Specimen monitoring system and method
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- ABBOTT DIABETES CARE INC
- Filing Date
- 2021-06-02
- Publication Date
- 2026-07-30
Smart Images

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Abstract
Description
Technical Field
[0004] , , , ,
[0003]
[0001] The subject matter described herein relates generally to improvements in specimen monitoring systems in addition to computer-related methods and associated apparatus.
Background Art
[0002] The detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be extremely important to the health of individuals suffering from diabetes. Patients suffering from diabetes can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients are generally required to monitor their glucose levels and ensure that they are maintained clinically within a safe range, and this information can also be used to determine whether insulin is needed and / or when it is needed to lower the glucose level in the body, or when additional glucose is needed to raise the glucose level in the body.
[0003] Increasing clinical data shows a strong correlation between the frequency of glucose monitoring and glycemic control. However, despite such a correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, test discretion, pain associated with glucose testing, and cost.
[0004] To increase adherence to frequent glucose monitoring plans among patients, in vivo sample monitoring systems can be used. These systems may involve attaching sensor devices to the body of the individual requiring sample monitoring. To enhance individual comfort and convenience, the sensor devices have small form factors and can be attached by the individual using a sensor attachment device. The attachment process involves inserting at least a portion of the sensor, which detects sample levels in bodily fluids within layers of the user's body, using an attachment device or insertion mechanism so that the sensor comes into contact with the bodily fluids. The sensor devices may also be configured to transmit sample data to another device, which allows the individual, healthcare provider (HCP), or caregiver to view the data and make treatment decisions. [Overview of the project] [Problems that the invention aims to solve]
[0005] However, despite its advantages, some people are reluctant to use specimen monitoring systems for a variety of reasons. These reasons include the complexity and volume of data presented, the learning curve associated with the software and user interface of the specimen monitoring system, and the overall lack of information presented and available.
[0006] Therefore, there is a need for improved digital interfaces, graphical user interfaces, and software for specimen monitoring systems, as well as related methods and apparatus that enable robust, user-friendly, and timely responses. [Means for solving the problem]
[0007] Embodiments of improvements to in vivo sample monitoring systems and related computer-related methods and apparatus are provided herein. According to some embodiments, a range time (TIR) GUI of the sample monitoring system is provided, the TIR GUI comprising a plurality of bars or bar segments, each bar or bar segment indicating the amount of time during which the user's sample level is within a predetermined sample range corresponding to that bar or bar segment. In some embodiments, for example, the amount of time may be expressed as a percentage of the total time.
[0008] According to another embodiment, a sample level / trend alert GUI is provided for the sample monitoring system, which includes visual notifications (e.g., warnings, alarms, pop-up windows, banner notifications, etc.), and the visual notifications include an alarm state, a sample level measurement related to the alarm state, and a trend indicator related to the alarm state. In some embodiments, the trend indicator is, for example, a trend direction arrow.
[0009] According to several embodiments, a sensor usage interface is provided to measure and prompt user interaction with a specimen monitoring system. The sensor usage interface may include one or more view metrics, which consist of instances in which the sensor results interface is represented or becomes the foremost process. In some embodiments, the sensor usage interface may be part of a specimen monitoring system report, such as a monthly summary report, a weekly summary report, or a daily record report.
[0010] According to other embodiments, a method for data filling in a sample monitoring system is provided. In some embodiments, the data filling method may be performed in a sample monitoring system comprising a first device and a second device communicating with each other. According to one aspect of this method, the second device can request historical sample data from the first device according to a life count metric. The life count metric is a numerical value indicating the amount of time elapsed since the first device was started. In another embodiment, a data filling method is provided in which, in response to a reconnection, a reader can identify the last successful data transmission to a trusted computer system and transmit historical data that has not yet been received by the trusted computer system.
[0011] According to another embodiment, a method is provided for aggregating disconnection and reconnection events of wireless communication links in a sample monitoring system, where these disconnection and reconnection events are recorded and transmitted to a reliable computer system for analysis.
[0012] Other embodiments provide an improved method for transmitting expired or faulty sensors. In some embodiments, a sensor control device detects an expired or faulty sensor condition. The sensor control device then transmits an indication of the expired or faulty sensor condition until a first predetermined period has elapsed or the indication has been received, whichever comes first. In some embodiments, the sensor control device also allows data refilling for a second predetermined period.
[0013] According to another embodiment, a method is provided for merging sample data from multiple devices. In some embodiments, a method is provided for receiving, combining, and deduplication sample data from multiple readers. Subsequently, a first type of reporting metric may be generated based on the combined and deduplication-reduced sample data. According to another aspect of these embodiments, the sample data is further analyzed to eliminate any overlapping areas of the deduplication-reduced sample data. Subsequently, a second type of reporting metric may be generated based on the deduplication-reduced and non-overlapping sample data. In some embodiments, for example, the first type of reporting metric may be the mean glucose level and the second type of reporting metric may be a low glucose event.
[0014] According to several embodiments, a system and method are provided for migrating an already activated sensor control unit to a new reader. In some embodiments, a method is provided in which, for example, a user interface application is installed on the user's new reader and generates a device identifier. Subsequently, the user can log in to a trusted computer system and the device identifier associated with the user's user account is updated. According to one aspect of these embodiments, the user is then prompted to scan the already activated sensor control unit. In response to the scan, the already activated sensor control unit may terminate its connection with the old reader. Subsequently, the new reader and the already activated sensor control unit are paired, and the new reader can receive historical glucose data (e.g., filling data) from the already activated sensor control unit. In some embodiments, the sensor control unit can provide historical glucose data for the entire endurance period.
[0015] In some embodiments, a system and method for migrating an already activated sensor control unit to a new reader may include security checks performed by the reader, where the reader's user interface application compares a sensor serial number received from a trusted computer system with a sensor serial number received from the sensor control unit. In some embodiments, a system and method for migrating an already activated sensor control unit to a new reader may include security checks performed by the sensor control unit, where the sensor control unit verifies the authenticity of an identifier sent from the reader.
[0016] According to other embodiments, a method for generating a sensor insertion failure system alarm is provided. In some embodiments, a method is provided in which a sensor control device detects a sensor insertion failure condition. In response, the sensor control device stops sample measurement and sends a sensor check instruction to the reader until a predetermined waiting time has elapsed or until it receives confirmation of receipt of the sensor check instruction from the reader, whichever comes first. Subsequently, the sensor control device enters a storage state which may be restarted later.
[0017] According to other embodiments, a method for generating a sensor termination system alarm is provided. In some embodiments, a method is provided for the sensor control unit to detect a sensor termination state. In response, the sensor control unit stops sample measurement and transmits a sensor replacement instruction to the reader until a predetermined waiting time has elapsed or until it receives confirmation of receipt of the sensor replacement instruction from the reader, whichever comes first. In some embodiments, after receiving confirmation of receipt of the sensor replacement instruction, in response to a data fill request from the reader, the sensor control unit may also provide historical glucose data. Subsequently, the sensor control unit enters a termination state that cannot be restarted later.
[0018] Many of the embodiments provided in this book are improved GUIs or GUI functions for specimen monitoring systems that are highly intuitive, easy to use, and enable users to quickly access physiological information. More specifically, these embodiments allow users to browse and easily navigate between different user interfaces that can quickly show users various physiological states and / or possible responses, eliminating the need for users (or HCPs) to experience the arduous task of examining large amounts of specimen data. In addition, several GUIs and GUI functions, such as sensor usage interfaces, enable users (and caregivers) to better understand and improve their level of interaction with the specimen monitoring system. Similarly, many other embodiments described in this book include improved digital interfaces and / or functions for specimen monitoring systems that improve the accuracy and completeness of specimen data collected by the specimen monitoring system by enabling data fill-in, improve the flexibility of the specimen monitoring system by allowing users to move between different readers, and improve the alarm function of the specimen monitoring system by enabling more robust inter-device communication during adverse conditions, etc.
[0019] The various forms of GUI improvements and claims described in this book have technical benefits, at least in that they help the user of the device operate it more accurately, efficiently, and safely. It will be understood that the clarity of the information provided to the user by the GUI, the order in which the information is provided, and the organization of the information can have a significant impact on how the user interacts with the system and how the system operates. Thus, the GUI guides the user in the technical tasks of operating the system, taking necessary measurements, and / or obtaining information accurately and efficiently. Other improvements and benefits are also provided. Various configurations of these devices are described in detail as embodiments for illustrative purposes only.
[0020] Other systems, apparatus, methods, features, and advantages of the subject matter described herein will become apparent to those skilled in the art by considering the following figures and detailed description. All such additional systems, apparatus, methods, features, and advantages are included in the description, are within the scope of the subject matter described herein, and are intended to be protected by the appended claims. Aspects of embodiments are described in independent claims, and preferred features are described in dependent claims. Preferred features of dependent claims may be provided in combination in a single embodiment, and preferred features of one embodiment may be provided together with other embodiments. Unless there is an express description of the features in a claim, these features of embodiments should never be construed as limiting the appended claims. [Brief explanation of the drawing]
[0021] Details regarding both the structure and operation of the subject matter described in this book may become clear by examining the accompanying diagrams. In the diagrams, similar symbols refer to similar parts. The parts in the diagrams are not necessarily to a fixed scale, and the emphasis is on illustrating the principles of the subject matter. Furthermore, all diagrams are intended to convey concepts, and relative size, shape, and other detailed attributes may be illustrated in a general manner, not strictly or precisely. [Figure 1] This is a schematic diagram of a sample monitoring system, comprising a sensor mounter, sensor control device, reader, network, reliable computer system, and local computer system. [Figure 2A] This is a block diagram illustrating an embodiment of the reading device. [Figure 2B] This is a block diagram illustrating an embodiment of a sensor control device. [Figure 2C] This is a block diagram illustrating an embodiment of a sensor control device. [Figure 2D] This is an embodiment of a GUI consisting of a sensor result interface. [Figure 2E] This is an embodiment of a GUI consisting of a sensor result interface. [Figure 2F] This is an embodiment of a GUI consisting of a sensor result interface. [Figure 2G] An embodiment of a GUI consisting of a sensor result interface. [Figure 2H] An embodiment of a GUI consisting of a sensor result interface. [Figure 2I] An embodiment of a GUI consisting of a sensor result interface. [Figure 3A] An embodiment of a GUI consisting of an in-range time interface. [Figure 3B] An embodiment of a GUI consisting of an in-range time interface. [Figure 3C] An embodiment of a GUI consisting of an in-range time interface. [Figure 3D] An embodiment of a GUI consisting of an in-range time interface. [Figure 3E] An embodiment of a GUI consisting of an in-range time interface. [Figure 3F] An embodiment of a GUI consisting of an in-range time interface. [Figure 4A] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4B] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4C] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4D] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4E] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4F] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4G] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4H] An embodiment of a GUI consisting of a specimen level and trend warning interface. [Figure 4I] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4J] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4K] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4L] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4M] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4N] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 4O] This is an embodiment of a GUI consisting of a sample level and trend warning interface. [Figure 5A] This is an embodiment of a GUI consisting of a sensor usage interface. [Figure 5B] This is an embodiment of a GUI consisting of a sensor usage interface. [Figure 5C] This is an embodiment of a reporting GUI that includes sensor usage information. [Figure 5D] This is an embodiment of a reporting GUI that includes sensor usage information. [Figure 5E] This is an embodiment of a reporting GUI that includes sensor usage information. [Figure 5F] This is an embodiment of a reporting GUI that includes sensor usage information. [Figure 6A] This flowchart illustrates an embodiment of the data filling method in a sample monitoring system. [Figure 6B] This flowchart illustrates an embodiment of the data filling method in a sample monitoring system. [Figure 6C] This flowchart illustrates an embodiment of a method for aggregating disconnection and reconnection events within a specimen monitoring system. [Figure 7] This flowchart illustrates an embodiment of the method for transmitting expired or malfunctioning sensor data within a sample monitoring system. [Figure 8A] This flowchart illustrates an example of a method for merging data within a sample monitoring system. [Figure 8B] This flowchart illustrates an example of a method for merging data within a sample monitoring system. [Figure 8C] This graph depicts data at various processing stages according to an embodiment of the data merging method within the sample monitoring system. [Figure 8D] This graph depicts data at various processing stages according to an embodiment of the data merging method within the sample monitoring system. [Figure 8E] This graph depicts data at various processing stages according to an embodiment of the data merging method within the sample monitoring system. [Figure 9A] This flowchart illustrates an embodiment of the method for migrating sensors within a sample monitoring system. [Figure 9B] This flowchart illustrates an embodiment of the method for migrating sensors within a sample monitoring system. [Figure 9C] This flowchart illustrates an embodiment of the method for migrating sensors within a sample monitoring system. [Figure 9D] This is an embodiment of a GUI displayed according to an embodiment of the method for sensor migration within a specimen monitoring system. [Figure 9E] This is an embodiment of a GUI displayed according to an embodiment of the method for sensor migration within a specimen monitoring system. [Figure 9F] This is an embodiment of a GUI displayed according to an embodiment of the method for sensor migration within a specimen monitoring system. [Figure 10A] This flowchart illustrates an embodiment of a method for generating a sensor insertion failure system alarm. [Figure 10B] This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor insertion failure system alarm. [Figure 10C] This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor insertion failure system alarm. [Figure 10D]This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor insertion failure system alarm. [Figure 11A] This flowchart illustrates an embodiment of a method for generating a sensor termination system alarm. [Figure 11B] This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor termination system alarm. [Figure 11C] This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor termination system alarm. [Figure 11D] This is an embodiment of a GUI displayed according to an embodiment of a method for generating a sensor termination system alarm.
[0022] In addition, a color version of the figure is included as Appendix A and cited in this book. [Modes for carrying out the invention]
[0023] Before describing the subject matter in detail, it should be understood that this disclosure is not limited to the specific embodiments described and, therefore, may vary. It should also be understood that the terminology used herein is for the purpose of describing only specific embodiments and is not intended to limit them. The scope of this disclosure is limited only by the appended claims.
[0024] As used in this book and in the attached claims, unless the context clearly indicates otherwise, the English singular forms "a," "an," and "the" refer to a plural noun.
[0025] The publications described herein are provided solely for disclosure prior to the filing date of this application. This disclosure should not be construed as acknowledging that prior disclosures do not qualify for such prior disclosures. Furthermore, the provided publication dates may differ from the actual publication dates (which must be independently verified).
[0026] Generally, embodiments of this disclosure include GUIs, software, and digital interfaces for specimen monitoring systems, as well as related methods and apparatus. Accordingly, many embodiments include in vivo specimen sensors structurally configured such that at least a portion of the sensors are placed, or can be placed, within the user's body to obtain information from at least one specimen of the body. However, it should be noted that the embodiments described herein may be used in conjunction with in vitro specimen monitoring systems having in vitro capabilities and purely in vitro or in vitro specimen monitoring systems (including entirely non-invasive systems).
[0027] Furthermore, in each and all embodiments of the methods disclosed herein, systems and apparatus capable of performing each of these embodiments are included within the scope of this disclosure. For example, embodiments of sensor control devices, readers, local computer systems, and trusted computer systems are disclosed, and these apparatus and systems may have one or more sensors, sample monitoring circuits (e.g., analog circuits), memory (e.g., for storing instruction sets), power supplies, communication circuits, transmitters, receivers, and processors and / or controllers (e.g., for executing instruction sets) capable of performing or enabling any and all method steps.
[0028] An improved graphical user and digital interface for the sample monitoring system is provided. For example, various embodiments of the GUI, including time range, sample level / trend warnings, and sensor usage interfaces, are disclosed in this document. Various embodiments of the digital interface are also described, including methods for data loading, transmission of expired or faulty sensors, merging data from multiple devices in the sample monitoring system, migration of already activated sample sensors to a new reader, and autonomous sensor system alarms.
[0029] As described above, the various embodiments described in this document enable improved GUIs for sample monitoring systems. These GUIs are highly intuitive, easy to use, and allow for fast access to the user's physiological information. According to some embodiments, a range time GUI is provided for the sample monitoring system. The range time GUI comprises multiple bars or bar segments, each bar or bar segment indicating the amount of time the user's sample level is within a predetermined range related to that bar or bar segment. According to another embodiment, a sample level / trend alert GUI is provided for the sample monitoring system. The sample level / trend alert GUI includes visual notifications (e.g., warnings, alarms, pop-up windows, banner notifications, etc.), where the visual notifications include an alarm state, a sample level measurement related to the alarm state, and a trend indicator related to the alarm state. In short, these embodiments offer advantages such as providing a robust and user-friendly interface that can increase user engagement with the sample monitoring system and enable timely and actionable responses by the user.
[0030] Furthermore, several embodiments described in this document enable improved digital interfaces for specimen monitoring systems. According to some embodiments, improved methods and related systems and devices are provided for data loading, aggregation of wireless communication link disconnection and reconnection events, expired or faulty sensor transmission, merging data from multiple devices, migration of already activated specimen sensors to a new reader, generation of sensor insertion failure system alarms, and generation of sensor termination system alarms. Collectively and individually, these digital interfaces improve the accuracy and integrity of specimen data collected by the specimen monitoring system, improve the flexibility of the specimen monitoring system by allowing users to migrate between different readers, and improve the alarm capabilities of the specimen monitoring system by enabling more robust inter-device communication during adverse conditions. Other improvements and advantages are also provided. Various configurations of these devices are described in detail as exemplary embodiments.
[0031] However, before describing these embodiments in detail, it is desirable to first describe examples of devices that may be present in, for example, an in vivo sample monitoring system and examples of their operation. All of these examples can be used in conjunction with the embodiments described herein.
[0032] Various types of in vivo sample monitoring systems exist. For example, a continuous sample monitoring system (or continuous glucose monitoring system) can continuously transmit data from a sensor control unit to a reader without prompting, for example, according to a schedule. Another example is a flash sample monitoring system (or flash glucose monitoring system or simply a flash system), which transfers data from a sensor control unit in response to scanning or data requests by a reader, for example, using a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. Furthermore, in vivo sample monitoring systems can operate without the need for finger prick calibration.
[0033] In vivo sample monitoring systems can be distinguished from extra vivo systems that typically involve contact with biological samples outside the body and include instruments. These instruments have ports for receiving sample test strips containing the user's bodily fluids that can be analyzed to measure the user's blood glucose levels.
[0034] An in vivo monitoring system may include sensors located inside the body that come into contact with the user's bodily fluids and detect the level of a sample within them. The sensors may be part of a sensor control unit attached to the user's body, including electronic circuits and a power supply that enable and control the sample detection. Sensor control units and their variations may also be called "sensor control units," "body-attached electronic circuits" devices or units, "body-attached" devices or units, or "sensor data communication" devices or units.
[0035] In vivo monitoring systems may also include devices that receive, process, and / or display sample data detected by sensor control devices to the user in any number of formats. These devices and their variations are called “handheld readers,” “readers” (or simply “readers,” “handheld electronic devices” (or simply “handheld”)), “portable data processing” devices or units, “data receivers,” “receiving” devices or units (or simply “receivers”), or “remote” devices or units. Other devices, such as personal computers, have also been used with or incorporated into in vivo and in vivo monitoring systems.
[0036] Embodiment of an in vivo specimen monitoring system Figure 1 is a conceptual diagram illustrating an embodiment of the specimen monitoring system 100, which includes a sensor mounter 150, a sensor control device 102, and a reader 120. The sensor mounter 150 may be used to deliver the sensor control device 102 to a monitoring location on the user's skin. The sensor 104 is held in the appropriate position for a period of time by an adhesive patch 105. The sensor control device 102 is further described in Figures 2B and 2C and can communicate with the reader 120 using wired or wireless technology via a communication channel 140. Examples of wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), and Near Field Communication (NFC). The user can view and use applications installed in the memory of the reader 120 using the screen 122 (which may be a touch screen in many embodiments) and input 121. The device battery of the reader 120 can be recharged using the power port 123. Although only one reader device 120 is shown, the sensor control device 102 can communicate with multiple reader devices 120. Each reader device 120 can communicate with each other and share data. Further details of the reader device 120 are described below with respect to Figure 2A. The reader device 120 can communicate with the local computer system 170 via channel 141 using a wired or wireless communication protocol. The local computer system 170 may include one or more of the following: laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and wireless communication may include any applicable wireless network protocol, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, etc. Just as the reader device 120 can communicate with the network 190 via channel 142 using a wired or wireless communication protocol as described above, the local computer system 170 can communicate with the network 190 via channel 143. The network 190 may be any network, such as a private network, public network, local area network, or wide area network.The trusted computer system 180 may include a cloud-based platform or server, enabling authentication services, secure data storage, and report generation, and can communicate with the network 190 via communication channel 144 using wired or wireless technology. Figure 1 also depicts the trusted computer system 180 and local computer system 170 communicating with a single sensor control device 102 and a single reader device 120, but those skilled in the art will understand that the local computer system 170 and / or the trusted computer system 180 can communicate with multiple readers and sensor control devices via wired or wireless communication, respectively.
[0037] Embodiment of a reading device Figure 2A is a block diagram illustrating an embodiment of a reader 120 (which in some embodiments may be a smartphone). Here, the reader 120 may comprise a display 122, an input component 121, and a processing core 206 including a communication processor 222 coupled with memory 223 and an application processor 224 coupled with memory 225. It may also comprise another memory 230, an RF transceiver 228 with an antenna 229, and a power supply 226 with a power management module 238. Furthermore, the reader 120 may also comprise a multifunction transceiver 232 which includes a wireless communication circuit and can be configured to communicate via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234. As those skilled in the art will understand, these components are electrically and communicatively coupled to constitute a functional device.
[0038] Embodiment of a sensor control device Figures 2B and 2C are block diagrams depicting an embodiment of a sensor control device 102 having a sample sensor 104 and a sensor electronic circuit 160 (including a sample monitoring circuit). The sensor control device may have most of the processing power to prepare the final result data for display to the user. Figure 2B depicts a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC). A group of high-level functional units including an analog front-end (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communication circuit 168 (which may be a transmitter, receiver, transceiver, passive circuit, etc., depending on the communication protocol) are shown within the ASIC 161. In this embodiment, both the AFE 162 and the processor 166 are used as sample monitoring circuits, but in other embodiments, either circuit may perform the sample monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers (each of which may be on a separate chip or distributed (and partially) across multiple different chips).
[0039] Memory 163 is also included within the ASIC 161 and may be shared by various functional units present within the ASIC 161, or distributed among two or more of them. Memory 163 may also be a separate chip. Memory 163 may be volatile memory and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power supply 172 (which may be a coin cell battery, etc.). The AFE 162 connects to the in vivo sample sensor 104 and receives measurement data from it, outputs the data in digital format to the processor 166, which processes the data to obtain final results such as individual glucose values and trend values. This data may be provided to the communication circuit 168 for transmission to a reader 120 (not shown) via the antenna 171. At the reader 120, a resident software application requires minimal additional processing to display the data. In some embodiments, for example, the current glucose value may be transmitted from the sensor control device 102 to the reader 120 every minute, and historical glucose values may be transmitted from the sensor control device 102 to the reader 120 every five minutes.
[0040] In some embodiments, to conserve power and processing resources of the sensor control device 102, digital data received from the AFE 162 can be transmitted to the reader 120 (not shown) with minimal or no processing. In other embodiments, the processor 166 may be configured to store certain data types (e.g., current glucose value, historical glucose value) in memory 163 or generate them for transmission to the reader 120 (not shown) and to confirm certain alarm conditions (e.g., sensor failure conditions), while other processing and alarm functions (e.g., high / low glucose threshold alarms) may be performed by the reader 120. Those skilled in the art will understand that all or part of the methods, functions, and interfaces described herein may be performed by processing circuits in the sensor control device 102, the reader 120, the local computer system 170, or a trusted computer system 180.
[0041] Figure 2C is similar to Figure 2B, but instead includes two separate semiconductor chips 162 and 174, which can be packaged together or separately. The AFE 162 resides within the ASIC 161. The processor 166 is integrated on chip 174 with the power management circuit 164 and the communication circuit 168. The AFE 162 may include memory 163, and chip 174 may include memory 165, which may be separate or distributed. In one embodiment, the AFE 162 is coupled with the power management circuit 164 and the processor 166 on one chip, while the communication circuit 168 is on a separate chip. In another embodiment, both the AFE 162 and the communication circuit 168 are on one chip, while the processor 166 and the power management circuit 164 are on separate chips. Note that other chip combinations are possible, including three or more chips, each performing a different function or sharing one or more functions for fail-safe redundancy.
[0042] Embodiment of a graphical user interface for a specimen monitoring system Embodiments of a GUI for a sample monitoring system are described below. First, those skilled in the art will understand that the GUI described herein consists of a set of instructions stored in the memory of the reader 120, the local computer system 170, the trusted computer system 180, and / or any other device or system communicating with or part of the sample monitoring system 100. When these instructions are executed by one or more processors of the reader 120, the local computer system 170, the trusted computer system 180, or other devices or systems of the sample monitoring system 100, they cause those processors to perform method steps and / or output the GUI described herein. Those skilled in the art will recognize that the GUI described herein may be stored as a set of instructions in the memory of a single centralized device, or it may be distributed across multiple individual devices located in geographically scattered locations.
[0043] Embodiment of a sensor result interface Figures 2D-2I illustrate embodiments of the sensor results interface or GUI of a specimen monitoring system. According to one aspect of these embodiments, the sensor results GUI described herein is configured to display specimen data and other health information by a user interface application (e.g., software) installed on a reader such as a smartphone or receiver, as described with respect to Figure 2B. Those skilled in the art will understand that the user interface application and the sensor results interface or GUI may also run on a local computer system or other computing device (e.g., a wearable calculator, smartwatch, tablet computer, etc.).
[0044] Referring first to Figure 2D, the sensor results GUI 235 depicts an interface comprising a first part 236 which may include a numerical representation of the current sample concentration value (e.g., current glucose value), a directional arrow indicating the sample trend direction, and a descriptive text providing contextual information, such as whether the user's sample level is within range (e.g., "glucose is within range"). The first part 236 may also include a color or shade indicating the sample concentration or trend. For example, as shown in Figure 2D, the first part 236 is green to indicate that the user's sample level is within the target range. According to some embodiments, for example, a red tone may indicate a sample level below a low sample level threshold, an orange tone may indicate a sample level above a high sample level threshold, and a yellow tone may indicate a sample level outside the target range. Also according to some embodiments, the sensor results GUI 235 also comprises a second part 237 consisting of a graphical representation of the sample data. In particular, the second part 237 includes a sample trend graph representing the sample concentration (indicated by the y-axis) over a predetermined period of time, as indicated by the x-axis. In some embodiments, a predetermined period may be shown in 5-minute increments, and a total of 12 hours of data may be displayed. However, other time increments and durations of sample data may be available, and those skilled in the art will understand that these are within the scope of the disclosure. The second part 237 may also include a point 239 on a sample trend graph showing the current sample concentration value, a shaded green area 240 showing the target sample range, and two dotted lines 238a and 238b showing the high and low sample thresholds, respectively. According to some embodiments, the GUI 235 may also include a third part 241 consisting of a graphical indicator and textual information representing the remaining sensor life.
[0045] Next, referring to Figure 2E, another embodiment 245 of the sensor results GUI is depicted. According to one aspect of this embodiment, the first portion 236 is shown in yellow to indicate that the user's current sample concentration is not within the target range. The second portion 237 includes a sample trend line 241 that may represent historical sample levels over time and a current sample data point 239 showing the current sample concentration value (shown in yellow to indicate that the current value is outside the target range).
[0046] In another embodiment, the data on the sensor results GUI 245 is automatically updated according to an update interval (e.g., every second, every minute, every 5 minutes). For example, in many embodiments, when the reader receives sample data, the sensor results GUI 245 updates (1) the current sample concentration value shown in the first part 236 and (2) the sample trend line 241 and the current sample data point 239 shown in the second part 237. In some embodiments, automatically updating the sample data may prevent the display of older historical sample data (e.g., within the left portion of the sample trend line 241).
[0047] Figure 2F shows another embodiment 250 of the sensor results GUI. According to this embodiment, the sensor results GUI 250 includes a first section 236 shown in an orange tone to indicate that the user's sample level is above the high glucose threshold (e.g., above 250 mg / dL). The sensor results GUI 245 also displays health information icons 251, such as an exercise icon or an apple icon, to reflect user-recorded items indicating the time the user exercised or ate a meal.
[0048] Figure 2G shows another embodiment 255 of the sensor results GUI. According to this embodiment, the sensor results GUI 255 includes a first section 236, shown in an orange tone, to indicate that the user's sample level is above the high glucose threshold. As can be seen in Figure 2G, the first section 236 does not report a numerical value but instead displays the letters "HI" to indicate that the current sample concentration value is above the upper limit of the glucose reporting range. Although not depicted in Figure 2G, those skilled in the art will understand that, conversely, a sample concentration below the lower limit of the glucose reporting range will not display a numerical value in the first section 236 but instead display the letters "LO".
[0049] Figure 2H shows another embodiment 260 of the sensor results GUI. According to this embodiment, the sensor results GUI 260 includes a first section 236, shown in green to indicate that the user's current sample level is within the target range. Also according to this embodiment, the first section 236 of the GUI 260 may include the sentence "Glucose will decrease" to indicate to the user that the user's sample concentration value is expected to decrease below a predicted low sample level threshold within a given time (for example, the expected glucose will decrease below 75 mg / dL within 15 minutes). Those skilled in the art will understand that if the user's sample level is expected to increase above a predicted high sample level threshold within a given time, the sensor results GUI 260 may display the message "Glucose will increase".
[0050] Figure 2I shows another embodiment 265 of the sensor results GUI. According to this embodiment, the sensor results GUI 265 displays a first section 236 when there is a sensor error. According to one aspect of this embodiment, the first section 236 includes three dashes 266 instead of the current sample concentration value to indicate that the current sample value is not available. In some embodiments, the three dashes 266 may indicate one or more error conditions, such as (1) no signal, (2) loss of signal, (3) sensor too hot / too cold, or (4) glucose level not available. Also, as can be seen in Figure 2I, the first section 236 is gray (not green, yellow, orange, or red) to indicate that the current sample value is not available. Also, according to another aspect of this embodiment, the second section 237 may be configured to display historical sample data on the sample trend graph despite the presence of error conditions that prevent the display of the current sample concentration value in the first section 236. However, as shown in Figure 2I, the current sample concentration value data point is not shown on the sample trend graph of the second section 237.
[0051] Implementation of a time-in-range interface Figures 3A–3F depict embodiments of a GUI for a sample monitoring system. In particular, Figures 3A–3F depict an in-range time (also called in-range time and / or target time) GUI, each consisting of multiple bars or bar segments, where each bar or bar segment indicates the amount of time the user's sample level is within the default sample range associated with that bar or bar segment. In some embodiments, the amount of time may be expressed, for example, as a percentage of a default amount of time.
[0052] Referring to Figures 3A and 3B, embodiments of the range time GUI 305 are shown. The range time GUI 305 includes a “custom” range time view 305A and a “standard” range time view 305B, with a slideable element 310 allowing the user to switch between the two views. According to one aspect of this embodiment, the range time views 305A and 305B each include a plurality of bars, each bar indicating the amount of time the user’s sample level is within a default sample range associated with that bar. In some embodiments, the range time views 305A and 305B further include a date range index 308 indicating the dates associated with the plurality of bars displayed, and a data availability index 314 indicating the period during which the sample data is available as sample data to be displayed (e.g., “Data available for 7 out of 7 days”).
[0053] Referring to Figure 3A, the "Custom" range time view 305A includes six bars. The six bars (from top to bottom) include: the first bar indicating that the user's glucose range is greater than 250 mg / dL for 10% of the default time period; the second bar indicating that the user's glucose range is between 141 and 250 mg / dL for 24% of the default time period; the third bar 316 indicating that the user's glucose range is between 100 and 140 mg / dL for 54% of the default time period; the fourth bar indicating that the user's glucose range is between 70 and 99 mg / dL for 9% of the default time period; the fifth bar indicating that the user's glucose range is between 54 and 69 mg / dL for 2% of the default time period; and the sixth bar indicating that the user's glucose range is less than 54 mg / dL for 1% of the default time period. Those skilled in the art will recognize that the glucose range and time percentage associated with each bar may vary depending on the range defined by the user and the user's available sample data. Furthermore, while Figures 3A and 3B show a predetermined time unit 314 equal to 7 days, those skilled in the art will understand that other predetermined time units (e.g., 1 day, 3 days, 14 days, 30 days, 90 days, etc.) are available and are entirely within the scope of this disclosure.
[0054] According to another aspect of this embodiment, the “custom” range time view 305A also includes a user-defined custom target range 312, which includes a useful “edit” link that allows the user to define and / or modify a custom target range. As shown in the “custom” range time view 305A, the custom target range 312 is defined as a glucose range between 100 and 140 mg / dL, corresponding to the third bar 316 of a plurality of bars. In other embodiments, two or more ranges may be user-adjustable, and those skilled in the art will understand that such embodiments are entirely within the scope of this disclosure.
[0055] Referring to Figure 3B, the “Standard” range time view 305B includes five bars. The five bars (from top to bottom) include: the first bar indicating that the user’s glucose range is greater than 250 mg / dL for 10% of the default time period; the second bar indicating that the user’s glucose range is between 181 and 250 mg / dL for 24% of the default time period; the third bar indicating that the user’s glucose range is between 70 and 180 mg / dL for 54% of the default time period; the fourth bar indicating that the user’s glucose range is between 54 and 69 mg / dL for 10% of the default time period; and the fifth bar indicating that the user’s glucose range is less than 54 mg / dL for 2% of the default time period. As with the “Custom” range time view 305A, a person skilled in the art will recognize that the percentage of time associated with each bar may vary depending on the user’s available sample data. However, unlike the “Custom” range time view 305A, the user cannot adjust the glucose range shown in the “Standard” view 305B.
[0056] Figures 3C and 3D depict another embodiment 320 of the range time GUI having multiple views 320A and 320B similar to the views shown in Figures 3A and 3B. According to some embodiments, the range time GUI 320 may further include one or more selectable icons 322 (e.g., radio buttons, checkboxes, sliders, switches, etc.) that allow the user to select a default amount of time for the user's sample data to be shown in the range time GUI 320. For example, as shown in Figures 3C and 3D, the selectable icon 322 may be used to select a default amount of time of 7 days, 14 days, 30 days, or 90 days. Those skilled in the art will understand that other default amounts of time may be available and are entirely within the scope of this disclosure.
[0057] Figure 3E illustrates an embodiment of the In-Target Time GUI 330 that may be output to a display of a reading device (e.g., a dedicated reading device, instrument, etc.). According to one aspect of this embodiment, the In-Target Time GUI 330 includes three bars. The three bars (from top to bottom) include a first bar indicating that the user's glucose range is above the default target range for 34% of a default time period, a second bar indicating that the user's glucose range is within the default target range for 54% of a default time period, and a third bar indicating that the user's glucose range is below the default target range for 12% of a default time period. Those skilled in the art will recognize that the percentage of time associated with each bar may vary depending on the user's available sample data. Furthermore, while Figure 3E shows a default time dose 332 equivalent to the most recent 7 days and a default target range 334 of 80–140 mg / dL, those skilled in the art will understand that other default time doses (e.g., 1 day, 3 days, 14 days, 30 days, 90 days, etc.) and / or default target ranges (e.g., 70–180 mg / dL) may be used and are entirely within the scope of this disclosure.
[0058] Figure 3F depicts another embodiment 340 of the range time GUI, which includes a single bar comprising five bar segments. The five bar segments (from top to bottom) include: a first bar segment indicating that the user's glucose range is "very high" or greater than 250 mg / dL for 1% (14 minutes) of the default time amount; a second bar segment indicating that the user's glucose range is "high" or between 180 and 250 mg / dL for 18% (4 hours and 19 minutes) of the default time amount; a third bar segment indicating that the user's glucose range is within the "target range" or between 70 and 180 mg / dL for 78% (18 hours and 43 minutes) of the default time amount; a fourth bar segment indicating that the user's glucose range is "low" or between 54 and 69 mg / dL for 3% (43 minutes) of the default time amount; and a fifth bar segment indicating that the user's glucose range is "very low" or less than 54 mg / dL for 0% (0 minutes) of the default time amount. As shown in Figure 3F, according to some embodiments, the range time GUI 340 may display text near each bar portion indicating the actual amount of time, for example, in hours and / or minutes.
[0059] According to one embodiment shown in Figure 3F, each bar portion of the range time GUI 340 may be of a different color. In some embodiments, the bar portions may be separated by dashed or dotted lines 342 and / or marked with numerical markers 344 to indicate the range represented by adjacent bar portions. In some embodiments, the range time represented by the bar portions may be further expressed as a percentage, an actual amount of time (e.g., 4 hours and 19 minutes), or both, as shown in Figure 3F. Furthermore, those skilled in the art will recognize that the time percentage associated with each bar portion may vary depending on the user's sample data. In some embodiments of the range time GUI 340, the target range may be configured by the user. In other embodiments, the user cannot change the target range of the range time GUI 340.
[0060] Embodiments of Sample Level and Trend Warning Interface Figures 4A–4O illustrate embodiments of a sample level / trend alert GUI for a sample monitoring system. According to one aspect of these embodiments, the sample level / trend alert GUI may consist of visual notifications (e.g., warnings, alarms, pop-up windows, banner notifications, etc.). The visual notifications include an alarm status, a sample level measurement related to the alarm status, and a trend indicator related to the alarm status.
[0061] Referring to Figures 4A-4C, embodiments of a high glucose alert 410, a low glucose alert 420, and a critical low glucose alert 430 are depicted, respectively. Each alert consists of a pop-up window 402 containing an alert status text 404 (e.g., "Low Glucose Alert"), a sample level measurement 406 related to the alert status (e.g., current glucose level 67 mg / dL), and a trend indicator 408 related to the alert status (e.g., a trend arrow or directional arrow). In some embodiments, an alert icon 412 may be located near the alert status text 404.
[0062] Referring to Figures 4D-4G, another embodiment 440, 445 of a low glucose alarm, another embodiment 450 of a critical low glucose alarm, and another embodiment 455 of a high glucose alarm are depicted. As shown in Figure 4D, the low glucose alarm 440 is similar to the low glucose alarm in Figure 4B (e.g., consisting of a pop-up window containing alarm status text, a sample level measurement related to that alarm status, and a trend index related to that alarm status), but further includes a critical warning icon 442 indicating that the alarm is configured as a critical warning (e.g., it displays, sounds, and vibrates even if the device is locked or the device is set to "do not wake"). With respect to Figure 4E, the low glucose alarm 445 is also similar to the low glucose alarm in Figure 4B, but instead of a trend arrow, the low glucose alarm 445 includes a text trend index 447. According to one aspect of the embodiment, the character tendency index 447 is made available by the device's accessibility settings, and the device can read the character tendency index 447 to the user by a character-to-speech function (e.g., VoiceOver for iOS or Select-to-Speak for Android).
[0063] Referring to Figure 4F, the low glucose alert 450 is similar to the low glucose alert in Figure 4D (including a critical warning icon), but instead of displaying a sample level measurement related to the alarm state and a trend indicator related to the alarm state, the low glucose alert 450 displays an out-of-range indicator 452 indicating that the current glucose level is above or below a predetermined reportable sample level range (e.g., "HI" or "LO"). With respect to Figure 4G, the high glucose alert 455 is similar to the high glucose alert in Figure 4A (e.g., consisting of a pop-up window with alarm state text, a sample level measurement related to the alarm state, and a trend indicator related to the alarm state), but further includes instructions 457 for the user. In some embodiments, for example, the instructions may be a prompt urging the user to "check blood glucose levels." Those skilled in the art will understand that other instructions or prompts (e.g., administer an antidote, eat a meal, etc.) may be given.
[0064] Furthermore, Figures 4A to 4G depict embodiments of the sample level / trend warning GUI displayed on a smartphone with the iOS operating system, but those skilled in the art will understand that the sample level / trend warning GUI can run on other devices, including, for example, smartphones with other operating systems, smartwatches, wearable devices, readers, tablet calculators, blood glucose meters, laptops, desktops, and workstations. Figures 4H to 4J depict embodiments of high glucose alerts, low glucose alerts, and critical low glucose alerts for, for example, a smartphone with the Android operating system. Similarly, Figures 4K to 4O depict embodiments of critical low glucose alerts, low glucose alerts, high glucose alerts, critical low glucose alerts (with blood glucose check icon), and high glucose alerts (with out-of-range indicator), respectively, for readers.
[0065] Embodiment of a sensor usage interface Figures 5A-5F depict embodiments of sensor user interfaces relating to a GUI for a sample monitoring system. According to one aspect of these embodiments, the sensor user interface provides technical improvements, including the ability to quantify, and facilitates user interaction with the sample monitoring system. According to several embodiments, for example, the sensor user interface may include a visual display of one or more “view” metrics. Each metric may indicate the degree of user interaction with the sample monitoring system. The “view” may be, for example, an instance in which the sensor results interface is displayed or comes to the forefront. In several embodiments, the sensor user interface may include a visual display of a “scan” metric indicating another degree of user interaction with the sample monitoring system. The “scan” may be, for example, an instance in which the user scans a sensor control device in, for example, a flash sample monitoring system, using a reader (e.g., a smartphone, a dedicated reader, etc.).
[0066] Figures 5A and 5B depict embodiments of sensor user interfaces 500 and 510, respectively. According to one aspect of these embodiments, sensor user interfaces 500 and 510 may be represented and displayed by a mobile application or software residing in the persistent memory of the reader 120, for example, as described with respect to Figures 1 and 2A. Referring to Figure 5A, the sensor user interface 500 may include a predetermined time interval 508 indicating the period (e.g., a date range) over which the view metrics are measured, a total view metric 502 indicating the total number of views during the predetermined time interval 508, a daily view metric 504 indicating the average number of views per day during the predetermined time interval 508, and a percentage-time sensor activity metric 506 indicating the percentage of the predetermined time interval 508 over which the reader 120 is communicating with the sensor control device 102, as described with respect to Figures 1, 2B, and 2C. Referring to Figure 5B, the sensor user interface 510 may include the daily view metric 504 and the percentage-time sensor activity metric 506. Each metric is measured over the predetermined time interval 508.
[0067] In another aspect of these embodiments, while the predetermined period 508 is shown as one week, those skilled in the art will recognize that other predetermined periods (e.g., 3 days, 14 days, 30 days) may be used. Furthermore, the predetermined period 508 may be an individual period with a start date and an end date, as shown in the sensor usage interface 500 of Figure 5A, or a period relative to the current day or time (e.g., "the last 7 days", "the last 14 days", etc.), as shown in the sensor usage interface 510 of Figure 5B.
[0068] Figure 5C depicts an embodiment 525 of the sensor usage interface as part of the specimen monitoring system reporting GUI 515. According to one aspect of this embodiment, the GUI 515 is a snapshot report for a given period 516 (e.g., 14 days) and has multiple reporting parts on a single reporting GUI, the reporting parts of which include the sensor usage interface part 525, a glucose trend interface 517 which may include a glucose trend graph, a low glucose event graph, and other relevant glucose metrics (e.g., glucose management indicators), a health information interface 518 which may include information about the user's average daily carbohydrate intake and medication dosage (insulin dosage) recorded by the user, and a comment interface 519 which may include additional information presented in a descriptive format about the user's specimen and medication patterns. According to another aspect of this embodiment, the sensor usage interface 525 may include a percentage-time sensor activity metric 526, an average scan / view metric 527 (e.g., showing the average sum of the number of scans and the number of views), and a percentage-time sensor activity graph 528. As shown in Figure 5C, the axis of the percentage time sensor activity graph is aligned with the corresponding axis of one or more other graphs (e.g., mean glucose trend graph, low glucose event graph), allowing the user to visually correlate data across multiple graphs from two or more parts of the reporting GUI by a common unit of aligned axes (e.g., time).
[0069] Figure 5D illustrates an embodiment of another sample monitoring system reporting GUI 530 that includes sensor usage information. According to one aspect of this embodiment, the GUI 530 is a monthly summary that includes a first part consisting of a symbolic description 531, each containing a series of graphical icons adjacent to a descriptive text. As shown in Figure 5D, the symbolic description 531 includes icons and descriptions for "average glucose," icons and descriptions for "scans / views," and icons and descriptions for "low glucose events." The GUI 530 also includes a second part consisting of a calendar interface 532. For example, as shown in Figure 5D, the GUI 530 includes a monthly calendar interface, where each day of the month may include one or more of the average glucose metric, low glucose event icons, and sensor usage metrics 532. In some embodiments, as shown in Figure 5D, the sensor usage metric ("scans / views") represents the sum of the number of scans and views per day.
[0070] Figure 5E depicts an embodiment of another specimen monitoring system reporting GUI 540 that includes sensor usage information. According to one aspect of this embodiment, GUI 540 is a weekly summary report comprising multiple reporting parts, each reporting part representing a different day of the week, and includes a glucose trend graph 541 which may include the user's glucose levels measured over a 24-hour period, and a health information interface 543 which may include information about the user's average daily glucose, carbohydrate intake, and / or insulin dose. In some embodiments, the glucose trend graph 541 may include a sensor usage marker 542 which may indicate that it was scanned, viewed, or both occurred at a specific time within that 24-hour period.
[0071] Figure 5F illustrates an embodiment of another sample monitoring system reporting GUI 550 that includes sensor usage information. According to one aspect of this embodiment, GUI 550 is a daily record report that includes a glucose trend graph 551 which may include the user's glucose levels over a 24-hour period. In some embodiments, the glucose trend graph 551 may include sensor usage markers 552 which may indicate that a scan, view, or both occurred at a specific time within that 24-hour period. The glucose trend graph 551 may also include recorded event markers such as recorded carbohydrate intake markers, recorded insulin dose markers 554, and glucose event markers such as a low glucose event marker 555.
[0072] Any GUI, reporting interface, or any part thereof described herein is intended for illustrative purposes only, and a person skilled in the art will understand that any individual element or any combination of elements depicted and / or described in a particular embodiment or figure may be freely combined with any element or combination of elements depicted and / or described in relation to other embodiments.
[0073] Embodiment of a digital interface for a specimen monitoring system Embodiments of a digital interface for a specimen monitoring system are described below. According to one aspect of these embodiments, the digital interface may consist of instruction sequences, routines, subroutines, and / or algorithms, for example, software and / or firmware stored in persistent memory and executed by one or more processors of one or more devices in the specimen monitoring system. The instruction sequences, routines, subroutines, or algorithms are configured to enable certain functions and inter-device communication. First, those skilled in the art will understand that the digital interfaces described herein may consist of instruction sequences stored in the persistent memory of the sensor control device 102, the reader 120, the local computer system 170, the trusted computer system 180, and / or any other device or system that is part of or communicates with the specimen monitoring system 100 described with respect to Figures 1, 2A, and 2B. When these instructions are executed by one or more processors of the reader 120, the local computer system 170, the trusted computer system 180, or the other device or system of the specimen monitoring system 100, those processors are caused to perform the method steps described herein. Those skilled in the art will recognize that the digital interfaces described in this book can be stored as a set of instructions in the memory of a single centralized device, or they can be distributed across multiple individual devices located in geographically scattered locations.
[0074] Embodiment of Data Filling Method Embodiments of data filling methods in a sample monitoring system are described below. According to one aspect of these embodiments, gaps in sample data and other information may arise from interruptions in communication links between various devices of the sample monitoring system 100. These interruptions may occur because a device is powered off (e.g., the user's smartphone battery runs out) or because a first device temporarily moves out of the wireless communication range from a second device (e.g., a user wearing the sensor control device 102 accidentally leaves their smartphone at home when going to work). As a result of these interruptions, the reader 120 may not receive sample data and other information from the sensor control device 102. Therefore, it would be advantageous to have a robust and flexible data filling method in the sample monitoring system to ensure that each sample monitoring device can receive a complete set of data after the communication link is re-established.
[0075] Figure 6A is a flowchart illustrating an embodiment of a data filling method 600 in a specimen monitoring system. According to one aspect of this embodiment, method 600 may be performed to provide data filling between a sensor control device 102 and a reader 120. In step 602, specimen data and other information are communicated autonomously between the first and second devices at predetermined intervals. In some embodiments, the first device may be the sensor control device 102, and the second device may be the reader 120 described with respect to Figures 1, 2A, and 2B. According to one aspect of this embodiment, specimen data and other information may include, but are not limited to, data indicating the specimen level in body fluids, the rate of change of the specimen level, the predicted specimen level, low or high specimen level warning conditions, sensor failure conditions, or communication link events. According to another aspect of this embodiment, the autonomous communication at predetermined intervals may include transmitting specimen data and other information at one or more predetermined rates (e.g., every minute, every 5 minutes, every 15 minutes, etc.) according to a standard wireless communication network protocol, such as Bluetooth or Bluetooth Low Energy Protocol. In some embodiments, different types of sample data and other information can be autonomously communicated between the first and second devices at different predetermined rates (e.g., historical glucose data every 5 minutes, current glucose value every 1 minute).
[0076] In step 604, a disconnection event or condition occurs that causes an interruption in the communication link between the first and second devices. As described above, a disconnection event may result from the second device (e.g., reader 120, smartphone, etc.) running out of battery power or being manually powered off by the user. A disconnection event may also result from the first device moving out of the wireless communication range of the second device, the presence of a physical barrier interfering with the first and / or second devices, or anything else that prevents wireless communication from taking place between the first and second devices.
[0077] In step 606, a communication link is re-established between the first and second devices (for example, the first device returns to the wireless communication range of the second device). After reconnection, the second device requests historical sample data according to the last life count metric it received for the data. According to one aspect of this embodiment, the life count metric may be a numerical value that is incremented and tracked in units of time (e.g., minutes) by the second device, indicating the amount of time that has elapsed since the sensor control device was activated. For example, in some embodiments, after the second device (e.g., reader 120, smartphone, etc.) re-establishes a Bluetooth wireless communication link with the first device, the second device may identify the last life count metric it received for the data. Then, according to some embodiments, the second device may send a request to the first device for historical sample data and other information having a life count metric greater than the identified last life count metric it received for the data.
[0078] In some embodiments, instead of requesting historical sample data related to a life count metric greater than the last identified life count metric for which data was received, the second device may send a request to the first device for historical sample data and other information related to a specific life count range.
[0079] In step 608, upon receiving a request, the first device retrieves the requested historical sample data from its storage unit (e.g., the persistent memory of the sensor control device 102) and transmits the requested historical sample data to the second device in step 610. In step 612, upon receiving the requested historical sample data, the second device stores the requested historical sample data in its storage unit (e.g., the persistent memory of the reader 120). According to one aspect of this embodiment, when the second device stores the requested historical sample data, it may store it together with the associated life count metric. In some embodiments, the second device can also output the requested historical sample data to a display of the second device, for example, a glucose trend graph of the sensor results GUI described with respect to Figures 2D-2I. For example, in some embodiments, the requested historical sample data may be used to fill gaps in the glucose trend graph by displaying it together with previously received sample data.
[0080] Furthermore, those skilled in the art will understand that the data filling method can be performed between multiple various devices within the sample monitoring system that are wired or wirelessly connected to one another.
[0081] Figure 6B is a flowchart illustrating another embodiment 620 of a data filling method in a specimen monitoring system. According to one aspect of this embodiment, method 620 may be performed to provide data filling between a reader 120 (e.g., a smartphone, a dedicated reader) and a trusted computer system 180, e.g., a cloud-based platform for generating reports. In step 622, specimen data and other information are communicated between the reader 120 and the trusted computer system 180 based on a plurality of upload triggers. According to one aspect of this embodiment, specimen data and other information may include, but are not limited to, data indicating the specimen level in body fluids (e.g., current glucose level, historical glucose data), rate of change of specimen level, predicted specimen level, low or high specimen level warning status, user-recorded information, information regarding the sensor control device 102, alarm information (e.g., alarm settings), wireless connection events, and reader settings.
[0082] According to another aspect of this embodiment, the multiple upload triggers may include, but are not limited to, one or more of the following: activating the sensor control device 102, user input or deletion of recorded items, a re-established wireless communication link (e.g., Bluetooth) between the reader 120 and the sensor control device 102, a changed alarm threshold, alarm notification, update, or cancellation, a re-established internet connection, a restarted reader 120, receiving one or more current glucose measurements from the sensor control device 102, the sensor control device 102 being terminated, signal loss alarm notification, update, or cancellation, signal loss alarm on / off switching, viewing the sensor results screen GUI, or a user signing in to a cloud-based platform.
[0083] According to another aspect of this embodiment, in order to track data transmission and reception between devices, the reader 120 may mark sample data and other information to be transmitted to a trusted computer system 180. In some embodiments, for example, upon receiving sample data and other information, the trusted computer system 180 may send a return response to the reader 120 to indicate that it has successfully received the sample data and other information. The reader 120 may then mark that data as having been successfully transmitted. In some embodiments, the sample data and other information may be marked by the reader 120 before transmission and after receiving the return response. In other embodiments, the sample data and other information may be marked by the reader 120 only after receiving the return response from the trusted computer system 180.
[0084] Referring to Figure 6B, step 624 occurs a disconnection event that causes an interruption in the communication link between the reader 120 and the reliable computer system 180. For example, the disconnection event may occur as a result of the user putting the reader 120 into "airplane mode" (e.g., disabling the wireless communication module), the user turning off the power to the reader 120, or the reader 120 moving out of wireless communication range.
[0085] In step 626, the communication link (and the internet) between the reader 120 and the trusted computer system 180 is re-established. This is one of several upload triggers. Next, the reader 120 identifies the last successful transmission of data to the trusted computer system 180 based on the previously marked and transmitted sample data and other information. Then, in step 628, the reader 120 can transmit sample data and other information that the trusted computer system 180 has not yet received. In step 630, the reader 120 receives notification from the trusted computer system 180 that the sample data and other information have been successfully received.
[0086] While Figure 6B illustrates a reader communicating with a trusted computer system, those skilled in the art will understand that the data filling method can be applied between other devices within a specimen monitoring system and the computer system (e.g., between the reader and the local computer system, between the reader and the medical supply device, between the reader and the wearable calculator, etc.). These embodiments and their variations and rearrangements are entirely within the scope of this disclosure.
[0087] In addition to data filling, an embodiment of a method for aggregating disconnection and reconnection events of wireless communication links within a sample monitoring system is described. According to one aspect of this embodiment, there can be a wide range of causes for disconnection of wireless communication links between various devices within a sample monitoring system. Some causes may be inherently technical (e.g., the reader is outside the wireless communication range of the sensor control device), while others may be related to user behavior (e.g., the user leaves the reader at home). Therefore, it would be beneficial to collect information on disconnection and reconnection events between various devices within a sample monitoring system in order to improve connectivity and data integrity within the system.
[0088] Figure 6C is a flowchart illustrating an embodiment of method 640 for aggregating disconnection and reconnection events of wireless communication links within a sample monitoring system. In some embodiments, method 640 may be used, for example, to detect and record Bluetooth or Bluetooth Low Energy disconnection and reconnection events between a sensor control device 102 and a reader 120 and upload them to a trusted computer system 180. According to one aspect of this embodiment, the trusted computer system 180 may aggregate disconnection and reconnection events transmitted from multiple sample monitoring systems. The aggregated data is then analyzed to determine if any conclusions can be drawn about ways to improve connectivity and data integrity within the sample monitoring system.
[0089] In step 642, sample data and other information are communicated between the reader 120 and the trusted computer system 180 based on multiple upload triggers, for example, as described with respect to method 620 in Figure 6B. In step 644, a disconnection event occurs that causes an interruption of the wireless communication link between the sensor control unit 102 and the reader 120. Examples of disconnection events, but not limited to these, may include, but are not limited to, the user putting the reader 120 into "airplane mode", the user turning off the reader 120, the reader 120 running out of battery, the sensor control unit 102 moving out of the wireless communication range of the reader 120, or a physical barrier blocking the sensor control unit 102 and / or the reader 120.
[0090] Referring again to Figure 6C, in step 646, the wireless communication link between the sensor control device 102 and the reader 120 is re-established. This is one of several upload triggers. Next, the reader 120 determines the disconnection time and the reconnection time. The disconnection time is the time when the interruption of the wireless communication link began, and the reconnection time is the time when the wireless communication link between the sensor control device 102 and the reader 120 was re-established. According to some embodiments, the disconnection and reconnection times may be stored in the event log of the reader 120. In step 648, the reader 120 transmits the disconnection and reconnection times to a trusted computer system 180.
[0091] In some embodiments, disconnection and reconnection times may be stored in the persistent memory of a reliable computer system 180, for example, a database, and aggregated with disconnection and reconnection times collected from other sample monitoring systems. In some embodiments, disconnection and reconnection times may also be transmitted from the computer system 180 storing sample data to and stored on a different cloud-based platform or server. In yet another embodiment, disconnection and reconnection times may be anonymized.
[0092] Furthermore, those skilled in the art will recognize that Method 640 can be used to collect disconnection and reconnection times between other devices in a specimen monitoring system, such as between the reader 120 and a reliable computer system 180, between the reader 120 and a wearable calculator (e.g., a smartwatch, smart glasses), between the reader 120 and a drug delivery device (e.g., an insulin pump, an insulin pen), between the sensor control unit 102 and a wearable calculator, between the sensor control unit 102 and a drug delivery device, and any other combination of devices in a specimen monitoring system. Those skilled in the art will also understand that Method 640 can be used to analyze disconnection and reconnection times for different wireless communication protocols, such as Bluetooth or Bluetooth Low Energy, NFC, 802.11x, UHF, cellular connectivity, or any other standard or proprietary wireless communication protocol.
[0093] Improved Expired / Faulty Sensor Transmission Embodiment Embodiments of improved methods for transmitting expired and / or faulty sensors within a sample monitoring system are described. According to one aspect of these embodiments, an expired or faulty sensor condition detected by the sensor control device 102 can trigger a critical warning in the reader 120. However, if the reader 120 is in "airplane mode," or powered off, or outside the wireless communication range of the sensor control device 102, or unable to communicate wirelessly with the sensor control device 102 for any other reason, the reader 120 may not receive these critical warnings. This could cause the user to miss important information, such as the need to promptly replace the sensor control device 102. Failure to take action on detected sensor failures could also lead to the user being unaware of harmful glucose conditions (e.g., hypoglycemia and / or hyperglycemia) due to the expired sensor.
[0094] Figure 7 is a flowchart illustrating an embodiment of the improved expired or faulty sensor transmission method 700 in a sample monitoring system. According to one aspect of this embodiment, the method 700 may be performed to enable improved sensor transmission by the sensor control device 102 after an expired or faulty sensor condition has been detected. In step 702, the sensor control device 102 detects an expired or faulty sensor condition. In some embodiments, the sensor fault condition may be one or both of the following: a sensor insertion failure condition or a sensor termination condition. According to some embodiments, the sensor insertion failure condition or sensor termination condition may include, but is not limited to, one or more of the following: a detected FIFO overflow condition, a sensor signal below a predetermined sensor insertion failure threshold, a detected water intrusion, an electrode voltage above a predetermined diagnostic voltage threshold, an early signal attenuation (ESA) condition, or a slow signal attenuation (LSA) condition.
[0095] Referring again to Figure 7, in step 704, the sensor control device 102 stops acquiring sample-level measurements from the sample sensor in response to the detection of a sensor failure condition. In step 706, the sensor control device 102 begins transmitting a sensor failure condition indication to the reader 120, while allowing the reader 120 to connect to the sensor control device 102 for data filling. According to one aspect of this embodiment, the transmission of the sensor failure condition indication may consist of transmitting a plurality of Bluetooth or Bluetooth Low Energy notification packets, each of which may contain a sensor failure condition indication. In some embodiments, the plurality of Bluetooth or Bluetooth Low Energy notification packets may be transmitted repeatedly, continuously, or intermittently. Those skilled in the art will recognize that other modes of wirelessly transmitting or broadcasting the sensor failure condition indication can be performed. According to another aspect of this embodiment, in response to receiving the sensor failure condition indication, the reader 120 may visually display a warning or a prompt for user confirmation.
[0096] In step 708, the sensor control device 102 may be configured to monitor for a return response or acknowledgment of the reception of a sensor fault indicator from the reader 120. In some embodiments, for example, the return response or acknowledgment of reception may be generated by the reader 120 when the user dismisses a warning regarding a sensor fault indicator on the reader 120 or responds to a prompt for acknowledgment. Once the sensor control device 102 receives a return response or acknowledgment of the reception of a sensor fault indicator, in step 714, the sensor control device 102 may enter a storage state or an exit state. According to some embodiments, in the storage state, the sensor control device 102 enters a low-power mode and can be restarted by the reader 120. In the exit state, on the other hand, the sensor control device 102 cannot be restarted and must be removed or replaced.
[0097] If the sensor control device 102 does not receive a fault status indication, in step 710, the sensor control device 102 stops transmitting the fault status indication after a predetermined first period. In some embodiments, the predetermined first period may be one of the following: 1 hour, 2 hours, 4 hours, etc. Next, in step 712, if the sensor control device 102 still does not receive a fault status indication, the sensor control device 102 also stops allowing data filling after a predetermined second period. In some embodiments, the predetermined second period may be one of the following: 24 hours, 48 hours, etc. The sensor control device 102 then enters a storage state or an end state in step 714.
[0098] By allowing the sensor control device 102 to continue transmitting the sensor failure status for a predetermined period, embodiments of the present disclosure mitigate the risk of unreceived sensor failure warnings. Furthermore, while the embodiments described above relate to a sensor control device 102 communicating with a reader 120, those skilled in the art will recognize that the sensor failure status indication can also be transmitted between the sensor control device 102 and other types of portable computing devices, such as wearable computing devices (e.g., smartwatches, smart glasses) or tablet computing devices.
[0099] Implementation of data merging in a specimen monitoring system Embodiments of a method for merging data received from one or more sample monitoring systems are described. As previously described with respect to Figure 1, a reliable computer system 180, such as a cloud-based platform, may be configured to generate various reports based on sample data and other information received from multiple readers 120 and sensor control devices 102. However, a large and diverse group of readers and sensor control devices can create complexity and challenges in generating reports based on the received sample data and other information. For example, a single user may have multiple readers and / or sensor control devices, each of which may be in different versions, simultaneously or sequentially over time. This can lead to further complexity in that there may be overlapping and / or redundant sets of data for each user. Therefore, having a method for merging data in a reliable computer system would be beneficial for report generation.
[0100] Figure 8A is a flowchart illustrating an embodiment of Method 800, which merges user-related data to generate one or more reporting metrics. The data originates from multiple readers and multiple sensor control devices. According to one aspect of this embodiment, Method 800 may be performed to merge sample data to generate different types of reporting metrics used in various reports. In step 802, data is received from one or more readers 120 and combined for merging. In step 804, the combined data is deduplication to remove historical data from multiple readers originating from the same sensor control device. According to one aspect of this embodiment, the data deduplication process may include (1) identifying or assigning a priority to each reader from which the sample data was received, and (2) saving the data associated with the reader with the higher priority if there is duplicate data. In some embodiments, for example, newer readers (e.g., newer models with a more recent version of software installed) are assigned a higher priority than older readers (e.g., older models with an older version of software installed). In some embodiments, priority may be assigned according to the type of device (for example, a smartphone may have a higher priority than a dedicated reader).
[0101] Referring to Figure 8A, step 806 determines whether one or more of the generated reporting metrics require the elimination of overlapping data. If not, step 808 may generate the first type of reporting metric based on the deduplicated data without further processing. In some embodiments, the first type of reporting metric may include, for example, the average glucose level used in reports, such as snapshots or monthly summary reports (described with respect to Figures 5C and 5D). If it is determined that one or more of the generated reporting metrics require the elimination of overlapping data, step 810 performs a method for eliminating the overlapping data. Embodiments of the method for eliminating the overlapping data are described below with respect to Figure 8B. Next, in step 812, the second type of reporting metric is generated based on the data that has been processed to eliminate duplicates and overlapping data portions. In some embodiments, the second type of reporting metric may include, for example, the low glucose event calculation used in reports, such as daily record reports (described with respect to Figure 5F).
[0102] Figure 8B is a flowchart illustrating an embodiment of method 815 for eliminating overlapping regions of sample data, which may be performed, for example, in step 810 of method 800 described with respect to Figure 8A. In step 817, the deduplication data from each reader (obtained from step 804 of method 800 described with respect to Figure 8A) may be sorted from earliest to newest. In step 819, the deduplication and sorted data are separated according to a predetermined period based on the generated reporting metric. In some embodiments, for example, if the reporting metric is a graph reflecting glucose values over a specific day, the deduplication and sorted data may be separated for that specific day. Next, in step 821, a contiguous portion of the deduplication and sorted data for each reader is separated. According to one aspect of this embodiment, discontinuous data points may be discarded or ignored (e.g., not used) to generate the reporting metric. In step 823, for each contiguous portion of the deduplication and sorted data from a reader, it is determined whether there is any overlap with other contiguous portions of deduplication and sorted data from other readers. In step 825, for each overlapping region identified, the deduplication and sorting data from the higher-priority reader is saved. If, in step 827, it is determined that all contiguous portions have been analyzed according to the previous steps, method 815 terminates in step 829. Otherwise, method 815 returns to step 823 to continue identifying and resolving any overlapping regions between contiguous portions of deduplication and sorting data for different readers.
[0103] Figures 8C-8E are graphs (840, 850, 860) illustrating the various stages of duplicate-deleted and sorted data from multiple readers when data is processed according to method 815 for eliminating overlapping data regions. Referring first to Figure 8C, graph 840 illustrates duplicate-deleted and sorted data from three different readers: a first reader (reflected by circular data points), a second reader (reflected by diamond-shaped data points), and a third reader (reflected by square data points). In one aspect of graph 840, the data in step 821 of method 815 after duplicate-deleted, sorted, and separated over a predetermined period is depicted. As can be seen in Figure 8C, the contiguous portions of the data from each of the three readers (841, 842, 843) are identified, and three trace lines are shown. In another aspect of graph 840, the discontinuity point 844 is not included in the three trace lines.
[0104] Next, referring to Figure 8D, Graph 850 plots the data from readers 841, 842, and 843 in step 823 of Method 815, and identifies three overlapping regions between consecutive parts of the data. These are the first overlapping region 851 between all three consecutive parts of the data, the second overlapping region 852 between two consecutive parts of the data (from readers 842 and 843), and the third overlapping region 853 between two consecutive parts of the data (likewise from readers 842 and 843).
[0105] Figure 8E is a graph 860 illustrating the data in step 825 of method 815, where a single trace line 861 shows the merged, duplicate-removed, and sorted data from the three readers 841, 842, and 843 after overlapping regions 851, 852, and 853 have been eliminated by using the priority of each reader. According to graph 860, the highest to lowest priority order is reader 843, reader 842, and reader 841.
[0106] Figures 8C, 8D, and 8E depict three consecutive portions of data and three identified overlapping regions, but also show the overlapping regions with fewer or more consecutive portions of data (discontinuous data points). A person skilled in the art will understand that such overlaps are possible. For example, if a user has only two readers, a person skilled in the art will recognize that there may be overlaps (if any) with fewer contiguous portions of the data. Conversely, if a user has five readers, a person skilled in the art will understand that there may be overlaps with three or more contiguous portions of the data.
[0107] Sensor migration embodiment Embodiments of sensor migration methods are described below. According to one aspect of these embodiments, as portable computing and wearable technologies continue to advance rapidly and become more widespread, users will find it easier to replace or update their smartphones more frequently. Therefore, in the context of sample monitoring systems, it would be beneficial to have a sensor migration method that allows users to continue using an already activated sensor control device with a new smartphone. It would also be beneficial to ensure that historical sample data from the sensor control device can be easily and securely loaded into the new smartphone (and then uploaded to a reliable computer system).
[0108] Figure 9A is a flowchart illustrating an embodiment of method 900 for migrating a sensor control device. According to one aspect of this embodiment, method 900 is performed in a sample monitoring system and may allow a user to continue using an already activated sensor control device with a new reader (e.g., a smartphone). In step 902, a user interface application (e.g., a mobile software application or app) is installed on the reader 120 (e.g., a smartphone) to generate and store a new unique device identifier or device ID on the reader 120. In step 904, after the app is installed and launched, the user is prompted to enter authentication information to log in to a trusted computer system 180 (e.g., a cloud-based platform or server). An embodiment of GUI 988 for prompting the user to enter authentication information is shown in Figure 9D. According to one aspect of this embodiment, GUI 988 may include a username field 990 which may contain a unique username or email address and a masked or unmasked password field 992 where the user can enter a password.
[0109] Referring again to Figure 9A, in step 906, after the user enters their authentication information into the app, a prompt appears asking for user confirmation to log in to computer system 180. An embodiment of GUI994 for prompting user confirmation to log in to computer system 180 is shown in Figure 9E. According to one aspect of this embodiment, GUI994 may also include a warning that once the login is confirmed, as shown in Figure 9E, the user will be logged off from other reading devices (e.g., the user's old smartphone).
[0110] Once the user confirms their login, in step 908, the user's authentication information is sent to the computer system 180 for verification. In some embodiments, the device ID is also sent from the reader 120 to the computer system 180 and stored in the persistent memory of the computer system 180. In some embodiments, for example, in response to receiving the device ID, the computer system 180 may update the device ID field in the database that relates to the user's record.
[0111] After the user's authentication information is verified by the computer system 180, in step 910 the user is prompted to scan the sensor control device 102 which has already been activated by the app. According to one aspect of this embodiment, scanning may include bringing the reader 120 into the vicinity of the sensor control device 102 and causing the reader 120 to transmit one or more wireless questioning signals according to a first wireless communication protocol. In some embodiments, the first wireless communication protocol may be, for example, the Near Field Communication (NFC) protocol. However, those skilled in the art will understand that other wireless communication protocols (e.g., infrared, UHF, 802.11x, etc.) may be implemented. An embodiment of the GUI 998 that prompts the user to scan the sensor control device 102 which has already been activated is shown in Figure 9F.
[0112] Referring again to Figure 9A, in step 912, the scanning of the sensor control device 102 by the reader 120 causes the sensor control device 102 to terminate any existing wireless communication link (if currently established) with the user's previous reader. According to one aspect of this embodiment, the existing wireless communication link may be a link established according to a second wireless communication protocol different from the first wireless communication protocol. In some embodiments, for example, the second wireless communication protocol may be Bluetooth or Bluetooth Low Energy Protocol. Next, the sensor control device 102 enters a “pairable” state in which it can establish a wireless communication link with the reader 120 according to the second wireless communication protocol.
[0113] In step 914, the reader 120 initiates a sequence to pair with the sensor control unit 102 using a second wireless communication protocol (e.g., Bluetooth or Bluetooth Low Energy). Subsequently, in step 916, the sensor control unit 102 completes a sequence to pair with the reader 120. In step 918, the sensor control unit 102 may begin transmitting current glucose data to the reader 120 according to the second wireless communication protocol. In some embodiments, for example, the current glucose data may be transmitted wirelessly to the reader 120 at predetermined intervals (e.g., every minute, every two minutes, every five minutes).
[0114] Referring further to Figure 9A, in step 920, the reader 120 receives current glucose data from the sensor control device 102 and stores it in the reader 120's persistent memory. Furthermore, according to some embodiments, the reader 120 can request historical glucose data from the sensor control device 102 for refilling. According to some embodiments, for example, the reader 120 can request historical glucose data for the entire lifespan (stored in the sensor control device 102's persistent memory) from the sensor control device 102. In other embodiments, the reader 120 can request historical glucose data for a specific predetermined time range (e.g., day 3 to present, day 5 to present, last 3 days, last 5 days, life count > 0, etc.). Those skilled in the art will understand that other refilling schemes (as described with respect to Figures 6A and 6B) can be implemented and are entirely within the scope of this disclosure.
[0115] Upon receiving a request in step 922, the sensor control unit 102 may retrieve historical glucose data from persistent memory and transmit it to the reader 120. Then, in step 924, the reader 120 may store the received historical glucose data in persistent memory. Also, according to some embodiments, the reader 120 may also display the current and / or historical glucose data in an app (e.g., on a sensor results screen). In this regard, a new reader may display all available sample data for the entire lifespan of the sensor control unit. In some embodiments, the reader 120 may also transmit the current and / or historical glucose data to a computer system 180. In step 926, the received glucose data may be stored in the persistent memory (e.g., a database) of the computer system 180. In some embodiments, the received glucose data may also be duplicate-removed before being stored in persistent memory.
[0116] Figure 9B is a flowchart illustrating another embodiment 930 of a method for migrating a sensor control device, which includes a security check ("app-side check") performed by a user interface application. Similar to method 900 in Figure 9A, method 930 may be performed in a sample monitoring system and allow the user to continue using an already activated sensor control device with a new reader (e.g., a smartphone). In one embodiment, method 930 includes many of the same or similar method steps described with respect to method 900. For example, steps 932, 934, 936, 948, 950, 952, 954, and 956 of method 930 are the same or similar to steps 902, 904, 906, 918, 920, 922, 924, and 926 of method 900, respectively.
[0117] According to one aspect of this embodiment, method 930 may include a security check performed by a user interface application installed on the reader 120. Referring further to Figure 9B, in step 938, after the user confirms login, the user's authentication information is sent to a trusted computer system 180 for verification. Also according to some embodiments, the device ID may also be sent from the reader 120 to the computer system 180 and stored in the persistent memory of the computer system 180. According to some embodiments, for example, in response to receiving the device ID, the computer system 180 can update the device ID field in the database related to the user's record. Also according to some embodiments, the computer system 180 can retrieve the stored sensor serial number related to the sensor control device 102 and send it to the reader 120.
[0118] After the user's authentication information is verified by the computer system 180, in step 940, the app prompts the user to scan the already activated sensor control device 102. According to one aspect of this embodiment, scanning may include bringing the reader 120 into the vicinity of the sensor control device 102 and causing the reader 120 to transmit one or more wireless questioning signals according to a first wireless communication protocol. In some embodiments, the first wireless communication protocol may be, for example, the Near Field Communication (NFC) protocol. However, those skilled in the art will understand that other wireless communication protocols (e.g., infrared, UHF, 802.11x, etc.) may be implemented. An embodiment of the GUI 998 prompting the user to scan the already activated sensor control device 102 is shown in Figure 9F.
[0119] Referring again to Figure 9B, in step 942, the scanning of the sensor control device 102 by the reader 120 may cause the sensor control device 102 to transmit its serial number to the reader 120. In step 944, the user interface application of the reader 120 compares the serial number received from the sensor control device 102 with the serial number received from the computer system 180. If the serial numbers do not match, in step 945, the user interface application may output a message to the display of the reader 120 indicating that the sensor control device 102 cannot be transferred, and then method 930 terminates. If the serial numbers match, the pairing process begins, and in step 946, the sensor control device 102 terminates any existing wireless communication link with the user's previous reader (if currently established). According to one aspect of this embodiment, the existing wireless communication link may be a link established according to a second wireless communication protocol different from the first wireless communication protocol. In some embodiments, for example, the second wireless communication protocol may be Bluetooth or Bluetooth Low Energy Protocol. Next, the sensor control device 102 enters a "pairable" state and can establish a wireless communication link with the reader 120 according to a second wireless communication protocol. Subsequently, the reader 120 initiates and completes a sequence to pair with the sensor control device 102 using the second wireless communication protocol (e.g., Bluetooth or Bluetooth Low Energy). Referring again to Figure 9B, method 930 then proceeds to steps 948-956 (which are the same as or similar to steps 918-926 of method 900 described with respect to Figure 9A, respectively).
[0120] Referring next to Figure 9C, the flowchart depicts another embodiment 960 of the method for migrating the sensor control unit. Method 960 includes a security check ("patch-side check") performed by the sensor control unit 102. Similar to methods 900 and 930 in Figures 9A and 9B, method 960 may be performed in a sample monitoring system and allow the user to continue using an already activated sensor control unit with a new reader (e.g., a smartphone). In one embodiment, method 960 also includes many of the same or similar method steps as described with respect to method 900. For example, steps 962, 964, 966, 978, 980, 982, 984, and 986 of method 960 are the same or similar to steps 902, 904, 906, 918, 920, 922, 924, and 926 of method 900, respectively.
[0121] According to one aspect of this embodiment, method 960 may include a security check performed by the sensor control device 102. Referring further to Figure 9C, in step 968, after the user has confirmed the login, the user's authentication information is transmitted to a trusted computer system 180 for verification. Also according to some embodiments, a device ID may also be transmitted from the reader 120 to the computer system 180 and stored in the persistent memory of the computer system 180. According to some embodiments, for example, in response to receiving the device ID, the computer system 180 may update the device ID field in the database that relates to the user's record. Also according to some embodiments, the computer system 180 may retrieve a stored account ID related to the user and transmit it to the reader 120.
[0122] After the user's authentication information is verified by the computer system 180, in step 970, the user interface application receives an account ID and generates a receiver ID based on the received account ID. In some embodiments, the receiver ID may be, for example, a compressed or truncated version of the account ID. In other embodiments, the user interface application may generate the receiver ID using an algorithm, such as a hash function, based on the account ID. In yet another embodiment, the receiver ID may be the account ID. Subsequently or in parallel, the app prompts the user to scan the already activated sensor control device 102. According to one aspect of this embodiment, scanning may include bringing the reader 120 near the sensor control device 102 and causing the reader 120 to transmit one or more radio interrogation signals according to a first radio communication protocol. In some embodiments, the first radio communication protocol may be, for example, the Near Field Communication (NFC) protocol. However, those skilled in the art will understand that other radio communication protocols (e.g., infrared, UHF, 802.11x, etc.) may be implemented. Figure 9F shows an embodiment of the GUI998 that prompts the user to scan the sensor control device 102 which has already been activated.
[0123] Referring further to Figure 9C, according to another aspect of this embodiment, in step 972, the reader 120 scans the sensor control device 102, causing the sensor control device 102 to prepare for a sequence to pair with the reader 120. Next, in step 974, the reader 120 can initiate a sequence to pair with the sensor control device 102 using a second wireless communication protocol (e.g., Bluetooth or Bluetooth Low Energy). According to some embodiments, the reader 120 can also transmit a receiver ID to the sensor control device 102 as part of the pairing sequence or immediately after the execution of the pairing sequence. In step 976, the sensor control device 102 verifies that the receiver ID is authentic. In some embodiments, the sensor control device 102 can verify the received receiver ID by comparing it with a receiver ID stored in the persistent memory of the sensor control device 102. In other embodiments, the received receiver ID can be verified using a hash function stored in the persistent memory of the sensor control device 102. Those skilled in the art will understand that other methods for verifying the authenticity of the received receiver ID are possible and are entirely within the scope of this disclosure.
[0124] According to one aspect of several embodiments, if the sensor control device 102 cannot verify the receiver ID, the sensor control device 102 can send a notification to the reader 120 causing the user interface application to output a message indicating sensor transition failure on the reader 120's display. In other embodiments, if the user interface application does not receive a notification from the sensor control device 102 indicating that the receiver ID has been verified as correct within a predetermined time, the user interface application can output a message indicating sensor transition failure on the reader 120's display.
[0125] Once the receiver ID is verified by the sensor control device 102, the sensor control device 102 can terminate any existing wireless communication link (e.g., Bluetooth or Bluetooth Low Energy Link) with the user's previous reader (if one is currently established). Subsequently, the sensor control device 102 can complete the sequence of pairing with the reader 120, and then method 960 proceeds to steps 978-986 (which are the same as or similar to steps 918-926 of method 900 described with respect to Figure 9A, respectively).
[0126] Referring again to Figure 9C, the verification of the receiver ID is described in step 976, but those skilled in the art will understand that in some embodiments, the receiver ID may be verified earlier in step 972 as part of or in response to the scanning of the sensor control device 102 by the reader 120. Similarly, the termination of an existing wireless communication link is described with respect to step 976, but those skilled in the art will understand that in some embodiments, the termination of an existing wireless communication link may occur earlier in step 972 as part of or in response to the scanning of the sensor control device 102 by the reader 120.
[0127] Furthermore, although presented as different steps in different methods, those skilled in the art will understand that both “app-side inspection” and “patch-side inspection” can be performed as part of a single sensor migration process. That is, according to some embodiments, in a single sensor migration, the app can verify the serial number (as described with respect to method 930 in Figure 9B), and the sensor control device 102 can verify the receiver ID (as described with respect to method 960 in Figure 9C). Conversely, the sensor migration process can be performed without using method 930 or 960.
[0128] According to several embodiments, any of the methods 900, 930, and / or 950 in Figures 9A, 9B, and 9C may terminate after the completion of the paired steps, at which point the sensor control unit begins to transmit glucose data to a new reader (e.g., steps 918, 948, 978). That is, the step of requesting and transmitting historical (filled) glucose data may be optional.
[0129] Although methods 900, 930, and 960 in Figures 9A, 9B, and 9C describe glucose measurement, those skilled in the art will understand that the sensor control unit 102 can also be configured to measure other samples (e.g., lactate, ketones, etc.). Furthermore, although methods 900, 930, and 960 describe method steps performed by the reader 120, those skilled in the art will understand that any or all of these method steps can be performed by other devices in the sample monitoring system, such as a local computer system, a wearable calculator, or a drug delivery device.
[0130] Embodiment of Sensor Check and Sensor Replacement System Alarm Embodiments of autonomous sensor check system alarms, sensor replacement system alarms, and related methods are described. According to one aspect of these embodiments, a sensor control device may be able to detect certain adverse conditions affecting the operation of a sample sensor and sensor electronic circuit. For example, if the average glucose level measurement over a predetermined period is determined to be below an insertion failure threshold, an improperly inserted sample sensor may be detected. However, due to small form factor and limited power capacity, sensor control devices may not have sufficient alarm capabilities. Therefore, it would be advantageous for the sensor control device to transmit an indication of an adverse condition to another device, such as a reader (e.g., a smartphone), to warn the user of the adverse condition.
[0131] Figure 10A is a flowchart illustrating an embodiment of method 1000 for generating a sensor insertion failure system alarm (also known as a "sensor check" system alarm). In step 1002, the sensor control device 102 detects a sensor insertion failure condition. In some embodiments, a sensor insertion failure condition may be detected when the average glucose value over a predetermined period (e.g., 5 minutes, 8 minutes, 15 minutes, etc.) is below an insertion failure glucose level threshold. In step 1004, in response to the detection of the insertion failure condition, the sensor control device 102 stops glucose measurement. In step 1006, the sensor control device 102 generates a sensor check instruction and transmits it to the reader 120 via a wireless communication circuit. Subsequently, as shown in steps 1012 and 1014, the sensor control device 102 continues to transmit the sensor check instruction until (1) it receives confirmation of receipt of the instruction from the reader 120 (step 1012) or (2) a predetermined waiting period has elapsed (step 1014), whichever comes first.
[0132] According to another aspect of these embodiments, once a wireless communication link is established between the sensor control device 102 and the reader 120, the reader 120 receives a sensor check instruction in step 1008. In response to receiving the sensor check instruction, the reader 120 displays a sensor check system alarm in step 1010. Figures 10B-10D show embodiments of the sensor check system alarm interface displayed on the reader 120. In some embodiments, the sensor check system alarm may be a notification box, banner, or pop-up window output to the display of a smartphone, such as interfaces 1020 and 1025 in Figures 10B and 10C. In some embodiments, the sensor check system alarm, such as interface 1030 in Figure 10D, may be output to the display of the reader 120, such as a glucose meter or receiving device. According to the embodiment, the reader 120 can also reply to the sensor control device 102 that it has received a sensor check instruction. In some embodiments, a sensor check instruction reception may be automatically generated and transmitted after, for example, the display of a sensor check system alarm 1020, 1025, or 1030. In other embodiments, the sensor check instruction reception is generated and / or transmitted in response to a predetermined user input (e.g., canceling the sensor check system alarm, pressing the confirmation "OK" button 1032, etc.).
[0133] Next, in step 1011, the reader 120 disconnects the sensor control device 102. According to one aspect of this embodiment, for example, step 1011 may include one or more of the following: terminating an existing wireless communication link with the sensor control device 102; disabling the pair with the sensor control device 102; invalidating the authentication or digital authorization associated with the sensor control device 102; creating or partially modifying a record stored in the reader 120 indicating that the sensor control device 102 is in storage; or sending an update to the computer system 180 to indicate that the sensor control device 102 is in storage.
[0134] Returning to Figure 10A, when the sensor control device 102 receives a sensor check instruction (step 1012) or after a predetermined waiting period has elapsed (step 1014), in step 1016 the sensor control device 102 stops transmitting the sensor check instruction. Next, in step 1018, the sensor control device 102 enters a storage state, does not measure glucose, and the wireless communication circuit stops operating or enters a sleep mode. In one embodiment, while in the storage state, the sensor control device 102 may be restarted by the reader 120.
[0135] Although Method 1000 in Figure 10A is described in relation to glucose measurement, those skilled in the art will understand that the sensor control device 102 may also be configured to measure other samples (e.g., lactate, ketones, etc.). Furthermore, although Method 1000 in Figure 10A describes method steps performed by the reader 120 (e.g., receiving a sensor check instruction, displaying a sensor check system alarm, and transmitting a sensor check instruction receipt), those skilled in the art will understand that any or all of these method steps may be performed by other devices in the sample monitoring system, such as a local computer system, a wearable calculator, or a drug delivery device. Furthermore, those skilled in the art will understand that Method 1000 in Figure 10A may be combined with any of the other methods described herein (including, but not limited to, Method 700 in Figure 7 relating to expired or faulty sensor transmissions).
[0136] Figure 11A is a flowchart illustrating an embodiment of method 1100 for generating a sensor termination system alarm (also known as a "sensor replacement" system alarm). In step 1102, the sensor control device 102 detects a sensor termination state. As described above, the sensor termination state may include, but is not limited to, one or more of the following: a detected FIFO overflow state, a sensor signal below a predetermined insertion failure threshold, detected moisture intrusion, an electrode voltage exceeding a predetermined diagnostic voltage threshold, an early signal attenuation (ESA) state, or a slow signal attenuation (LSA) state.
[0137] In step 1104, in response to the detection of the sensor termination state, the sensor control device 102 stops glucose measurement. In step 1106, the sensor control device 102 generates a sensor replacement instruction and transmits it to the reader 120 via the wireless communication circuit. Subsequently, in step 1112, the sensor control device 102 continues to transmit the sensor replacement instruction while confirming that it has received confirmation of receipt of the sensor replacement instruction from the sensor control device 102. According to one aspect of this embodiment, the sensor control device 102 continues to transmit the sensor replacement instruction until (1) a predetermined waiting period has elapsed (step 1113) or (2) confirmation of receipt of the sensor replacement instruction has been received (step 1112), and the sensor control device 102 successfully transmits the filling data to the reader 120 (steps 1116, 1120).
[0138] Referring further to Figure 11A, once a wireless communication link is established between the sensor control device 102 and the reader 120, the reader 120 receives a sensor replacement instruction in step 1108. In response to receiving the sensor replacement instruction, the reader 120 displays a sensor replacement system alarm in step 1110. Figures 11B-11D show embodiments of the sensor replacement system alarm interface displayed on the reader 120. In some embodiments, the sensor replacement system alarm may be a notification box, banner, or pop-up window output to the smartphone display, e.g., interfaces 1130 and 1135 in Figures 11B and 11C. In some embodiments, a sensor check alarm, e.g., interface 1140 in Figure 11D, may be output to the reader 120, e.g., the display of a glucose meter or receiving device. According to the embodiments, to indicate receipt of the instruction, the reader 120 may also reply to the sensor control device 102 that it has received the sensor replacement instruction. In some embodiments, a sensor replacement instruction reception may be automatically generated and transmitted after, for example, the display of a sensor replacement system alarm 1130, 1135, or 1140. In other embodiments, the sensor replacement instruction is generated and / or transmitted in response to a predetermined user input (e.g., clearing the sensor check system alarm, pressing the confirmation "OK" button 1142, etc.).
[0139] In step 1114, after displaying a sensor replacement system alarm and transmitting a sensor replacement instruction, the reader 120 may request historical glucose data from the sensor control device 102. In step 1116, the sensor control device 102 can collect the requested historical glucose data and transmit it to the reader 120. According to one aspect of this embodiment, the steps of requesting, collecting, and communicating historical glucose data may consist of a data filling routine, for example, the method described with respect to Figures 6A and 6B.
[0140] Referring again to Figure 11A, in response to receiving the requested historical glucose data, the reader 120 can transmit the receipt of historical glucose data to the sensor control device 102 in step 1118. Subsequently, in step 1119, the reader 120 disconnects the sensor control device 102. According to one aspect of this embodiment, for example, step 1119 may include one or more of the following: terminating the existing wireless communication link with the sensor control device 102, disabling the pair with the sensor control device 102, invalidating the authentication or digital authorization associated with the sensor control device 102, creating or partially modifying a record stored in the reader 120 indicating that the sensor control device 102 has been terminated, or transmitting an update to the computer system 180 to indicate that the sensor control device 102 has been terminated.
[0141] In step 1120, the sensor control device 102 receives the historical glucose data. Subsequently, in step 1122, the sensor control device 102 stops transmitting the sensor replacement instruction, and in step 1124, the sensor control device 102 may enter an exit state where it does not measure glucose, and the wireless communication circuit stops operating or enters sleep mode. According to one aspect of these embodiments, while in the exit state, the sensor control device 102 cannot be restarted by the reader 120.
[0142] Although Method 1100 in Figure 11A is described in relation to glucose measurement, those skilled in the art will understand that the sensor control device 102 may also be configured to measure other samples (e.g., lactate, ketones, etc.). Furthermore, although Method 1100 in Figure 11A describes method steps performed by the reader 120 (e.g., receiving a sensor replacement instruction, displaying a sensor replacement system alarm, and transmitting a sensor replacement instruction received), those skilled in the art will understand that any or all of these method steps may be performed by other devices in the sample monitoring system, such as a local computer system, a wearable calculator, or a drug delivery device. Furthermore, those skilled in the art will understand that Method 1100 in Figure 11A may be combined with any of the other methods described herein (including, but not limited to, Method 700 in Figure 7 relating to expired or faulty sensor transmissions).
[0143] Furthermore, all features, elements, components, functions, and steps described in any embodiment provided herein are intended to be freely combined and substituted with those of any other embodiment. If a feature, element, component, function, or step is described in relation to only one embodiment, it should be understood that, unless otherwise stated, that feature, element, component, function, or step can be used with all other embodiments described herein. Therefore, this paragraph serves as prior art and support for introducing claims that combine features, elements, components, functions, and steps of multiple different embodiments, or replace features, elements, components, functions, and steps of one embodiment with those of another embodiment, even if such combinations or substitutions are not explicitly stated in the specific examples of this description. Given that a person skilled in the art would readily recognize that all such combinations and substitutions are permissible, it is clearly acknowledged that specifying all possible combinations and substitutions would be an undue burden.
[0144] While the embodiments can take on various variations and alternative forms, specific examples of these are illustrated and described in detail herein. However, these embodiments are not limited to the specific forms disclosed; rather, they should be understood to include all variations, equivalents, and alternatives contained within the gist of this disclosure. Furthermore, any feature, function, step, or element of an embodiment may be described or added to the claims, and negative limitations may be described that define the scope of the claims by features, functions, steps, or elements that are not within that scope. Preferred embodiments of the present invention are described below in separate sections. Embodiment 1 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, A sample monitoring system in which the memory is configured to store a set of instructions that, when executed by the one or more processors, cause the one or more processors to output a plurality of bars to the display, each bar indicating the amount of time the user's sample level is within a predetermined sample range associated with that bar, and the plurality of bars are based on the data indicating the sample level. Embodiment 2 The sample monitoring system according to Embodiment 1, wherein the amount of time comprises a percentage of a predetermined period. Embodiment 3 The sample monitoring system according to Embodiment 1, wherein the data indicating the sample level consists of data indicating the glucose level in body fluids. Embodiment 4 The aforementioned plurality of bars are a first plurality of bars, and when the instruction set is executed by the one or more processors, the one or more processors cause a second plurality of bars to output to the display. Each of the second plurality of bars indicates the amount of time the user's sample level is within a predetermined sample range associated with that bar, and the second plurality of bars are based on the data indicating the sample level. The specimen monitoring system according to Embodiment 1, wherein the first plurality of bars are customizable by the user, and the second plurality of bars are not customizable by the user. Embodiment 5 The specimen monitoring system according to Embodiment 4, wherein when the set of instructions is executed by one or more processors, the one or more processors further cause the display to output a sliding element configured to allow the user to select to display either the first or second set of bars on the display. Embodiment 6 The sample monitoring system according to Embodiment 1, wherein when the set of instructions is executed by one or more processors, the one or more processors further cause the display to output a date range index consisting of date ranges related to the plurality of bars, and the data indicating the sample level. Embodiment 7 The sample monitoring system according to Embodiment 1, wherein when the set of instructions is executed by one or more processors, the one or more processors further cause the one or more processors to output to the display a data availability index consisting of a period during which the data indicating the sample level is available. Embodiment 8 The sample monitoring system according to Embodiment 1, wherein at least one default sample range associated with the plurality of bars is adjustable by the user. Embodiment 9 The sample monitoring system according to Embodiment 4, wherein none of the default sample ranges associated with the second plurality of bars are adjustable by the user. Embodiment 10 The sample monitoring system according to Embodiment 1, wherein when the set of instructions is executed by one or more processors, the one or more processors further cause the one or more processors to output to the display a plurality of selectable icons configured to allow the user to select a predetermined amount of time associated with the data indicating the sample level. Embodiment 11 A specimen monitoring system, Display unit, One or more processors coupled to memory, wherein the memory is configured to store a set of instructions that, when executed by the one or more processors, cause the one or more processors to output a bar consisting of multiple bar portions to the display, and Equipped with, A sample monitoring system in which each of the aforementioned bar segments indicates the amount of time the user's sample level is within a predetermined sample range associated with that bar segment, and the aforementioned bar segments are based on data indicating the sample level. Embodiment 12 The sample monitoring system according to Embodiment 11, wherein the amount of time consists of a percentage of a predetermined period and the actual amount of time. Embodiment 13 The sample monitoring system according to Embodiment 11, wherein the data indicating the sample level consists of data indicating the glucose level in body fluids. Embodiment 14 The specimen monitoring system according to Embodiment 11, wherein the one or more processors are one or more processors of a cloud-based platform. Embodiment 15 The sample monitoring system according to embodiment 11, wherein each of the aforementioned bar portions consists of a different color. Embodiment 16 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, A sample monitoring system in which the memory is configured to store a set of instructions that, when executed by the one or more processors, cause the one or more processors to output a warning interface to the display, which includes an alarm state, a sample level measurement related to the alarm state, and a trend indicator related to the alarm state. Embodiment 17 The sample monitoring system according to Embodiment 16, wherein the alarm state is one of low glucose state, severe low glucose state, or high glucose state. Embodiment 18 The specimen monitoring system according to Embodiment 16, wherein the warning interface further includes a warning icon adjacent to the alarm state. Embodiment 19 The specimen monitoring system according to embodiment 18, wherein the alarm icon is a critical warning icon. Embodiment 20 The specimen monitoring system according to embodiment 16, wherein the warning interface is a pop-up window. Embodiment 21 The specimen monitoring system according to embodiment 16, wherein the warning interface is a banner notification. Embodiment 22 The sample monitoring system according to Embodiment 16, wherein the trend indicator is a directional arrow. Embodiment 23 The sample monitoring system according to Embodiment 16, wherein the trend index is a character trend index, and when the instruction group is executed by the one or more processors, the one or more processors further cause the character trend index to be read using a character-to-speech conversion function. Embodiment 24 The sample monitoring system according to embodiment 16, wherein the sample level measurement is currently the glucose level. Embodiment 25 The specimen monitoring system according to embodiment 16, wherein the warning interface further includes instructions to the user. Embodiment 26 The specimen monitoring system according to Embodiment 25, wherein the instruction given to the user is one of the following: an instruction to check blood glucose levels, an instruction to administer medication, or an instruction to eat a meal. Embodiment 27 The sample monitoring system according to embodiment 16, wherein the reading device is a smartphone. Embodiment 28 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, A specimen monitoring system in which the memory is configured to store a set of instructions that, when executed by the one or more processors, cause the one or more processors to output a warning interface to the display, including an alarm state, an out-of-range indicator related to the alarm state, and a trend indicator related to the alarm state. Embodiment 29 The specimen monitoring system according to Embodiment 27, wherein the out-of-range indicator is one of a high out-of-range indicator or a low out-of-range indicator. Embodiment 30 The sample monitoring system according to embodiment 27, wherein the reading device is a smartphone. Embodiment 31 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a sensor usage interface including one or more view metrics to the display. Viewmetric is a sample monitoring system consisting of instances where the sensor results interface is represented or becomes the foremost process. Embodiment 32 The specimen monitoring system according to Embodiment 31, wherein the sensor usage interface further includes one or more scanning metrics, the scanning metrics comprising instances in which a user scans the sensor control device with the reading device. Embodiment 33 The specimen monitoring system according to Embodiment 31, wherein the one or more view metrics include a total number of views metric, and the total number of views metric indicates the total number of views over a predetermined period. Embodiment 34 The specimen monitoring system according to Embodiment 31, wherein the one or more view metrics include a metric for views per day, and the metric for views per day indicates the average number of views per day over a predetermined period. Embodiment 35 The sample monitoring system according to Embodiment 31, wherein the sensor usage interface further includes a percentage time sensor activity metric, the percentage time sensor activity metric indicating a percentage of a predetermined period during which the reader is communicating with the sensor control device. Embodiment 36 The sample monitoring system according to Embodiment 31, wherein the sensor usage interface further includes a predetermined period description, the predetermined period description indicating a predetermined period over which the one or more view metrics are measured. Embodiment 37 The specimen monitoring system according to embodiment 36, wherein the predetermined period is one week. Embodiment 38 The specimen monitoring system according to Embodiment 36, wherein the predetermined period is a date range. Embodiment 39 The specimen monitoring system according to Embodiment 36, wherein the predetermined period is the period relative to the current day. Embodiment 40 When the aforementioned set of instructions is executed by one or more processors, the one or more processors further cause the sample monitoring system reporting interface to output to the display. The specimen monitoring system according to embodiment 31, wherein the specimen monitoring system reporting interface includes the sensor usage interface. Embodiment 41 The sample monitoring system according to Embodiment 40, wherein the sample monitoring system reporting interface further includes a glucose trend interface that includes a glucose trend graph, a low glucose event graph, and a glucose management index metric. Embodiment 42 The specimen monitoring system according to Embodiment 40, wherein the specimen monitoring system reporting interface further includes a health information interface including a daily carbohydrate intake metric and a drug dosage metric. Embodiment 43 The specimen monitoring system according to Embodiment 40, wherein the specimen monitoring system reporting interface further includes a comment interface containing information presented in a descriptive format about the user's specimens and medication patterns. Embodiment 44 The specimen monitoring system according to Embodiment 40, wherein the one or more view metrics include a percentage time sensor activity metric, a percentage time sensor activity graph, and average scan and view metrics, the average scan and view metrics representing the average sum of the number of scans and the number of views. Embodiment 45 The sample monitoring system according to Embodiment 44, wherein the axis of the percentage time sensor activity graph is aligned with one or more corresponding axes from a glucose trend graph or a low glucose event graph. Embodiment 46 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a sample monitoring report to the display device, which includes a monthly calendar interface containing multiple days. A sample monitoring system in which each of the aforementioned days includes an average glucose metric, one or more low glucose event icons, and a sensor usage metric, the sensor usage metric representing the sum of the number of scans and views per day. Embodiment 47 A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a weekly summary report, including multiple reporting sections, to the display. Each of the aforementioned reporting sections represents a different day of the week and includes a glucose trend graph with one or more sensor usage markers. A sample monitoring system in which each of the aforementioned sensor usage markers indicates an instance in which the sensor result interface is represented or becomes the foremost process, or an instance in which the sensor control device is scanned by the reader. Embodiment 48 A method for data filling in a sample monitoring system, The steps include autonomously communicating data from the first device to the second device at predetermined intervals, Steps include: in response to a reconnection following an interruption of the communication link between the first and second devices, the second device requests historical sample data from the first device according to a life count metric, wherein the life count metric is a numerical value indicating the amount of time elapsed since the first device was started; The first device retrieves the requested historical sample data from the first memory, The first device transmits the requested historical sample data to the second device via the communication link, The second device stores the requested historical sample data in the second memory. A method that includes this. Embodiment 49 The method according to embodiment 48, wherein the first apparatus is a sensor control device comprising a sample sensor coupled with a sensor electronic circuit. Embodiment 50 The method according to Embodiment 48, wherein the second device is a reading device. Embodiment 51 The method according to embodiment 48, wherein the communication link is a wireless communication link. Embodiment 52 The method according to embodiment 51, wherein the wireless communication link consists of Bluetooth or Bluetooth Low Energy connection. Embodiment 53 The method according to embodiment 48, further comprising the step of determining the life count value at a point in time prior to the interruption of the communication link. Embodiment 54 The method according to Embodiment 53, wherein the step of requesting the historical sample data from the first device according to the life count metric comprises requesting the historical sample data after the life count value at a point in time prior to the interruption of the communication link. Embodiment 55 The method according to embodiment 48, further comprising the step of determining the life count range of the time between the interruption and reconnection of the communication link. Embodiment 56 The method according to Embodiment 55, wherein the step of requesting the first device to request the historical sample data according to the life count metric comprises requesting historical sample data within the life count range. Embodiment 57 The method according to Embodiment 48, further comprising the step of the second device visually outputting the requested historical sample data to a sensor results graphical user interface (GUI). Embodiment 58 The method according to Embodiment 57, wherein the sensor result GUI includes the requested historical sample data and previously received historical sample data. Embodiment 59 The method according to Embodiment 48, wherein the autonomously communicated data includes one or more of the following: data indicating the sample level in body fluid, the rate of change of the sample level, the expected sample level, a low sample level warning state, a high sample level warning state, a sensor failure state, or a communication link event. Embodiment 60 The autonomously communicated data includes a first type of sample data communicated at a first predetermined interval and a second type of sample data communicated at a second predetermined interval, wherein the first predetermined interval is greater than the second predetermined interval, according to Embodiment 48. Embodiment 61 The method according to embodiment 48, wherein the life count metric is in units of minutes or seconds. Embodiment 62 A method for data filling in a sample monitoring system, The steps include communicating data from a reader to a trusted computer system at predetermined intervals based on multiple upload triggers, The steps include: In response to a reconnection following an interruption of the communication link, the reader identifies the last successful data transmission to the trusted computer system; The reading device transmits to the reliable computer system historical data that has not yet been received by the reliable computer system; The steps include: the reader receiving notification of the successful reception of the historical data from the trusted computer system; A method that includes this. Embodiment 63 The method according to Embodiment 62, wherein the data includes one or more of the following: data indicating the sample level in body fluids, current glucose level, historical glucose data, rate of change of sample level, expected sample level, low sample level warning status, high sample level warning status, user-recorded information, information regarding the sensor control device, alarm settings, wireless connection events, or reader device settings. Embodiment 64 The method according to Embodiment 62, wherein the plurality of upload triggers include one or more of the following: activating a sensor control device, user inputting or deleting recorded items, re-establishing a wireless communication link between the sensor control device and the reader, changing an alarm threshold, displaying, updating, or canceling an alarm, re-establishing an internet connection, restarting the reader, receiving current glucose measurements from the sensor control device, terminating the sensor control device, displaying, updating, or canceling a signal loss alarm, turning a signal loss alarm on or off, viewing the sensor results screen graphical user interface (GUI), or user sign-in to the trusted computer system. Embodiment 65 The method according to embodiment 62, further comprising the step of marking data to be communicated to the trusted computer system. Embodiment 66 The method according to Embodiment 65, wherein the step of marking the data comprises marking a copy of the data stored in the reader in response to receiving notification from the trusted computer system of the successful reception of the communicated data. Embodiment 67 The step of identifying the last successful transmission of data to the trusted computer system is based on identifying the last marked data stored in the reader, as described in Embodiment 65. Embodiment 68 A method for aggregating disconnection and reconnection events of wireless communication links in a specimen monitoring system, The steps include communicating data from a reader to a trusted computer system at predetermined intervals based on multiple upload triggers, A step of identifying the disconnection time and reconnection time in response to a reconnection following an interruption of the communication link, The steps include transmitting the disconnection time and reconnection time to the reliable computer system. A method that includes this. Embodiment 69 The method according to embodiment 68, further comprising the step of recording the disconnection time and reconnection time in an event record stored in the memory of the reader. Embodiment 70 The method according to embodiment 68, wherein the communication link is a Bluetooth or Bluetooth Low Energy connection between the sensor control device and the reading device. Embodiment 71 The method according to embodiment 68, wherein the communication link is an internet connection between the reader and the trusted computer system. Embodiment 72 The method according to embodiment 68, further comprising the step of anonymizing the disconnection time and reconnection time. Embodiment 73 An improved method for transmitting expired or faulty sensors, The steps include: the sensor control device detecting an expired or malfunctioning sensor; The sensor control device stops measuring the sample level, The steps include transmitting an indication of the expired or malfunctioning sensor status and enabling data refilling, In response to receiving the aforementioned marking, the step of entering a storage state or a termination state, The steps include stopping the transmission of the indication in response to the expiration of a first predetermined period, In response to the expiration of a second predetermined period, the process includes a step of disallowing data entry and entering a storage or termination state. A method that includes this. Embodiment 74 The method according to embodiment 73, wherein the expired or malfunctioning sensor state is a sensor insertion failure state or a sensor termination state. Embodiment 75 The method according to Embodiment 74, wherein the sensor insertion failure state or sensor termination state includes one or more of the following: a detected FIFO overflow state, a sensor signal below a predetermined insertion failure threshold, detected moisture intrusion, an electrode voltage exceeding a predetermined diagnostic voltage threshold, an early signal attenuation (ESA) state, or a slow signal attenuation (LSA) state. Embodiment 76 The method according to embodiment 73, wherein the first predetermined period is shorter than the second predetermined period. Embodiment 77 The method according to Embodiment 73, wherein the step of transmitting the indicator of the expired or malfunctioning sensor status comprises transmitting a plurality of Bluetooth or Bluetooth Low Energy notification packets. Embodiment 78 The method according to Embodiment 73, wherein the step of transmitting the indicator of the expired or malfunctioning sensor status comprises transmitting the indicator to all parties or broadcasting it simultaneously. Embodiment 79 The method according to embodiment 73, wherein the step of transmitting the indicator of the expired or malfunctioning sensor status comprises transmitting the indicator repeatedly or intermittently. Embodiment 80 The method according to embodiment 73, further comprising the step of the reader displaying a warning or a prompt requesting user confirmation in response to receiving the indication of the expired or malfunctioning sensor condition. Embodiment 81 The method according to embodiment 73, further comprising the step of the sensor control device monitoring for the receipt of the indicator. Embodiment 82 The method according to embodiment 73, wherein the storage state is a state in which the sensor control device can be restarted. Embodiment 83 The method according to embodiment 73, wherein the termination state is a state in which the sensor control device cannot be restarted. Embodiment 84 A method for merging sample data related to a single user from multiple devices, The steps include receiving and combining the sample data from multiple reading devices, The steps include: deleting duplicates of the combined sample data and deleting historical sample data from the multiple readers generated from the same sensor control device; The steps include generating a first type of reporting metric based on the sample data after duplicates have been removed, The steps include resolving the overlapping regions of the previously deleted sample data, The steps include generating a second type of reporting metric based on the previously duplicated and non-overlapping sample data, and A method that includes this. Embodiment 85 The step of removing duplicates from the combined sample data is: The steps include assigning a priority to each of the aforementioned plurality of reading devices, The steps include saving combined sample data from a higher-priority reader from duplicate sets of sample data, and The method according to Embodiment 84, including the method described above. Embodiment 86 The method according to Embodiment 85, wherein the priority of each reader is based on one or more of the following: the version of the software installed on the reader, the model of the reader, or the type of the reader. Embodiment 87 The method according to Embodiment 84, wherein the first type of reporting metric consists of the mean glucose level. Embodiment 88 The method according to Embodiment 84, wherein the second type of reporting metric consists of low glucose events. Embodiment 89 The step of eliminating overlapping regions in the previously deleted sample data is as follows: The steps include sorting the sample data from which duplicates have been removed in order from earliest to newest, The steps include separating the duplicate-deleted sample data for a predetermined period to be plotted, A step of separating consecutive portions of the duplicate-deleted sample data, wherein each consecutive portion represents sample data from a different reader among the plurality of readers, For each consecutive section, a step is to determine if there is an overlapping region with another consecutive section. For each overlapping region, the steps include: retaining the duplicate-deleted sample data associated with the higher-priority reader; The method according to Embodiment 84, including the method described above. Embodiment 90 The method according to Embodiment 89, wherein the steps of determining whether there are overlapping regions and, if so, retaining the duplicate-removed sample data are performed for each consecutive portion. Embodiment 91 The method according to embodiment 89, wherein the predetermined period is one day. Embodiment 92 The method according to embodiment 89, further comprising the step of discarding discontinuous sample data. Embodiment 93 The method according to embodiment 89, further comprising the step of plotting a sample level graph based on the duplicate-removed and non-overlapping sample data. Embodiment 94 A method for migrating an already activated sensor control device to a new reading device, The steps include installing a user interface application on the new reader and generating a new device identifier, The steps include requesting user authentication information from the user to log in to a trusted computer system, The aforementioned step of the user confirming login, The steps include examining the user authentication information and updating the device identifier associated with the user account of the user in the trusted computer system, The steps include prompting the user to scan the already activated sensor control device, The steps include: terminating the connection with the old reading device in response to the aforementioned scan; The steps include pairing the new reading device with the already activated sensor control device, The current step is to receive glucose data and store it in the new reading device, The steps include requesting historical glucose data from the already activated sensor control device, The steps include receiving the historical glucose data and storing it in the new reader, The steps include: transmitting the current glucose data and the historical glucose data to the reliable computer system; A method that includes this. Embodiment 95 The method according to embodiment 94, wherein the new reading device is a smartphone. Embodiment 96 The method according to embodiment 94, further comprising the step of the user scanning the already activated sensor control device with the new reading device. Embodiment 97 The method according to embodiment 96, wherein the step of scanning the already activated sensor control device with the new reader device comprises causing the new reader device to communicate wirelessly with the already activated sensor control device in accordance with the Near Field Communication (NFC) protocol. Embodiment 98 The method according to Embodiment 94, wherein the connection to the aforementioned older reader is via Bluetooth or Bluetooth Low Energy connection. Embodiment 99 The method according to Embodiment 94, wherein the step of pairing the new reader with the already activated sensor control device comprises the reader initiating a pairing sequence using Bluetooth or the Bluetooth Low Energy Protocol. Embodiment 100 The method according to embodiment 94, further comprising the step of the already activated sensor control device wirelessly transmitting the current glucose data to the new reading device. Embodiment 101 The method according to Embodiment 100, wherein the step of wirelessly transmitting the current glucose data comprises transmitting the current glucose data at predetermined intervals. Embodiment 102 The method according to Embodiment 94, wherein the step of requesting the historical glucose data from the already activated sensor control device comprises requesting the historical glucose data for the entire service life of the already activated sensor control device. Embodiment 103 The method according to embodiment 94, wherein the step of requesting the historical glucose data from the already activated sensor control device comprises requesting historical glucose data within a predetermined time range. Embodiment 104 The method according to Embodiment 103, wherein the predetermined time range is based on a life count metric consisting of a numerical value indicating the amount of time elapsed since the activation of the already activated sensor control device. Embodiment 105 The method according to embodiment 94, further comprising the step of displaying either or both of the current glucose data and the historical glucose data on the display of the new reader. Embodiment 106 The method according to embodiment 94, further comprising the step of the reliable computer system deleting duplicate current glucose data and historical glucose data. Embodiment 107 A method for generating an alarm for a sensor insertion failure system, The sensor control device detects a sensor insertion failure condition, The steps include stopping the measurement of the sample by the sensor control device, The steps include sending a sensor check instruction to the reader, In response to the elapsed predetermined waiting time, the transmission of the sensor check instruction is stopped and the system enters storage mode. In response to receiving a sensor check instruction from the aforementioned reading device, the transmission of the sensor check instruction is stopped and the device enters a storage state. A method that includes this. Embodiment 108 The reading device receives the sensor check instruction, The steps include displaying a sensor check alarm on the display of the reading device, The steps include transmitting a sensor check instruction to the sensor control device and The method according to embodiment 107, further comprising the following: Embodiment 109 The method according to Embodiment 107, wherein the step of detecting the sensor insertion failure state comprises detecting an average glucose value below an insertion failure glucose level threshold over a predetermined period. Embodiment 110 The method according to embodiment 108, wherein the sensor check alarm consists of one of a notification box, a banner, or a pop-up window. Embodiment 111 The method according to embodiment 108, further comprising the step of prompting the user to acknowledge or dismiss the sensor check alarm. Embodiment 112 The method according to embodiment 111, further comprising the step of generating a sensor check instruction receipt in response to the user's confirmation or cancellation of the sensor check alarm. Embodiment 113 The method according to Embodiment 108, further comprising one or more of the following steps: terminating an existing wireless communication link with the sensor control device; disabling the pair with the sensor control device; invalidating an authentication or digital authorization associated with the sensor control device; creating or partially modifying a record stored in the reader indicating that the sensor control device is in the storage state; or transmitting an update indicating that the sensor control device is in the storage state to a trusted computer system. Embodiment 114 The method according to embodiment 107, wherein the reading device is a smartphone. Embodiment 115 The method according to Embodiment 107, wherein the sample measurement is the measurement of glucose levels in the user's body fluids. Embodiment 116 The method according to embodiment 107, wherein the storage state is a state in which the sensor control device can be restarted. Embodiment 117 A method for generating a sensor termination system alarm, The steps include: the sensor control device detecting the sensor termination state, The steps include stopping the measurement of the sample by the sensor control device, The steps include sending a sensor replacement instruction to the reader, In response to the elapsed predetermined waiting time, the transmission of the sensor replacement instruction is stopped and the system enters a termination state. The steps include: in response to receiving a sensor replacement instruction, collecting historical glucose data and transmitting it to the reader, stopping the transmission of the sensor replacement instruction and entering an end state; A method that includes this. Embodiment 118 The reading device receives the sensor replacement instruction, The steps include displaying a sensor replacement alarm on the display of the reading device, The steps include transmitting a sensor replacement instruction to the sensor control device, and The method according to embodiment 117, further comprising the following: Embodiment 119 The method according to Embodiment 117, wherein the step of detecting the sensor termination state comprises one or more of the following: detecting a FIFO overflow state, detecting a sensor signal below a predetermined insertion failure threshold, detecting moisture intrusion, detecting an electrode voltage exceeding a predetermined diagnostic voltage threshold, detecting an early signal attenuation (ESA) state, or detecting a slow signal attenuation (LSA) state. Embodiment 120 The method according to embodiment 117, further comprising the step of the reader requesting historical glucose data for data filling. Embodiment 121 The method according to Embodiment 120, wherein transmitting the historical glucose data to the reader is in response to receiving a request from the reader for the historical glucose data. Embodiment 122 The method according to embodiment 121, further comprising the step of the reader receiving the historical glucose data and transmitting a notification of receipt of the historical glucose data. Embodiment 123 The method according to embodiment 122, further comprising the step of the sensor control device receiving the historical glucose data. Embodiment 124 The method according to embodiment 118, wherein the sensor replacement alarm consists of one of a notification box, a banner, or a pop-up window. Embodiment 125 The method according to embodiment 118, further comprising the step of prompting the user to acknowledge or cancel the sensor replacement alarm. Embodiment 126 The method according to embodiment 125, further comprising the step of generating a sensor replacement instruction receipt in response to the user's confirmation or cancellation of the sensor replacement alarm. Embodiment 127 The method according to Embodiment 118, further comprising one or more of the following steps: terminating an existing wireless communication link with the sensor control device; disabling the pair with the sensor control device; invalidating an authentication or digital authorization associated with the sensor control device; creating or partially modifying a record stored in the reader indicating that the sensor control device is in the terminated state; or transmitting an update indicating that the sensor control device is in the terminated state to a trusted computer system. Embodiment 128 The method according to embodiment 117, wherein the reading device is a smartphone. Embodiment 129 The method according to Embodiment 117, wherein the sample measurement is the measurement of glucose levels in the user's bodily fluids. Embodiment 130 The method according to embodiment 117, wherein the termination state is a state in which the sensor control device cannot be restarted. Embodiment 131 A method for migrating an already activated sensor control device to a new reading device, The steps include installing a user interface application on the new reader and generating a new device identifier, The steps include requesting user authentication information from the user to log in to a trusted computer system, The aforementioned step of the user confirming login, The steps include examining the user authentication information and updating the device identifier associated with the user account of the user in the trusted computer system, The steps include prompting the user to scan the already activated sensor control device, The steps include: terminating the connection with the old reading device in response to the aforementioned scan; The steps include pairing the new reading device with the already activated sensor control device, The current step is to receive glucose data and store it in the new reading device, The steps include requesting historical glucose data from the already activated sensor control device, The steps include receiving the historical glucose data and storing it in the new reader, The steps include: transmitting the current glucose data and the historical glucose data to the reliable computer system; A method that includes this. Embodiment 132 The steps include: the new reader generates a receiver identifier (ID); The steps include transmitting the receiver ID to the sensor control device that has already been activated, The method according to embodiment 131, further comprising the step of verifying the received receiver ID by the already activated sensor control device. Embodiment 133 The method according to embodiment 132, wherein the receiver ID is generated based on an account identifier associated with the user. Embodiment 134 The steps include: the reliable computer system transmitting the first sensor serial number to the new reader; The steps include: the already activated sensor control device transmits the second sensor serial number to the new reader; The method according to embodiment 131, further comprising the step of verifying that the new reading device matches the first and second sensor serial numbers. Embodiment 135 The method according to embodiment 134, wherein the second sensor serial number is transmitted by the already activated sensor control device in response to the scan. Embodiment 136 The method according to embodiment 134, further comprising the step of displaying a message on the display of the new reader indicating that the already activated sensor control device cannot be switched to the new reader. Embodiment 137 The method according to embodiment 131, wherein the new reading device is a smartphone. Embodiment 138 The method according to embodiment 131, further comprising the step of the user scanning the already activated sensor control device with the new reading device. Embodiment 139 The method according to embodiment 133, wherein the step of scanning the already activated sensor control device with the new reader device comprises causing the new reader device to communicate wirelessly with the already activated sensor control device in accordance with the Near Field Communication (NFC) protocol. Embodiment 140 The method according to Embodiment 131, wherein the connection to the aforementioned older reader is via Bluetooth or Bluetooth Low Energy connection. Embodiment 141 The method according to embodiment 131, wherein the step of pairing the new reader with the already activated sensor control device comprises the reader initiating a pairing sequence using Bluetooth or the Bluetooth Low Energy Protocol. Embodiment 142 The method according to embodiment 131, further comprising the step of the already activated sensor control device wirelessly transmitting the current glucose data to the new reading device. Embodiment 143 The method according to Embodiment 142, wherein the step of wirelessly transmitting the current glucose data comprises transmitting the current glucose data at predetermined intervals. Embodiment 144 The method according to Embodiment 131, wherein the step of requesting the historical glucose data from the already activated sensor control device comprises requesting historical glucose data for the entire service life of the already activated sensor control device. Embodiment 145 The method according to embodiment 131, wherein the step of requesting the historical glucose data from the already activated sensor control device comprises requesting historical glucose data within a predetermined time range. Embodiment 146 The method according to Embodiment 145, wherein the predetermined time range is based on a life count metric consisting of a numerical value indicating the amount of time elapsed since the activation of the already activated sensor control device. Embodiment 147 The method according to embodiment 131, further comprising the step of displaying one or both of the current glucose data and the historical glucose data on the display of the new reader. Embodiment 148 The method according to embodiment 131, further comprising the step of the reliable computer system deleting duplicate current glucose data and historical glucose data. [Explanation of Symbols]
[0145] 102 Sensor control device 104 Sample Sensor 105 Adhesive Patches 120 Reader 121 Input Components 122 Display 123 Power Ports Channels 140, 141, and 142 160 Sensor Electronic Circuits 162 Analog Front End 170 Local Computer System 180 Reliable Computer Systems 222 Communication Processors 223, 225, 230 memory 224 Application Processors 226 Power supply 228 RF Transceiver 232 Multifunctional Transmitter 235, 245, 250, 255, 260, 265 Sensor Results GUI 238 Power Management Modules Time GUI within ranges of 305, 320, and 340. 305A Custom Range Time View 305B Standard Range Time View 320A, 320B View 330 Time within target GUI 500, 510 sensor usage interface Reporting GUI for sample monitoring systems 515, 530, 540, 550
Claims
1. A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a sensor usage interface including one or more view metrics to the display. The view metric consists of the number of times the sensor result interface was displayed or brought to the forefront of the process. The sensor usage interface further includes a percentage time sensor activity metric, the percentage time sensor activity metric indicating the percentage of a predetermined period during which the reader is communicating with the sensor control device, in a sample monitoring system.
2. The sample monitoring system according to claim 1, wherein the sensor usage interface further includes one or more scanning metrics, the scanning metrics comprising the number of times the user scans the sensor control device with the reading device.
3. The specimen monitoring system according to claim 1, wherein the one or more view metrics include a total number of views metric, and the total number of views metric indicates the total number of views over a predetermined period.
4. The specimen monitoring system according to claim 1, wherein the one or more view metrics include a metric for views per day, and the metric for views per day indicates the average number of views per day over a predetermined period.
5. The sample monitoring system according to claim 1, wherein the sensor usage interface further includes a predetermined period description, the predetermined period description indicating a predetermined period during which one or more view metrics are measured.
6. The specimen monitoring system according to claim 5, wherein the predetermined period is one week.
7. The specimen monitoring system according to claim 5, wherein the predetermined period is a date range.
8. The specimen monitoring system according to claim 5, wherein the predetermined period is the period for the current day.
9. When the aforementioned set of instructions is executed by one or more processors, the one or more processors further cause the sample monitoring system reporting interface to output to the display. The specimen monitoring system according to claim 1, wherein the specimen monitoring system reporting interface includes the sensor usage interface.
10. The sample monitoring system according to claim 9, wherein the sample monitoring system reporting interface further includes a glucose trend interface that includes a glucose trend graph, a low glucose event graph, and a glucose management index metric.
11. The specimen monitoring system according to claim 9, wherein the specimen monitoring system reporting interface further includes a health information interface including a daily carbohydrate intake metric and a drug dosage metric.
12. The specimen monitoring system according to claim 9, wherein the specimen monitoring system reporting interface further includes a comment interface containing information presented in a descriptive format about the user's specimens and medication patterns.
13. The specimen monitoring system according to claim 9, comprising one or more view metrics, a percentage time sensor activity graph, and average scan and view metrics, wherein the average scan and view metrics represent the average sum of the number of scans and the number of views.
14. The sample monitoring system according to claim 13, wherein the axis of the percentage time sensor activity graph is aligned with one or more corresponding axes from a glucose trend graph or a low glucose event graph.
15. A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a sample monitoring report to the display device, which includes a monthly calendar interface containing multiple days. A sample monitoring system in which each of the aforementioned days includes an average glucose metric, one or more low glucose event icons, and a sensor usage metric, the sensor usage metric indicating the number of times per day the sensor results interface was displayed or became the foremost process, and further includes a daily percentage-time sensor activity metric, the percentage-time sensor activity metric indicating the percentage of a predetermined period during which the reader is communicating with the sensor control device.
16. A specimen monitoring system, A sensor control device comprising a sample sensor coupled with a sensor electronic circuit and configured to transmit data indicating the sample level, A reader comprising a display, a wireless communication circuit configured to receive the data indicating the sample level, and one or more processors coupled with memory. Equipped with, The memory is configured to store a set of instructions that, when executed by one or more processors, cause one or more processors to output a weekly summary report, including multiple reporting sections, to the display. Each of the aforementioned reporting sections represents a different day of the week and includes a glucose trend graph with one or more sensor usage markers. A sample monitoring system in which each of the aforementioned sensor usage markers indicates the number of times the sensor result interface has been displayed or brought to the forefront of the process, and each of the aforementioned reporting portions further includes a percentage-time sensor activity metric, the percentage-time sensor activity metric indicating the percentage of a predetermined period of time during which the reader is communicating with the sensor control device.