof), and from Apple, Blackberry, Google and other lesser known software and hardware providers. Various methods described herein can be used to generate software code using commercially available software development tools such as "SDK". However, these methods may be translated or potted into other software languages depending on the requirements and availability of the new software language coding methods. In addition, any of the described methods, when executed by a suitable microprocessor or computer, which perform the steps described in these methods along with any other necessary steps, may be converted into suitable software code, provided that any computer -Can be implemented in a readable storage medium.

While the invention has been described in terms of specific changes and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the changes or drawings described. In addition, where the methods and steps described above represent certain events occurring in a certain order, those skilled in the art will recognize that the order of certain steps may be altered, and such changes are subject to variations of the present invention. In addition, certain steps may be performed simultaneously in a parallel process where possible, and may also be performed sequentially as described above. Thus, if there are variations of the invention that are within the spirit of the disclosure or equivalent to the inventions found in the claims, this patent is intended to cover these changes as well.

Claims (39)

As a mobile computing device,
A touch sensitive display responsive to a command by finger contact;
Memory;
At least one microprocessor coupled to the display and a memory; And
Program instructions stored in the memory and configured to be executed by the at least one microprocessor,
The program command
Generate at least one information screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory,
Displaying a segmented selection button on the at least one information screen upon finger touch longer than a preset time,
Upon momentary finger contact on one segmented select button, overlay a help screen on the at least one information screen that causes the help information to be displayed on the at least one information screen,
Overlaying a shared screen on the at least one information screen upon momentary finger contact on another segmented select button that allows information related to the at least one information screen to be transmitted to different devices, including other mobile computing devices. , Mobile computing device. The screen of claim 1, wherein the information screen includes a screen selected from one of a logbook screen for the touch-sensitive display, a logbook screen having a high / low trend indicia, a graphic screen, or a summary screen. , A mobile computing device. The mobile computing device of claim 1, wherein the different device comprises at least one of a desktop computer, a server, a printer, and a combination thereof. The method of claim 1, wherein the at least one microprocessor
(a) storing a plurality of analyte measurements,
(b) determine whether the most recent analyte measurement is below the first threshold at a given time of day;
(c) at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days is determined by the first Assess whether it is below a threshold,
(d) at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days, the second threshold value; To see if it's exceeded,
(e) upon completion of the evaluation and validation, to notify the plurality of analyte measurements showing a trend below a lower threshold or above a second threshold in the same time frame of at least two days over the N days. Further programmed, mobile computing device. 5. The method of claim 4, wherein the notifying is in a table having a plurality of rows and a plurality of columns having respective row headers and column headers and at least one trend on the touch screen display of the mobile communication device. And displaying a plurality of analyte measurements, wherein the column headers represent different periods of the day, the details of each column header representing pre- or post-meal analyte measurements within each period of the day, and The header indicates the date of each analyte measurement and the numerical values representing the analyte values identified as part of one analyte trend indicate the analyte values represented by the first label and identified as part of the other analyte trend. The numerical values represented are represented by a second marker different from the first marker. A mobile computing device,
A touch sensitive display responsive to a command by finger contact;
Memory;
At least one microprocessor coupled to the display and a memory; And
Program instructions stored in the memory and configured to be executed by the at least one microprocessor,
The program command
(a) storing a plurality of analyte measurements,
(b) determine whether the most recent analyte measurement is below the first threshold at a given time of day;
(c) at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days is determined by the first Assess whether it is below a threshold,
(d) at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days, the second threshold value; To see if it's exceeded,
(e) upon completion of the evaluation and validation, notifying that the plurality of analyte measurements show a trend below a lower threshold or above a second threshold in the same time frame for at least two days over the N days; ,
(f) generating at least one information screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory,
(g) displaying a segmented selection button on said at least one information screen upon finger touch longer than a preset time,
(h) upon momentary finger contact on one segmented select button, overlaying a help screen on the at least one information screen that causes the help information to be displayed on the at least one information screen,
(i) sharing a shared screen on the at least one information screen upon momentary finger contact on another segmented select button that causes information related to the at least one information screen to be transmitted to a different device, including another mobile computing device. A mobile computing device to overlay. The mobile computing device of claim 6, wherein the information screen comprises a screen selected from one of a logbook screen for the touch sensitive display, a logbook screen with a high / low trend indicator, a graphic screen, or a summary screen. The mobile computing device of claim 7, wherein the different device comprises at least one of a desktop computer, a server, a printer, and a combination thereof. The microprocessor of claim 1, wherein the microprocessor is programmed to display the plurality of analyte measurements on the display of the mobile communication device in a table having a plurality of rows and a plurality of columns with respective row headers and column headers. Wherein the column headers represent different periods of the day, the details of each column header represent pre- or post-meal analyte measurements within each period of the day, and the row headers represent the date of each analyte measurement, Numeric values representing analyte values identified as part of one analyte trend are indicated by the first label and numerical values representing analyte values identified as part of another analyte trend are different from the first label. A mobile computing device, represented by two marks. The method of claim 1, wherein the microprocessor determines whether the most recent analyte measurement has been flagged as one of certain conditions, including (a) a measurement made before a meal or (b) a measurement made during a fasting period. A mobile computing device, further programmed to verify. The system of claim 10, wherein the microprocessor is further programmed to verify that the most recent analyte measurement is below a first threshold as the predetermined condition. The system of claim 11, wherein the N days comprise any number of days from about 2 days to about 14 days, and wherein the X time comprises any number of hours from about 0 hours to about 7 hours. The system of claim 11, wherein the X time comprises any number of hours from about 0 hours to about 3 hours. The system of claim 16, wherein the first threshold comprises about 70 mg of glucose per 1 deciliter of blood and the second threshold comprises about 150 mg of glucose per 1 deciliter of blood. A method of notifying a user of high or low trends in blood sugar values obtained by an analyte measurement unit and used in connection with a mobile communication device, each having a microprocessor coupled to a respective display and memory storage device, the method comprising:
Physically converting the analyte in physiological fluid into an enzymatic by-product by the analyte measuring unit, and in this process providing a measurement of the analyte in the physiological fluid;
Storing one or more of the analyte measurements in the memory of the analyte measurement unit;
Determining, by the mobile communication device, whether the most recent analyte measurement at a given time of day is below a first threshold;
Measuring, by the mobile communication device, at least one of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days Evaluating whether it is lower than said first threshold;
In the same time frame over the N days, notifying that the plurality of analyte measurements, including the at least one analyte measurement, exhibits analyte trends below a lower threshold,
The notifying step
Displaying an information screen indicating said analyte trend on said touch-sensitive display,
Displaying a segmented selection button on the at least one information screen upon finger touch longer than a preset time;
Upon instantaneous finger contact on one segmented selection button, further comprising overlaying on the at least one information screen a help screen that causes the help information to be displayed on the at least one information screen; Way. 16. The system of claim 15, wherein upon instantaneous finger contact on another segmented select button to cause information related to the at least one information screen to be transmitted to a different device, including another mobile computing device. Overlaying the shared screen. A method of notifying a user of high or low trends in blood sugar values obtained by an analyte measurement unit and used in connection with a mobile communication device, each having a microprocessor coupled to a respective display and memory storage device, the method comprising:
Initiating a physical conversion of the analyte in the physiological fluid to an enzymatic byproduct by the analyte measurement unit, and in this process providing a measurement of the analyte in the physiological fluid;
Storing one or more of the analyte measurements in the memory of the analyte measurement unit;
Determining whether the most recent analyte measurement is above a second threshold at a given time of day;
Confirming that the most recent analyte measurement was flagged as (a) a measurement made before a meal or (b) a measurement made during a fasting period;
Measuring, by the mobile communication device, at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days Evaluating whether each one is above the second threshold;
In the same time frame over the N days, notifying that the plurality of analyte measurements exhibit an analyte trend higher than the second threshold,
The notifying step
Displaying an information screen indicating said analyte trend on said touch-sensitive display,
Displaying a segmented selection button on the at least one information screen upon finger touch longer than a preset time;
Upon instantaneous finger contact on one segmented selection button, further comprising overlaying on the at least one information screen a help screen that causes the help information to be displayed on the at least one information screen; Way. 18. The system of claim 17, wherein upon instantaneous finger contact on another segmented select button that causes information related to the at least one information screen to be transmitted to a different device, including another mobile computing device. Overlaying the shared screen. 18. The method of claim 15 or 17, wherein the notifying comprises:
Displaying a plurality of analyte measurements on the display of the mobile communication device in a table having a plurality of rows and a plurality of columns having respective row headers and column headers,
The column headers represent different periods of the day, the details of each column header represent pre- or post-meal analyte measurements within each period of the day, and the row headers represent the date of each analyte measurement, one Numerical values indicative of analyte values identified as part of an analyte tendency of are represented by a first label and numerical values indicative of analyte values identified as part of another analyte tendency are different from the first label. The method, represented by the label. The method of claim 19, wherein the analyte comprises glucose. 21. The method of claim 20, wherein displaying indicates a tendency of analyte measurements below the first threshold within a time frame of X time around the given time of the most recent analyte measurement over a period of N days. Showing the distribution of said first label of stored analytes for linkage with each other. 21. The method of claim 20, wherein said displaying comprises trending analyte measurements higher than said second threshold within a time frame of time X about said given time of said most recent analyte measurement over a period of N days. Showing the distribution of said second label of stored analytes as linked together. The method of claim 19, wherein the first mark includes at least two circles with connectors in between, and the two circles comprise a first color. The method of claim 19, wherein the second mark includes at least two circles, with a connector between each circle, and wherein the circle comprises a second color. The method of claim 19, wherein the most recent N days comprise any number of days from about 2 days to about 14 days. The method of claim 19, wherein the X time comprises any number of hours from about 0 hours to about 7 hours. The method of claim 19, wherein the X time comprises any number of hours from about 0 hour to about 3 hours. The method of claim 19, wherein the first threshold comprises about 70 mg of glucose per 1 deciliter of blood. The method of claim 19, wherein the second threshold comprises about 150 mg of glucose per 1 deciliter of blood. As a diabetes management system,
Glucose test strips; And
As an analyte measurement unit,
A housing including a test strip port configured to receive the glucose test strip,
The analyte measurement unit, comprising a measurement microprocessor coupled to the test strip port and further coupled to a memory to provide data regarding the amount of glucose measured in the physiological fluid of the user deposited on the test strip;
A mobile communication unit comprising a mobile processor coupled to a display,
One of the measurement microprocessor or the mobile microprocessor
(a) measuring the analyte in the physiological fluid to provide an analyte measurement,
(b) store one or more of the analyte measurements,
(c) determine whether the most recent analyte measurement is below a first threshold at a given time of day,
(d) at least one analyte measurement of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days is determined by the first Assess whether it is below the threshold,
(e) at least two analyte measurements of the plurality of analyte measurements performed within a time frame of X time around the given time of the most recent analyte measurement over a period of N days, the second threshold value; To see if it's higher,
(f) upon completion of one of the evaluations and confirmations, that the plurality of analyte measurements tend to be lower than the lower threshold or higher than the second threshold in the same time frame of at least two days over the N days. Notice,
(j) generate at least one information screen on the touch-sensitive display indicative of a plurality of analyte measurements stored in the memory,
(k) displaying a segmented selection button on the at least one information screen upon finger touch longer than a preset time,
(l) overlaying a help screen on the at least one information screen that causes, upon momentary finger contact on one segmented select button, the help information to be displayed on the at least one information screen,
(g) sharing a shared screen on the at least one information screen upon momentary finger contact on another segmented select button that causes information related to the at least one information screen to be transmitted to a different device, including another mobile computing device. Diabetes management system, programmed to overlay. The processor of claim 30, wherein the processor is configured to display the plurality of analyte measurements on the display of the mobile communication device in a table having a plurality of rows and a plurality of columns with respective row headers and column headers,
The column headers represent different periods of the day, the details of each column header represent pre- or post-meal analyte measurements within each period of the day, and the row headers represent the date of each analyte measurement, one Numerical values indicative of analyte values identified as part of an analyte tendency of are represented by a first label and numerical values indicative of analyte values identified as part of another analyte tendency are different from the first label. Diabetes management system, represented by the marker. The microprocessor of claim 30, wherein the microprocessor determines whether the most recent analyte measurement has been flagged as one of certain conditions, including (a) a measurement made before a meal or (b) a measurement made during a fasting period. Diabetes management system, further programmed to check. 31. The system of claim 30, wherein the microprocessor is further programmed to verify that the most recent analyte measurement is below a first threshold as the predetermined condition. The system of claim 30, wherein the last N days comprise any number of days from about 2 days to about 14 days, and the X time period comprises any number of hours from about 0 hours to about 7 hours. The system of claim 30, wherein the X time comprises any number of hours from about 0 hours to about 3 hours. The system of claim 30, wherein the first threshold comprises about 70 mg of glucose per 1 deciliter of blood and the second threshold comprises about 150 mg of glucose per 1 deciliter of blood. A method of notifying a user of a high or low trend in blood sugar values obtained by an analyte measurement unit and used in connection with a mobile communication device, each unit and device having a microprocessor coupled to a memory storage device, The above method, wherein the mobile communication device comprises a touch screen or a touch sensitive display.
Initiating a physical conversion of the analyte in the physiological fluid into an enzymatic by-product by the analyte measurement unit, and in this process providing a measurement of the analyte in the physiological fluid;
Storing one or more of the analyte measurements in the memory of the analyte measurement unit;
Evaluating one or more of the analyte measurements to determine one or more of a high tendency for blood glucose values to increase over a set time frame or a low tendency for blood sugar values to decrease over the set time frame;
Displaying an information screen on the touch screen indicative of the one or more analyte measurements including the high or low trend;
Displaying a segmented button that provides at least two finger selectable options upon contact of a finger on the information screen for a duration longer than a timed threshold;
Upon finger tapping on the information screen of one of the at least two finger selectable options, information related to the information screen indicating the one or more analyte measurements including the high or low trend. Notifying; or
Upon finger tapping on the information screen of another of the at least two finger selectable options, causing data representing the information screen to be sent to a different device including another mobile communication device, server or printer; , Way. The method of claim 37, wherein the at least two finger selectable options include a print option, a sharing option, or a help option. The method of claim 38, wherein the information screen comprises a screen selected from one of a logbook screen, a logbook screen with a high / low trend indicator, a graphic screen, or a summary screen.

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