Analyte monitoring system and method

Abstract

Improved graphical user interfaces for analyte monitoring systems are provided. For example, various embodiments of GUIs are disclosed, each including a graph portion including a trendline showing a user's analyte levels over a predetermined time period, and a plurality of summary metrics including a plurality of minimum and maximum analyte levels associated with a plurality of time increments within the predetermined time period. In many embodiments, the plurality of minimum and maximum analyte levels are aligned with the x-axis of the graph portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 538,592, filed September 15, 2023, and U.S. Provisional Patent Application No. 63 / 407,430, filed September 16, 2022, both of which are expressly incorporated by reference herein in their entireties. [Technical Field]

[0002] TECHNICAL FIELD The subject matter described herein relates generally to improvements in analyte monitoring systems and related computer-related methods and apparatus. [Background technology]

[0003] Detecting and / or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, and hemoglobin A1C, can be critical to the health of diabetic patients. Patients suffering from diabetes can experience complications, including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to ensure they remain within a clinically safe range, and can use this information to determine whether 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.

[0004] A growing body of clinical data demonstrates a strong correlation between frequency of glucose monitoring and glycemic control. Despite this correlation, many patients diagnosed with diabetic conditions do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.

[0005] To increase patient compliance with a frequent glucose monitoring plan, an in-vivo analyte monitoring system may be used in which a sensor control device is worn on the body of each patient requiring analyte monitoring. To increase each patient's comfort and convenience, the sensor control device has a small form factor and may be applied by each patient using a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user's analyte level in bodily fluids located in a layer of the human body using an applicator or insertion mechanism to contact the sensor with the bodily fluid. The sensor control device may also be configured to transmit analyte data to another device, from which an individual patient, a healthcare provider ("HCP"), or a caregiver may review the data and make treatment decisions.

[0006] Although they have advantages, some patients are reluctant to use analyte monitoring systems for a variety of reasons, including the complexity and volume of data provided, the learning curve associated with the analyte monitoring system software and user interface, and the overall lack of actionable information provided. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need for improved analyte monitoring system reporting interfaces and software, and related methods and apparatus, that are robust, user-friendly, and provide timely, actionable responses. [Means for solving the problem]

[0008] Provided herein are exemplary embodiments that improve in vivo analyte monitoring systems and related computer-related methods and devices. According to some embodiments, a graphical user interface ("GUI") for an analyte monitoring system is provided, the GUI including a graph portion including a trendline indicating a user's analyte level over a predetermined time period, the trendline being based on data indicating the user's analyte level received from a sensor control device. In some embodiments, the graph portion includes a graphical representation of the user's analyte level over the predetermined time period. The graph portion may have an x-axis representing the predetermined time period. For example, the graph portion may include multiple data points representing the user's analyte level over the predetermined time period (e.g., in the form of a scatter plot). In some examples, the multiple data points may be connected by a line (e.g., in the form of a line graph). In other examples, the multiple data points may be discrete and not connected by a line. According to some aspects of some embodiments, the GUI further includes multiple summary metrics associated with the predetermined time period. In some examples, the summary metrics are associated with the user's analyte level. According to some aspects of embodiments, the plurality of summary metrics includes a plurality of minimum and maximum analyte levels associated with a plurality of time increments within a predetermined time period. In other words, the plurality of summary metrics may include a minimum and maximum analyte level for each time increment within the predetermined time period. In some embodiments, the predetermined time period is one day. For example, the plurality of time increments may include 24 one-hour increments. In other words, each time increment may have a continuous length of, for example, one hour. In some embodiments, the plurality of minimum and maximum analyte levels are aligned with the x-axis of the graph portion. For example, the minimum and maximum analyte levels are each aligned with a corresponding time interval on the x-axis, and the plurality of minimum and maximum analyte levels for different time intervals are displayed along the x-axis.

[0009] Numerous embodiments described herein improve upon the reporting GUI or GUI features for analyte monitoring systems to be more intuitive, user-friendly, and provide quick access to a user's physiological information. More specifically, these embodiments allow a user to easily navigate through and between different user interfaces that can instantly present various physiological conditions and / or actionable responses to the user without requiring the user (or HCP) to undergo the arduous task of reviewing large amounts of analyte data.

[0010] The various aspects of the improvements to the GUI described and claimed herein produce technical effects in that they at least assist a user of the device in operating the device more accurately, more efficiently, and more safely. It will be appreciated that the information provided to the user via the report GUI, the order in which the information is presented, and the clarity of the information's structure have a significant impact on the way the user interacts with the system and the way the system operates. Thus, the report GUI guides the user in the technical task of operating the system, encouraging them to make necessary readings and / or obtain information accurately and efficiently. Other improvements and advantages are also provided. Various configurations of these devices are described in detail in exemplary embodiments only.

[0011] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or become apparent to one of ordinary skill in the art upon examination of the following drawings and detailed description. All such additional systems, methods, features, and advantages are intended to be included herein, be within the scope of the subject matter described herein, and be protected by the accompanying claims. Aspects of embodiments are set forth in independent claims, and preferred features are set forth in dependent claims. Preferred features of the dependent claims may be provided in combination in a single embodiment, and preferred features of one aspect may be provided with other aspects. Unless features of example embodiments are explicitly recited in the accompanying claims, they should not be construed as limiting the claims in any respect.

[0012] Details of the subject matter presented herein, both in structure and operation, will become apparent upon examination of the accompanying drawings, in which like reference numerals indicate like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all figures are intended to convey concepts and may depict relative sizes, shapes, and other detailed attributes in a schematic, rather than literal, manner. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a system schematic diagram of an analyte monitoring system including a sensor applicator, a sensor control device, a reader, a network, a trusted computer system, and a local computer system. [Figure 2A] FIG. 1 is a block diagram illustrating an exemplary embodiment of a reading device. [Figure 2B] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3B] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3C] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3D] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3E] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3F] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3G] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3H] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3I] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3J] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3K] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 3L] 1A-1C are exemplary embodiments of various graphical user interfaces ("GUIs") and a report GUI showing a user's analyte levels and multiple summary metrics over a given period of time. [Figure 4A] 10 is an exemplary embodiment of a report settings GUI for enabling and / or disabling the display of minimum and maximum analyte levels. [Figure 4B]10 is an exemplary embodiment of a GUI and a report GUI in which the display of minimum and maximum analyte levels is enabled or disabled. [Figure 4C] 10 is an exemplary embodiment of a GUI and a report GUI in which the display of minimum and maximum analyte levels is enabled or disabled. [Figure 4D] 10 is an exemplary embodiment of a GUI and a report GUI in which the display of minimum and maximum analyte levels is enabled or disabled. [Figure 4E] 10 is an exemplary embodiment of a GUI and a report GUI in which the display of minimum and maximum analyte levels is enabled or disabled. [Figure 5] 10 is an exemplary embodiment of a report GUI showing analyte levels and summary metrics for multiple analytes over multiple predetermined time periods. DETAILED DESCRIPTION OF THE INVENTION

[0014] Before describing the present subject matter in detail, it is to be understood that the present disclosure is not limited to particular embodiments described, as such may, of course, vary. Further, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0015] As used in this specification and the appended claims, indefinite and definite articles indicating the singular include the plural as well, unless the context clearly indicates otherwise.

[0016] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such publications by virtue of their prior disclosure. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0017] Generally, embodiments of the present disclosure include GUIs, software, and digital interfaces for analyte monitoring systems, as well as related methods and devices. Accordingly, many embodiments include an in-vivo analyte sensor, where at least a portion of the sensor is located or structurally configured to be located within a user's body, to obtain information about at least one analyte in the body. It should be noted that the embodiments disclosed herein may be used in in-vivo analyte monitoring systems that incorporate in-vitro capabilities, as well as purely in-vitro or ex-vivo analyte monitoring systems, including completely non-invasive systems.

[0018] Additionally, systems and devices capable of performing the method embodiments disclosed herein are also encompassed within the scope of the present disclosure. For example, sensor control devices, reading devices, local computer systems, and trusted computer system embodiments are disclosed, which may include one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processing circuitry, and / or controllers (e.g., for executing instructions) that may perform or facilitate the execution of any and all method steps.

[0019] An improved reporting graphical user interface for an analyte monitoring system is provided. For example, this specification discloses various embodiments of a graphical user interface ("GUI") that is highly intuitive, user-friendly, and provides a user with quick access to physiological information. That is, among other advantages, these embodiments provide a robust, user-friendly interface that may increase a user's engagement with the analyte monitoring system, and further provide timely, user-actionable responses. Other improvements and advantages are also provided. Various configurations of these devices are described in detail in the embodiments, but are by way of example only.

[0020] Before describing these aspects of the embodiments in detail, it is desirable to first describe, for example, examples of devices that may be found in an in vivo analyte monitoring system, and examples of their operation, all of which may be used in the embodiments described herein.

[0021] There are various types of in-vivo analyte monitoring systems. A "continuous analyte monitoring" system (or "continuous glucose monitoring" system), for example, may transmit data from the sensor controller to the reader continuously, automatically, unprompted, e.g., on a schedule. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system, or simply "flash" system) may transfer data from the sensor controller in response to a scan or request for data by the reader, such as using near-field communication (NFC) or radio frequency identification (RFID) protocols. Furthermore, in-vivo analyte monitoring systems may operate without the need for fingerstick calibration.

[0022] In vivo analyte monitoring systems are distinguished from "ex vivo" systems, which contact a biological sample outside the body (or "ex vivo"); "ex vivo" systems typically include a metering device having a port that accepts an analyte test strip carrying a user's bodily fluid, which can be analyzed to determine the user's blood glucose level.

[0023] An in-vivo monitoring system includes a sensor that, when placed in vivo, contacts a user's bodily fluid and senses the level of an analyte therein. The sensor is part of a sensor control device located on the user's body and includes electronics and a power source that enable and control analyte sensing. Sensor control devices and variations thereof may also be referred to as, for example, "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units.

[0024] In-vivo monitoring systems may also include devices that receive sensed analyte data from the sensor control device and process and / or display the sensed analyte data to a user in any number of forms. These reading devices may process and / or display the sensed analyte or sensor data to a user in any number of forms. These devices and variations thereof may be referred to as "handheld reading devices," "readers" (or simply "readers"), "handheld electronic devices" (or simply "handheld"), "portable data processing" devices or units, "data receivers," "receiver" devices or units (or simply "receivers"), or "remote" devices or units, to name a few. Other devices, such as personal computers, may also be used with or incorporated into in-vivo and in-vitro monitoring systems.

[0025] Exemplary Embodiments of an In Vivo Analyte Monitoring System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitoring system 100, including a sensor applicator 150, a sensor control unit 102, and a reader 120. Here, the sensor applicator 150 is used to deliver the sensor control unit 102 to a monitoring location on a user's skin, and the sensor 104 may be maintained in place for a period of time by an adhesive patch 105. Additionally, the sensor control unit 102, also shown in FIGS. 2B and 2C, may communicate with the reader 120 via a communication path 140 using wired or wireless technology. Examples of wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), near-field communication (NFC), etc. A user may use a screen 122 (which, in many embodiments, may include a touchscreen) and an input 121 (which may be part of the touchscreen) to view and use applications installed in the memory of the reader 120. The device battery of the reader 120 may be rechargeable using the power port 123. Although only one reader 120 is shown, the sensor control device 102 may communicate with multiple readers 120. Each reader 120 may communicate or share data with each other. The reader 120 will now be described in more detail with reference to FIG. 2A . The reader 120 may communicate with a local computer system 170 over communication path 141 using a wired or wireless communication protocol. The local computer system 170 may include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication may include any of a number of available wireless network protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, etc. The local computer system 170 may communicate with the network 190 via communication path 143 using wired or wireless communication protocols as previously described, in the same manner as the reading device 120 communicates with the network 190 via communication path 142.Network 190 can be any of a number of networks, including private and public networks, local area or wide area networks, etc. Trusted computer system 180 may include a cloud-based platform or server, provide authentication services, secure data storage, and report generation, and may communicate with network 190 via communication path 144 using wired or wireless technology. Additionally, while FIG. 1 depicts trusted computer system 180 and local computer system 170 in communication with a single sensor control device 102 and a single reader device 120, those skilled in the art will recognize that local computer system 170 and / or trusted computer system 180 can each communicate with multiple readers and sensor control devices via wired or wireless communication.

[0026] Exemplary embodiments of a reading device FIG. 2A is a block diagram illustrating an exemplary embodiment of a reader 120, which in some embodiments may comprise a smartphone. Here, reader 120 may include a display 122, an input 121, and a processing core 206 including a communication processor 222 connected to memory 223 and an application processor 224 connected to memory 225. It may also include a separate memory 230, an RF transceiver 228 having an antenna 229, and a power supply 226 having a power management module 238. Reader 120 also includes a multi-function transceiver 232, which may include wireless communication circuitry and may be configured to communicate with antenna 234 via Wi-Fi, NFC, Bluetooth, BTLE, and GPS. As will be appreciated by those skilled in the art, these components are electrically and communicatively connected to form a functional device. Reader 120 may be provided in combination with sensor controller 102 to form an analyte monitoring system, or may be provided separately (e.g., for use with sensor controller 102). The reading device 120 and / or the sensor control device 102 may be provided in combination with a sensor applicator 150 for delivering the sensor control device 102 to the skin of a user. For example, the sensor applicator 150 may be used to insert a portion of the analyte sensor 104 into the skin of a user.

[0027] Exemplary Embodiments of a Sensor Control Device 2B and 2C are block diagrams illustrating an example embodiment of a sensor controller 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry), which may contain most of the processing power for rendering final result data suitable for display to a user. The analyte sensor 104 includes a portion that is inserted into a user, and may be configured, for example, such that a portion of the analyte sensor 104 is positioned in contact with bodily fluids (e.g., interstitial fluid). FIG. 2B shows a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC). Within the ASIC 161, several high-level functional units are shown, including an analog front-end (AFE) 162, power management (or control) circuitry 164, processing unit 166, and communication circuitry 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or other aspects depending on a communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. Processor 166 includes one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be individual chips or may be distributed across (part of) multiple different chips.

[0028] Memory 163 is also included within ASIC 161 and may be shared with various functional units within ASIC 161 or distributed among two or more of them. Memory 163 may also be a separate chip. Memory 163 may be volatile and / or non-volatile memory. In this embodiment, ASIC 161 may be connected to a power source 172, which may be a coin battery or the like. AFE 162 interfaces with in-vivo analyte sensor 104 to receive measurement data therefrom and outputs the data in digital form to processor 166, which then processes the data into final results such as glucose discrete data and trend values. This data is then provided to communication circuitry 168, which transmits it via antenna 171 to reader 120 (not shown), which may require minimal further processing by a resident software application, for example, to display the data. According to some embodiments, for example, current glucose values ​​may be transmitted from sensor controller 102 to reader 120 periodically (e.g., every minute). In some examples, historical glucose values ​​may be transmitted from the sensor control device 102 to the reader 120 periodically (eg, every 5 minutes).

[0029] In some embodiments, to conserve power and processing resources of the sensor controller 102, digital data received from the AFE 162 may be transmitted to the reader 120 (not shown) with minimal or no processing. In yet other embodiments, the processor 166 is configured to generate certain predetermined data types (e.g., current glucose value, historical glucose values) for either storage in the memory 163 or transmission to the reader 120 (not shown), and also to identify certain alarm conditions (e.g., sensor fault conditions), while other processing and alarm functions (e.g., upper / lower glucose threshold alarms) may be performed on the reader 120. Those skilled in the art will appreciate that the methods, functions, and interfaces described herein may be performed, in whole or in part, by processing circuitry on the sensor controller 102, the reader 120, the local computer system 170, or the trusted computer system 180.

[0030] FIG. 2C is similar to FIG. 2B but instead includes two discrete semiconductor chips 162, 174, which may be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processing unit 166 is integrated with power management circuitry 164 and communications circuitry 168 on chip 174. AFE 162 includes memory 163, and chip 174 may include memory 165, which may be separate from or distributed within it. In one exemplary embodiment, AFE 162 is combined with power management circuitry 164 and processing unit 166 on one chip, and communications circuitry 168 is on another chip. In another exemplary embodiment, both AFE 162 and communications circuitry 168 are on one chip, and processing unit 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations, including three or more chips, are also possible, with each chip responsible for a separate function as described, or sharing one or more functions for fail-safe redundancy.

[0031] Exemplary Embodiments of a Graphical User Interface for an Analyte Monitoring System An exemplary embodiment of a GUI for the analyte monitoring system will now be described. At the outset, those skilled in the art will appreciate that the GUI described herein includes instructions stored in memory of trusted computer system 180, reader 120, local computer system 170, and / or any other device or system that is part of or in communication with analyte monitoring system 100. These instructions, when executed by one or more processors of trusted computer system 180, reader 120, local computer system 170, or other devices or systems of analyte monitoring system 100, cause the one or more processors to perform method steps and / or output a GUI described herein. Those skilled in the art will further appreciate that the GUI described herein may be stored as instructions in the memory of a single central device or, alternatively, may be distributed across multiple geographically dispersed devices.

[0032] FIG. 3A illustrates an exemplary embodiment of a GUI 300 for an analyte monitoring system, showing a user's analyte levels over a predetermined time period along with multiple summary metrics. Generally, GUI 300 displays a graph representing a user's analyte levels over a predetermined time period in a single, user-friendly format, along with useful summary metrics based on or related to analyte data obtained from the analyte monitoring system. Furthermore, the multiple summary metrics displayed in GUI 300 may be associated with a predetermined time period, such as a day, week, or month. In other words, the multiple summary metrics may relate to analyte data from a predetermined time period. For example, as shown in FIG. 3A, GUI 300 is configured to display a graph of a user's analyte levels and multiple summary metrics for a single day, as indicated by date 302 (e.g., "Sunday, June 3").

[0033] According to one aspect of the embodiment, the GUI 300 may include a graph portion including an x-axis 309 in units of time and a y-axis 307 showing analyte concentration. For example, the GUI 300 may include an x-axis 309 labeled with two-hour increments over a 24-hour period and a y-axis 307 labeled with glucose in milligrams per deciliter (mg / dL). One skilled in the art will recognize that the x-axis and / or y-axis may be labeled with other increments or units. For example, the x-axis may be labeled with 30-minute increments, one-hour increments, or four-hour increments. As another example, the y-axis may be labeled with glucose in millimoles per liter (mmol / L).

[0034] According to another aspect of the embodiment, the graph of GUI 300 may further display an upper analyte threshold value ("180 mg / dL") and a lower analyte threshold value ("70 mg / dL") for the target analyte range 308, as indicated by the numeric labels on the left side. In some embodiments, the numeric values ​​for the target analyte range 308 may be a different color than the labels on the x-axis and / or y-axis to make them more visible. Additionally, in some embodiments, multiple lines, each reflecting a corresponding threshold value in the target analyte range 308, may extend across a portion of the graph to provide a visual reference for the relationship between the user's analyte level and the target analyte range 308 at any point in time. For example, the lines may include an upper analyte threshold line and a lower analyte threshold line. In some examples, the lines may be colored, e.g., a different color line for each threshold value. This allows a user to more easily compare an analyte level at a particular time with the target analyte range 308, thereby improving patient safety. Additionally, according to some embodiments, the target analyte range 308 may be configured by the user, for example, by adjusting either or both of the upper and lower analyte thresholds. In some embodiments, the threshold lines may be provided without numerical labels.

[0035] 3A , the graph portion of the GUI 300 may include a trendline 310 that indicates a user's analyte concentration over a predetermined period of time. According to one aspect of an embodiment, one portion 310 of the trendline may be displayed in a first color (e.g., green) to indicate that the user's analyte level is within the target analyte range 308 at the indicated time. Another portion 312 of the trendline may be displayed in a second color (e.g., orange) to indicate that the user's analyte level is higher than the target analyte range 308 at a different indicated time. Similarly, another portion 318 of the trendline may be displayed in a third color (e.g., red) to indicate that the user's analyte level is lower than the target analyte range 308 at a different indicated time. In some embodiments, each area below (or above) the trendline may be shaded or filled in (e.g., with a particular color) if the user's analyte level is higher or lower than the target analyte range. For example, if the user's analyte level is higher than the target analyte range, the area below (or above) the trendline may be shaded or filled with a second color, and / or if the user's analyte level is lower than the target analyte range, the area below (or above) the trendline may be shaded or filled with a third color. As shown in FIG. 3A , the colored areas may extend from the analyte threshold exceeded line to the trendline. In this regard, these colored areas may graphically represent to the user the severity and / or duration of the analyte deviation. Conversely, if the user's value remains within the target analyte range 308 for a predetermined period of time, the trendline may remain colored a first color (e.g., green).

[0036] According to some embodiments, each area below (or above) the trendline may remain uncolored. In yet other embodiments, the trendline may be a single color regardless of whether it is above, below, or within the target analyte range 308.

[0037] According to some embodiments, certain information may also be overlaid on the graph adjacent to the trendline. For example, in some analyte monitoring systems, a user-initiated analyte check 315 may be graphically displayed as one or more discrete points on the graph to indicate the time of the check. A user-initiated analyte check may be, for example, a fingerprick blood glucose test, a scan of a sensor control device, downloading analyte data from a trusted computer system, viewing an analyte monitoring program on a reader, and / or rendering a particular GUI (e.g., a home screen, a sensor results screen) of an analyte monitoring program on a reader. Those skilled in the art will recognize that other types of user-initiated analyte checks are possible and within the scope of the present disclosure. According to another aspect of some embodiments, an exercise event may be graphically displayed as an exercise icon 316 on the graph to indicate the time the exercise event occurred. Information (e.g., corresponding to an event such as a user-initiated analyte check 315 and the exercise icon 316) may be displayed on or adjacent to the graph, aligned with the x-axis.

[0038] According to other aspects of some embodiments, GUI 300 may include one or more summary metrics. For example, in some embodiments, GUI 300 includes a "time in range" metric 304, which represents the percentage of time (e.g., "79%) that a user's analyte data was within the target analyte range over a given period of time. In other embodiments, "time in range" metric 304 may be displayed graphically (e.g., as a pie chart, multiple bar segments, partially filled ring) or alternatively as a quantity of time. Graphical displays of other types of "time in range" metrics are disclosed in U.S. Patent Application Publication Nos. 2021 / 0282673, 2022 / 0248988, 2021 / 037860, 2022 / 0000399, 2021 / 0030323, 2022 / 0092019, and 2022 / 0110551, all of which are incorporated by reference in their entirety for all purposes.

[0039] 3A , the summary metrics may also include the total amount of food or medication 306 ingested during a given time period. In some embodiments, for example, the summary metrics may include the amount of carbohydrates (in grams) ingested by the user during a given time period and / or the type of insulin (e.g., fast-acting or long-acting) and number of units infused by the user during a given time period. The summary metrics may include separate metrics for different types of insulin (e.g., fast-acting and long-acting), or these may be combined. According to another aspect of the embodiment, specific food and / or medication events 314 may then be displayed graphically (e.g., above a trendline, below a trendline) such that each food and / or medication event is aligned with the time indicated along the x-axis. According to one aspect of some embodiments, each type of summary metric may be shown in a different color associated with the associated event shown in the graph portion of the report GUI 300, as described below.

[0040] Referring now to FIG. 3B, an exemplary embodiment of a report GUI 320 of an analyte monitoring system is shown. The report GUI 320 includes multiple interfaces 320-A, 320-B, 320-C, 320-D, and 320-E, each showing a user's analyte levels over a different predetermined time period along with multiple summary metrics. First, each of the multiple interfaces 320-A, 320-B, 320-C, 320-D, and 320-E includes similar features to the GUI 300 of FIG. 3A . Therefore, those similar features will not be repeated here. For example, interface 320-A shows a daily view of the user's analyte levels for Thursday, May 31, along with multiple summary metrics for that particular day. Similarly, interface 320-B shows a daily view of the user's analyte levels for Friday, June 1, along with multiple summary metrics for that particular day. In other words, the report GUI 320 includes a daily view of the user's analyte levels for multiple predetermined time periods, e.g., multiple days. However, unlike the GUI 300 of FIG. 3A, the report GUI 320 interface shows labeling for the y-axis and target analyte ranges along the right side of each graph instead of the left side. In other examples, the labeling can be on the left side.

[0041] According to another aspect of the embodiment, the report GUI 320 may have a particular arrangement that enhances the user's ability to recognize patterns across multiple time periods. For example, the x-axes of each interface 320-A, 320-B, 320-C, 320-D, and 320-E may be aligned with one another such that the particular time increments for each interface are also aligned. In this regard, a user may immediately recognize whether their analyte levels exceed the analyte threshold at a particular time of day (e.g., after lunch).

[0042] According to another aspect of the embodiment, the report GUI 320 includes a user name 322, a label indicating the selected reporting period 324, and a "CGM Run Time" statistic 325 indicating the amount of analyte data available for the selected reporting period 324. According to some embodiments, the selected reporting period 324 may be configurable by the user. For example, in some embodiments, the selected reporting period 324 may be configured by a selected start date and a selected end date. In other embodiments, the selected reporting period 324 may be configured to be a specific duration (e.g., one week, two weeks, one month, etc.). Furthermore, in some embodiments, the "CGM Run Time" statistic may include the proportion of time during the selected reporting period 324 during which analyte data was acquired, expressed as a percentage. In other embodiments, the "CGM Run Time" statistic may include the actual length of time (e.g., "12 days, 11 hours, 32 minutes"). Report GUI 320 may also include a legend 326 that provides a textual explanation of one or more icons displayed in any one or more of interfaces 320-A, 320-B, 320-C, 320-D, and / or 320-E.

[0043] According to another aspect of the embodiment, the report GUI 320 may also include a device label 328, which may indicate the type of device and / or software used to acquire the analyte data for the report. For example, the device label 328 may indicate that the user was using a particular analyte monitoring program on their smartphone with a particular brand and / or model of on-body analyte sensor. In some embodiments, the device label 328 may also indicate that data from a medication delivery device (e.g., a connected insulin pen, insulin pump, etc.) was acquired for the report GUI 320.

[0044] 3C, another exemplary embodiment of a GUI 330 for an analyte monitoring system is shown, which displays a user's analyte levels over a predetermined period of time along with a number of summary metrics. First, GUI 330 includes similar features to GUI 300 of FIG. 3A. Therefore, those similar features will not be repeated here.

[0045] According to one aspect of the embodiment, the plurality of summary metrics of the GUI 330 may include a maximum analyte level 332 and a minimum analyte level 334 for a given time period. Additionally, a maximum analyte level 336 and a minimum analyte level 338 for each time increment of the plurality of time increments may be displayed along the x-axis adjacent to the graph portion of the GUI 330. For example, as shown in FIG. 3C , a pair of maximum analyte level 336 and minimum analyte level 338 metrics may be displayed for each hour in a 24-hour period. The maximum analyte level 336 and minimum analyte level 337 may be particularly useful because the numerical values ​​associated with the trend line are not always easily ascertained through visual observation.

[0046] 3D, another exemplary embodiment of a GUI 340 for an analyte monitoring system is shown, which displays a user's analyte levels over a predetermined period of time along with a number of summary metrics. First, GUI 340 includes similar features to GUI 330 of FIG. 3B. Therefore, those similar features will not be repeated here.

[0047] According to one aspect of the embodiment, GUI 340 may include an icon region along the x-axis for the indication of certain events. For example, in some embodiments, an alarm icon 342 may be displayed in the icon region to indicate the detection of an alarm condition. Additionally, the location of alarm icon 342 along the x-axis may indicate to the user the specific time that the alarm condition was detected. Additionally, according to some embodiments, an alarm label 341 may be displayed next to alarm icon 342 to indicate the type of alarm condition. As can be seen in FIG. 3D , for example, alarm icon 342 may be displayed at 3:00 a.m. with alarm label 341 indicating that a "lower" analyte alarm condition was detected at that time.

[0048] According to some embodiments, other alarm conditions that may display an alarm label may include a "high" analyte alarm condition, an "urgent low" or "severe low" analyte alarm condition, a "predicted high" analyte alarm condition, a "predicted low" analyte alarm condition, a "sudden drop" analyte alarm condition, a "sudden rise" analyte alarm condition, a "loss of signal" condition, and the like.

[0049] According to other aspects of the embodiment, a carbohydrate icon 343 and / or a medication icon 344 may be displayed in the icon area to indicate a meal event or an insulin event, respectively. Additionally, according to some embodiments, a specific amount of carbohydrates (in grams) and / or the type of insulin (e.g., fast-acting or long-acting) and number of units infused by the user may also be displayed next to the carbohydrate icon 343 or medication icon 344. Thus, at a glance, the user may be able to visually see whether an event (e.g., meal or insulin) and specific details about that event (e.g., grams of carbohydrates or units of fast-acting insulin) affected the trend line.

[0050] Additionally, while the icons are shown in an icon region separate from the graph portion of GUI 340, one skilled in the art will recognize that in alternative embodiments, the icons may be displayed directly on the graph adjacent to the trendline. Similarly, details of any alert conditions, grams of carbohydrates, and / or units of insulin may also be displayed directly on the graph adjacent to the trendline. In some examples, information corresponding to events such as a user-initiated analyte check 315 and / or an exercise icon 316 may be included in the icon region along the x-axis (e.g., instead of on the graph portion adjacent to the trendline).

[0051] Referring now to FIG. 3E, another exemplary embodiment of a report GUI 345 of an analyte monitoring system is shown, where the report GUI 345 includes multiple interfaces 345-A, 345-B, and 345-C, each showing a user's analyte levels over a different predetermined time period along with multiple summary metrics. First, the report GUI 345 includes similar features to the report GUI 320 of FIG. 3B. Furthermore, each of the multiple interfaces 345-A, 345-B, and 345-C includes similar features to those of the GUI 340 of FIG. 3D. Therefore, those similar features will not be repeated here.

[0052] 3F, another exemplary embodiment of a report GUI 350 for an analyte monitoring system is shown, where report GUI 350 includes multiple interfaces 350-A, 350-B, and 350-C, each showing a user's analyte levels over different predetermined time periods along with multiple summary metrics. First, report GUI 350 includes similar features to report GUI 345 of FIG. 3E, except that report GUI 350 does not include an alert label. Therefore, those similar features will not be repeated here.

[0053] 3G, another exemplary embodiment of a GUI 355 for an analyte monitoring system is shown, where GUI 335 shows a user's analyte levels over a predetermined time period along with a number of summary metrics. First, GUI 355 includes similar features to GUI 330 of FIG. 3C. Therefore, those similar features will not be repeated here.

[0054] According to one aspect of the embodiment, GUI 355 may include a maximum analyte level 356 and a minimum analyte level 357 for a given time period. Similarly, a maximum analyte level 359 and a minimum analyte level 358 for each time increment (e.g., hourly) may be displayed adjacent to the graph portion along the x-axis. Further, as can be seen in FIG. 3G , if either the minimum or maximum analyte level is higher than the target analyte range, then the numerical value may be displayed in a first color (e.g., orange). The first color may correspond to the color of the portion of the trend line and / or the shaded area where the user's analyte level is higher than the target analyte range. Similarly, if either the minimum or maximum analyte level is lower than the target analyte range, then the numerical value may be displayed in a second color (e.g., red). The second color may correspond to the color of the portion of the trend line and / or the shaded area where the user's analyte level is lower than the target analyte range. In contrast, if either the minimum or maximum analyte level is within the target analyte range, then the numerical value may be displayed without coloring. Instead, the numerical value may be displayed in a color corresponding to the color of the portion of the trend line when the user's analyte level is within the target analyte range. Thus, GUI 355 draws the user's attention to the portion of the trend line that is outside the target analyte range and the corresponding minimum or maximum analyte level numerical value, allowing the user to ascertain the underlying reason.

[0055] Referring now to FIG. 3H, another exemplary embodiment of a GUI 360 for an analyte monitoring system is shown, which displays a user's analyte levels over a predetermined time period along with several summary metrics. First, GUI 360 includes similar features to GUI 355 of FIG. 3G, except for the color scheme. In particular, if either the minimum or maximum analyte level is higher than the target analyte range, then the numerical value is displayed in a first, muted color (e.g., yellow). The muted color may correspond to a muted shade of the color of the portion of the trendline and / or the shaded area where the user's analyte level is higher than the target analyte range. A detailed description of similar features will not be repeated here.

[0056] Referring now to FIG. 3I, another exemplary embodiment of a report GUI 365 of an analyte monitoring system is shown, where report GUI 365 includes multiple interfaces 365-A, 365-B, 365-C, and 365-D, each showing a user's analyte levels over a different predetermined time period along with multiple summary metrics. First, report GUI 365 includes similar features to report GUI 350 of FIG. 3F. Furthermore, each of multiple interfaces 365-A, 365-B, 365-C, and 365-D includes similar features to those of GUI 360 of FIG. 3H. Accordingly, a detailed description of those similar features will not be repeated here.

[0057] Referring now to FIG. 3J , another exemplary embodiment of a GUI 370 for an analyte monitoring system is shown, which displays a user's analyte levels over a predetermined time period along with several summary metrics. First, GUI 370 includes similar features to GUI 355 of FIG. 3G . For example, GUI 370 includes a maximum analyte level 372 and a minimum analyte level 374 for each time increment (e.g., hourly), each displayed adjacent to a graph portion along the x-axis. Furthermore, as can be seen in FIG. 3J , if either the minimum or maximum analyte level is higher than the target analyte range, then the numerical value may be displayed in a first color (e.g., orange). Similarly, if either the minimum or maximum analyte level is lower than the target analyte range, then the numerical value may be displayed in a second color (e.g., red). Conversely, if either the minimum or maximum analyte level is within the target analyte range, then the numerical value may be displayed without coloring.

[0058] However, according to some embodiments, GUI 370 may have a number of differences from GUI 355 of FIG. 3G . In particular, GUI 370 does not include some of the summary metrics included in some of the previously described embodiments. For example, GUI 370 does not include a “time in range” metric. Furthermore, GUI 370 does not include the highest or lowest test substance level for a given overall time period. Similarly, GUI 370 does not include the total amount of food or medication ingested for a given time period. GUI 370 may be configured to include only dietary information without displaying any medication information. For example, in some embodiments, GUI 370 may include a carbohydrate icon 376 displayed directly on the graph portion, with a carbohydrate amount 378 displayed adjacent to (e.g., below) the graph. In other examples, GUI 370 may be configured to include only medication information without displaying any dietary information.

[0059] Referring now to FIG. 3K, another exemplary embodiment of a report GUI 380 of an analyte monitoring system is shown, where report GUI 380 includes multiple interfaces 380-A, 380-B, 380-C, and 380-D, each showing a user's analyte levels over a different predetermined time period along with multiple summary metrics. First, report GUI 380 includes similar features to report GUI 365 of FIG. 3I. Furthermore, each of multiple interfaces 380-A, 380-B, 380-C, and 380-D includes similar features to those of GUI 360 of FIG. 3H. Therefore, a detailed description of those similar features will not be repeated here.

[0060] However, according to one aspect of the embodiment, GUI 380 differs from the previously described embodiments in that each interface 380-A, 380-B, 380-C, and 380-D displays a minimum analyte level 382 or a maximum analyte level 384 for each time increment (e.g., hourly) only if it is outside of a target analyte range. For example, if minimum analyte level 382 is lower than the target analyte range, then the numerical value may be displayed in a first color (e.g., red). Similarly, if maximum analyte level 384 is higher than the target analyte range, then the numerical value may be displayed in a second color (e.g., yellow). In contrast, if the minimum analyte level or maximum analyte level for a particular time increment is within the target analyte range, then no numerical value is displayed to the user at all. In this manner, GUI 380 may highlight values ​​that are outside of the target analyte ranges, allowing the user to further focus on identifying the underlying reasons for such analyte deviations. In other words, the minimum and maximum analyte levels may be displayed if they are higher or lower than the target analyte range, but not within the target analyte range.

[0061] Referring now to FIG. 3L, another exemplary embodiment of a report GUI 385 of an analyte monitoring system is shown, where the report GUI 385 includes multiple interfaces 385-A, 385-B, and 385-C, each showing a user's analyte levels over a different predetermined time period along with multiple summary metrics. First, the report GUI 385 includes similar features to the report GUI 350 of FIG. 3F. Furthermore, each of the multiple interfaces 385-A, 385-B, and 385-C includes similar features to those of the GUI 330 of FIG. 3C. Accordingly, a detailed description of those similar features will not be repeated here.

[0062] However, according to one aspect of the embodiment, GUI 385 differs from the previous embodiments in that each interface 385-A, 385-B, and 385-C also includes a graphical representation of the medication taken. For example, interface 385-C shows a first bar portion 387 sized proportionally to the amount of fast-acting insulin taken around 7:00 a.m., which in this case is "1 u." Additionally, interface 385-C shows a second bar portion 388 sized proportionally to the amount of fast-acting insulin taken around 11:00 a.m., which in this case is "3 u." Therefore, second bar portion 388 is larger than first bar portion 387. Additionally, interface 385-C shows a medication icon 389 labeled "20 u," indicating the amount of long-acting insulin taken around 9:00 p.m. According to some embodiments, icons 389 are used to reflect different types of insulin (e.g., fast acting vs. long acting) and / or to take into account scale (i.e., the bar portions for 20u may not fit together when scaled by the first and second bar portions).

[0063] Referring now to FIG. 4A , an exemplary embodiment of a report settings GUI 405 of an analyte monitoring system is shown. According to one aspect of some embodiments, the display of minimum and maximum analyte levels may be enabled and / or disabled through the report settings GUI 405. In some embodiments, for example, the report settings GUI 405 includes an edit button 407 that, when pressed, further provides a checkbox 409 that allows the display of minimum and maximum analyte levels to be enabled or disabled. In some embodiments, the checkbox 409 may be provided via another interface, such as a modal. In other embodiments, the checkbox 409 may be provided on the report settings GUI 405. Furthermore, while the illustrated embodiment shows a checkbox 409, one skilled in the art will recognize that other GUI objects and / or features may be used, such as radio buttons, sliders, drop-down menus, switches, etc. In some embodiments, the display of minimum and maximum analyte levels may be enabled by default. In other embodiments, the display of minimum and maximum analyte levels may be disabled by default.

[0064] 4B, an exemplary embodiment of a report GUI 415 of an analyte monitoring system is shown, with the display of minimum and maximum analyte levels enabled via report settings GUI 405 (FIG. 4A). In many respects, report GUI 415 includes similar features as GUI 360 (FIG. 3H) and report GUI 365 (FIG. 3I). Accordingly, a detailed description of those similar features will not be repeated here. It should further be noted that the functionality to enable and / or disable the display of minimum and maximum analyte levels may be implemented in any of the GUIs and report GUIs described herein, including minimum and maximum analyte levels.

[0065] 4C-4E, exemplary embodiments of GUIs for an analyte monitoring system are shown. According to one aspect of the embodiment, GUIs 425, 435, and 445 are exemplary embodiments of GUIs configured to display a user's analyte levels over a predetermined time period, with the display of minimum and maximum analyte levels disabled via report settings GUI 405 (FIG. 4A). For example, FIG. 4C is an exemplary embodiment of GUI 425 showing a user's analyte levels over a predetermined time period, with the analyte data being transmitted from the sensor controller to a reader upon scanning or requesting data (e.g., via NFC) by the reader. As another example, FIG. 4D is an exemplary embodiment of GUI 435 showing a user's analyte levels over a predetermined time period, with the analyte data being transmitted from the sensor controller to a reader both automatically and upon scanning or requesting data (e.g., via NFC) by the reader. As yet another example, Figure 4E is an exemplary embodiment of a GUI 445 showing a user's analyte levels over a predetermined period of time, with the analyte data automatically transmitted (e.g., via Bluetooth) from the sensor control device to the reader. Additionally, although not shown, according to numerous embodiments, GUIs 425, 435, 445 can be configured to display a graph portion along with multiple summary metrics, such as those shown in Figures 3A and 3B and elsewhere throughout this disclosure.

[0066] According to another aspect of some embodiments, information related to multiple analytes may be displayed in a GUI or report GUI in a manner similar to the previously disclosed embodiments. Figure 5 illustrates an exemplary embodiment of a report GUI 510 for an analyte monitoring system, where the report GUI 510 includes multiple interfaces, each showing a user's analyte levels over different predetermined time periods along with multiple summary metrics. In many respects, the GUI 510 includes similar features to the report GUI described with respect to Figure 3I. Accordingly, a detailed description of those similar features will not be repeated here.

[0067] According to another aspect of some embodiments, the report GUI 510 may further include information related to a second analyte, such as, for example, ketones. In particular, multiple interfaces may be provided, each showing a user's glucose and ketone levels over a predetermined time period. Additionally, in some embodiments, summary metrics 515 for the second analyte (e.g., ketones) may be displayed, which may include, for example, the number of high ketone threshold alarms 517, the number of rising ketone threshold alarms 518, and / or the highest ketone level 519 over a predetermined time period. Additionally, in some embodiments, a graph portion 520 adjacent to the glucose graph portion shows ketone levels over a predetermined time period, and the graph portion 520 is aligned along the same x-axis (e.g., time) as the glucose graph portion. As shown in FIG. 5 , in some embodiments, the graph portion 520 may include a trendline 521 showing the user's ketone levels over a predetermined time period. In other embodiments, discrete points of data may be displayed instead of the trendline 521. Additionally, graph portion 520 may also include numerical values ​​522, 523 that exceed a high or elevated ketone threshold. As can be seen in FIG. 5, the numerical values ​​may be displayed with distinctive shading or coloring associated with a particular threshold. In some embodiments, graph portion 520 may also include an alarm indicator 525 (e.g., text, a marker, an icon, or a symbol) to indicate to the user when a ketone alarm condition has been triggered. According to aspects of some embodiments, numerical values ​​522, 523 and alarm indicator 525 may be positioned on graph portion 520 and aligned on the same x-axis (e.g., time) as trendline 521 and the glucose graph portion.

[0068] According to another aspect of some embodiments, the report GUI 510 may be configured to not display a trendline if the level of a second analyte (e.g., ketones) is within a predetermined target range over a predetermined time period. Referring again to FIG. 5 , an exemplary embodiment of a second interface is shown, including a second summary metric portion 550 and a second graph portion 555, as shown below the first interface described above. Here, during the second predetermined time period (e.g., "Monday, June 4"), the level of the second analyte is within the predetermined target range. Thus, the second summary metric 550 may indicate that no alarms were activated during the second predetermined time period. Furthermore, the second graph portion 555 may not include a trendline, but instead may include an indicator (e.g., text, a marker, an icon, or a symbol) indicating that the level of the second analyte was "normal" during the second predetermined time period. In some embodiments, the second graph portion 555 may be compact compared to the first graph portion 520 because the report GUI 510 requires less space.

[0069] Those skilled in the art will recognize that any GUI, report interface, or portions thereof described herein are intended to be illustrative only, and that any individual element or combination of elements shown and / or described with respect to a particular embodiment or figure may be freely combined with any element or combination of elements shown and / or described with respect to any other embodiment. For example, each described embodiment may provide or omit display of meal information (e.g., carbohydrate amount) and medication information (e.g., fast-acting and long-acting insulin) for each time increment. Furthermore, each described embodiment may provide or omit display of alert icons and alert labels for a given time period. Each described embodiment may also provide or omit display of a graphical representation of medication amounts. Each described embodiment may provide or omit display of summary metrics for total meal amount information and / or total medication amount information over a given time period. Each described embodiment may provide or omit display of a "time in range" metric. In each of the described embodiments, coloring of the graphs (eg, trend lines, threshold lines, and / or shading) may be provided or omitted.

[0070] In some embodiments, data indicative of the user's analyte level may be transmitted automatically (i.e., without user intervention) wirelessly from the sensor control device 102 to the reader 120. For example, the sensor control device 102 may periodically transmit analyte data to the reader (e.g., via Bluetooth or BLE) without requiring the user to perform a manual scan (e.g., via NFC).

[0071] In an analyte monitoring system in which data indicative of a user's analyte levels is wirelessly and automatically transmitted from the sensor control device 102 to the reader device 120, embodiments described herein may advantageously display a numerical value associated with the subject's analyte level for each time increment within a predetermined time period (or a subset thereof) to enable the user (or the user's HCP) to make a more informed decision. The numerical value associated with each time increment may further be correlated with events such as medication, exercise, and / or meals, thereby providing the user (or the user's HCP) with a robust overview of the user's overall glycemic control over a predetermined period of time.

[0072] Those skilled in the art will also appreciate that any of the GUIs, reporting interfaces, or portions thereof described herein can be provided with an analyte monitoring system that monitors one or more types of analytes. These analytes can include one or more of glucose, ketones, lactate, alcohol, or any other analyte detectable in a user's bodily fluids. Preferably, the analyte includes glucose. Those skilled in the art will also appreciate that the GUIs, reporting interfaces, or portions thereof described herein can incorporate data received from multiple analyte monitoring systems and associated devices, including incorporating data from devices that obtain ex vivo analyte measurements and / or physiological measurements.

[0073] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with any other embodiment. When a 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 unless expressly stated otherwise. Therefore, this paragraph serves as a precursor and supporting description for introducing claims that combine features, elements, components, functions, and steps from different embodiments or replace features, elements, components, functions, and steps from one embodiment with those from other embodiments, even if the following description does not explicitly state that such combinations and substitutions are possible in a particular case. We expressly state that explicitly listing all possible combinations and substitutions would be an excessive burden, especially given that those skilled in the art would readily recognize that such combinations and substitutions are possible.

[0074] While the embodiments are susceptible to various modifications and alternative forms, specific examples have been shown in the drawings and are described in detail herein. However, it should be understood that these embodiments are not limited to the particular forms disclosed; rather, these embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of the embodiments may be recited or added to the claims, and negative limitations may be added to the claims that define the scope of the claims by any feature, function, step, or element not included in the scope of the claims.

[0075] That is, an improved graphical user interface for an analyte monitoring system is provided. For example, various embodiments of GUIs are disclosed herein, each including a graph portion including a trendline showing a user's analyte levels over a predetermined time period, and a plurality of summary metrics including a plurality of minimum and maximum analyte levels associated with a plurality of time increments within the predetermined time period. In many embodiments, the plurality of minimum and maximum analyte levels are aligned with the x-axis of the graph portion.

[0076] The present disclosure also includes the following bulleted items: 1. In a test substance monitoring system, a sensor control device including an analyte sensor connected to sensor electronics, the sensor control device configured to be worn on a body of a user and to transmit data indicative of the user's analyte level; A reading device and and the reading device includes: A display unit; wireless communication circuitry configured to receive data indicative of the analyte level of the user; one or more processing units coupled to a memory configured to store instructions; the instructions, when executed by the one or more processors, cause the one or more processors to output a graphical user interface (GUI) on a display unit, the graphical user interface (GUI) including: a graph portion including a trend portion showing the user's analyte level over a predetermined period of time based on the received data showing the user's analyte level; Multiple summary metrics related to a given time period and and the plurality of summary metrics includes a plurality of minimum and maximum analyte levels associated with a plurality of time step sizes within a predetermined time period; An analyte monitoring system wherein the graph portion includes an x-axis containing units of time, and wherein a plurality of minimum analyte levels and maximum analyte levels are aligned with the x-axis of the graph portion. 2. A test substance monitoring system as described in paragraph 1, wherein the predetermined period is one day. 3. The test substance monitoring system of claim 1, wherein the plurality of time step widths includes 24 one-time step widths. 4. A test substance monitoring system according to any one of paragraphs 1 to 3, wherein the x-axis includes a plurality of labels arranged in two-time intervals. 5. The analyte monitoring system of claim 1, wherein the graph portion further includes a y-axis containing units indicating analyte level concentration. 6. The test substance monitoring system of any one of paragraphs 1 to 5, wherein the graph portion further includes a first label for an upper test substance threshold and a second label for a lower test substance threshold. 7. The graph portion further includes a first line indicating an upper analyte threshold; and 7. The analyte monitoring system of any one of paragraphs 1 to 6, further defining a second line indicating a lower analyte threshold. 8. Multiple minimum and maximum test substance levels are one or more lowest analyte levels shown in a first color if the one or more lowest analyte levels are above the upper analyte level threshold; If one or more highest test substance levels are above the upper test substance level threshold, the one or more highest test substance levels are shown in a first color. 8. The test substance monitoring system of any one of claims 1 to 7, comprising: 9. The plurality of minimum test substance levels and the plurality of maximum test substance levels further comprise: one or more lowest analyte levels shown in a second color if the one or more lowest analyte levels are below the lower analyte level threshold; If one or more highest test substance levels are below the lower test substance level threshold, the one or more highest test substance levels will be shown in a second color. 9. The test substance monitoring system of claim 8, comprising: 10. The analyte monitoring system of any one of claims 1 to 9, wherein the plurality of summary metrics further includes a time-in-range metric. 11. The test substance monitoring system of paragraph 10, wherein the time-in-range metric is displayed as a percentage. 12. The test substance monitoring system of any one of paragraphs 1 to 11, wherein the plurality of summary metrics further includes a total amount of carbohydrates ingested over a given period of time. 13. The test substance monitoring system of any one of paragraphs 1 to 12, wherein the plurality of summary metrics further includes a total amount of medication taken over a given period of time. 14. The analyte monitoring system of any one of paragraphs 1 to 13, wherein the trend portion includes a first portion of a first color and a second portion of a second color, the first portion indicating an analyte level above an upper analyte threshold and the second portion indicating an analyte level between the lower analyte threshold and the upper analyte threshold. 15. The analyte monitoring system of paragraph 14, wherein the trend portion further includes a third portion of a third color, the third portion indicating an analyte level below the lower analyte threshold. 16. An icon region configured to display multiple event icons; Further including, 16. The analyte monitoring system of any one of paragraphs 1 to 15, wherein the plurality of event icons includes at least one of an alarm icon, a carbohydrate icon, and a medication icon. 17. A test substance monitoring system according to paragraph 16, wherein the alarm icon includes an alarm label configured to textually describe the alarm condition associated with the alarm icon. 18. The analyte monitoring system of paragraph 16 or 17, wherein the alarm condition is selected from the group of a high analyte alarm condition, an urgent low analyte alarm condition, a predicted high analyte alarm condition, a predicted low analyte alarm condition, a sudden drop analyte alarm condition, a sudden rise analyte alarm condition, and a loss of signal condition. 19. A test substance monitoring system as described in any one of paragraphs 16 to 18, wherein the multiple event icons are configured to be displayed in alignment with the x-axis of the graph portion. 20. The analyte monitoring system of any one of paragraphs 1 to 19, wherein the data indicative of the user's analyte level includes glucose data. [Explanation of symbols]

[0077] 102 Sensor control device 104 Test substance sensor 120 Reading Device

Claims

1. In the test substance monitoring system, a sensor control device including an analyte sensor connected to sensor electronics, the sensor control device configured to be worn on a body of a user and to transmit data indicative of an analyte level of the user; A reading device and The reading device includes: A display unit; wireless communication circuitry configured to receive the data indicative of the analyte level of the user; one or more processing units coupled to a memory configured to store instructions; the instructions, when executed by the one or more processing units, cause the one or more processing units to output a graphical user interface (GUI) on the display unit, the graphical user interface (GUI) comprising: a graph portion including a trend portion showing the user's analyte level over a predetermined period of time based on the received data showing the user's analyte level; a plurality of summary metrics associated with the predetermined time period; and the plurality of summary metrics includes a minimum analyte level for the predetermined time period and a maximum analyte level for the predetermined time period; The graph portion further includes an x-axis containing units of time, and a plurality of minimum analyte levels for a plurality of time increments and a plurality of maximum analyte levels for the plurality of time increments are aligned with the x-axis of the graph portion.

2. The analyte monitoring system of claim 1 , wherein the predetermined period is one day.

3. The analyte monitoring system of claim 1 , wherein the plurality of time step sizes includes 24 one-time step sizes.

4. The analyte monitoring system of claim 3 , wherein the x-axis includes a plurality of labels arranged in two-time increments.

5. 10. The analyte monitoring system of claim 1, wherein the graph portion further comprises a y-axis containing units indicating analyte level concentration.

6. 10. The analyte monitoring system of claim 1, wherein the graph portion further includes a first label for an upper analyte threshold and a second label for a lower analyte threshold.

7. The graph portion further includes a first line indicating the upper analyte threshold; 7. The analyte monitoring system of claim 6, further defining a second line indicating a lower analyte threshold.

8. The plurality of minimum analyte levels for the plurality of time step sizes and the plurality of maximum analyte levels for the plurality of time step sizes are one or more lowest analyte levels shown in a first color if the one or more lowest analyte levels are above the upper analyte level threshold; and one or more highest analyte levels shown in the first color if the one or more highest analyte levels are greater than the upper analyte level threshold.

7. The analyte monitoring system of claim 6, comprising:

9. The minimum analyte levels for the plurality of time step sizes and the maximum analyte levels for the plurality of time step sizes may further comprise: one or more lowest analyte levels shown in a second color if the one or more lowest analyte levels are below the lower analyte level threshold; If one or more highest analyte levels are below the lower analyte level threshold, the one or more highest analyte levels are shown in the second color.

9. The analyte monitoring system of claim 8, comprising:

10. The analyte monitoring system of claim 1 , wherein the plurality of summary metrics further comprises a time-in-range metric.

11. The analyte monitoring system of claim 10 , wherein the time in range metric is displayed as a percentage.

12. The analyte monitoring system of claim 1 , wherein the plurality of summary metrics further comprises a total amount of carbohydrates ingested during the predetermined time period.

13. The analyte monitoring system of claim 1 , wherein the plurality of summary metrics further comprises a total amount of medication taken during the predetermined period of time.

14. 7. The analyte monitoring system of claim 6, wherein the trend portion includes a first portion of a first color and a second portion of a second color, the first portion indicating analyte levels above the upper analyte threshold and the second portion indicating analyte levels between the lower analyte threshold and the upper analyte threshold.

15. 15. The analyte monitoring system of claim 14, wherein the trend portion further includes a third portion of a third color, the third portion indicating an analyte level below the lower analyte threshold.

16. an icon region configured to display a plurality of event icons; Further including, The analyte monitoring system of claim 1 , wherein the plurality of event icons includes at least one of an alarm icon, a carbohydrate icon, and a medication icon.

17. 17. The analyte monitoring system of claim 16, wherein the alarm icon includes an alarm label configured to textually describe an alarm condition associated with the alarm icon.

18. 17. The analyte monitoring system of claim 16, wherein the alarm condition is selected from the group of a high analyte alarm condition, an urgent low analyte alarm condition, a predicted high analyte alarm condition, a predicted low analyte alarm condition, a sudden drop analyte alarm condition, a sudden rise analyte alarm condition, and a loss of signal condition.

19. 17. The analyte monitoring system of claim 16, wherein the plurality of event icons are configured to be displayed aligned with an x-axis of the graph portion.

20. The analyte monitoring system of claim 1 , wherein the data indicative of the user's analyte level includes glucose data.

21. The analyte monitoring system of claim 1 , wherein the trend portion comprises a continuous trendline.

22. 10. The analyte monitoring system of claim 1, wherein the trend portion includes a plurality of discrete data points.

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