Graphical User Interface for an Analyte Monitoring System

Abstract

Presented herein are improved graphical user interfaces for analyte monitoring systems. In particular, disclosed herein are various embodiments of a time-per-variation band interface and an analyte value and trend alert interface.

Description

Technical Field

[0001] The subject matter described herein generally relates to a graphical user interface of an analyte monitoring system, as well as related methods and apparatus.

Background Art

[0002] The detection, monitoring, or both of analyte values such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc. can be very important for the health of individuals suffering from diabetes. Patients suffering from type 2 diabetes may develop complications such as loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their blood glucose levels to ensure that they are maintained within a clinically safe range, and use this information to determine whether insulin is needed to lower their blood glucose levels in their body, when it is needed, or both, or to determine when additional glucose is needed to increase their blood glucose levels in their body.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Increasing clinical data has demonstrated a strong correlation between the frequency of blood glucose monitoring and blood glucose management. However, despite such a correlation, many people diagnosed with diabetes symptoms do not monitor their blood glucose levels as often as they should, and this is due to a combination of various factors such as convenience, the degree of discretion in testing, pain associated with blood glucose testing, cost, etc.

[0004] To enhance a patient's compliance with a frequent blood glucose monitoring plan, an in vivo analyte monitoring system can be utilized. In such a system, a sensor control device may be attached to the body of an individual who requires analyte monitoring. To improve the comfort and convenience of the individual, the sensor control device has a small form factor and can be operated by the individual who has the sensor applicator. The application process involves using an applicator or inserter to insert at least a portion of a sensor that senses the user's analyte value in a body fluid located within a layer of the human body, so as to bring the sensor into contact with the body fluid. The sensor control device may also be configured to transmit analyte data to another device, and upon receiving it, the individual or their healthcare provider (HCP) can examine the data and make a treatment decision.

[0005] However, despite these advantages, there are some individuals who are reluctant to use an analyte monitoring system for various reasons, such as the complexity and large volume of the presented data, the issue of time-dependent familiarity related to the software and user interface for the analyte monitoring system, and the overall lack of information that can be implemented on the spot when presented.

[0006] Therefore, there is a need for a graphical user interface for an analyte monitoring system that is robust, user-friendly, and prepared for timely on-the-spot implementation, as well as related methods and devices.

Means for Solving the Problem

[0007] This specification presents various specific embodiments of a graphical user interface (GUI) for an in-body analyte monitoring system. In some embodiments, a time-in-range (TIR) graphical user interface for the analyte monitoring system is provided, where the TIR graphical user interface includes a plurality of graph bars or portions of graph bars, and each bar or portion of a bar indicates the amount of time that the user's analyte value has remained within a predetermined analyte value range associated with that bar or portion of a bar. For example, in some embodiments, the amount of time may be expressed as a percentage of the total time. According to another embodiment, an analyte value trend warning graphical user interface for the analyte monitoring system is presented, in which case the analyte value trend warning graphical user interface includes visual notifications (e.g., warnings, alerts, pop-up windows, banner notifications, etc.), where the visual notifications include an alert state, an analyte measurement value associated with the alert state, and a trend indicator associated with the alert state. In some embodiments, for example, the trend indicator may include a trend arrow indicating a direction.

[0008] The embodiments presented in this specification are an improved graphical user interface (GUI) or GUI functionality for an analyte monitoring system that is highly intuitive, easy to use from the user's perspective, and provides quick access to the user's physiological information. More specifically, these embodiments enable two or more different user interfaces to quickly present the user with various physiological symptoms, in-situ actionable responses, or both, and enable the user to perform simple operations between these user interfaces, without the user (or healthcare provider) being required to perform the time-consuming task of reviewing large amounts of analyte data. Various other improvements and advantages are similarly provided. The various configurations of such devices will be described in detail by each embodiment, but these embodiments are merely examples.

[0009] Various systems, devices, methods, features, and advantages of the subject matter described in this specification other than those described above will become apparent to those skilled in the art upon examination of the description of the figures and the detailed description hereinafter. All such various systems, devices, methods, features, and advantages in addition to those described above are included in the detailed description of the present case, are within the scope of the subject matter described in this specification, and are intended to be protected by the appended claims. The features of each specific embodiment should in no way be construed as limiting the appended claims unless there is a clear recitation of those features in the claims.

Brief Description of the Drawings

[0010] The details of the subject matter disclosed in this specification will likely become apparent upon examination of the accompanying drawings with respect to both its configuration and operation, where like reference numerals in the figures refer to like elements. The components in the figures are not necessarily to scale; rather, emphasis has been placed on depicting the principles of the subject matter. Further, all drawings are intended to convey concepts, and relative dimensions, shapes, and other detailed attributes may not be exact as stated or strict, but rather may be drawn schematically in some cases.

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[0011] Before describing the subject matter of the present application in detail, it should be understood that the present disclosure is not limited to the specific embodiments described as such and can naturally be modified. Since the scope of the present disclosure is limited only by the appended claims, it should also be understood that the terms used in this specification are only for the purpose of describing specific embodiments and are not intended to be limiting.

[0012] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0013] The publications discussed in this specification are presented only to show that they were disclosed prior to the filing date of the present application. It should not be construed from the prior art disclosure that the present disclosure is qualified to precede such publications. Further, the publication dates presented may differ from the actual publication dates and may need to be individually verified.

[0014] Generally, each embodiment of the present disclosure includes a graphical user interface (GUI) for an analyte monitoring system, as well as related methods and apparatuses. Thus, many embodiments include an in vivo analyte sensor, which is structured such that at least a portion of the sensor is present within the user's body or is installable within the body and configured to obtain information about at least one analyte in the body. However, it should be noted that each embodiment disclosed herein can be used in combination with an in vivo analyte monitoring system that includes an ex vivo function, and can also be used in combination with a purely ex vivo or ex vivo analyte monitoring system, such as various fully non-invasive systems.

[0015] Furthermore, for any one of the embodiments of the methods disclosed herein, the various systems and apparatuses capable of implementing each of these embodiments are included within the scope of the present disclosure. For example, embodiments of various sensor control devices, reading devices, local computer systems, and trusted computer systems are disclosed, and these various devices and systems can perform any method step or facilitate the execution of any method step, and are preferably provided with one or more sensors, analyte monitoring circuits (e.g., analog circuits), memories (e.g., for storing various instructions), power supplies, communication circuits, transmitters, receivers, arithmetic processing circuits, control devices (e.g., for executing various instructions), or various combinations thereof.

[0016] As described above, a number of the embodiments described herein provide improved graphical user interfaces (GUIs) for various analyte monitoring systems, each graphical user interface being highly intuitive, user-friendly from the user's perspective, and equipped for rapid access to the user's physiological information. Some embodiments provide a time amount graph graphical user interface for each range of variation for an analyte monitoring system, the time amount graph graphical user interface for each range of variation including a plurality of graph bars or bar portions, each bar or bar portion indicating the amount of time the user's analyte value has remained within a predetermined analyte value range associated with each such bar or bar portion. According to another embodiment, an analyte value-trend warning graphical user interface for an analyte monitoring system is provided, the analyte value-trend warning graphical user interface including visual notifications (such as warnings, alerts, pop-up windows, banner notifications, etc.), the visual notifications including an alert state, an analyte measurement value associated with the alert state, and a trend indicator associated with the alert state. In short, these embodiments provide various interfaces that are robust and user-friendly from the user's perspective, which, if listing several advantages, can make the user more actively engage with the analyte monitoring system and are equipped for the user to make timely on-site responses.

[0017] However, prior to discussing these aspects of each embodiment in detail, it is desirable to first describe, for example, specific examples of various devices that can be incorporated within an in vivo analyte monitoring system, as well as specific examples of their operations, all of which can be used in combination with the embodiments described herein.

[0018] There are various types of in - vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can operate without prompting the user to send data continuously from a sensor control device to a reader device, and can be executed automatically, for example, according to a schedule. As another example, an "instantaneous analyte monitoring" system (or "instantaneous glucose monitoring" system or simply "instantaneous" system) can be executed by responding to a scan or data request by a reader device that uses a near - field communication (NFC) protocol or a radio - frequency identification (RFID) protocol when sending data from a sensor control device. The in - vivo analyte monitoring system can also operate without the need for finger - stick assays.

[0019] The in - vivo analyte monitoring system can be differentiated from an "ex - vivo" system, which typically includes a measurement device having a port for receiving an analyte test strip that contacts a biological sample ex - vivo (i.e., "ex - vivo") and can hold a user's body fluid that can be an analyte for analysis to determine a blood glucose value.

[0020] The in - vivo monitoring system includes a sensor that can contact the user's body fluid and sense the analyte value contained in the body fluid while being installed in the body. The sensor may form part of a sensor control device that resides in the user's body and is equipped with electronic devices and a power source that enable and control analyte sensing. The sensor control device and its various variations may be referred to, by way of example, as a "sensor control unit", a "body - mounted electronic device" or "body - mounted electronic device" unit, a "body - mounted" device or "body - mounted" unit, or a "sensor - data communication" device or "sensor - data communication" unit.

[0021] The in-vivo monitoring system may also be equipped with another type of device. After receiving the sensed analyte data from the sensor control device, this device processes the sensed analyte data and displays it to the user in multiple forms, regardless of the number. This device and its various variants may be referred to by several names, such as "handheld reader", "reader" (or simply "leader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or "portable data processing" unit, "data receiver", "receiver" device or "receiver" unit (or simply "receiver"), or "remote" device or "remote" unit. Various devices other than the above, such as personal computers, may also be used in combination with the in-vivo monitoring system and the ex-vivo monitoring system, or may be incorporated into a part of both systems.

Example

[0022] Embodiment of a specific example of an in-vivo analyte monitoring system FIG. 1 is a conceptual diagram depicting an embodiment of a specific example of an analyte monitoring system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor control device 102 can be applied to a monitoring site on the user's skin using the sensor applicator 150, where the sensor 104 is maintained in place for a period of time by the adhesive patch 105. The sensor control device 102 is further described in FIGS. 2B and 2C and can communicate with the reader device 120 via the communication path 140 by utilizing a wired or wireless technology. Specific examples of wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), and others. The user can view and use the applications installed in the memory of the reader device 120 by using the image display device 122 (which may include a touch screen in many embodiments) and the input unit 121. The device battery of the reader device 120 can be recharged using the power port 123. Although only one reader device 120 is shown in the figure, the sensor control device 102 can communicate with multiple reader devices 120. The reader devices 120 can communicate with each other and share data. Further details regarding the reader device 120 are specified below with respect to FIG. 2A. The reader device 120 can communicate with the local computer system 170 via the communication path 141 using a wired communication protocol or a wireless communication protocol. The local computer system 170 may include one or more of a laptop type, a desktop type, a tablet type, a phablet type, a smartphone type, a set-top box type, a video game console type, or other computing devices, and the wireless communication may be provided with any of Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or other various communication standards.The local computer system 170 can communicate with the network 190 via the communication path 143 in the same way that the reading device 120 can communicate with the network 190 via the communication path 142 by the aforementioned wired communication protocol or wireless communication protocol. The network 190 can be any of a number of networks, such as a private network and a public network, a local area network or a wide area network. The trusted computer system 180 may include a server, can provide authentication services and a protected data storage location, and can communicate with the network 190 via the communication path 144 by wired technology or wireless technology.

[0023] Embodiment of a specific example of a reading device FIG. 2A is a block diagram depicting an embodiment of a specific example of the reading device 120, and in some embodiments, it may include a smartphone. Here, the reading device 120 may be composed of, for example, a processing core 206 including an image display device 122, an input unit 121, and a communication processing device 222 connected to a memory 223 and an application processing device 224 connected to a memory 225. It may also include a separate memory 230, a radio frequency (RF) transceiver 228 equipped with an antenna 229, and a power supply 226 equipped with a power management module 238. Further, the reading device 120 may be equipped with a multifunctional transceiver 232 that can communicate via Wi-Fi, near field communication (NFC), Bluetooth, BTLE, and GPS using an antenna 234. As will be understood by those skilled in the art, these components are electrically and communicatively connected in such a manner as to provide functional devices.

[0024] Embodiment of a specific example of a sensor control device 2B and 2C are block diagrams illustrating an exemplary embodiment in which the sensor controller 102 includes an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that can provide the majority of the processing power to provide final result data suitable for display to a user. Although FIG. 2B illustrates a single semiconductor chip 161, the chip may be a custom-made application specific integrated circuit (ASIC). Illustrated within the application specific integrated circuit 161 are certain highly functional devices, such as an analog front end (AFE) 162, power management (or power control) circuitry 164, a processor 166, and communication circuitry 168 (implemented as a transmitter, receiver, transceiver, passive circuitry, or other devices depending on the communication protocol). In this embodiment, both the analog front end 162 and the processor 166 are used as analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. The processor 166 may be comprised of one or more processors, microprocessors, controllers, microcontrollers, or various combinations thereof, each of which may be a discrete chip or may be distributed among many different chips (or among some of these chips).

[0025] Memory 163 is also included within the application specific integrated circuit (ASIC) 161 and may be shared by various functional devices present within the ASIC 161 or may be distributed among two or more of such functional devices. Memory 163 may be a separate chip. Memory 163 may be volatile memory, non-volatile memory, or both. In this embodiment, the application specific integrated circuit 161 is connected to a power source 170, which may be a coin-type battery or the like. The analog front end (AFE) 162 serves as an intermediary function with the in vivo analyte sensor 104, receives measurement data from the sensor, and outputs the data in digital form to the arithmetic processing unit 166. In turn, the arithmetic processing unit 166 processes the data to arrive at the final result of the blood glucose discrete value, blood glucose trend value, and other various final result values. This data is then provided to the communication circuit 168 and transmitted via the antenna 171 to, for example, a reader device 120 (not shown), in which case, minimal further processing is required to display the data on the screen by a resident software application.

[0026] FIG. 2C is similar to FIG. 2B, but instead includes two discrete semiconductor chips 162, 174, which may be packaged together or separately. Here, the analog front end (AFE) 162 resides in the application specific integrated circuit (ASIC) 161. The arithmetic processing unit 166 is integrated on chip 174 together with the power management circuit 164 and the communication circuit 168. The analog front end 162 includes a memory 163, and the chip 174 includes a memory 165, and these memories may be isolated internally or distributed internally. In a specific embodiment, the analog front end 162 is combined with the power management circuit 164 and the arithmetic processing unit 166 on a single chip, while the communication circuit 168 is on a separate chip. In another specific example embodiment, both the analog front end 162 and the communication circuit 168 are on a single chip, and the arithmetic processing unit 166 and the power management circuit 164 are on another single chip. It should be noted that combinations of chips including three or more chips other than the above are also possible, and each of the chips is responsible for the individual functions described above or shares one or more functions to obtain fail-safe redundancy.

[0027] Example embodiment of the user interface of the analyte monitoring system This section describes an embodiment of a specific example of a graphical user interface (GUI) for an analyte monitoring system. As an initial matter, those skilled in the art will appreciate that the graphical user interface described in this section is composed of various instructions stored in the memory of the reader 120, the memory of the local computer system 170, the memory of the trusted computer system 180, the memory of any other device or system that may be part of or communicate with the analyte monitoring system 100, or a combination of these. These instructions, when executed by one or more processing units of the reader 120, one or more processing units of the local computer system 170, one or more processing units of the trusted computer system 180, or one or more processing units of any other device or system of the analyte monitoring system 100 other than those described above, cause the one or more processing units to perform each step of the method described in this section, output each of the various graphical user interfaces described in this section, or both. Further, those skilled in the art will appreciate that each graphical user interface described in this section may be stored as instructions in the memory of a single information aggregation device, or, as an alternative, each graphical user interface may be distributed among a number of discrete devices in a geographically dispersed arrangement.

[0028] Figures 3A through 3F depict various specific embodiments of a graphical user interface (GUI) for an analyte monitoring system. Figures 3A through 3F depict, in particular, a graphical user interface of the amount of time per range of variation (also referred to as time-in-range, time-in-target, or amount of time of a target range), each including a plurality of graph bars or bar segments, where each bar or bar segment indicates the amount of time that the user's analyte value has remained within a predetermined range of analyte value ranges associated with that bar or bar segment. In some embodiments, for example, the amount of time is expressed as a percentage of a predetermined amount of time.

[0029] Referring back to FIGS. 3A and 3B, an embodiment of a specific example of a time amount graphical user interface (GUI) 305 for each variation range is illustrated. In this figure, the time amount graphical user interface 305 for each variation range is composed of a "customized" time amount screen display 305A for each variation range and a "standard" time amount screen display 305B for each variation range. In this case, it is provided with a toggle, switch, or slidable element 310 that allows the user to select between these two types of screen displays. According to one aspect of various embodiments, the time amount screen displays 305A and 305B for each variation range may each include a number of graph bars. In this case, what each bar indicates is the amount of time that the user's analyte value remains within the range of a predetermined analyte value range associated with each bar. Depending on the embodiment, the time amount screen displays 305A and 305B for each variation range further include a date range indicator 308 indicating the relevant date associated with the analyte data being displayed on the screen and a data validity indicator 314 indicating the period during which the analyte data is valid for the analyte data being displayed on the screen (for example, "the data is valid for 7 days out of 7 days", etc.).

[0030] Referring to FIG. 3A, the per-customized amount-of-time screen display 305A for each variation amount consists of six graph bars (from top to bottom) as follows. That is, the first bar indicating that the user's blood glucose range is higher than 250 mg / dL for 10% of a predetermined amount of time, the second bar indicating that the user's blood glucose range is between 141 mg / dL and 250 mg / dL for 24% of a predetermined amount of time, the third bar 316 indicating that the user's blood glucose range is between 100 mg / dL and 140 mg / dL for 54% of a predetermined amount of time, the fourth bar indicating that the user's blood glucose range is between 70 mg / dL and 99 mg / dL for 9% of a predetermined amount of time, the fifth bar indicating that the user's blood glucose range is between 54 mg / dL and 69 mg / dL for 2% of a predetermined amount of time, and the sixth bar indicating that the user's blood glucose range is lower than 54 mg / dL for 1% of a predetermined amount of time. Those skilled in the art will understand that the percentage of blood glucose range and time associated with each graph bar can vary depending on the range defined by the user and the analyte data available from the user. Further, FIGS. 3A and 3B show that the predetermined amount of time 314 is 7 days, but other predetermined amounts of time can also be used (e.g., 1 day, 3 days, 14 days, 30 days, 90 days, etc.) and are fully within the scope of this disclosure, which those skilled in the art will understand.

[0031] According to another aspect of each embodiment, the per-customized amount-of-time screen display 305A for the variation range also includes a user-definable target area of interest 312, and the target area of interest includes an "edit" link that can be implemented on the spot to allow the user to define, change, or both define and change the target area. As illustrated in the per-customized amount-of-time screen display 305A for each variation range, the target area of interest 312 is defined as the blood glucose range between 100 mg / dL and 140 mg / dL and corresponds to the third bar 316 among the plurality of graph bars.

[0032] Referring to FIG. 3B, the time amount screen display 305B for each "standard" variation range is composed of five graph bars (from the top to the bottom) as follows. That is, the first bar indicating that the user's blood glucose range is higher than 250 mg / dL is a period of 10% of the predetermined time amount, the second bar indicating that the user's blood glucose range is between 181 mg / dL and 250 mg / dL is a period of 24% of the predetermined time amount, the third bar indicating that the user's blood glucose range is between 70 mg / dL and 180 mg / dL is a period of 54% of the predetermined time amount, the fourth bar indicating that the user's blood glucose range is between 54 mg / dL and 69 mg / dL is a period of 10% of the predetermined time amount, and the fifth bar indicating that the user's blood glucose range is lower than 54 mg / dL is a period of 2% of the predetermined time amount. Similar to the time amount 305A for each "customized" variation range, it will be understood by those skilled in the art that the percentage of time associated with each graph bar can vary depending on the analyte data available from the user. However, unlike the time amount screen display 305A for each "customized" variation range, each blood glucose range illustrated in the "standard" screen display 305B cannot be adjusted by the user.

[0033] Figures 3C and 3D depict another specific example embodiment of a variable-range time amount graphical user interface (GUI) 320 that includes a plurality of screen displays 320A, 320B, which are similar to the screen displays illustrated in Figures 3A and 3B, respectively. Depending on the embodiment, the variable-range time amount graphical user interface 320 further includes one or more selectable icons 322 (e.g., radio buttons, check boxes, sliders, switches, etc.), whereby the user can select a predetermined amount of time for which their analyte data will be continuously shown in the variable-range time amount graphical user interface 320. For example, as illustrated in Figures 3C and 3D, a selectable icon 322 can be used to select a predetermined amount of time from among 7 days, 14 days, 30 days, or 90 days. Other predetermined amounts of time may be employed, and it will be understood by those skilled in the art that this is fully within the scope of the present disclosure.

[0034] FIG. 3E depicts an embodiment of a specific example of a graphical user interface (GUI) 330 for the time amount of the target range, which is visually output on the display screen of a reading device (e.g., a dedicated reading device, a measuring device, etc.). According to one aspect of each embodiment, the graphical user interface 330 for the time amount of the target range is composed of three graph bars (from top to bottom) as follows. That is, a first bar indicating that the user's blood glucose range is higher than the predetermined target range for a period of 34% of the predetermined time amount, a second bar indicating that the user's blood glucose range is within the range of the predetermined target range for a period of 54% of the predetermined time amount, and a third bar indicating that the user's blood glucose range is lower than the predetermined target range for a period of 12% of the predetermined time amount. It will be understood by those skilled in the art that the percentages associated with each graph bar may vary depending on the analyte data obtainable from the user. Further, FIG. 3E shows that the predetermined time amount 332 is the most recent past 7 days and the predetermined target range 334 is between 80 mg / dL and 140 mg / dL. However, other predetermined time amounts (e.g., 1 day, 3 days, 14 days, 30 days, 90 days, etc.), other predetermined target ranges (e.g., between 70 mg / dL and 180 mg / dL, etc.), or various combinations of both may be employed, and it will be understood by those skilled in the art that this is fully within the scope of the present disclosure.

[0035] FIG. 3F depicts another specific example embodiment of the time amount graphical user interface (GUI) 340 for each variation range, the GUI comprising one graph bar composed of five bar portions, including (from top to bottom) the following. That is, a first bar portion indicating that the user's blood glucose range is "very high", i.e., higher than 250 mg / dL, for a period of 1% of the predetermined time amount (14 minutes), a second bar portion indicating that the user's blood glucose range is "high", i.e., between 180 mg / dL and 250 mg / dL, for a period of 18% of the predetermined time amount (4 hours and 19 minutes), a third bar portion indicating that the user's blood glucose range is within the "target range", i.e., between 70 mg / dL and 180 mg / dL, for a period of 78% of the predetermined time amount (18 hours and 43 minutes), a fourth bar portion indicating that the user's blood glucose range is "low", i.e., between 54 mg / dL and 69 mg / dL, for a period of 3% of the predetermined time amount (43 minutes), and a fifth bar portion indicating that the user's blood glucose range is "very low", i.e., lower than 54 mg / dL, for a period of 0% of the predetermined time amount (0 minutes).

[0036] According to one aspect of the embodiment illustrated in FIG. 3F, the bar portions of the time amount graphical user interface (GUI) 340 for each variation range may each have a different color from each other. In some embodiments, each bar portion is divided by a dashed line or a dotted line 342, and a plurality of numerical labels 344 are inserted, or both, to indicate each variation range reflected by the bar portions adjacent to each other. In some embodiments, the time amount for each variation range reflected by each bar portion can be represented as a percentage, as an actual time amount (e.g., 4 hours and 19 minutes, etc.), or both as illustrated in FIG. 3F. Further, those skilled in the art will understand that the percentage of time associated with each bar portion can vary depending on the analyte data from the user. Some embodiments of the time amount graphical user interface 340 for each variation range allow the user to set a target range. In other embodiments, the time amount graphical user interface 340 for each variation range cannot be changed by the user.

[0037] FIGS. 4A through 4O depict embodiments of specific examples of an analyte value - trend warning graphical user interface (GUI) for an analyte monitoring system. According to one aspect of various embodiments, the analyte value - trend warning graphical user interface includes visual notifications (e.g., warnings, alerts, pop - up windows, banner notifications, etc.), in which case the visual notifications include an alert state, an analyte measurement value associated with the alert state, and a trend indicator associated with the alert state.

[0038] Referring back to FIGS. 4A through 4C, embodiments of specific examples of hyperglycemic alert 410, hypoglycemic alert 420, and severe hypoglycemic alert 430 (sometimes also referred to as "emergency hypoglycemic alert") are each depicted. Here, each alert includes a pop-up window 402 composed of an alert status description text 404 (such as "hypoglycemic alert"), an analyte measurement value 406 associated with the alert status (such as 67 mg / dL), a trend indicator 408 associated with the alert status (such as a trend arrow), etc. In some embodiments, an alert icon 412 may be located next to the alert status description text 404.

[0039] Next, referring to FIGS. 4D through 4G, embodiments of further specific examples of hypoglycemic alerts 440, 445, severe hypoglycemic alert 450, and hyperglycemic alert 455 are each depicted. As illustrated in FIG. 4D, hypoglycemic alert 440 is similar to the hypoglycemic alert in FIG. 4B (e.g., including a pop-up window composed of an alert status description text, an analyte measurement value associated with the alert status, and a trend indicator associated with the alert status), but further includes a critical alert icon 442 to indicate that the alert is set as a critical warning (e.g., even when the device is locked or the device's "do not disturb" setting is enabled, it will display, sound, vibrate, etc.). Regarding FIG. 4E, hypoglycemic alert 445 is also similar to the hypoglycemic alert in FIG. 4B, but instead of having a trend arrow, hypoglycemic alert 445 includes a text-based trend indicator 447. According to one aspect of some embodiments, in activating the text-based trend indicator 447, the device can "read" the text-based trend indicator 447 to the user via the device's text-to-speech function (such as "VoiceOver" on iOS or "Select-to-Speak" on Android) according to the device's accessibility settings.

[0040] Next, referring to FIG. 4F, the hypoglycemia alert 450 is similar to the hypoglycemia alert of FIG. 4D (has a critical warning icon), but instead of displaying on the screen an analyte measurement value associated with the alert state and a trend indicator associated with the alert state, the hypoglycemia alert 450 displays an out-of-range indicator 452 on the screen to indicate whether the current blood glucose value is either higher or lower than a predetermined reportable analyte value range (e.g., "High (HI)" or "Low (LO)"). With respect to FIG. 4G, the hyperglycemia alert 455 is similar to the hyperglycemia alert of FIG. 4A (e.g., includes a pop-up window composed of an alert state description text, an analyte level measurement value associated with the alert state, and a trend indicator associated with the alert state), but further includes an instruction 457 to the user. According to embodiments, for example, the instruction may be a prompt instructing the user that "blood glucose check is required". It will be understood by those skilled in the art that other instructions or prompts (e.g., "improvement bolus administration is required", "meal intake is required", etc.) may also be executed.

[0041] Furthermore, FIGS. 4A through 4G depict various specific embodiments of an analyte value and trend warning graphical user interface (GUI) displayed on a screen of a smartphone having an iOS operating system. However, the analyte value and trend warning graphical user interface may be implemented on devices other than the above, for example, various smartphones having operating systems other than the above, smartwatches, wearable devices, readers, tablet computers, blood glucose measuring devices, laptop terminals, desktop terminals, workstations, etc. For example, FIGS. 4H through 4J depict embodiments of specific examples of hyperglycemic warnings, hypoglycemic warnings, and severe hypoglycemic warnings for a smartphone having an Android operating system. Similarly, FIGS. 4K through 4O depict embodiments of specific examples of severe hypoglycemic warnings, hypoglycemic warnings, hyperglycemic warnings, severe hypoglycemic warnings (with "blood glucose check required" icon), and hyperglycemic warnings (with out-of-range indicator) for a reader, respectively. As described above, severe hypoglycemic warnings are sometimes also referred to as emergency hypoglycemic warnings, and the description text "emergency hypoglycemic warning" is displayed on the screen instead of "severe hypoglycemic warning".

[0042] It should be noted that all features, elements, components, functions, and steps described in the description of any of the embodiments presented in this specification are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described for only one embodiment, then that feature, element, component, function, or step should be understood to be usable in all the remaining embodiments described in this specification, unless otherwise clearly stated. Therefore, the description in this paragraph serves as a criterion prior to introducing each claim that combines features, elements, components, functions, and steps from multiple different embodiments or substitutes features, elements, components, functions, and steps from one embodiment with those from another embodiment, and always has meaning as a textual underpinning, even if the subsequent description of each item does not clearly state that such combination or substitution is possible in a particular case. In particular, when it is readily apparent to those skilled in the art that any such combination or substitution is acceptable, it is obvious that it would be extremely cumbersome to clearly describe all possible combinations and substitutions.

[0043] While each embodiment is susceptible to various modifications and alternative forms, some specific examples of those embodiments are illustrated in the drawings and described in detail herein. However, these embodiments are not limited to the specific forms disclosed, but rather should be understood to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of an embodiment can of course be listed or added to the claims, and there may also be cases where negative limitations that limit the scope of the invention of each claim by various features, functions, steps, or elements not included in the claims are listed or added to the claims. Hereinafter, preferred embodiments of the present invention will be described item by item. Embodiment 1 An analyte monitoring system, A sensor control device having an analyte sensor and sensor electronics, and configured to transmit data indicating an analyte value; A reading device having a screen display device, a transceiver configured to receive data indicating an analyte value, and a memory connected to one or more arithmetic processing units; Comprising: The memory is configured to store various instructions, and when the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output a plurality of graph bars to the screen display device. Each of the plurality of graph bars indicates the amount of time that the user's analyte value remains within a predetermined analyte value range associated with each graph bar, and the plurality of graph bars are based on the data indicating the analyte value. An analyte monitoring system. Embodiment 2 The analyte monitoring system according to Embodiment 1, wherein the amount of time includes a percentage of a predetermined period. Embodiment 3 The analyte monitoring system according to Embodiment 1, wherein the data indicating the analyte value includes data indicating a blood glucose value in body fluid. Embodiment 4 The plurality of graph bars are a first plurality of bars, and when the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to further output a second plurality of bars to the screen display device. Each of the second plurality of bars indicates the amount of time that the user's analyte value remains within a predetermined analyte value range associated with each bar, and the second plurality of bars are based on the data indicating the analyte value. The analyte monitoring system according to Embodiment 1, wherein the first plurality of bars can be ordered customized by the user, but the second plurality of bars cannot be ordered customized by the user. Embodiment 5 When the various commands are executed by one or more arithmetic processing units, the commands cause the one or more arithmetic processing units to further output to the screen display device an element that can be slid, and the user can select whether to display a first plurality of bars or a second plurality of bars on the screen display device by the slidable element. The analyte monitoring system according to Embodiment 4. Embodiment 6 When the various commands are executed by one or more arithmetic processing units, the commands cause the one or more arithmetic processing units to further output to the screen display device a data area indicator including a data area associated with the plurality of graph bars and the data indicating the analyte value. The analyte monitoring system according to Embodiment 1. Embodiment 7 When the various commands are executed by one or more arithmetic processing units, the commands cause the one or more arithmetic processing units to further output to the screen display device a data validity indicator including a period during which the data indicating the analyte value is valid. The analyte monitoring system according to Embodiment 1. Embodiment 8 At least one predetermined analyte value range associated with the plurality of graph bars can be adjusted by the user. The analyte monitoring system according to Embodiment 1. Embodiment 9 None of the predetermined analyte value ranges associated with the second plurality of bars can be adjusted by the user. The analyte monitoring system according to Embodiment 4. Embodiment 10 When the various commands are executed by one or more arithmetic processing units, the commands cause the one or more arithmetic processing units to further output to the screen display device a plurality of selectable icons configured such that a user can select a predetermined amount of time associated with the data indicating the analyte value. The analyte monitoring system according to Embodiment 1. Embodiment 11 An analyte monitoring system, A screen display device, One or more arithmetic processing units connected to a memory configured to store various commands, wherein when the various commands are executed by the one or more arithmetic processing units, the commands cause the one or more arithmetic processing units to output a plurality of graph bar portions to the screen display device. An arithmetic processing unit, Comprising, Each of the plurality of graph bar portions indicates the amount of time that the user's analyte value remains within a predetermined analyte value range associated with each graph bar portion, and the plurality of graph bar portions are based on data indicating the analyte value. An analyte monitoring system. Embodiment 12 The analyte monitoring system according to Embodiment 11, wherein the amount of time includes a percentage of a predetermined period and an actual amount of time. Embodiment 13 The analyte monitoring system according to Embodiment 11, wherein the data indicating the analyte value includes data indicating a blood glucose value in a body fluid. Embodiment 14 The analyte monitoring system according to Embodiment 11, wherein the one or more arithmetic processing units include one or more arithmetic processing units of a cloud-based infrastructure. Embodiment 15 The analyte monitoring system according to Embodiment 11, wherein each of the plurality of graph bar portions has a different color from each other. Embodiment 16 An analyte monitoring system, comprising: An analyte sensor connected to sensor electronics, and a sensor control device configured to transmit data indicating an analyte value; A reading device having a screen display device, a wireless communication circuit configured to receive data indicating an analyte value, and one or more arithmetic processing units connected to a memory configured to store various instructions, wherein when the various instructions are executed by the one or more arithmetic processing units, the one or more arithmetic processing units output a warning interface including an alarm state, an analyte measurement value associated with the alarm state, and a trend indicator associated with the alarm state to the screen display device; An analyte monitoring system comprising the above. Embodiment 17 The analyte monitoring system according to Embodiment 16, wherein the alarm state is one of a hypoglycemic state, a severe hypoglycemic state, a hyperglycemic state, and the like. Embodiment 18 The analyte monitoring system according to Embodiment 16, wherein the warning interface includes an alarm icon at a position adjacent to the alarm state. Embodiment 19 The analyte monitoring system according to Embodiment 18, wherein the alarm icon is a critical warning icon. Embodiment 20 The analyte monitoring system according to Embodiment 16, wherein the warning interface is a pop-up window. Embodiment 21 The analyte monitoring system according to Embodiment 16, wherein the warning interface is a banner notification. Embodiment 22 The analyte monitoring system according to Embodiment 16, wherein the trend indicator is an arrow indicating a direction. Embodiment 23 The trend indicator is the trend indicator in the description. Also, when the various instructions are executed by one or more arithmetic processing units, the one or more arithmetic processing units further read out the trend indicator of the description using the description reading function, according to the instructions. The analyte monitoring system according to Embodiment 16. Embodiment 24 The analyte measurement value is the current blood glucose value. The analyte monitoring system according to Embodiment 16. Embodiment 25 The warning interface includes instructions to the user. The analyte monitoring system according to Embodiment 16. Embodiment 26 The instruction to the user includes one of instructions such as to check blood glucose, to administer medicine, and to ingest food. The analyte monitoring system according to Embodiment 25. Embodiment 27 The reading device is a smartphone. The analyte monitoring system according to Embodiment 16. Embodiment 28 An analyte monitoring system, having an analyte sensor connected to sensor electronics, and a sensor control device configured to transmit data indicating an analyte value, a reading device having a screen display device, a wireless communication circuit configured to receive data indicating an analyte value, and one or more arithmetic processing units connected to a memory configured to store various instructions. When the various instructions are executed by the one or more arithmetic processing units, the one or more arithmetic processing units output, according to the instructions, a warning interface including an alarm state, an out-of-range indicator associated with the alarm state, and a trend indicator associated with the alarm state, to the screen display device. An analyte monitoring system comprising the above. Embodiment 29 The out-of-range indicator includes one of a high out-of-range indicator and a low out-of-range indicator. The analyte monitoring system according to Embodiment 28. Embodiment 30 The reading device is a smartphone. The analyte monitoring system according to Embodiment 28. Embodiment 31 An analyte monitoring system, having an analyte sensor and sensor electronics, and a body attachment device configured to transmit data indicating a user's analyte value, a reading device having a screen display device, a transceiver configured to receive data indicating an analyte value, and a memory connected to one or more arithmetic processing units, comprising the above. The memory is configured to store various instructions. When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output a first screen including a first set of graphic elements to a screen display device. At this time, each of the first set of graphic elements indicates the amount of time that the user's analyte value remains within a predetermined analyte value range associated with each of the first set of correlated graphic elements. At least one of the first set of graphic elements can be customized by the user. Further output a second screen including a second set of graphic elements to a screen display device. At this time, each of the second set of graphic elements indicates the amount of time that the user's analyte value remains within a predetermined analyte value range associated with each of the second set of correlated graphic elements. The second set of graphic elements cannot be customized by the user. Analyte monitoring system. Embodiment 32 When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to further output a switch element to an image display device. The switch element is configured to output to the screen display device of the reading device on the first screen or the second screen. The analyte monitoring system according to Embodiment 31. Embodiment 33 The switch element includes a toggle switch. The analyte monitoring system according to Embodiment 32. Embodiment 34 The switch element includes a slidable element. The analyte monitoring system according to Embodiment 32. Embodiment 35 At least one of the first set of graphic elements that can be customized by the user includes an analyte target range that can be customized. The analyte monitoring system according to Embodiment 31. Embodiment 36 Each of the first set of graphic elements has a different color from the other graphic elements of the first set. The analyte monitoring system according to Embodiment 31. Embodiment 37 Each of the second set of graphic elements has a different color from the other graphic elements of the second set. The analyte monitoring system according to Embodiment 31. Embodiment 38 The total number of the first set of graphic elements is equal to the total number of the second set of graphic elements. The analyte monitoring system according to Embodiment 31. Embodiment 39 The analyte monitoring system according to Embodiment 31, wherein the total number of graphic elements in the first set is not equal to the total number of graphic elements in the second set. Embodiment 40 The analyte monitoring system according to Embodiment 31, wherein the reading device includes a smartphone. Embodiment 41 The analyte monitoring system according to Embodiment 31, wherein the reading device includes a smartwatch. Embodiment 42 The analyte monitoring system according to Embodiment 31, wherein the amount of time during which the user's analyte value remains within a predetermined analyte value range includes a percentage of a predetermined period. Embodiment 43 The analyte monitoring system according to Embodiment 31, wherein the data indicating the analyte value includes data indicating a blood glucose value in the user's body fluid. Embodiment 44 When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output, to a screen display device, a data area indicator including a data area associated with the first set of graphic elements and the second set of graphic elements. The analyte monitoring system according to Embodiment 31. Embodiment 45 When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output, to a screen display device, a data validity indicator including a period during which the data indicating the analyte value is valid. The analyte monitoring system according to Embodiment 31. Embodiment 46 When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output, to a screen display device, a plurality of selectable icons configured such that a user can select a predetermined amount of time associated with the data indicating the analyte value. The analyte monitoring system according to Embodiment 31. Embodiment 47 When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output, to a screen display device, a link to an interface configured such that a user can edit the analyte target range that can be ordered on a special order. The analyte monitoring system according to Embodiment 35.

Explanation of Symbols

[0044] 100 Analyte Monitoring System 102 Sensor Control Device 104 Analyte Sensor 120 Reading Device 122 Image Display Device 150 Sensor Applicator 160 Sensor Electronic Devices 310 Slide-Movable Element 330 Time Quantity Graphical User Interface for Target Region 305, 320, 340 Time Quantity Graphical User Interface (TIR GUI) for Each Variation Range

Claims

1. An analyte monitoring system, comprising: a body-mounted device having an analyte sensor and sensor electronics, configured to transmit data indicating a user's analyte value; a reading device having a screen display device, a transceiver configured to receive data indicating an analyte value, and a memory connected to one or more arithmetic processing units; wherein: the memory is configured to store various instructions, and when the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to: output a first screen including a first set of graphic elements to the screen display device, wherein, on the first screen, each of the first set of graphic elements indicates the amount of time in a correlation relationship in which the user's analyte value remains within the range of an analyte value range associated with each graphic element of the first set, and at least one analyte value range associated with the first set can be customized by the user, and further output a second screen including a second set of graphic elements to the screen display device, wherein, on the second screen, each of the second set of graphic elements indicates the amount of time in a correlation relationship in which the user's analyte value remains within the range of an analyte value range associated with each graphic element of the second set, and none of the analyte value ranges associated with the second set can be customized by the user. An analyte monitoring system.

2. When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to further output a switch element to the image display device, wherein the switch element is configured to cause the reading device's screen display device to output to the first screen or the second screen. The analyte monitoring system according to claim 1.

3. The switch element of claim 2, wherein the switch element comprises a toggle switch or a slidable element. The analyte monitoring system according to claim 2.

4. The analyte monitoring system according to claim 1, wherein at least one analyte value range associated with the first set that can be customized by the user includes an analyte target range that can be customized.

5. The analyte monitoring system according to claim 1, wherein each of the first set of graphic elements has a different color from the other graphic elements of the first set.

6. The analyte monitoring system according to claim 1, wherein each of the second set of graphic elements has a color different from that of the other graphic elements of the second set.

7. The analyte monitoring system according to claim 1, wherein the total number of the first set of graphic elements is not equal to the total number of the second set of graphic elements.

8. The analyte monitoring system according to claim 1, wherein the reading device includes a smartphone or a smartwatch.

9. The amount of time of the correlation in which the user's analyte value remains within the range of the analyte value range associated with each of the first set of graphic elements includes a percentage of a first predetermined period, and the amount of time of the correlation in which the user's analyte value remains within the range of the analyte value range associated with each of the second set of graphic elements includes a percentage of a second predetermined period. The analyte monitoring system according to claim 1.

10. The analyte monitoring system according to claim 1, wherein the data indicating the analyte value includes data indicating a blood glucose value in the user's body fluid.

11. When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output to a screen display device a data area indicator including a data area associated with the first set of graphic elements and the second set of graphic elements. The analyte monitoring system according to claim 1.

12. When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output to a screen display device a data validity indicator including a period during which the data indicating the analyte value is valid. The analyte monitoring system according to claim 1.

13. When the various instructions are executed by one or more arithmetic processing units, the instructions cause the one or more arithmetic processing units to output to a screen display device a plurality of selectable icons configured such that a user can select a predetermined amount of time associated with the data indicating the analyte value. The analyte monitoring system according to claim 1.

14. The analyte monitoring system according to claim 4, wherein when the various commands are executed by one or more arithmetic processing units, the one or more arithmetic processing units output, to a screen display device, a link to an interface configured to allow a user to edit the analyte target region that can be customized.

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