JPWO2021243016A5 - - Google Patents

Description

The subject matter generally relates to systems, devices, and methods for collecting information about test substance values for a particular individual and information about medication actions taken by the user when that user was at or near a particular test substance value in the past. The subject matter also relates to processing, analyzing, and/or presenting such information to correlate past test substance and medication information, identify patterns in the past test substance and medication information, and present the patterns to an individual to assist with treatment decisions.

The rise in the prevalence of type 2 diabetes and metabolic syndrome over the past few decades is thought to be due to changes in diet and activity levels. For example, the consumption of relatively readily available foods with a high glycemic index (GI) causes a rapid rise in blood glucose and insulin levels after meals, which is positively correlated with weight gain and obesity. Furthermore, follow-up studies have shown that weight gain and obesity may increase the risk of developing the diseases mentioned above.

Detecting and/or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be critical to the health of individuals with diabetes. Patients with diabetes can suffer from complications such as loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to ensure that glucose levels are maintained within a clinically safe range, and can also use this information to determine if and/or when insulin is needed to lower glucose levels in the body, or when additional glucose is needed to raise glucose levels in the body.

And there is a growing body of clinical data showing a strong correlation between frequency of glucose monitoring and glycemic control. Despite this correlation, many people diagnosed with diabetes do not monitor their glucose levels as frequently as they should due to a combination of factors including the hassle, caution about testing, and the pain and expense associated with glucose testing.

For example, for diabetic patients who require insulin, glucose levels are typically measured using blood glucose test strips or an inserted glucose sensor. However, maintaining multiple separate devices to monitor test substance levels and administer medication can be a burden to patients. Furthermore, this can be further complicated when there is a lack of interoperability between the various devices used by diabetic patients, for example when the drug delivery device, reading device, and sensor device are made by different manufacturers. For example, if the patient had to manually enter information from one device into another device, this was cumbersome and prone to human error.

In addition, many existing medication-related programs require users to input food or carbohydrate information about the meal they are about to consume. This requirement, combined with the fact that it is often difficult for an individual to accurately determine the carbohydrate content, discourages many users from using the programs.

Therefore, there is a need for improved systems, devices, and methods to assist individuals in making treatment decisions.

Aspects and/or embodiments and/or examples disclosed in the following description that are not included within the scope of the appended claims are not considered part of the present invention and are disclosed merely as examples. Mealtime insulin dosing can be quite a challenge as it is often done by trial and error or a hazy memory of the individual. Adjusting insulin doses is often easier than estimating the amount of food or carbohydrate content. As such, many insulin users do not calculate carbohydrates. Additionally, hypoglycemia is a major concern. Thus, there is a strong need for an easy-to-use application that does not require configuration or intervention by a healthcare professional (HCP) compared to existing dosing applications.

This application is easy to use and uses simple graphics to select and present past data.

The application can help users understand their insulin dosing patterns. The application can also provide guided interpretation of insulin dosing history. The application can enable users to make more confident insulin dosing decisions. The application can also help users understand how insulin dosing affects their glucose levels. The application can also assist users with real-time decision-making and behavioral decisions, and assist with correction dosing decisions.

The medication pattern management application can have a novel function of determining whether or not to administer insulin during meals, which can be utilized through or in conjunction with diabetes-related applications such as glucose monitoring applications. The medication pattern management application uses only past glucose and insulin data to display important data to help diabetes patients (e.g., type 2 diabetes patients) on multiple daily injections (MDI) therapy make more appropriate medication decisions more easily. The purpose of the medication pattern management application is to allow diabetes patients on MDI therapy to learn from their own best past decisions and easily calculate what kind of administration will keep them in the target glucose range. When the user is struggling to make a treatment decision, the medication pattern management application can assist the user in choosing a dosage by showing which past medication actions most effectively and safely returned the patient to the postprandial target range.

Because glucose monitoring occurs as the user adjusts insulin dosage for a variety of factors not necessarily related to glucose (i.e., carbohydrate intake, sickness, etc.), it is unlikely that the exact same glucose value and dosage pair will appear twice. Therefore, in at least a preferred embodiment, the medication pattern management application solves this problem by grouping past mealtime medication actions where the user's glucose value was close to the same value. Thus, this feature allows a database of similar decisions to be built, even if there are no exact matches. Past correct medication actions that resulted in the user reaching the goal can be flagged to the user, for example, in some embodiments, by coloring them green and/or using any other indicator, mark, icon, etc. to highlight correct medication actions. Thus, if a particular dosage has been successful in reaching the goal many times in the past, this can be indicated to the user by associating many green tiles with that dosage. The medication pattern management application can also tell the user which medication actions caused the user to experience hypoglycemia (e.g., below 70 mg/dL) within four hours of administration.

Details of the subject matter described herein, both in terms of its structure and operation, will become apparent from a review of the accompanying drawings, in which like reference numbers refer to like parts throughout the drawings. In addition, the components in the drawings are not necessarily shown to scale, with emphasis instead being placed on illustrating the principles of the subject matter. Furthermore, the drawings are intended to convey concepts, and detailed attributes such as relative size and shape may be shown diagrammatically and not faithfully or accurately.

FIG. 1 is an overview of an exemplary embodiment of an analyte monitoring system that provides real-time analyte (e.g., glucose) measurement, data acquisition, and/or data processing. FIG. 1 is a block diagram illustrating an exemplary embodiment of a reading device configured as a smartphone. FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. FIG. 1 illustrates components used in one embodiment of a medication pattern management application. FIG. 1 is a flow diagram illustrating an exemplary embodiment of a method for managing medication patterns. FIG. 1 is a flow diagram illustrating an exemplary embodiment of a method for managing medication patterns. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays that an amount of medication has been administered. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that can be used by a user to edit information regarding administered medications. FIG. 1 illustrates an exemplary embodiment of a graphical user interface through which a user can make goal selections. FIG. 1 illustrates an exemplary embodiment of a graphical user interface through which a user can make goal selections. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that allows a user to access a medication pattern management application from a test substance monitoring application. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays past medication actions associated with a particular analyte value. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays past medication actions associated with a particular analyte value. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays past medication actions associated with a particular analyte value. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays additional administration information associated with a particular medication action. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays additional administration information associated with a particular medication action. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays additional administration information associated with a particular medication action. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that displays additional administration information associated with a particular medication action. FIG. 1 illustrates an example embodiment of a graphical user interface that displays a message prompting a user to review their past medication history. FIG. 1 illustrates an example embodiment of a graphical user interface that displays a message prompting a user to review their past medication history. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that allows a user to access other embodiments of a medication pattern management application from an analyte monitoring application. FIG. 1 illustrates an exemplary embodiment of a graphical user interface for displaying medication actions with star ratings. FIG. 1 illustrates an exemplary embodiment of a graphical user interface for displaying medication actions with star ratings. FIG. 13 illustrates an additional exemplary embodiment of a graphical user interface for displaying medication actions with star ratings. FIG. 13 illustrates an additional exemplary embodiment of a graphical user interface for displaying medication actions with star ratings. FIG. 13 illustrates an example embodiment of an alternative graphical user interface that allows a user to add tags to a medication action. FIG. 13 illustrates an example embodiment of an alternative graphical user interface that allows a user to add tags to a medication action. FIG. 1 illustrates an exemplary embodiment of a graphical user interface that allows a user to access other embodiments of a medication pattern management application from an analyte monitoring application. FIG. 1 illustrates an exemplary embodiment of a graphical user interface for tagging and displaying medication actions. FIG. 13 illustrates an additional exemplary embodiment of an alternative graphical user interface displaying medication actions according to associated tags. FIG. 13 illustrates an additional exemplary embodiment of an alternative graphical user interface displaying medication actions according to associated tags. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 illustrates various embodiments of the methods, systems, and interfaces described herein. FIG. 1 shows various graphical displays for evaluating the effects of medication. FIG. 1 shows various graphical displays for evaluating the effects of medication. FIG. 1 shows various graphical displays for evaluating the effects of medication. FIG. 1 illustrates an exemplary embodiment of a graphical user interface for displaying dosage recommendations. FIG. 1 illustrates an exemplary embodiment of a graphical user interface for displaying dosage ranges. FIG. 1 illustrates an exemplary embodiment of a graphical display of various past medication actions. FIG. 1 illustrates an exemplary embodiment of a graphical display of various past medication actions. FIG. 1 illustrates an exemplary embodiment of a graphical display of various past medication actions. FIG. 13 illustrates an exemplary embodiment of a graphical user interface or report showing how many injections or meals were or are near to the goal. FIG. 13 illustrates an exemplary embodiment of a graphical user interface or report showing how many injections or meals were or are near to the goal. FIG. 13 illustrates an exemplary embodiment of a graphical user interface or report showing how many injections or meals were or are near to the goal. FIG. 13 illustrates an exemplary embodiment of a graphical user interface or report showing how many injections or meals were or are near to the goal. FIG. 13 illustrates an example embodiment of a graphical user interface or report showing how many meals in a time period met the goal. FIG. 13 illustrates an example embodiment of a graphical user interface or report showing how many meals in a time period met the goal. FIG. 13 illustrates an example embodiment of a graphical user interface or report showing how many meals in a time period met the goal.

This specification provides exemplary embodiments of systems, devices, and methods for managing medication patterns. For example, when a user is trying to determine the amount of insulin to inject before consuming a meal, an application can utilize historical glucose and insulin data to assist the user in making appropriate medication decisions. From the user's current glucose value, the application can display the insulin doses the user took in the past when they had the same or similar glucose value. Additionally, the application can display whether a particular medication action kept the user in the goal/target range and whether they experienced hypoglycemia after administration.

Before describing the present subject matter in more detail, it would be helpful to describe exemplary embodiments of systems, devices, and methods in which the present subject matter may be implemented.

A number of systems have been developed to automatically monitor (one or more) analytes, such as glucose, in bodily fluids, such as blood flow, interstitial fluid ("ISF"), dermal fluid in the dermis, and other biological fluids. Some of these systems are configured to obtain information about at least one analyte in the body by placing at least a portion of a sensor below the surface of the user's skin (e.g., within the user's blood vessels or subcutaneous tissue).

Such a system may be referred to as an "in vivo" monitoring system. An in vivo analyte monitoring system may be a "Continuous Analyte Monitoring" system (or a "Continuous Glucose Monitoring (CGM)" system). A continuous analyte monitoring system is a system that can broadcast data from a sensor control device to a reading device continuously (e.g., automatically according to a broadcast schedule) rather than prompting. Another in vivo analyte monitoring system may be a "Flash Analyte Monitoring" system (or a "Flash Glucose Monitoring" system, or simply a "Flash" system). A flash analyte monitoring system is a system that can transmit data from a sensor control device in response to a data scan or data request by a reading device, for example, using a Near Field Communication (NFC) protocol or a Radio Frequency Identification (RFID) protocol. An in vivo analyte monitoring system may also operate without the need for finger-prick calibration.

In vivo analyte monitoring systems can be distinguished from "in vitro" systems that contact a biological sample outside the body (or more accurately, "ex vivo"). In vitro systems typically include a metering device with a port for receiving a analyte strip carrying a user's bodily fluid, which can be analyzed to determine the user's blood glucose level. Note that while in many of the embodiments, the monitoring is performed in vivo, the embodiments disclosed herein can also be used in in vivo analyte monitoring systems that incorporate in vitro capabilities, or in fully in vitro or ex vivo analyte monitoring systems.

The sensor may be part of a sensor control device, which is a device that is placed on the user's body and contains the electronics and power source responsible for enabling and controlling analyte sensing. Sensor control devices and variations thereof may also be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, "sensor data communication" devices or units, to name just a few examples.

The in-vivo monitoring system may also include devices that receive the analyte sensor data from the sensor control device and process and/or display the analyte sensor data to a user in any number of forms. Such devices and variations thereof may also be referred to as "reader devices" (or simply "readers"), "handheld electronics" (or handhelds), "portable data processing" devices or units, "data receivers", "receiver" devices or units (or simply receivers), or "remote" devices or units, to name just a few examples. Devices such as personal computers may also be used or incorporated into in-vivo and in-vitro monitoring systems.

By way of example and not by way of limitation to embodiments of an in-vivo monitoring system , the graphical user interface (GUI) and associated software described herein may be used in connection with an exemplary analyte monitoring system, such as that shown in FIG. 1. FIG. 1 illustrates an exemplary in-vivo analyte monitoring system 100 to which any and/or all of the embodiments described herein may be applied. System 100 may include a sensor control device 102 and a reader device 120 that communicate with each other via a local communication path (or link) 140. Local communication path 140 may be wired or wireless, and may be unidirectional or bidirectional. In embodiments in which local communication path 140 is wireless, communication protocols such as any Near Field Communication (NFC) protocol, RFID protocol, BLUETOOTH or "BLUETOOTH" Low Energy protocol, WI-FI protocol, proprietary protocols, and communication protocols in existence as of the filing date of this application or variations thereof developed thereafter may be used.

"BLUETOOTH" is a well-known short-range wireless communication protocol standard, and "BLUETOOTH" Low Energy is a version of the same standard that can operate with less power. Note that "BLUETOOTH" Low Energy ("BLUETOOTH" LE, BTLE (trademark), BLE (trademark)) is also called BLUETOOTH SMART (registered trademark) or BLUETOOTH SMART READY (registered trademark). The BTLE version is described in "BLUETOOTH (registered trademark) Specification, version 4.0" announced on June 30, 2010. The term "NFC" is a term used for a number of protocols (or standards) that define the operating parameters, modulation schemes, coding, transmission rates, frame formats, and command definitions of "NFC" devices. Examples of these protocols, which are not intended to be exhaustive, include ECMA-340, ECMA-352, ISO/IEC 14443, ISO/IEC 15693, ISO/IEC 16000-3, ISO/IEC 18092, and ISO/IEC 21481 .

The reading device 120 may also communicate bidirectionally or unidirectionally with wired, wireless, or combined communication with any or all of the following: a medication delivery device 160 (such as a connected insulin pen) via communication link 143; a local computer system 170 via communication link 141; and a network 190 via communication link 142. The same wireless protocols described for link 140 may be used for all or some of links 141, 142, and 143 as well.

The reading device 120 can communicate with any number of entities via the network 190. The network 190 can be part of an electronic communication network, such as a data network for one-way or two-way communication, such as a "WI-FI" network, a local area network (LAN), a wide area network (WAN), or the Internet. The trusted computer system 180 can then be accessed via the network 190. In an alternative embodiment, the communication paths 141 and 142 can be the same path, which can include the network 190 and/or additional networks. All communications via the communication paths 140, 141, 142, and 143 can be encrypted, and the sensor control device 102, the reading device 120, the drug delivery device 160, the remote computer system 170, and the trusted computer system 180 can each be configured to encrypt and decrypt communications sent and received.

Variations of devices 102 and 120, as well as other components of an in vivo analyte monitoring system, suitable for use in combination with embodiments of the systems, devices, and methods described herein are described in U.S. Patent Application Publication No. 2011/0213225 (hereinafter the "'225 Publication") . Variations of devices 102 and 120 suitable for use in combination with embodiments of the systems, devices, and methods described herein, including a connected drug delivery device 160, such as a connected insulin pen, are described in WO 2018/152241 .

The sensor control device 102 may include a housing 103 that houses an in-vivo analyte monitoring circuit and a power source (not shown). The in-vivo analyte monitoring circuit may be electrically connected to an analyte sensor 104 that extends through an adhesive patch 105 and protrudes outwardly of the housing 103. The adhesive patch 105 includes an adhesive layer (not shown) for attachment to a user's body skin surface. Note that other forms of attachment to the body may be used in addition to or instead of adhesion.

The sensor 104 is configured to be at least partially inserted into a user's body and in fluid contact with the user's bodily fluid (e.g., interstitial fluid (ISF), dermal fluid, or blood) at an insertion site, and thus can be used in combination with an in vivo analyte monitoring circuit to measure analyte-related data of the user. In general, the sensor control device 102 and its components can be attached to the body in one or more steps using a mechanical applicator 150 , as described in the ' 225 publication, or can be attached in any other desired manner.

Once activated, the sensor control device 102 may wirelessly communicate collected analyte data (e.g., data corresponding to the analyte value being monitored, and/or temperature data being monitored, and/or stored past analyte-related data, etc.) to the reading device 120, which may then, in certain embodiments, perform algorithmic processing on the data to convert it into data indicative of the user's analyte value, which may then be displayed to the user and/or otherwise incorporated into the diabetes monitoring regimen.

Various embodiments disclosed herein relate to a reading device 120 that may have a user interface including one or more of a display 122, a keyboard, user interface components 121 (optional), and the like, where the display 122 may output information to a user and/or accept input from a user (e.g., when the display 122 is configured as a touch panel). The reading device 120 may optionally include one or more user interface components 121, such as buttons, actuators, touch-sensitive switches, capacitive switches, pressure-sensitive switches, jog wheels, and the like. The reading device 120 may also include one or more data communication ports 123 for wired data communication with an external device, such as a local computer system 170. The reading device 120 may further include an integrated or attached in-vitro meter that may include an in-vitro test strip port (not shown) for receiving an in-vitro analyte test strip for performing in-vitro measurements of an analyte in blood.

The drug delivery device 160 can inject or infuse a drug into the body of an individual wearing the sensor control device 102. Drugs include, but are not limited to, insulin. Like the reading device 120, the drug delivery device can also include a processing circuit, a non-transitory memory that stores instructions executable by the processing circuit, a wireless or wired communication circuit, and a user interface including one or more of a display, a touch panel, a keyboard, input buttons or input devices, etc. The drug delivery device 160 can include a connected insulin pen, a drug reservoir, a pump, an infusion tube, and an infusion cannula configured to be implanted at least partially in the user's body. The pump can deliver insulin from the reservoir through the tube and the cannula in that order into the user's body. The drug delivery device 160 can include processor-executable instructions for controlling the pump and thus the amount of insulin delivered. These instructions may also cause the calculation of insulin delivery amount and insulin delivery time (e.g., bolus and/or basal infusion profiles) based on analyte value measurements obtained directly or indirectly from the sensor control device 102. Alternatively, the calculation of insulin delivery amount and insulin delivery time, as well as the control of the pump, may be performed directly by the reading device 120. The drug delivery device may be configured to communicate directly with the reading device 120 in a closed or semi-closed loop system. Alternatively, the drug delivery device may have the functionality of the reading device 120 described herein, or vice versa, to provide an integrated reading and drug delivery device.

Computer system 170 may be any suitable data processing device, such as a personal computer, laptop, or tablet. Computer 170 may be local to reading device 120 (e.g., accessible via a direct wired connection such as USB) or remote from reading device 120 and may be (or include) software for managing and analyzing data and communicating with components of analyte monitoring system 100. The operation and use of computer 170 is described in further detail in the ' 225 publication. Analyte monitoring system 100 may also be configured to operate with a data processing module (not shown), as described in the ' 225 publication.

The trusted computer system 180 may be used to authenticate the sensor control device 102 and/or the reading device 120, store sensitive data received from the devices 102 and/or 120, output sensitive data to the devices 102 and/or 120, or may be configured to do other things. The trusted computer system 180 may include one or more computers, servers, networks, databases, etc. The trusted computer system 180 may be owned by the manufacturer or distributor of the sensor control device 102, physically or virtually via a secure connection, or may be maintained and operated by a different party (e.g., a third party).

The term "trusted" for the highly trusted computer system 180 may mean that the system 100 can assume that the computer system 180 is providing authentic data or information. In other words, the "trusted" nature of the highly trusted computer system 180 is merely guaranteed by being under the ownership or control of the manufacturer, and may be as "trusted" as a normal web server. Alternatively, the highly trusted computer system 180 may be implemented in a more secure manner, for example, by strengthening the security of Internet access, such as additional password requirements, encryption, or firewalls, to provide enhanced protection against counterfeiting attacks and attacks by computer hackers.

Data processing and software execution within the system 100 may be performed by one or more processors in the reading device 120, the computer system 170, and/or the sensor control device 102. For example, raw data measured by the sensor 104 may be subjected to algorithmic processing to convert the raw data into a value representative of the analyte level and suitable for display to a user, which processing may be performed in either the sensor control device 102, the reading device 120, or the computer system 170. Information derived from the raw data, such as this information, may be displayed on any display provided in either the sensor control device 102, the reading device 120, or the computer system 170, in any of the formats described above (with respect to the display 122). This information may then be used by a user to determine corrective actions required to ensure that the analyte value remains within an acceptable and/or clinically safe range.

2A is a diagram illustrating an exemplary embodiment of the reading device 120, and FIG. 2B is a diagram illustrating an exemplary embodiment of the sensor control device 102. As described above, the reading device 120 can be a mobile communication device such as, for example, a "WI-FI" or Internet-enabled smartphone, tablet terminal, or personal digital assistant (PDA). Examples of smartphones include, but are not limited to, smartphones based on the WINDOWS (registered trademark) operating system, the ANDROID (registered trademark) operating system, the IPHONE (registered trademark) operating system, the PALM WEBOS (trademark), the BLACKBERRY (registered trademark) operating system, and the SYMBIAN (trademark) operating system, and having network connectivity for data communication over the Internet or a local area network (LAN).

The sensor control device 102 and the reading device can communicate with the integrated drug delivery device 160 over a communication path 143 using wired or wireless technology (or a combination thereof). Communication over the communication path can be direct from the sensor control device 102 to the integrated device 160 without an intermediary. Alternatively, in an alternative embodiment, the sensor control device 102 can communicate with the integrated drug delivery device 160 indirectly through an intermediary, for example by the sensor control device 102 communicating with a first device which then communicates with the integrated device 160. This first device can be, for example , a display device or a data processing module as described in U.S. Patent Application Publication No. 2011/0213225 (the "'225 Publication").

The reading device 120 can also be configured as a mobile smart wearable electronics assembly, such as an optical assembly (e.g., monocular or binocular smart glasses, such as GOOGLE GLASS™) that is worn over or adjacent to the user's eyes. Such an optical assembly can have a transparent display that allows the user to see through the display while displaying information (described herein) about the user's analyte values to the user, minimizing interference with the user's overall field of vision. The optical assembly can have wireless communication capabilities similar to a smartphone. Other examples of wearable electronics include devices worn around or near the user's wrist (e.g., watch type), neck (e.g., necklace type), head (e.g., headband type, hat type), chest, etc.

2A is a block diagram illustrating an exemplary embodiment of a reading device 120 according to various embodiments disclosed herein. In this example, the reading device 120 is in the form of a smartphone on which the various software, applications, and graphical user interfaces disclosed herein may reside. Here, the reading device 120 includes an input component 121, a display 122, and processing hardware 206. The processing hardware 206 may include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which may be separate chips or may be distributed across multiple different chips (and portions thereof). Here, the processing hardware 206 includes a communications processor 222 having an on-board non-transitory memory 223, and an application processor 224 having an on-board non-transitory memory 225. The reading device 120 further includes an RF transceiver 228 coupled to an RF antenna 229, a memory 230, a multifunction circuit 232 having one or more associated antennas 234, a power source 226, and a power management circuit 238. FIG. 2A shows a simplified view of the internal components of a smartphone, and of course it may also include other hardware and functionality (e.g., codecs, drivers, glue logic, etc.).

The communications processor 222 interfaces with the RF transceiver 228 and performs functions such as analog-to-digital conversion, coding/decoding, digital signal processing, and the like that assist in converting audio, video, and data signals into a suitable format (e.g., in-phase and quadrature) for presentation to the RF transceiver 228 so that the RF transceiver 228 can transmit these signals wirelessly. The communications processor 222 also interfaces with the RF transceiver 228 and performs the functions necessary to receive wireless transmissions from the RF transceiver 228 in the opposite direction and convert them into digital data, audio, and video.

The application processor 224 may be configured to run the operating system and any software applications (e.g., any sensor interface application or analyte monitoring application, including SLL 304) resident on the reading device 120, and perform functions unrelated to processing communications transmitted and received via the RF antenna 229, such as video and graphics processing. Any number of applications may be running simultaneously on the reading device 120 at any time. Such applications would typically include one or more applications related to a diabetes monitoring therapy, as well as general applications unrelated to such therapy, such as, for example, email, calendar, weather, etc.

The memory 230 may be shared by one or more of the various functional units present in the reading device 120, or may be distributed among two or more of them (e.g., as separate memories present in different chips). The memory 230 may also be a separate chip in its own right. The memory 230 is a non-transitory memory and may be a volatile memory (e.g., RAM, etc.) and/or a non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

The multifunction circuitry 232 may be implemented as one or more chips and/or components with communication circuitry to perform other functions, such as local wireless communication (e.g., WI-FI, BLUETOOTH, BLUETOOTH Low Energy) and determining the geographic location of the reading device 120 (e.g., global positioning system (GPS) hardware). And one or more other antennas 234 are associated with the multifunction circuitry 232 as appropriate.

The power source 226 may include one or more batteries, which may be rechargeable or disposable. The power management circuitry 238 may control battery charging and power monitoring, power boosting, DC conversion, and the like. As mentioned above, the reading device 120 may further include one or more data communication ports, such as a USB port (or connector) or an RS-232 port (or any other wired communication port) for data communication with a remote computer system 170 (see FIG. 1) or the sensor control device 102, to name a few.

FIG. 2B is a block schematic diagram illustrating an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 250 (including analyte monitoring circuitry). While any number of chips can be used, in the illustrated example, most of the sensor electronics 250 are integrated on a single semiconductor chip 251, which can be, for example, a custom application specific integrated circuit (ASIC). Inside the ASIC 251, several higher-order functional units are provided, such as an analog front end (AFE) 252, a power management circuit 254, a processor 256, and a communication circuit 258 (which can be implemented as a transmitter, receiver, transceiver, passive circuitry, etc., according to a communication protocol). In the embodiment shown in FIG. 2B, both the AFE 252 and the processor 256 are utilized as analyte monitoring circuits, but in other embodiments, either circuit can perform the analyte monitoring function. Processor 256 may include one or more processors, microprocessors, controllers, and/or microcontrollers.

Also included within the ASIC 251 is a non-transitory memory 253, which may be shared among the various functional units present within the ASIC 251 or may be distributed among two or more of them. The memory 253 may be a volatile memory and/or a non-volatile memory. In this embodiment, the ASIC 251 is coupled to a power source 260, which may be a coin cell battery or the like. The AFE 252 interfaces with the in-vivo analyte sensor 104 to receive measurement data from the sensor 104 and outputs such data in digital form to the processor 256, which then processes the data to determine final results such as discrete analyte values and trend values. The data may then be provided to a communication circuit 258 for transmission via an antenna 261 to the reading device 120 (not shown), where further processing may be performed, such as by a sensor interface application. It should be noted that the functional components of the ASIC 251 may also be distributed among two or more separate semiconductor chips.

By performing data processing functions within the electronic components of the sensor control device 102, the system 100 can flexibly schedule communications from the sensor control device 102 to the reading device 120, thereby reducing the number of unnecessary communications and achieving further power savings in the sensor control device 102.

The information transmission from the sensor control device 102 to the reading device 120 can be automatic and/or continuous when the test substance information is available, or it can be non-automatic and/or continuous and stored or archived in the memory of the sensor control device 102 (e.g., for later output).

The sensor control device 102 may transmit data to the reading device 120 at the initiative of either the sensor control device 102 or the reading device 120. For example, in many exemplary embodiments, the sensor control device 102 may transmit data periodically, either autonomously or by broadcast, so that a suitable reading device 120 may receive the transmitted data (e.g., analyte sensor data) if the reading device 120 is in range and listening. In this case, the sensor control device 102 is at the initiative of the sensor control device 102, since the reading device 120 does not need to send an initial request to the sensor control device 102 to communicate. Broadcasting may be performed, for example, using an enabled "WI-FI", "BLUETOOTH" or "BTLE" connection. Broadcasting may be performed according to a schedule (e.g., about every minute, about every five minutes, about every ten minutes, etc.) programmed within the device 102. Broadcasts can also be performed in a random or pseudo-random manner whenever the sensor control device 102 detects a change in the analyte sensor data. Additionally, broadcasts can be performed repeatedly, regardless of whether each broadcast is actually received by the reading device 120.

The system 100 can also be configured to send a prompt from the reading device 120 to the sensor control device 102 to transmit data that the sensor control device 102 has to the reading device 120. This is commonly referred to as "on-demand" data transmission. On-demand data transmission can be initiated based on a schedule stored in the memory of the reading device 120 or upon a user request via the user interface of the reading device 120. For example, if a user wants to check their analyte values, the user can scan the sensor control device 102 using an "NFC", "BLUETOOTH", "BTLE", or "WI-FI" connection. Data exchange can be by broadcast only, on-demand transmission only, or a combination of these.

Thus, when the sensor control device 102 is placed on the body, at least a portion of the sensor 104 contacts bodily fluids and electrically connects with electronics within the device 102, allowing the sensor control device 102 to transmit analyte information from the sensor to the reading device 120 on-demand or spontaneously (broadcast). On-demand transmission can be performed by first powering up the reading device 120 (or the reading device 120 may remain powered on) and executing a software algorithm stored in and accessed from the memory of the reading device 120 to generate and transmit one or more requests, commands, control signals, or data packets to the sensor control device 102. The software algorithm then (e.g., under control of the processing hardware 206 of the reading device 120) can include a routine for detecting the relative position of the sensor control device 102 with respect to the reading device 120 and initiating transmission of the generated requests, commands, control signals, and/or data packets.

Test substance value data can be transmitted from system 100 to a medication pattern management application.

The dosing pattern management application 300 can provide the user with insight into what dosing the user has done in the past when the user was at or near a particular analyte value or analyte range. The dosing pattern management application 300 can be a standalone application or can be incorporated in part or in whole into other applications or software. As shown in FIG. 3A, the system includes the dosing pattern management application 300, which is downloaded and installed on the electronic device 120 that communicates with the sensor control device 102 and the drug delivery device 160, such as a connected insulin pen. The dosing pattern management application 300 can receive the analyte values from the sensor control device 102 at a sensor user interface application, or at another network server on the cloud, and transfer the data from the cloud to the dosing pattern management application. For example, the analyte data can be uploaded to a first server or servers responsible for collecting the analyte data, and then the analyte data can be downloaded to the dosing pattern management application by a second server or servers responsible for downloading data used by the dosing pattern management application.

The medication pattern management application 300 can similarly receive data regarding medication actions taken by the individual at various times via the medication delivery device 160 (e.g., insulin pen or insulin pump). Each time a user uses a connected medication delivery device to administer insulin, the dosage can be paired with the test substance value at (or near) the time of injection. This pairing can represent medication decisions made by the user during meals. Pairing the medication action with the test substance value at the time of administration is important because users base their medication decisions on the starting value of the test substance and the food they are about to consume.

The medication pattern management application 300 can associate data regarding each past medication action with a corresponding analyte value (e.g., glucose value) measured in the individual at or near the time of administration of the medication (e.g., insulin). The measurement of the analyte value can be performed simultaneously with administration, or within about 1 minute, or within about 2 minutes, or within about 3 minutes, or within about 4 minutes, or within about 5 minutes, or within about 10 minutes, or within about 15 minutes, or within about 20 minutes of administration.

Rather than reporting only medication actions for the same analyte value, medication actions can be grouped according to what medication actions were taken for the analyte range that includes the corresponding analyte value. For example, if a glucose measurement is 220 mg/dL, the program can identify any medication actions taken when the individual had a glucose measurement between about 170 mg/dL and 270 mg/dL (±50 mg/dL), or between about 180 mg/dL and 260 mg/dL (±40 mg/dL), or between about 190 mg/dL and 250 mg/dL (±30 mg/dL), or between about 200 mg/dL and 240 mg/dL (±20 mg/dL), or between about 210 mg/dL and 230 mg/dL (±10 mg/dL), or any combination thereof. A test substance range can be defined as a test substance value of ±30% of a test substance value, or a test substance value of ±25% of a test substance value, a test substance value of ±20% of a test substance value, a test substance value of ±15% of a test substance value, or a test substance value of ±10% of a test substance value.

The test substance range may change over time. For example, during the first two weeks of use, the number of data pairs paired in the app may not be sufficient to reveal patterns, and the application may record data with very sparse user data for each test substance range. Thus, for example, during the first two to three weeks of use, the application may adopt a wider test substance range (i.e., ±50 mg/dL). As the medication pattern management application 300 continues to collect data and the data becomes more abundant, the application 300 may continue to narrow the test substance range used for this function (e.g., ±40 mg/dL, ±30 mg/dL, ±20 mg/dL, etc.). Thus, the upper and lower limits of the test substance range may be determined based on data availability, and the user may not be allowed to set them.

3B is a flow chart diagram illustrating steps of an exemplary method for managing medication patterns. In step 310, the application 300 may receive analyte values (e.g., glucose concentrations or glucose values) of the user at various times ( _T1 , _T2 , ..., _TN ). In step 312, the application 300 may receive insulin doses administered to the user at various times ( _T1 , _T2 , ..., _TN ). In step 314, the dosages may be paired with analyte values measured at the same or similar times ( _T1 , _T2 , ..., _TN ) as the dosages. In step 316, the paired dosage and analyte value pairs may be stored in a database. In step 318, the paired dosage and analyte value pairs may be grouped according to analyte range(s). In step 320, the application receives the user's current analyte value. In step 322, the analyte range within which the current analyte value falls is identified. At step 324, the application displays past medication events associated with the analyte range.

FIG. 3C is a continuation of the flow chart diagram of FIG. 3B and outlines various ways in which past medication actions may be output and displayed. At step 326, the past medication actions may be divided into multiple (e.g., three) groups and a representative dose for each group may be displayed. In other embodiments, at step 327, the past medication actions may be displayed with a rating (e.g., a star rating). In other embodiments, at step 328, the past medication actions may be tagged and displayed, either by tagging alone or in addition to the star rating.

The display of past medication actions can be done in a variety of ways that allow the viewer to immediately know whether a particular medication action was appropriate (e.g., reached the user's target range within a predetermined time after administration), ineffective (e.g., did not reach the user's target range within a predetermined time after administration), or inappropriate (e.g., the user became hypoglycemic within a predetermined time after administration). The medication actions can then be evaluated in a variety of ways that allow the viewer to determine whether the medication action was appropriate, effective, or superior to other medication actions. To determine whether a particular medication action was appropriate or ineffective, the application can analyze the user's test substance measurement (e.g., glucose value) at a predetermined time after administration (e.g., about 1 hour, or about 2 hours, or about 3 hours, or about 4 hours) and determine whether the test substance measurement reached the user's target range. As shown in FIG. 17A, the blood glucose value after a certain time 404 (e.g., 1 hour, or about 2 hours, or about 3 hours, or about 4 hours) can be used as an endpoint. If the user's blood glucose level is within a target range 406 (e.g., between about 70 mg/dL and about 180 mg/dL) at the end of a certain time 404, the medication can be classified as a "good" medication. As shown in FIG. 17B, the total time spent within the target range 406 at a certain time 404 after administration can be used to determine whether the medication is good (effective). The total time spent within the target range 406 can be a length of time (e.g., hours) or a percentage of the total length of time spent within the target range. As shown in FIG. 17C, the proportion of time spent within each range at a certain time after administration can be used to determine whether the medication is good (effective). The ranges can be a target range 406 (e.g., between about 70 mg/dL and about 180 mg/dL), a lower target range 407 (e.g., less than about 70 mg/dL), and a higher target range 405 (e.g., greater than about 180 mg/dL). The amount of time within each of these ranges can be weighted, and medication actions can be rated based on the weighted percentage of time.

To determine whether a particular medication action was improper, causing the user to experience a period of hypoglycemia, the application can analyze the test substance measurement data and determine whether the test substance measurement fell below a hypoglycemia threshold. The hypoglycemia threshold can be set by the application or the user, for example, to less than 80 mg/dL, or less than 75 mg/dL, or less than 70 mg/dL, or less than 65 mg/dL.

The medication action group application 300 can analyze medication actions associated with a particular analyte range to identify the minimum, maximum, average, median, or most commonly used dose (modal dose). Additionally, the application can display the minimum, maximum, and standard doses (e.g., median or most commonly used dose) to allow a user to review the range and type of medication actions taken in the past in similar situations (e.g., similar analyte values).

The application 300 can also divide the dosing actions performed for a given test substance range into multiple groups (e.g., two, three, four, or five groups) based on the amount of drug in each dosing action. For example, the dosing actions can be ordered according to the amount of drug in each dosing action, for example, from the smallest dose to the largest dose, or from the largest dose to the smallest dose. The multiple dosing actions can then be grouped into three groups: a low dose group, a medium dose (or standard dose) group, and a high dose group. In other words, the first dosing action group (e.g., the low dose group or the smallest dose group) includes the smallest amount of dosing actions, the second dosing action group (e.g., the high dose group or the largest dose group) includes the largest amount of dosing actions, and the third dosing action group (the medium dose group or the standard dose group) includes the median amount of dosing actions. A representative dose in each group can then be displayed. The representative dose can be the modal dose (i.e., the most commonly used dose for that group). Alternatively, the minimum or maximum dose for a particular group can be displayed. For example, the minimum dose can be displayed for a first group and the maximum dose can be displayed for a second group.

Such display may include an indication of when these medication actions were taken (e.g., time and date) and may also include a visual indication of whether the medication action caused the user to reach the target range (e.g., a good image such as coloring the date record tile green 376). Also, if a medication action does not cause the user to reach the target range (e.g., the user's glucose level remains above the target range), the date record tile for that medication action may be colored gray 378. However, if a medication action causes the user to become hypoglycemic (e.g., below 70 mg/dL), the medication action tile may be colored gray 378 and may further include a hypoglycemia symbol 380 (e.g., a sad face emoji or an emoji representing typical hypoglycemia symptoms such as shaking or sweating (e.g., wearing a sweatband emoji)). If the user reaches the target range but hypoglycemia occurs between about 30 minutes and about 4 hours after injection, the tile may remain gray since the occurrence of hypoglycemia takes precedence over the determination of proper administration.

The application can also group medication actions by what time of day or meal they were administered during. For example, medication actions can be associated with breakfast, lunch, dinner, or snacks. The application can also analyze and group correction medication actions that are not associated with a meal. Alternatively, medication actions can be associated with morning, midday, evening, or night. If the meal to which a medication action is associated is not accurate, the user can override the default meal setting to modify the type of meal associated with a particular medication action. The application can also allow the user to set typical times for breakfast, lunch, and dinner. Such a feature can be useful for users who have a different eating schedule than the typical eating schedule. The application can also allow the user to filter and view by meal or time period. For each meal or time period, different types of medication actions (e.g., "minimum," "normal," "maximum") can be displayed.

As shown in FIG. 4A, with the medication delivery device 160 connected to the medication pattern management application 300 and/or the sensor user interface application 330, when a medication action has been taken, a window 334 or alert 336 may appear indicating that the action has just been taken. The window 334 or alert 336 may indicate the type of medication administered, the amount of medication, and the meal associated with the medication action. Clicking or selecting the View 338 or Edit 340 links, or simply tapping on the notification, opens a medication details screen 342 (see FIG. 4B) where the user may edit various fields such as the administration method ("Injection": "Yes/No") 344, administration time 346, amount of medication administered 348, type of medication 350, and at which meal the administration was administered 352.

5A and 5B, the user may also select a goal range 354 by setting a maximum value for the test substance goal/target range, which allows a comparison of the test substance value obtained after administration to the goal range 354. For example, the user may select less than 180 mg/dL, less than 170 mg/dL, less than 160 mg/dL, less than 150 mg/dL, less than 140 mg/dL, less than 130 mg/dL, and/or less than 120 mg/dL. Additionally, the user may be allowed to input the target range, rather than selecting it from predefined options (not shown). The target range may be set to a minimum of less than 100 mg/dL and a maximum of less than 200 mg/dL.

As shown in FIG. 6A, when the user is deciding how much medication (e.g., insulin) to administer for a meal that is about to be consumed, the user can check the current test substance value 362. The user can then easily access the medication pattern management application 300 from the sensor user interface application 330, for example, by clicking on a link 356 labeled "View Tile." Clicking on the link 356 opens a home screen 360 (see FIGS. 6B, 6C, and 6D), which displays three groups of medication actions (e.g., a minimum dose group, a standard dose group, and a maximum dose group that the user performed when the user's test substance value was near the current test substance value 362 in the past). As described above, the doses displayed here are the doses performed when the user's test substance value was near the current test substance value, i.e., within a predefined test substance range 366 that includes the current test substance value 362. As shown in FIGS. 6B and 6C, the user can view the test substance range 366 for the displayed medication action by clicking or selecting the link 364 labeled "around" to expand the screen and display the test substance range 366.

The past medication actions 370 may be displayed grouped into a minimum dosage group 370a, a standard dosage group 370b, and a maximum dosage group 370c, with all groups displayed for a particular meal 372 or time period. The past medication actions display 370 may be displayed as tiles 374 that include the day, date, or time that a particular medication action occurred. The application may display at least one, or at least two, or at least three, or at least four past medication action tiles 374 for each group for each meal or time period.

...

As shown in Figures 7A-7D, the user can select or click on tile 374, which will reveal detail screens 382a-382c. Detail screens 382a-382c include the date the dose was administered, the time the dose was administered, the starting glucose value (i.e., the test substance value at the time of administration), the glucose value after 2 hours, and the duration of hypoglycemia (if applicable). As shown in Figure 7A, when gray tile 378 is expanded, detail screen 382a will show that the glucose value after 2 hours was outside the target range (e.g., 187 mg/dL > 180 mg/dL). As shown in Figure 7B, when green tile 376 is selected, detail screen 382b will show that the glucose value after 2 hours was within the target range (e.g., 127 mg/dL < 180 mg/dL). As shown in FIG. 7C, when the gray tile with the hypoglycemia symbol 380 is selected, a details screen 382c displays that the glucose value after 2 hours was less than 70 mg/dL (e.g., 68 mg/dL<70 mg/dL). Additionally, the details screen 382c displays the duration of the hypoglycemia 384. The details screens 382a-382c may also include a graph of the user's glucose concentration over time and other details about the hypoglycemia event (e.g., when within the time period after administration the hypoglycemia event occurred, the lowest glucose value recorded within the time period, etc.). The predetermined time period for the hypoglycemia event monitoring period may be about 4 hours, or about 3 hours, or about 2 hours, or about 1 hour. Additionally, if an additional medication (e.g., insulin) is injected, the hypoglycemia event monitoring period may be restarted based on the time the additional medication was administered. This is because the application cannot determine whether the initial administration or the additional administration caused the hypoglycemia. FIG. 7D illustrates a state including tiles of each color described in other embodiments (e.g., a gray or white tile 378, a green tile 376, and a gray tile with a hypoglycemia mark 380), but as shown in FIG. 7D, a graph display 382d that tracks the glucose value for a target time corresponding to the selected tile 381 can also be displayed (e.g., above the medication action tile). The graph display 382d can display the starting glucose value at the time of administration and the ending glucose value after a specific time (e.g., about 2 hours) together with the dosage.

A window or alert can appear in the sensor user interface application or lock screen to prompt the user to check the tile display of the medication pattern management application 300. As shown in FIG. 8A, if the user has previously reached the target range through a medication action taken when the user's analyte value was approximately the same as the current analyte value 362, a window 386 can appear suggesting that the user check their tile. Alternatively, as shown in FIG. 8B, a window 388 can include a message encouraging the user to check their tile and adjust the dosage to return to the target value.

Star Rating In another embodiment, the medication pattern management application 300 can include a star rating system to assist the user in making optimal medication decisions. The medication actions taken by the user in the past can receive a starting rating value. The medication action that the user takes closest to reaching the target range after a meal is given the highest number of stars. For example, if the user takes a medication by injection at breakfast and returns to the target value within two hours without experiencing hypoglycemia, the medication action will receive a rating of five out of five stars. However, if the glucose level is 200 mg/dL two hours after administration, the medication action can only receive a rating of four out of five stars because the user approached but did not reach the target range of less than 180 mg/dL. Additionally, if the user experiences hypoglycemia within four hours after administration, a star is subtracted from the rating.

9A and 9B, clicking on link 390 opens a home screen window 392 that displays medication actions organized either by date or by rating. Unlike some other embodiments, this display does not require similar dosages to be grouped together. Medication log 394 includes the dosage, the date or time the dose was administered, and a rating. When the user clicks on medication log 394, it can be further expanded to display a graph 396 of glucose concentration from the time of administration to a period of time after administration (e.g., about 2 hours after administration). Medication log 394 can be sorted by date (see FIGS. 9B and 9C) or by rating (see FIG. 10A) (e.g., most stars first). The user can also select various meals 398 to display various medication actions associated with the selected meals, as shown in FIG. 10B.

Tags In another embodiment, the medication pattern management application 300 may include tags 400. A user may associate tags 400 with a medication record, which may help jog the user's memory of the circumstances surrounding a particular medication event. As shown in FIGS. 11A and 11B, a user may open a medication details screen 342 by clicking a link 340 (e.g., "Edit") on a medication alert 336, or by simply tapping on the notification. In addition to the various user-editable fields described above, such as the method of administration ("Injection": "Yes/No") 344, the time of administration 346, the amount of medication administered 348, the type of medication 350, and the meal during which the dose was administered 352, the user may also add tags 400 to the medication record. The tags 400 may be existing tags or new tags 402 may be added by the user. The tags 400 may be related to a particular food item or may be non-food related (e.g., stress or exercise). As shown in Figures 12A and 12B, clicking on link 390 opens a home screen window 392 displaying a medication details screen that shows medication events organized either by date, rating, or tag 400. Unlike some other embodiments, this display does not require similar dosages to be grouped together. Medication log 394 includes the dosage, when it was administered, a rating, and tags 400. Medication log 394 can be sorted by date (see Figure 12B), rating, or tag (see Figures 13A and 13B). The user can also select various meals to display various medication events associated with the selected meals.

Recommended Dosage and Dose Range In another embodiment, the medication pattern management application 300 may display the current recommended dosage. As shown in FIG. 18, the recommended dosage interface 420 may include a meal name 422 for which the recommended dosage is to be provided, a recommended dosage 424, a description 426 indicating that the recommended dosage corresponds to a standard dosage to be provided during a meal, a link "+" 428 and a link "-" 430 that the user selects to increase or decrease the dosage from the recommended dosage, and a home button 432. The meal name 422 for which the recommended dosage is to be provided may display a list of meal names, and may further display a list indicating that the current meal is to be provided. For example, "breakfast", "lunch", "dinner", "breakfast (now)", "lunch (now)", "dinner (now)", etc. may be displayed in a list. The dosage 424 may be prominently displayed as the number of dosage units recommended, for example, "10 units". Below the recommended dosage 424, a description 426 may be provided indicating that the dosage is to be provided for a "standard" breakfast, lunch, or dinner. The recommended dosage 424 can be determined, for example, as described in U.S. Patent Application No. 16/944,736 (corresponding publication: U.S. Patent Application Publication No. 2021/0050085) .

The dosing pattern management application 300 can also display a dosage range for a particular meal. As shown in FIG. 19A, the dosage range interface 440 can include a meal name 422, a lower dosage limit 442, an upper dosage limit 444, a description 446 of the displayed safety range, and a home button 432. The meal names 422 for which the recommended dosage is applicable can be displayed as a list of meal names, and can further be displayed as a list of the meals for which the recommended dosage is applicable. For example, "breakfast", "lunch", "dinner", "breakfast (now)", "lunch (now)", "dinner (now)", etc. can be displayed as a list. The lower recommended dosage 442 and the upper recommended dosage 444 can both be displayed in units. The safety range interface 440 can also indicate that the lower recommended dosage 442 should be administered for a low carbohydrate meal and the upper recommended dosage 444 should be administered for a high carbohydrate meal. The explanation 446 can indicate that the displayed dosage is the upper and lower limits of the recommended dosage, and that the user can decide which dosage within the displayed range to use, taking into account diet and exercise.

The medication pattern management application 300 may also generate a graphical display that visually indicates the user's response to various dosage amounts within the safe range. As shown in FIGS. 19B-19D, various graphical displays 480a-480d indicating whether a medication action was appropriate may be grouped by dosage amount 482a-482d (e.g., X units). Also, the difference in units from the recommended dosage amount 484a-484d may be displayed (e.g., -3 units, -2 units, -1 unit, +1 unit, +2 units, +3 units, etc.). As shown in FIG. 19D, the graphical displays 480a-480d may include a record for each medication action taken at that dosage (e.g., four boxes for four injections of that dosage). For each medication action taken, the graphical display may be color-coded to indicate whether the medication action was deemed appropriate or not, as described elsewhere in this application. Also, the current date may be highlighted with a dot pattern or other color.

The medication pattern management application 300 may also generate a display or report that indicates, in text or graph form, how often the user's postprandial target was met or nearly met by the injections given by the user. As shown in FIG. 20A, the display or report 450 may include an indicator or description indicating how many injections achieved the user's postprandial target glucose value (e.g., X injections out of a total of Y injections, such as "3 out of 10" or "5 out of 10"). The display may also indicate whether the indicator indicates the number of injections that achieved or nearly achieved the postprandial target value 462 or the number of injections that achieved the postprandial target glucose value 463. The display or report 450 may also include a graphic or diagrammatic representation indicating how many injections achieved or nearly achieved the target. For example, a group of icons 464, such as a square, a circle, an apple, a bowl, etc., may be displayed. Among these, those related to the indicator 460 shown in the report may be displayed with shading. For example, if three out of ten injections achieved or nearly achieved the target, a group of ten icons (e.g., apples) may be displayed with three of the ten icons shaded. The color of the icon representing the injection that achieved the postprandial target may be the same color as the icon representing the injection that achieved or nearly achieved the target, or it may be a different color.

In other embodiments, as shown in FIGS. 20B-20D, the display or report 500, 520, 530 may include an indicator or description indicating the number of times the user achieved their postprandial glucose target (e.g., X meals out of Y total meals, such as "3 out of 7" or "5 out of 7"). The indicator or description 516 may be displayed for at least one meal (breakfast 510, lunch 512, and/or dinner 514) or for all three meals over a period of time. The period of time may be a week, a month, several months (e.g., 3 months), or a year. For example, if the user achieved their postprandial glucose target after a meal (e.g., breakfast) 3 out of 7 days, a group of seven icons 516 (e.g., emojis indicating celebration) may be displayed with three of the seven icons highlighted (e.g., shaded or bolded) and the other four icons unhighlighted. The color of the icon indicating a meal for which the postprandial target was achieved may be the same as or different from the color of the icon indicating an injection for which the target was achieved or nearly achieved. The indicators may also be reported in the form of "X/Y" as shown in FIG. 20B, or in the form of "X of Y" as shown in FIG. 20C. Alternatively, as shown in FIG. 20D, a group of seven icons 536 may correspond to each day of the week, and if the postprandial glucose target was achieved after a meal, the icon corresponding to that day may be highlighted, such as by shading. The seven icons 536 in the group may be arranged in chronological order, starting on Sunday or starting on Monday. Each display or report 500, 520, 530 may further include a description 504 of the display. For example, the description 504 of the display may indicate that the report corresponds to the number of times or days that the user achieved the postprandial glucose target for the week. Each display or report 500, 520, 530 may further include a description 506 of the postprandial glucose target. For example, the target postprandial glucose level can be less than 180 mg/dL two hours after injection.

21A-21C, the display or report 550 may include an indication or description of the number of times the user achieved their postprandial glucose target for each meal (breakfast 554, lunch 556, and dinner 558) during a particular month. The GUI may display all days of the month 552 and may highlight days 560 where the postprandial glucose target was achieved, for example, by shading or by changing the color of the numbers indicating the day. The user may switch between views by selecting a meal type to display results for different meals 554, 556, 558. The user may also be able to switch between months by selecting the appropriate arrows 562. Each display or report 550 may further include a description 506 of the postprandial glucose target. For example, the postprandial glucose target may be less than 180 mg/dL 2 hours after injection.

As a summary and/or supplement to the above described embodiments, various aspects of the present subject matter are presented below. It should be noted that the emphasis here is on the interrelationship and interchangeability of the following embodiments. In other words, the emphasis is on the fact that each feature of the multiple embodiments can be combined with any other feature, unless otherwise expressly stated or without logical validity. It should be noted that although no explicit reference is made below to the drawings, the following paragraphs are a reprint and development of the embodiments described in this specification.

A system, device, and method are described for identifying and managing medication patterns to assist in decisions to administer medication (e.g., during meal intake). The application may include a novel mealtime insulin administration decision function that may be utilized via or in conjunction with a test substance monitoring application. The medication pattern management application uses only past test substance and medication data to display patterns of past medication actions, helping diabetic patients who administer frequent injection therapy to easily make more appropriate medication decisions.

In many embodiments, a computer-implemented method for managing medication patterns is described. The method includes receiving a user's analyte value, identifying an analyte range that includes the analyte value, and, if the analyte measurement is within the analyte range, referencing a database by a processing circuit to identify at least one dosage administered to the user, and outputting at least a portion of the at least one dosage on an electronic display.

In some embodiments, the test substance value is the user's current test substance value.

In some embodiments, the database includes a plurality of dosage amounts, each of which is paired with a test substance measurement of the user at or near the time of administration of at least one respective dosage amount.

In some embodiments, outputting at least a portion of the at least one dosage comprises displaying at least a portion of the at least one dosage.

In some embodiments, the method further includes analyzing the at least one dosage by the processing circuit to identify a minimum and a maximum dosage that have been administered in the past. In some embodiments, the method further includes analyzing the at least one dosage by the processing circuit to identify a mode dosage that has been administered in the past. In some embodiments, outputting at least a portion of the at least one dosage includes displaying a minimum, a maximum, and a mode dosage that have been administered in the past. In some embodiments, outputting at least a portion of the at least one dosage includes displaying a time or date when each of the minimum, maximum, and mode dosages was administered. In some embodiments, the at least one dosage is divided into groups based on a time of administration of each of the at least one portion of the plurality of dosages. In some embodiments, the at least one dosage is divided into groups based on a meal association when each of the at least one portion of the plurality of dosages was administered. In some embodiments, the meal association groups include breakfast, lunch, and dinner groups. In some embodiments, each of the at least one portion of the at least one dosage can be divided into groups, and each of the at least one portion of the at least one dosage can be displayed for a group.

In some embodiments, the method further includes analyzing at least a portion of the at least one dosage by the processing circuit to determine whether administration of at least a portion of each of the at least one dosage has caused the test substance measurement to fall within a target range a certain time after administration of at least a portion of each of the at least one dosage. In some embodiments, the certain time after administration is about 2 hours. In some embodiments, the target range is selected from the group consisting of less than about 180 mg/dL, less than about 160 mg/dL, and less than about 140 mg/dL. In some embodiments, the indication of the dosage when at least a portion of the at least one dosage has caused the test substance measurement to fall within the target range is visually distinguishable from the indication of the dosage when at least a portion of the at least one dosage has not caused the test substance measurement to fall within the target range. In some embodiments, the indication of the dosage when at least a portion of the at least one dosage has caused the test substance measurement to fall within the target range is colored green.

In some embodiments, the method further includes analyzing at least a portion of the at least one dosage by the processing circuit to determine whether administration of at least a portion of each of the at least one dosage results in a test substance measurement below about 70 mg/dL at about 4 hours after administration of at least a portion of each of the at least one dosage. In some embodiments, the display of the dosage when at least a portion of the at least one dosage results in a test substance measurement below about 70 mg/dL at about 4 hours after administration is visually distinguishable from the display of the dosage when at least a portion of the at least one dosage does not result in a test substance measurement below about 70 mg/dL at about 4 hours after administration. In some embodiments, the display of the dosage when at least a portion of the at least one dosage results in a test substance measurement below about 70 mg/dL at about 4 hours after administration includes a pictogram.

In some embodiments, the test substance range is defined by the test substance value ±25%.

In some embodiments, the upper and lower limits of the test substance range are selected from the group consisting of test substance value ±30%, test substance value ±25%, test substance value ±20%, test substance value ±15%, test substance value ±10%, and test substance value ±5%.

In some embodiments, the test substance value is a glucose value.

In some embodiments, at least one dosage is at least one insulin dose.

In some embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±50 mg/dL, analyte value ±40 mg/dL, analyte value ±30 mg/dL, analyte value ±25 mg/dL, analyte value ±20 mg/dL, and analyte value ±10 mg/dL.

In some embodiments, the at least one dosage is a plurality of dosages, and the method further includes analyzing the plurality of dosages by the processing circuitry to sequence the plurality of dosages according to their respective dosages, and forming a first group, a second group, and a third group from the plurality of dosages. In some embodiments, the first group includes a dosage action of a minimum dosage administered to the user, the second group includes a dosage action of a maximum dosage administered to the user, and the third group includes a dosage action of a median dosage administered to the user. In some embodiments, the method further includes determining, by the processing circuitry, a mode dosage for each of the first group, the second group, and the third group, and displaying the mode dosage for each of the first group, the second group, and the third group.

In some embodiments, the method further includes rating at least one dosage by the processing circuit. In some embodiments, the rating of each of the plurality of dosages is according to the proximity of the test substance measurement to a target range after a period of time following administration of each of the plurality of dosage acts. In some embodiments, the period of time is about 2 hours after administration. In some embodiments, the plurality of dosages are rated using stars. In some embodiments, outputting at least a portion of the at least one dosage includes displaying at least a portion of the at least one dosage and a rating associated with each of the at least one portion of the at least one dosage. In some embodiments, at least a portion of the at least one dosage is displayed according to a rating associated with each of the at least one portion of the at least one dosage.

In some embodiments, the method further includes associating a tag with at least a second portion of the at least one dosage by the processing circuit. In some embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the plurality of medication actions. In some embodiments, outputting at least a portion of the at least one dosage includes displaying at least a portion of the at least one dosage and a tag associated with each of the at least a second portion of the at least one dosage.

In many embodiments, an electronic system configured to display past medication information is described. The system includes a processing circuit and a non-transitory memory that includes a plurality of instructions, which, when executed, cause the processing circuit to perform the steps of receiving a analyte value for a user, identifying an analyte range that includes the analyte value, referencing a database to identify at least one dosage administered to the user if the analyte measurement is within the analyte range, and outputting at least a portion of the at least one dosage to an electronic display.

In some embodiments, the database includes a plurality of dosage amounts, each of which is paired with a test substance measurement of the user at or near the time of administration of at least one respective dosage amount.

In some embodiments, outputting at least a portion of the at least one dosage comprises displaying at least a portion of the at least one dosage.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of analyzing at least one dosage to identify a minimum dosage, a maximum dosage, and a mode dosage that have been administered in the past. In some embodiments, when the instructions are executed, the processing circuitry further performs the step of displaying the minimum dosage, the maximum dosage, and the mode dosage.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of dividing at least a portion of the at least one dosage into groups based on a meal association with which each of the at least a portion of the at least one dosage is administered.

In some embodiments, the upper and lower limits of the test substance range are selected from the group consisting of test substance value ±30%, test substance value ±25%, test substance value ±20%, test substance value ±15%, test substance value ±10%, and test substance value ±5%.

In some embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±50 mg/dL, analyte value ±40 mg/dL, analyte value ±30 mg/dL, analyte value ±25 mg/dL, analyte value ±20 mg/dL, and analyte value ±10 mg/dL.

In some embodiments, the at least one dosage is a plurality of dosages, and when the instructions are executed, the processing circuitry further performs the steps of analyzing the plurality of dosages to order the plurality of dosages according to their respective dosages, and forming a first group, a second group, and a third group from the plurality of dosages. In some embodiments, the first group includes a dosage action of a minimum dosage administered to the user, the second group includes a dosage action of a maximum dosage administered to the user, and the third group includes a dosage action of a median dosage administered to the user. In some embodiments, when the instructions are executed, the processing circuitry further performs the steps of determining a mode dosage for each of the first group, the second group, and the third group, and displaying a mode dosage for each of the first group, the second group, and the third group.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of grading at least one dosage. In some embodiments, the grading of each of the plurality of dosage actions is performed according to the proximity of the test substance measurement to a target range at a time period following administration of each of the at least one dosage.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of associating a tag with at least a second portion of the at least one dosage. In some embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the multiple dosage actions.

In many embodiments, a computer-implemented method for identifying and managing a medication pattern is provided. The method may include receiving an analyte value for a user, identifying an analyte range that includes the analyte value, and, if the analyte measurement is within the analyte range, referencing a database by a processing circuit to identify a plurality of dosages administered to the user, and outputting at least a portion of the plurality of dosages on an electronic display.

In some embodiments, the test substance value is the user's current test substance value.

In some embodiments, the database includes multiple dosage amounts, each of which is paired with a test substance measurement of the user at or near the time of administration of each of the multiple dosage amounts.

In some embodiments, outputting at least a portion of the multiple dosage amounts includes displaying at least a portion of the multiple dosage amounts.

In some embodiments, the method further includes analyzing the plurality of dosages by the processing circuit to identify a minimum and a maximum dosage that have been administered in the past. In some embodiments, the method further includes analyzing the plurality of dosages by the processing circuit to identify a mode dosage that has been administered in the past. In some embodiments, outputting at least a portion of the plurality of dosages includes displaying a minimum, a maximum, and a mode dosage that have been administered in the past. In some embodiments, outputting at least a portion of the plurality of dosages includes displaying a time or date when each of the minimum, maximum, and mode dosages was administered. In some embodiments, at least a portion of the plurality of dosages are divided into groups based on a time of administration of each of the at least a portion of the plurality of dosages. In some embodiments, at least a portion of the plurality of dosages are divided into groups based on a meal association when each of the at least a portion of the plurality of dosages was administered. In some embodiments, the meal association groups include breakfast, lunch, and dinner groups. In some embodiments, each of the at least a portion of the plurality of dosage actions can be divided into groups, and each of the at least a portion of the plurality of dosage actions can be displayed for one group.

In some embodiments, the method further includes analyzing at least some of the multiple dosages by the processing circuit to determine whether administration of at least some of the multiple dosages results in a test substance measurement within a target range after a period of time following administration of at least some of the multiple dosages. In some embodiments, the period of time following administration is about 2 hours. In some embodiments, the target range is selected from the group consisting of less than about 180 mg/dL, less than about 160 mg/dL, and less than about 140 mg/dL. In some embodiments, the indication of the dosage when at least some of the multiple dosages result in the test substance measurement within the target range is visually distinguishable from the indication of the dosage when at least some of the multiple dosages result in the test substance measurement not within the target range. In some embodiments, the indication of the dosage when at least some of the multiple dosages result in the test substance measurement within the target range is colored green.

In some embodiments, the method further includes analyzing at least some of the multiple dosages by the processing circuit to determine whether administration of at least some of the multiple dosages caused a test substance measurement to fall below about 70 mg/dL at about 4 hours after administration of at least some of the multiple dosages. In some embodiments, the display of the dosage when at least some of the multiple dosages caused a test substance measurement to fall below about 70 mg/dL at about 4 hours after administration is visually distinguishable from the display of the dosage when at least some of the multiple dosages did not cause a test substance measurement to fall below about 70 mg/dL at about 4 hours after administration. In some embodiments, the display of the dosage when at least some of the multiple dosages caused a test substance measurement to fall below about 70 mg/dL at about 4 hours after administration includes a pictogram.

In some embodiments, the test substance range is defined by the test substance value ±25%.

In some embodiments, the upper and lower limits of the test substance range are selected from the group consisting of test substance value ±30%, test substance value ±25%, test substance value ±20%, test substance value ±15%, test substance value ±10%, and test substance value ±5%.

In some embodiments, the test substance value is a glucose value.

In some embodiments, the multiple dosages are multiple insulin doses.

In some embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±50 mg/dL, analyte value ±40 mg/dL, analyte value ±30 mg/dL, analyte value ±25 mg/dL, analyte value ±20 mg/dL, and analyte value ±10 mg/dL.

In some embodiments, the method further includes analyzing the plurality of dosages by the processing circuitry to sequence the plurality of dosages according to their respective dosages, and forming a first group, a second group, and a third group from the plurality of dosages. In some embodiments, the first group includes a dosage action of a minimum dosage administered to the user, the second group includes a dosage action of a maximum dosage administered to the user, and the third group includes a dosage action of a median dosage administered to the user. In some embodiments, the method further includes determining, by the processing circuitry, a mode dosage for each of the first group, the second group, and the third group, and displaying the mode dosage for each of the first group, the second group, and the third group.

In some embodiments, the method further includes rating the plurality of medication actions by the processing circuit. In some embodiments, the rating of each of the plurality of medication actions is according to the proximity of the test substance measurement to a target range at a time period after administration of each of the plurality of medication actions. In some embodiments, the time period is about 2 hours after administration. In some embodiments, the plurality of medication actions are rated using stars. In some embodiments, outputting at least a portion of the plurality of medication actions includes displaying at least a portion of the plurality of medication actions and a rating associated with each of the at least a portion of the plurality of medication actions. In some embodiments, at least a portion of the plurality of medication actions is displayed according to a rating associated with each of the at least a portion of the plurality of medication actions.

In some embodiments, the method further includes associating, by the processing circuitry, a tag with at least a second portion of the plurality of medication actions. In some embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the plurality of medication actions. In some embodiments, outputting the plurality of medication actions includes displaying at least a portion of the plurality of medication actions and a tag associated with each of at least a second portion of the plurality of medication actions.

In many embodiments, an electronic system configured to display past medication information is provided. The system includes a processing circuit and a non-transitory memory including a plurality of instructions, the processing circuit performing the steps of receiving a analyte value for a user, identifying a analyte range that includes the analyte value, referencing a database to identify a plurality of dosages administered to the user if the analyte measurement is within the analyte range, and outputting at least a portion of the plurality of dosages to an electronic display when the analyte measurement is within the analyte range.

In some embodiments, the database includes multiple dosage amounts, each of which is paired with a test substance measurement of the user at or near the time of administration of each of the multiple dosage amounts.

In some embodiments, outputting at least a portion of the plurality of dosage amounts includes displaying at least a portion of the plurality of dosage amounts.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of analyzing the multiple dosages to identify a minimum, maximum, and mode dosage that have been administered in the past. In some embodiments, when the instructions are executed, the processing circuitry further performs the step of displaying the minimum, maximum, and mode dosage.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of dividing at least a portion of the plurality of dosages into groups based on a meal association with which each of the at least a portion of the plurality of dosages is administered.

In some embodiments, the upper and lower limits of the test substance range are selected from the group consisting of test substance value ±30%, test substance value ±25%, test substance value ±20%, test substance value ±15%, test substance value ±10%, and test substance value ±5%.

In some embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±50 mg/dL, analyte value ±40 mg/dL, analyte value ±30 mg/dL, analyte value ±25 mg/dL, analyte value ±20 mg/dL, and analyte value ±10 mg/dL.

In some embodiments, when the instructions are executed, the processing circuitry further performs the steps of analyzing the plurality of dosages to order the plurality of dosages according to their respective dosages, and forming a first group, a second group, and a third group from the plurality of dosages. In some embodiments, the first group includes a dosage action of a minimum dosage administered to the user, the second group includes a dosage action of a maximum dosage administered to the user, and the third group includes a dosage action of a median dosage administered to the user. In some embodiments, when the instructions are executed, the processing circuitry further performs the steps of determining a mode dosage for each of the first group, the second group, and the third group, and displaying a mode dosage for each of the first group, the second group, and the third group.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of ranking the plurality of medication actions. In some embodiments, the ranking of each of the plurality of medication actions is performed according to the proximity of the test substance measurement to a target range at a time period after administration of each of the plurality of medication actions.

In some embodiments, when the instructions are executed, the processing circuitry further performs the step of associating a tag with at least a second portion of the plurality of medication actions. In some embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the plurality of medication actions.

In many embodiments, a computer-implemented method for assisting in diabetes management is described. The method includes receiving data including a user's analyte values within a period of time after administration of a dose of insulin for each of a number of days within a time period; identifying a subset of the data including a number of analyte values corresponding to each of the multiple days that meet a target glucose condition; and displaying a plurality of icons including an icon for each of the multiple days within the time period, wherein a number of icons among the plurality of icons corresponding to the analyte values included in the subset are visually distinguished from the remaining number of icons among the plurality of icons that are not included in the subset.

In some embodiments, the period is one week.

In some embodiments, the period is one month.

In some embodiments, the target glucose condition includes the analyte value being below an upper glucose threshold. In some embodiments, the upper glucose threshold is about 170 mg/dL to about 190 mg/dL.

In some embodiments, the data further includes insulin doses for each of multiple days in the time period.

In some embodiments, a number of the plurality of icons equal to the number of analyte values included in the subset are a different color than the remaining number of the plurality of icons not included in the subset.

In some embodiments, a number of the plurality of icons equal to the number of test substance values included in the subset and corresponding icons are displayed with a thicker line than the remaining number of icons not included in the subset.

In some embodiments, a number of the plurality of icons equal to the number of analyte values included in the subset are emojis, and the remaining number of the plurality of icons not included in the subset are not emojis.

In some embodiments, a number of icons corresponding to the number of analyte values included in the subset are displayed adjacent to one another.

In some embodiments, a number of icons corresponding to the number of test substance values included in the subset are displayed in chronological order according to the icon's corresponding date.

In some embodiments, the multiple icons displayed are further divided according to the meal associated with each of the user's analyte values within a period of time following administration of a dose of insulin for each of the multiple days in the time period.

In some embodiments, the plurality of icons displayed is further divided into icons corresponding to breakfast, icons corresponding to lunch, and icons corresponding to dinner.

In many embodiments, an electronic system configured to display information related to diabetes management is described. The system includes a processing circuit and a non-transitory memory including a plurality of instructions that, when executed, cause the processing circuit to perform the steps of receiving a user's analyte values for each of a plurality of days within a time period within a period of time within a certain time period after administration of a dose of insulin, identifying a subset of the data including a number of analyte values corresponding to each of the plurality of days that meets a target glucose condition, and displaying a plurality of icons including an icon for each of the plurality of days within the period of time, wherein a number of icons of the plurality of icons corresponding to the number of analyte values included in the subset are visually distinct from the remaining number of icons of the plurality of icons that are not included in the subset.

In some embodiments, the period is one week.

In some embodiments, the period is one month.

In some embodiments, the target glucose condition includes the analyte value being below an upper glucose threshold. In some embodiments, the upper glucose threshold is about 170 mg/dL to about 190 mg/dL.

In some embodiments, the data further includes insulin doses for each of multiple days in the time period.

In some embodiments, a number of the plurality of icons equal to the number of analyte values included in the subset are a different color than the remaining number of the plurality of icons not included in the subset.

In some embodiments, a number of the plurality of icons equal to the number of test substance values included in the subset and corresponding icons are displayed with a thicker line than the remaining number of icons not included in the subset.

In some embodiments, a number of the plurality of icons equal to the number of analyte values included in the subset are emojis, and the remaining number of the plurality of icons not included in the subset are not emojis.

In some embodiments, a number of icons corresponding to the number of analyte values included in the subset are displayed adjacent to one another.

In some embodiments, a number of icons corresponding to the number of test substance values included in the subset are displayed in chronological order according to the icon's corresponding date.

In some embodiments, the multiple icons displayed are further divided according to the meal associated with each of the user's analyte values within a period of time following administration of a dose of insulin for each of the multiple days in the time period.

In some embodiments, the plurality of icons displayed is further divided into icons corresponding to breakfast, icons corresponding to lunch, and icons corresponding to dinner.

Some embodiments of the method may further include analyzing the plurality of dosages by the processing circuitry to identify a minimum, maximum, and/or mode dosage that has been previously administered. In some embodiments, the method may further include analyzing at least one dosage by the processing circuitry to identify a minimum, maximum, and mode dosage that has been previously administered. In some embodiments, the method may further include dividing at least a portion of the plurality of dosages into groups based on the administration time of each of at least a portion of the plurality of dosages.

Embodiments of the method may further include analyzing at least a portion of the multiple dosages by the processing circuit to determine whether administration of each of the at least a portion of the multiple dosages results in a test substance measurement within a target range a period of time after administration of each of the at least a portion of the multiple dosages.Embodiments of the method may further include analyzing at least a portion of the multiple dosages by the processing circuit to determine whether administration of each of the at least a portion of the multiple dosages results in a test substance measurement below about 70 mg/dL about 4 hours after administration of each of the at least a portion of the multiple dosages.

In certain exemplary embodiments, the database includes multiple dosages, each of which is paired with a test substance measurement of the user at or near the time of administration of each of the multiple dosages. In certain embodiments, the boundaries of the test substance ranges can change (fluctuate) over time as more data is collected.

In certain exemplary embodiments, outputting at least some of the plurality of dosages includes displaying a minimum, maximum, and mode dosage that have been administered in the past. In certain exemplary embodiments, outputting at least some of the plurality of dosages includes displaying a day, time, or date when each of the minimum, maximum, and mode dosages was administered. In certain exemplary embodiments, at least some of the plurality of dosages are divided into groups based on a time of administration of each of at least some of the plurality of dosages. In certain exemplary embodiments, at least some of the plurality of dosages are divided into groups based on a meal association when each of at least some of the plurality of dosages was administered. In certain exemplary embodiments, the meal association groups include breakfast, lunch, and dinner groups.

Embodiments of the method may further include analyzing the plurality of dosage amounts by the processing circuitry to sequence the plurality of dosage amounts according to their respective dosage amounts, and forming a first group, a second group, and a third group from the plurality of dosage amounts.Embodiments of the method may further include determining, by the processing circuitry, a mode dosage for each of the first group, the second group, and the third group, and displaying the mode dosage for each of the first group, the second group, and the third group.

In certain exemplary embodiments, the first group includes a minimum dose administered to the user, the second group includes a maximum dose administered to the user, and the third group includes a median dose administered to the user. In certain exemplary embodiments, the mode doses of each of the first group, second group, and third group are displayed.

Embodiments of the method may further include rating the plurality of medication actions by the processing circuit. In certain embodiments, rating each of the plurality of medication actions is according to the proximity of the test substance measurement to a target range at a time (e.g., about 2 hours) after administration of each of the plurality of medication actions. In certain embodiments, the plurality of medication actions are rated using stars. In certain embodiments, outputting at least a portion of the plurality of medication actions includes displaying at least a portion of the plurality of medication actions and a rating associated with each of the at least a portion of the plurality of medication actions. In certain embodiments, at least a portion of the plurality of medication actions is displayed according to a rating associated with each of the at least a portion of the plurality of medication actions.

Some embodiments of the method may further include associating, by the processing circuitry, a tag with at least a second portion of the plurality of medication actions. In certain embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the plurality of medication actions. In certain embodiments, outputting the plurality of medication actions includes displaying at least a portion of the plurality of medication actions and a tag associated with each of at least a second portion of the plurality of medication actions.

In certain exemplary embodiments, an electronic system configured to display past medication information is provided. The system may include a processing circuit and a non-transitory memory including a plurality of instructions that, when executed, cause the processing circuit to perform the steps of receiving an analyte value for a user, identifying an analyte range that includes the analyte value, referencing a database to identify a plurality of dosages administered to the user if the analyte measurement is within the analyte range, and outputting at least a portion of the plurality of dosages to an electronic display.

In certain exemplary embodiments, the database includes a plurality of dosages, each of which is paired with a test substance measurement of the user at or near the time of administration of each of the plurality of dosages. In certain exemplary embodiments, outputting at least a portion of the plurality of dosages includes displaying at least a portion of the plurality of dosages. In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs analyzing the plurality of dosages to identify a minimum dosage, a maximum dosage, and a mode dosage that have been administered in the past. In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs displaying the minimum dosage, the maximum dosage, and the mode dosage. In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs dividing at least a portion of the plurality of dosages into groups based on an association with a meal during which each of the at least a portion of the plurality of dosages was administered.

In certain exemplary embodiments, the analyte range is defined by analyte value ±25%. In certain exemplary embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±30%, analyte value ±25%, analyte value ±20%, analyte value ±15%, analyte value ±10%, and analyte value ±5%. In certain exemplary embodiments, the upper and lower limits of the analyte range are selected from the group consisting of analyte value ±50 mg/dL, analyte value ±40 mg/dL, analyte value ±30 mg/dL, analyte value ±25 mg/dL, analyte value ±20 mg/dL, and analyte value ±10 mg/dL.

In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs the steps of analyzing the plurality of dosages to sequence the plurality of dosages according to their respective dosages, and forming a first group, a second group, and a third group from the plurality of dosages. In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs the steps of determining a mode dosage for each of the first group, the second group, and the third group, and displaying the mode dosage for each of the first group, the second group, and the third group. In certain exemplary embodiments, the first group includes a dosage action of a minimum dosage administered to the user, the second group includes a dosage action of a maximum dosage administered to the user, and the third group includes a dosage action of a median dosage administered to the user.

In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs the step of ranking the plurality of medication actions. In certain exemplary embodiments, the ranking of each of the plurality of medication actions is performed according to the proximity of the test substance measurement to a target range at a time period after administration of each of the plurality of medication actions.

In certain exemplary embodiments, when the instructions are executed, the processing circuitry further performs the step of associating a tag with at least a second portion of the plurality of medication actions. In certain exemplary embodiments, the tag includes details of a food, emotion, or activity associated with at least a portion of the plurality of medication actions.

The improvements to the GUI in the various aspects described in the detailed description and claims of this specification provide at least the technical effect of assisting the user of the device to operate the device more accurately, efficiently, and safely. It will be understood that the information provided to the user on the GUI, the order in which the information is provided, and the clarity of the structure of the information can have a significant impact on how the user interacts with the system and how the system is operated. Thus, the GUI guides the user to perform technical tasks related to the operation of the system and enables the user to accurately and efficiently read the required measurements and obtain information.

All features, elements, components, functions, and steps described with respect to any embodiment described herein are intended to be freely combinable and interchangeable with any other embodiment. If a particular feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that the feature, element, component, function, or step can be used with all other embodiments described herein, unless expressly stated otherwise. Therefore, this paragraph serves as a priori basis and written support that allows the following description to include claims with such combinations or substitutions, even if not expressly stated as specific examples, that features, elements, components, functions, and steps of different embodiments can be combined or substituted between embodiments. It is clearly recognized that it would be an excessive burden to explicitly state all possible combinations and substitutions, especially considering that a person skilled in the art would easily recognize the permissibility of all such combinations and substitutions.

In this specification and claims, the singular forms "a," "an," and "the" are intended to include reference to the corresponding plurals unless the context clearly indicates otherwise.

Aspects of the invention are set out in the independent claims and preferred features are set out in the dependent claims. Preferred features set out in the dependent claims may be used in any combination in one embodiment and preferred features of one aspect may also be used in combination with other aspects.

Although the embodiments are susceptible to various modifications and variations, specific examples thereof are shown in the drawings and described in detail in the specification . Furthermore , any feature, function, step, or element of the embodiments may be described or included in the claims, and the scope of the invention of the claims may be defined by negative limitations of any feature, function, step, or element not included in the claims.

100 In-vivo analyte monitoring system 102 Sensor control device 103 Housing 104 Analyte sensor 105 Adhesive patch 120 Reading device 121 User interface component (input component)
122 Display 123 Data communication port 140 Local communication path (link)
141, 142, 143 Communication channel (link)
150 Mechanical applicator 160 Drug delivery device 170 Local computer system 180 High reliability computer system 190 Network 206 Processing hardware 222 Communication processor 223, 225, 230, 253 Memory 224 Application processor 226, 260 Power supply 228 RF transceiver 229 RF antenna 232 Multifunction circuit 234, 261 Antenna 238, 254 Power management circuit 250 Sensor electronics 251 Semiconductor chip (ASIC)
252 Analog Front End (AFE)
256 Processor 258 Communication circuit 300 Medication pattern management application 330 Sensor user interface application 334 Medication window 336 Medication alert 338 View link 340 Edit link 342 Medication details screen 344 Method of administration 346 Time of administration 348 Amount of medication administered 350 Type of medication 352 Meal during which the medication was administered 354, 406 Target range 356 Check tile link 360 Home screen 362 Current test substance value 364 Nearby link 366 Test substance range 370 Display of past medication actions 370a Minimum dose group 370b Standard dose group 370c Maximum dose group 372, 398 Meals 374 Tiles 376 Green tiles 378 Grey (white) tiles 380 Hypoglycemia symbol 381 Selected tile 382a-382c Details screen 382d Graph display 384 Length of hypoglycemia time 386, 388 "View tile" window 390 Link to "Medication details screen" 392 Home screen window 394 Medication record 396 Graph 400 Tag 402 New tag 404 Time 405 Range above target 407 Range below target 420 Recommended dose interface 422 Meal name 424 Recommended dose 426 Description of recommended dose 428 "+" link 430 "-" link 432 Home button 440 Dose range interface (safety range interface)
442 Lower recommended dose 444 Upper recommended dose 450, 500, 520, 530, 550 Display or report 446 Description of safety range 460 Indicator 462 Postprandial target value 463 Target postprandial glucose value 464 Icons 480a-480d Graphical representation 482a-482d Dose 484a-484d Difference in units from recommended dose 504 Display explanation 506 Description of target postprandial glucose value 510, 554 Breakfast 512, 556 Lunch 514, 558 Dinner 516, 536 Indicator or description (icon group)
552 Month 560 Day when target postprandial glucose value was achieved 562 Arrow

Claims (15)

1. A computer-implemented method for managing medication patterns, comprising:
receiving an analyte value for a user;
identifying an analyte range that includes the analyte value;
referencing a database, by a processing circuit, to identify at least one dosage administered to the user if the analyte measurement is within the analyte range;
outputting at least a portion of the at least one dosage on an electronic display. the analyte value is the user's current analyte value; and/or
the database includes a plurality of dosages, each of the plurality of dosages being paired with the test substance measurement of the user at or near the time of administration of each of the at least one dosage; and/or
The method of claim 1 , wherein outputting the at least a portion of the at least one dosage comprises displaying the at least a portion of the at least one dosage. The method,
analyzing the at least one dosage by a processing circuit to identify a minimum and a maximum dosage previously administered;
Optionally, further comprising analyzing, by a processing circuit, the at least one dosage to identify a previously administered mode dosage;
Further optionally,
(i) outputting the at least a portion of the at least one dosage comprises displaying the minimum dosage, the maximum dosage, and the mode dosage administered in the past; and/or
(ii) outputting the at least a portion of the at least one dosage comprises displaying a time or date when each of the minimum dosage, the maximum dosage, and the mode dosage was administered; and/or
(iii) dividing the at least a portion of the at least one dosage into groups based on the meal associations with which each of the at least a portion of the plurality of dosages is administered; and/or
13. The method of claim 1, wherein (iv) dividing the at least a portion of the at least one dosage into groups based on a time of administration of each of the at least a portion of the plurality of dosages, and optionally, the meal-based groups include breakfast, lunch, and dinner groups. the method further comprising: analyzing, by a processing circuit, the at least one portion of the at least one dosage to determine whether administration of each of the at least one portion of the at least one dosage results in an analyte measurement being within a target range a period of time after administration of each of the at least one portion of the at least one dosage;
Optionally,
(i) the period of time after administration is about 2 hours; and/or
(ii) the target range is selected from the group consisting of less than about 180 mg/dL, less than about 160 mg/dL, and less than about 140 mg/dL; and/or
2. The method of claim 1, wherein (iii) an indication of a dosage when at least a portion of the at least one dosage causes a test substance measurement to fall within the target range is visually distinguishable from an indication of a dosage when at least a portion of the at least one dosage causes a test substance measurement to fall within the target range, and optionally, the indication of a dosage when at least a portion of the at least one dosage causes a test substance measurement to fall within the target range is colored green. the method further comprising: analyzing, by a processing circuit, the at least one portion of the at least one dosage to determine whether administration of each of the at least one portion of the at least one dosage results in an analyte measurement below about 70 mg/dL at about 4 hours after administration of each of the at least one portion of the at least one dosage;
Optionally, a dosage indication where said at least a portion of said at least one dosage causes a test substance measurement below about 70 mg/dL at about 4 hours after administration is visually distinguishable from a dosage indication where said at least a portion of said at least one dosage does not cause a test substance measurement below about 70 mg/dL at about 4 hours after administration;
Further optionally, the display of dosages when at least a portion of the at least one dosage causes a test substance measurement below about 70 mg/dL about 4 hours after administration includes a pictogram. 2. The method of claim 1, wherein the analyte range is defined by the analyte value ±25%. (i) the upper and lower limits of the analyte range are selected from the group consisting of the analyte value ±30%, the analyte value ±25%, the analyte value ±20%, the analyte value ±15%, the analyte value ±10%, and the analyte value ±5%; and/or
(ii) the test substance value is a glucose value; and/or
2. The method of claim 1, wherein said at least one dosage is at least one insulin dose. 2. The method of claim 1 , wherein the upper and lower limits of the analyte range are selected from the group consisting of the analyte value ±50 mg/dL, the analyte value ±40 mg/dL, the analyte value ±30 mg/dL, the analyte value ±25 mg/dL, the analyte value ±20 mg/dL, and the analyte value ±10 mg/dL. said at least one dosage is a plurality of dosages;
The method,
analyzing the plurality of dosage amounts by a processing circuit and ordering the plurality of dosage amounts according to their respective administration amounts;
forming a first group, a second group, and a third group from the plurality of dosage amounts;
Optionally, the first group includes a medication action of a minimum dose administered to the user, the second group includes a medication action of a maximum dose administered to the user, and the third group includes a medication action of a median dose administered to the user;
Further optionally, the method further comprises:
determining, by a processing circuit, a modal dosage for each of the first group, the second group, and the third group;
2. The method of claim 1, further comprising the step of: displaying the mode dosage for each of the first group, the second group, and the third group. the method further comprising rating the at least one dosage by a processing circuit;
Optionally,
(i) ranking each of the plurality of dosages according to the proximity of the test substance measurement value to a target range at a fixed time after administration of each of the plurality of dosage actions, optionally the fixed time being about 2 hours after administration; and/or
(ii) the plurality of dosages are rated using stars; and/or
(iii)
outputting the at least a portion of the at least one dosage comprises displaying the at least a portion of the at least one dosage and a rating associated with each of the at least a portion of the at least one dosage; and optionally
The method of claim 1 , wherein the at least some of the at least one dosage are displayed according to the rating associated with each of the at least some of the at least one dosage. the method further comprising associating, by a processing circuit, a tag with at least a second portion of the at least one dosage;
Optionally,
(i) the tags include details of food, emotions, or activities associated with the at least some of the plurality of medication actions; and/or
2. The method of claim 1, wherein (ii) outputting the at least a portion of the at least one dosage comprises displaying the at least a portion of the at least one dosage and the tag associated with each of the at least a second portion of the at least one dosage. 1. An electronic system configured to display past medication information, the system comprising:
A processing circuit;
a non-transitory memory containing a plurality of instructions;
When the instructions are executed, the processing circuitry:
receiving an analyte value for a user;
identifying an analyte range that includes the analyte value;
referencing a database to identify at least one dosage administered to the user if the analyte measurement is within the analyte range;
outputting at least a portion of the at least one dosage on an electronic display;
A system that runs (i) the database includes a plurality of dosages, each of the plurality of dosages being paired with the analyte measurement of the user at or near the time of administration of each of the at least one dosage; and/or
(ii)
and/or wherein outputting the at least a portion of the at least one dosage comprises displaying the at least a portion of the at least one dosage;
(iii)
and/or wherein, when the instructions are executed, the processing circuitry further performs the step of analyzing the at least one dosage to identify a minimum dosage, a maximum dosage, and a mode dosage previously administered; and optionally, when the instructions are executed, the processing circuitry further performs the step of displaying the minimum dosage, the maximum dosage, and the mode dosage.
(iv) when the instructions are executed, the processing circuitry further performs the step of dividing the at least some of the at least one dosage into groups based on a meal association with which each of the at least some of the at least one dosage is administered; and/or
13. The system of claim 12, wherein (v) the upper and lower limits of the analyte range are selected from the group consisting of: the analyte value ±30%, the analyte value ±25%, the analyte value ±20%, the analyte value ±15%, the analyte value ±10%, and the analyte value ±5%. (i) the upper and lower limits of the analyte range are selected from the group consisting of the analyte value ±50 mg/dL, the analyte value ±40 mg/dL, the analyte value ±30 mg/dL, the analyte value ±25 mg/dL, the analyte value ±20 mg/dL, and the analyte value ±10 mg/dL; and/or
(ii) when the instructions are executed, the processing circuitry further performs the step of ranking the at least one dosage, optionally ranking each of the plurality of dosage actions according to the proximity of a test substance measurement to a target range at a time period following administration of each of the at least one dosage; and/or
13. The system of claim 12, wherein (iii) the processing circuitry, upon execution of the instructions, further performs the step of associating a tag with at least a second portion of the at least one medication dosage, optionally wherein the tag includes details of a food, emotion, or activity associated with the at least a portion of the plurality of medication actions. said at least one dosage is a plurality of dosages;
When the instructions are executed, the processing circuitry:
analyzing the plurality of dosage amounts and ordering the plurality of dosage amounts according to their respective administration amounts;
forming a first group, a second group, and a third group from the plurality of dosage amounts;
Further execute
Optionally, the first group includes a medication action of a minimum dose administered to the user, the second group includes a medication action of a maximum dose administered to the user, and the third group includes a medication action of a median dose administered to the user;
Further optionally, the processing circuitry, when executing the plurality of instructions:
determining a modal dosage for each of the first group, the second group, and the third group;
displaying the mode dosage for each of the first group, the second group, and the third group;
The system of claim 12 , further comprising: