Third party calibration check

Abstract

Peripheral medical monitoring devices may operate based on configured calibration values from one or more sources. The authenticity and reliability of the calibration values may be monitored by a central medical monitoring device. The central medical monitoring device may establish a wireless communication session with the peripheral medical monitoring device. The central medical monitoring device may receive updated reporting of calibration values associated with the peripheral medical monitoring device. The central medical monitoring device may compare the updated calibration values with previously stored calibration values to detect changes and notify a user of the detected change for enabling subsequent action.

Description

Matter No. P39495 -WOTHIRD PARTY CALIBRATION CHECKBACKGROUND

[0001] Medical monitoring systems have traditionally employed dedicated remote controllers manufactured by the medical device manufacturer and served a single purpose to communicate with a medical monitoring device, process data, and display data. In some cases, the dedicated remote controller may communicate with the medical monitoring device through proprietary communication protocols. The medical monitoring device industry has shifted towards the use of mobile monitoring applications on personal mobile user devices, which has caused a trend in interoperability and the use of open communication standards for communication between the medical monitoring device and the mobile user device. Multiple applications may be running simultaneously on a mobile user device for various purposes and certain limitations of the operating system leave a potential vulnerability for applications executing thereon, such as medical monitoring applications.SUMMARY

[0002] Systems, methods, and apparatus are described herein for maintaining an authenticity and reliability of calibration values configured for controlling the operation of a peripheral medical monitoring device. A central medical monitoring device may establish a wireless communication session with the peripheral medical monitoring device. The peripheral medical monitoring device may be an analyte monitoring device configured to measure one or more analyte values via one or more sensors. For example, the peripheral medical monitoring device may be a continuous glucose monitoring device. During or after the establishment of the wireless communication session, the central medical monitoring device may receive first information related to at least one calibration value associated with the peripheral medical monitoring device. The first information related to the at least one calibration value may include the at least one calibration value itself. The at least one calibration value may include an analyte value (e.g., a blood glucose value) configured to calibrate at least one sensor on the analyte monitoring device. The first information related to the at least one calibration value may include a calibration data record number, which may be a unique identifier indicating a value for theMatter No. P39495 -WO latest calibration record updated at the peripheral medical monitoring device. The first information related to the at least one calibration value may comprise communication parameters, sensor measurement intervals for measuring analyte values, analyte values configured as thresholds for detecting an extreme medical condition, or power management values. The first information related to the at least one calibration value may be stored in a calibration record stored locally at the central medical monitoring device and / or at another remote computing device.

[0003] The central medical monitoring device may transmit a polling message to the peripheral medical monitoring device. The polling message may be transmitted periodically or a period of time after a scheduled update at the peripheral medical monitoring device. The polling message may comprise a request for updated information related to the at least one calibration value associated with the peripheral medical monitoring device. The central medical monitoring device may receive, in response to the polling message, second information related to the at least one calibration value associated with the peripheral medical monitoring device. The central medical monitoring device may compare the first information related to the at least one calibration value with the second information related to the at least one calibration value. The central medical monitoring device may detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value. Based on the detected unacceptable difference in the first information and the second information related to the at least one calibration value associated with the peripheral medical monitoring device, the central medical monitoring device may provide a notification via a user interface.

[0004] The notification may be configured to provide the first information related to the at least one calibration value and the second information related to at least one calibration value indicating the unacceptable difference. The notification may provide an option for user input to indicate whether the detected difference is acceptable for maintaining the wireless communication session or future wireless communication sessions with the peripheral medical monitoring device. The notification may include an option to terminate the wireless communication session. The central medical monitoring device may receive an indication via user input to terminate the wireless communication session and terminate the wireless communication session with the peripheral medical monitoring device. In response to receivingMatter No. P39495 -WO the indication to terminate the wireless communication session, the central medical monitoring device may transmit a message to the peripheral medical monitoring device to cause the peripheral medical monitoring device to enter an end of life state.

[0005] The central medical monitoring device may detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value by detecting that the at least one calibration value has changed. The change in the at least one calibration value may be detected as unacceptably different by detecting that the change was not caused by a communication from the central medical monitoring device. The first information related to the at least one calibration value may be detected as unacceptably different from the second information related to the at least one calibration value by detecting that a calibration data record number has changed. The calibration data record number may include a unique identifier indicating a value for the latest calibration record updated at the peripheral medical monitoring device.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. l is a perspective view of representative systems in a user environment.

[0007] FIG. 2 is a system flow diagram illustrating communications that may be performed between devices for maintaining an authenticity and reliability of calibration values configured for controlling the operation of the peripheral medical monitoring device.

[0008] FIG. 3 is a flow diagram illustrating an example process for checking an authenticity or reliability of calibration values being used to operate one or more peripheral medical monitoring devices.

[0009] FIGs. 4A-4C are graphical representations of example user interfaces that may be implemented for providing notifications to a user and / or receiving user input for performing an action related to a peripheral medical monitoring device.

[0010] FIG. 5 is a block diagram of an example computing device.

[0011] FIG. 6 is a block diagram of an example continuous monitoring device.

[0012] FIG. 7 is a block diagram of an example blood glucose meter (BGM) device.DETAILED DESCRIPTIONMatter No. P39495 -WO

[0013] FIG. 1 is a perspective view of a representative system 101 in a user environment. As shown in FIG. 1, a user 100 may be a person with a medical condition. For example, the user 100 may be a person with a medical condition. The user 100 may use one or more medical monitoring devices to help monitor and / or treat the medical condition. For example, the user 100 may use one or more medical monitoring devices to help monitor analyte levels and / or treat the medical condition.

[0014] In one example, the medical condition may include a diabetic condition. The diabetic condition may include a metabolic syndrome, pre-diabetes, type 1 diabetes, type 2 diabetes, and / or gestational diabetes. The user 100 may be in an extreme diabetic state, such as hypoglycemia or hyperglycemia, when the blood glucose level of the user 100 is above or below a threshold blood glucose level.

[0015] The one or more devices that may be used to help monitor and / or treat the medical condition of the user 100 may include a central medical monitoring device and / or one or more peripheral medical monitoring devices. For example, a mobile device 104 of the user 100 may operate as a central medical monitoring device, as the mobile device 104 may be configured with applications and / or other software for managing the medical condition of the user, communicating with multiple devices for sending / receiving data for managing the medical condition, and / or performing other functionality central to the management of the medical condition of the user 100. In another example, a remote computing device 122 may operate as a central medical monitoring device. Though a single central medical monitoring device may be provided as an example, one or more central medical monitoring devices may be implemented for performing, as described herein. The peripheral medical monitoring device or peripheral device may also be referred to as a slave device.

[0016] One or more other medical monitoring devices may operate as peripheral devices or peripheral medical monitoring devices capable of connecting to the central medical monitoring device (e.g., mobile device 104) for transmitting data and / or receiving instructions that may allow the user 100 to monitor and / or treat their medical condition. In one example, the one or more peripheral medical monitoring devices may include sensors for measuring one or more analyte levels of the user 100. The central medical monitoring device (e.g., mobile device 104) may receive data from the one or more peripheral medical monitoring devices for beingMatter No. P39495 -WO displayed to the user 100 and / or for being communicated to other computing devices (e.g., remote computing device 122).

[0017] The peripheral medical monitoring devices may include one or more analyte monitoring devices comprising one or more sensors and configured to measure analyte levels of the user 100. In one example, the analyte monitoring devices may include glucose monitoring devices that may be used to monitor blood glucose levels for monitoring the diabetic condition of the user 100. A glucose monitoring device may include any device that detects and reports a level of glucose in the blood of the user, either through direct measurement of the blood or through an indirect detection process. A blood glucose level is also referred to as a blood sugar level. Examples of glucose monitoring devices include, but are not strictly limited to, continuous glucose monitoring devices, flash glucose monitoring devices, and blood glucose meters that provide a single measurement of blood glucose levels from a blood sample in a “spot” monitoring process. Though the glucose monitoring device may be provided as an example analyte monitoring device, other analyte monitoring devices may be implemented, including multi-analyte monitoring devices comprising multiple sensor types configured to sense different analytes in different sensing modes and / or intervals. Exemplary embodiments of multi-analyte monitoring devices may sense at least one of glucose, ketone, lactate, potassium, creatinine and / or natriuretic peptide tests (e.g., BNP or NT-proBNP).

[0018] The peripheral medical devices may be used to perform treatment of the medical condition of the user. For example, the peripheral medical devices may include blood glucose treatment devices, which may include any device that treats a diabetic condition of the user 100, either through direct treatment into the blood or through an indirect treatment process or by providing information to allow for treatment.

[0019] In some embodiments, the blood glucose monitoring device and / or blood glucose treatment device is a pen device 103. The pen device 103 may include any injector pen capable of monitoring and / or managing insulin delivery. Example pen devices may communicate with an external device, such as the mobile device 104 and / or a remote computing device 122, to determine insulin levels, calculate doses, track doses, deliver insulin, and / or provide other information such as notifications or alerts. In some examples, pen devices may periodically communicate data indicating the blood glucose levels of the user 100 to an external device, such as a mobile device 104, for computing or storing the blood glucose levels of the user 100.Matter No. P39495 -WO

[0020] Tn some embodiments, the blood glucose monitoring device is a continuous glucose monitor (CGM) 102. The CGM 102 includes a subcutaneous sensor that is used to sense and monitor the amount of glucose in interstitial fluid of the user 100. The CGM 102 includes a transmitting device that is located directly over the sensor that wirelessly powers the data transfer from the sensor. The CGM 102 periodically communicates data indicating the blood glucose levels of the user 100 to an external device, such as a mobile device 104, for computing or storing the blood glucose levels of the user 100.

[0021] Some embodiments of the mobile device 104 operate as a CGM controller device. Though the mobile device 104 is provided as an example of a device with which the CGM 102 communicates, the CGM 102 may communicate with other dedicated CGM controller devices for providing similar functionality that is described herein for the mobile device 104. In some cases, the CGM 102 processes the blood glucose data to provide an amount of glucose in interstitial fluid of the user 100. In some cases, the CGM 102 provides the blood glucose data to the mobile device 104 and / or pen device 103, and the mobile device 104 and / or pen device 103 processes the blood glucose data to manage the diabetic condition and provide treatment notifications as described herein.

[0022] In some embodiments, the blood glucose monitoring device is a flash glucose monitor (FGM) 111. The FGM 111 includes a subcutaneous sensor that is used to sense and monitor the amount of glucose in interstitial fluid of the user 100. A separate reader device, such as the mobile device 104, pen device 103, or another reader device, receives the blood glucose data from the sensor of the FGM 111 when the device is within range, such as but not limited to the RF range, of the sensor. The FGM 111 transmits an instantaneous blood glucose level or a graphical trend of the blood glucose level to the reader device for display. The mobile device 104 processes the blood glucose data to manage the diabetic condition and provide treatment notifications as described herein.

[0023] In some embodiments, the user 100 uses a blood glucose meter (BGM) 106 as a blood glucose monitoring device to monitor blood glucose levels. The BGM 106 includes a port 108 that receives a blood glucose measurement strip 110. The user 100 deposits a sample of blood on the blood glucose measurement strip 110. The BGM 106 analyzes the sample and measure the blood glucose level in the sample. The blood glucose level measured from the sample is displayed on a display 112 of the BGM 106 or communicated to an external device,Matter No. P39495 -WO such as the mobile device 104. The mobile device 104 processes the blood glucose data to manage the diabetic condition and provide treatment notifications as described herein.

[0024] The blood glucose level measured by the pen device 103 or BGM 106 or computed using data received from the CGM 102 or FGM 111, is used to treat the diabetic condition of the user 100. The mobile device 104 communicates with the CGM 102, FGM 111, the BGM 106, and / or pen device 103 using wired or wireless communications that are transmitted and received between devices on a wired or wireless communication medium. The mobile device 104 may also, or alternatively, receive data from a monitoring device (e.g, the CGM 102, FGM 111, the BGM 106, and / or pen device 103) indirectly via one or more other devices (e.g., a remote computing device 122 or another computing device). For example, a monitoring device may be capable of communicating data to one or more intermediate computing device for storing data thereon for being transmitted to and / or requested by the mobile device 104. The mobile device 104, the CGM 102, a CGM controller, the BGM 106, the FGM 111, or pen device 103 may be collectively referred to as user devices or computing devices. The mobile device 104 communicates with the CGM 102, the FGM 111, the BGM 106, and / or pen device 103 using the same or different wired or wireless protocols. For example, the mobile device 104 communicates with the CGM 102, FGM 111, the BGM 106, and / or pen device 103 using BLUETOOTH®, BLUETOOTH® low energy (BLE), near field communication (NFC), THREAD®, WIFI®, ZIGBEE®, WI-MAX®, a cellular communication protocol, a proprietary wireless communication protocol, or another radio frequency (RF) communication protocol.

[0025] Though various blood glucose monitoring devices (e.g, pen device 103, CGM 102, BGM 106, FGM 111, and / or another blood glucose monitoring device) are provided as examples of medical monitoring devices, other medical monitoring devices may be implemented as central or peripheral medical monitoring devices for measuring and / or monitoring other medical conditions of the user 100. For example, other medical monitoring devices may be implemented to monitor any other medical conditions based on analyte levels of the user 100 and / or communications between connected devices may similarly utilize one or more embodiments described herein.

[0026] The medical monitoring devices (e.g., central medical monitoring devices and / or peripheral medical monitoring devices) may be resource-restricted devices, as compared toMatter No. P39495 -WO other computing devices. One or more of the medical monitoring devices may be hardware and / or software restricted devices. For example, the medical monitoring devices may be battery powered or power-restricted devices. These devices may operate in sleep / wake states for battery conservation. The sleep / wake states and / or other power management processes may be managed by power management values on the devices. One or more of the medical monitoring devices may be restricted in processing power and / or memory capacity when compared to other computing devices in the system. As such, the user 100 may implement the one or more of the medical monitoring devices along with other computing devices for managing and / or treating their medical condition.

[0027] The mobile device 104 may establish a connection to one or more peripheral medical monitoring devices (e.g., pen device 103, CGM 102, BGM 106, FGM 111, and / or another medical monitoring device) at a time. For example, the mobile device 104 may establish a connection via a wired or wireless communication medium with one or more blood glucose monitoring devices. The connection may be established via a wired or a wireless communication link. The wireless communication link may be established using a defined RF communication spectrum and / or protocol, such as BLUETOOTH®, BLE, NFC, THREAD®, WIFI®, ZIGBEE®, WI-MAX®, or another RF communication protocol. The connection may be established and / or communications may be performed according to one or more communication parameter sets that define parameters for performing communication, as described herein. The mobile device 104 may transmit and / or receive data via the one or more established connections for assisting in monitoring and / or treating the medical condition (e.g., diabetic condition) of the user. The connection between devices may be initiated by the transmission and / or receipt of a connection request message from one of the devices via a communication medium. Another device may transmit a connection response message in response to the connection request message via the communication medium. The devices may detect that the connection has been established based on the exchange of the connection request / connection response messages and / or subsequent messages, such as acknowledgement messages, messages for establishing secure communications, or other subsequent messages (e.g., depending on the communication protocol). The secure communications may be established via an encrypted key exchange for enabling secure communications.Matter No. P39495 -WO

[0028] The mobile device 104 may receive data from other devices and / or input from the user 100 via a user interface for being provided on a display. The mobile device 104 may receive input via hard buttons or soft buttons provided on the display. In response to the data that is received at the mobile device 104, the mobile device may provide output to the user 100 in the form of visual output on the display, audio output via a speaker, haptic feedback via vibrations, and / or other output to the user.

[0029] The mobile device 104 may be a connected smart device and / or may be in communication with other connected smart devices. Example connected smart devices may include a wearable device. The connected smart device may be an armband (e.g., a smart watch, such as an APPLE® watch, a FITBIT® armband, or other device capable of being worn on the arm of the user 100), a ring, glasses (e.g., GOOGLE® GLASS™), a headset (e.g., BLUETOOTH® headset), clothing (e.g., shirts, gloves, etc. , or another wearable device capable of being worn by the user 100. The connected smart device may be a wearable device or other device capable of monitoring the heart rate of the user 100, such as a heart rate monitor. The connected smart device may include a device capable of monitoring a wake / sleep state of the user, such as a wearable device, a heart rate monitor, a smart bed, or another device.

[0030] In one example, the mobile device 104 may provide data received from one or more peripheral medical monitoring devices to the remote computing device 122, via the network 120. The mobile device 104 may receive data from the remote computing device 122 for providing information to the user 100.

[0031] The mobile device 104 may provide information to the user 100 about the user’s medical condition. For example, the mobile device 104 may provide blood glucose levels, meal- related information, exercise-related information, treatment notifications, and / or graphs and other graphical user interfaces, such as alerts or notifications, for display.

[0032] The mobile device 104 may communicate with other devices directly via a wired communication and / or a short-range wireless communication (e.g., WI-FI®, BLUETOOTH®, BLE, NFC, and / or another suitable short-range wireless communication). The mobile device 104 may communicate with remote computing device(s) 122 via a wired or wireless communication link. For example, the mobile device 104 may communicate with the remote computing device(s) 122 on a communication link via a network 120 (e.g., using a WI-FI® network, a cellular network, a WLMAX® network, or another wired or wireless network). TheMatter No. P39495 -WO network 120 is a wired or wireless network. The network 120 is used to communicate over the Internet to other devices. The wired or wireless communication link with which the mobile device 104 communicates with the remote computing device(s) 122 may be different than the wired or wireless communication link with which the mobile device communicates with the one or more medical monitoring devices. For example, the communication links may include a different defined RF communication spectrum and / or protocol.

[0033] The mobile device 104 may communicate with the remote computing device(s) 122 to generate user interfaces for display on the mobile device 104, perform remote computation, send and / or receive data, or to otherwise control a remote computing device 122. For example, the mobile device 104 may provide a user interface via an application (e. ., a web browser or other local application) that is generated locally for providing access to locally stored data or data from a remote computing device 122. The mobile device 104 may also operate as an intervening communication device for data or control instructions transmitted between a medical monitoring device (e.g., the pen device 103, CGM 102, BGM 106, FGM 111, and / or another medical monitoring device) and the remote computing device 122.

[0034] The mobile device 104 may communicate with one or more peripheral medical monitoring devices, such as the pen device 103, CGM 102, BGM 106, FGM 111, and / or another medical monitoring device in order to allow the user 100 to monitor and / or treat the medical condition. For example, the mobile device 104 may receive analyte levels (e.g., blood glucose levels and / or other analyte levels) and / or other data related to the medical condition of the user 100 from one or more peripheral medical monitoring devices. The peripheral medical monitoring devices may provide data to the mobile device 104 in response to the analyte levels or other medical data reaching a predefined threshold or coming within a predefined level of a predefined threshold.

[0035] The mobile device 104 may provide notifications to the user 100 in response to the data that is collected from the peripheral medical monitoring devices and / or in response to an indication to notify the user 100 based on the data related to the medical condition. The mobile device 104 may provide notifications via one or more notification types. For example, the notifications may be provided via a visual notification on a graphical user interface displayed on the mobile device 104, a visual notification provided via a light emitting diode (LED), an audible notification provided via a speaker or other audio device on the mobile device 104, a tactile orMatter No. P39495 -WO vibratory notification on the mobile device 104, and / or another notification type provided via the mobile device 104 or another device in the user environment. The notifications may be provided to the user 100 via an application (e.g., a medical application, such as a diabetes-related application, an exercise-related application, a nutrition or mealtime-related application, another health-related application, or another type of application) residing locally thereon and / or via one or more remote computing devices 122. For example, one or more remote computing devices 122 may be implemented to execute the application for providing a graphical user interface with the notifications for providing the information related to the medical condition of the user 100 and / or treatment thereof.

[0036] The mobile device 104 and the one or more peripheral medical monitoring devices may communicate with one another via the RF communications using a communication parameter set. For example, devices communicating via RF communication protocols that are used for RF communications, such as BLUETOOTH® or BLE, NFC, THREAD®, WIFI®, ZIGBEE®, WI-MAX®, a proprietary wireless communication protocol, or another RF communication protocol may utilize a communication parameter set for performing communications. The communication parameter set may include parameters, such as a connection interval or timeout, peripheral latency (e.g., slave latency), a supervision timeout, an advertisement interval, an advertisement count, an advertisement repetition time, and / or one or more other communication parameters. The connection interval or timeout may include an amount of time between two connection events. The connection interval or timeout may include a minimum connection interval or a maximum connection interval. The connection interval may range from a number of milliseconds to a number of seconds. A peripheral latency (e.g., slave latency) may allow a peripheral device, such as a peripheral medical device operating on battery power or in sleep / wake states, to skip waking up for a period of time (e.g., a number of connection events) when the peripheral device fails to have data to be transmitted. The supervision timeout may define the time for devices to wait for data transfer before assuming the connection was lost. The advertisement interval may be a period of time between advertisement packets, which may be sent periodically (e.g., on each advertising channel). The advertisement messages may be sent periodically as broadcast messages with identifying information from the broadcasting device. The advertisement interval between advertisement packets may be set with an interval and a random delay. A minimum and / or maximum advertisement interval may beMatter No. P39495 -WO used to decide the interval. The advertisement count may identify a number of advertisement messages (e.g., including repetition messages) received from a device within a period of time, which may indicate the quality of the communications between the devices. An advertisement repetition time may include a period of time between advertisement messages, which may also indicate a quality of the communications between devices.

[0037] The parameters of the communication parameter set may be configured for improvement in communication quality (e.g., latency, communication success rate, and / or other communication quality parameters), efficient use of battery power (e.g., for devices operating in sleep / wake states, transmit power for communications, etc.), reduced memory and / or processing resources, and / or efficient use of other device resources. Different values of the parameters in the communication parameter set may affect power consumption on a device, data transfer speeds between devices, and / or stability of a connection between devices.

[0038] In addition to being capable of communicating with the mobile device 104, each of the peripheral medical monitoring devices may be capable of communicating with other devices. In fact, the peripheral medical monitoring devices may be in communication with other devices, directly or via the mobile device 104 or another computing device, for receiving updates that may be implemented for operation. For example, each of the peripheral medical monitoring devices may receive updates from a remote computing device, such as the remote computing devices 122, via a communication with the mobile device 104 or one or more other computing devices. As the peripheral medical monitoring devices may each be capable of communicating with multiple devices, they may be susceptible to receiving data (e.g., corrupt or inaccurate data) that may affect the operation and / or performance of the peripheral medical monitoring device. The data may unintentionally or intentionally alter calibration values configured for controlling the operation of the peripheral medical monitoring device on which those values are stored. As the peripheral medical monitoring devices may be measuring and transmitting vital medical data being used to monitor, manage, and / or treat a medical condition (e.g., diabetes) having extreme states (e.g., an extreme diabetic state, such as hypoglycemia or hyperglycemia), maintaining the calibration values configured for controlling the operation of the peripheral medical monitoring device may be critical to ensuring proper management of the user 100’s medical condition and the health of the peripheral medical monitoring device itself. As a result, the authenticity andMatter No. P39495 -WO reliability of the calibration values may be maintained ensuring reliable operation of the peripheral medical monitoring device and overall health of the user 100.

[0039] In order to avoid improper alteration of the calibration values of the peripheral medical monitoring devices, the mobile device 104 or other central medical monitoring device may maintain calibration records for one or more peripheral medical monitoring devices with which they are in communication. FIG. 2 is a system flow diagram 200 illustrating communications that may be performed between a mobile device 204 and a peripheral medical monitoring device 202 for maintaining an authenticity and reliability of calibration values configured for controlling the operation of the peripheral medical monitoring device 202. Though the system flow diagram 200 illustrates the mobile device 204 and a single peripheral medical monitoring device 202, similar communications and / or procedures may be implemented at another central medical monitoring device and / or one or more other peripheral medical monitoring devices.

[0040] As shown in FIG. 2, the mobile device 204 may establish a communication session with the peripheral medical monitoring device 202 at 220. For example, the communication session may be established via one or more wireless communication protocols, such as BLUETOOTH®, BLUETOOTH® low energy (BLE), near field communication (NFC), THREAD®, WIFI®, ZIGBEE®, WLMAX®, or another radio frequency (RF) communication protocol. The mobile device 204 and the peripheral medical monitoring device 202 may exchange a connection request message / connection response message for establishing the communication session. The communication session may be a secure communication session established via an encrypted key exchange that may be used for subsequent communications. In response to the establishment of the communication session, the mobile device 204 may store an identifier of the peripheral medical monitoring device 202 and / or the encrypted key for the communication session in memory.

[0041] The mobile device 204 may maintain calibration records 230 of identified values that are configured for enabling operation of the peripheral medical monitoring device 202. For example, the mobile device 204 may store the calibration records 230 in memory. In one example, the calibration records 230 may include one or more analyte values that are used for calibration of the peripheral medical monitoring device 202. In an example in which the peripheral medical monitoring device 202 is a blood glucose monitoring device (e.g, such as aMatter No. P39495 -WOBGM, CGM, or other blood glucose monitoring device), the analyte values may include blood glucose values that may be entered for calibrating the blood glucose monitoring device. To calibrate a blood glucose monitoring device, the mobile device 204 may request a blood glucose level (e.g., current blood glucose level) of the user. The user may draw a sample using a fingerstick or test strip and use a blood glucose monitoring device (e.g., which may be separate from the blood glucose device being calibrated) to measure a current blood glucose level. The user may enter the blood glucose level via input to the mobile device 204. The mobile device 204 may store the blood glucose level as a calibration value and / or transmit the blood glucose level to the peripheral medical monitoring device 202 for calibrating measurements performed at the blood glucose monitoring device 202. For example, the blood glucose monitoring device may calibrate a measurement algorithm or a sensitivity / thresholds associated with measurements taken by one or more sensors at the blood glucose monitoring device. The blood glucose level may be updated at predefined times, such as at an initial use of the blood glucose monitoring device and / or one or more predefined times during operation of the blood glucose monitoring device. The period of operation of the blood glucose monitoring device may be predefined or limited to a predefined period of time (e.g., ten to fourteen days), such that an updated calibration of another blood glucose monitoring device may be performed after the period of time. Though a blood glucose level and a blood glucose monitoring device are provided as an example, other analyte values may similarly be used for calibrating other analyte monitoring devices and / or the measurements performed thereon. Additionally, though examples are provided for receiving an analyte value as a calibration value from the mobile device 204, the calibration value may be predefined and / or received from one or more other devices, as described herein.

[0042] The calibration records 230 may include analyte values and. / or other types of information. For example, the calibration records 230 may include different types of information stored in each calibration record. TABLE 1 provides an example of the types of information that may be maintained in the calibration records 230.TABLE 1Matter No. P39495 -WOAs shown in TABLE 1, the calibration records 230 may include information related to one or more calibration values. For example, the information related to one or more calibration values my include the calibration values themselves, a record type, a device type and / or a peripheral medical monitoring device identifier identifying the device for which the calibration values are stored, a source of the calibration values, a calibration data record number (e.g., a unique identifier indicating a value of the latest calibration record updated at the peripheral medical monitoring device), and / or a date / time at which the calibration value is received and / or stored at the mobile device 204. Though examples are provided for types of fields that may be included in the calibration records 230 for storing calibration values configured for enabling operation of the peripheral medical monitoring device 202, additional fields or a subset of the example fields of information may be stored in the calibration records 230. For example, the calibration records 230 may include a field that indicates a reason for a change in a calibration value for a given record from a previous value. The reason may include a user input at the mobile device 204, a user input at the peripheral medical monitoring device 202, an update from a remote computing device 210 (e.g., which may be recognized as a trusted computing device for performing updates), and / or a change request from other computing devices 212 (e.g, which may be unrecognized as trusted computing devices). The calibration records 230 may include a field that indicates a user or users (e.g, identified trusted users or unidentified users) associated with a change in calibration values.

[0043] The information related to the calibration values stored in the calibration records 230 may include a record of one or more calibration values and / or updates to that value over theMatter No. P39495 -WO course of time. For example, the calibration record 230 may include one or more analyte values (e.g., blood glucose value, and / or other analyte values that may be used to calibrate the analyte monitoring device) stored at the mobile device 204 and / or transmitted to the peripheral medical monitoring device 202 for performing calibration of a measurement algorithm or a sensitivity / thresholds associated with measurements taken by one or more sensors at the peripheral medical monitoring device 202. The calibration records 230 may include any updates to one or more analyte values that are stored as calibration values for calibrating the peripheral medical monitoring device 202.

[0044] The information related to the calibration values stored in the calibration records 230 may include one or more values per calibration record, depending on the record type. For example, the calibration values may include a range of values or threshold values for a given record in the calibration records 230. Where the calibration records 230 include different types of calibration values, the record type may identify the type of values stored in the corresponding record. For example, the calibration records 230 may include different types of calibration values in different records, such as analyte values that may be measured at the peripheral medical monitoring device, parameter values of the communication parameter set for communicating with the mobile device 204 and / or other computing devices, timing values, values configuring the settings of an operating system on the peripheral medical monitoring device, power management values for managing power usage on the peripheral medical monitoring device, values configuring the settings of a particular application on the peripheral medical monitoring device, user-specific values associated with one or more particular users, and / or values configured to change a mode of operation. The analyte values may include values for triggering messages or notifications. The analyte values may be user-specific values or predefined values defining certain thresholds. For example, the analyte values may include a high-end and / or low- end analyte value for triggering notifications (e.g, a value indicating the user is approaching or has reached an extreme medical state, such as a hyperglycemic or hypoglycemic state). The analyte value may be a sensed value from a glucose monitoring device (e.g, CGM sensor value or reading from a test strip for calibrating the CGM). The timing values may include timing intervals or threshold timing values for performing measurements (e.g., sensor measurements for measuring analyte values), communications, or triggering events for other operations. The power management values for managing power usage on the peripheral medical monitoringMatter No. P39495 -WO device may include timing intervals or other conditions for entering / exiting sleep / wake states for battery conservation, sensor measurement intervals for managing power utilized by activating / deactivating one or more sensors, battery conditioning parameters configured to set a recharge capacity (e.g., to 80% or 90%) to extend a life of a reusable battery having a rechargeable unit), and / or other values for managing power utilization on the peripheral medical monitoring device. The values configuring the settings of the operating system on the peripheral medical monitoring device may include values indicating an operating system version, values identifying processing and / or memory resources allocated to a particular application or functionality on the peripheral medical monitoring device, and / or other values for configuring functionality of an operating system. The values configuring the settings of a particular application on the peripheral medical monitoring device may include an application version, sensing values specific to the application, timing intervals for performing measurements specific to the application and / or communicating messages, and / or other values for operation of a particular application on the peripheral medical monitoring device. The user-specific values may include analyte values / thresholds and / or timing values associated with one or more particular users. The values configured to change a mode of operation may include values configured to change a mode of a sensing operation for a multi-analyte monitoring device, including thresholds and / or timing values for changing sensing modes for sensing different analyte values.

[0045] The calibration records 230 may include a source of calibration values, such as device from which the calibration values are received / transmitted / originated. The values of one or more of the calibration records 230 may be predefined at the mobile device 204. As shown in in FIG. 2, the values of one or more of the calibration records 230 may be received at 222 from the peripheral medical monitoring device 202 (e.g., via the established communication session 220 or another wired or wireless communication link). For example, the values of one or more of the calibration records 230 may be prestored at the peripheral medical monitoring device 202 and communicated to the mobile device 204 at 222. The values of the one or more calibration records 230 may be prestored at the peripheral medical monitoring device 202 at the time of manufacture, stored in response to user input at the peripheral medical monitoring device 202, or stored in response to messages received from one or more remote computing devices 210. For example, the peripheral medical monitoring device 202 may be in communication with the one or more remote computing devices 210, directly or via one or more intermediary devices (e.g.,Matter No. P39495 -WO the mobile device 204), for receiving updates to one or more of the calibration records 230. The mobile device 204 may receive the values of one or more calibration records 230 from the peripheral medical monitoring device 202 in response to a request or as another message that is pushed to the mobile device 204 in response to another triggering event (e.g., an update, an expiration of a period of time, a startup procedure during which the peripheral medical monitoring device 202 is being powered on, and / or another triggering event).

[0046] The information related to one or more values of the calibration records 230 may be generated and / or stored at the mobile device 204 based on messages received from the one or more remote computing devices 210 at 224. For example, the one or more values of the calibration records 230 may be received at the mobile device 204 from the one or more remote computing devices 210 in response to a request or as another message that is pushed to the mobile device 204 in response to another triggering event (e.g., an update sent to the peripheral medical monitoring device 202, an expiration of a period of time, and / or another triggering event). In one example, the one or more remote computing devices 210 may transmit a message to the mobile device 204 to communicate an update to one or more values of the calibration records 230 for being sent to the peripheral medical monitoring device 202 for performing a local update, or in response to another communication to the medical monitoring device 202 configured to perform a local update thereon.

[0047] In a request for calibration values from the peripheral medical monitoring device 202 and / or the one or more remote computing devices 210, the mobile device 204 may include authentication information (e.g., a security key or other security information, such as a username and / or password) that authorizes the mobile device 204 to receive the requested information. The authentication information may include information used to establish communication with the peripheral medical monitoring device 202 and / or the one or more remote computing devices 210.

[0048] One or more values of the calibration records 230 may be generated and / or stored at the mobile device 204 based on input received from a user of the mobile device 204 at 226. For example, the one or more values of the calibration records 230 may be received at the mobile device 204 as input received from the user of the mobile device 204. The input may be received in response to a prompt for setting calibration values. The input may be communicated to the peripheral medical monitoring device 202 at 227 for configuring the operation of the peripheralMatter No. P39495 -WO medical monitoring device 202. As described herein, the user may input one or more analyte values that may be used to calibrate a measurement algorithm or a sensitivity / thresholds associated with measurements taken by one or more sensors at the peripheral medical monitoring device 202. The input may be provided at predefined periods of time. The input may be provided to the peripheral medical monitoring device 202 at 227 for performing calibration thereon in response to the input from the user. In response to the message at 227, the mobile device 204 may receive an acknowledgement and / or a calibration data record number, which may be a unique identifier indicating that the calibration record provided at 227 is the latest calibration record updated (e.g., for a given record type or for any record types) at the peripheral medical monitoring device 202. One or more of the calibration records 230 may be generated and / or stored at the mobile device 204 in response to negotiation or communications (e.g., for establishing the communication session 220) between the mobile device 204 and the peripheral medical monitoring device 202.

[0049] The mobile device 204 may send a request to the peripheral medical monitoring device 202 at 228 for information related to one or more of the calibration values stored at the peripheral medical monitoring device 202. The request at 228 may be a polling request to confirm the authenticity and reliability of the calibration values configured for the operation of the peripheral medical monitoring device 202 after the calibration records are stored locally at the mobile device 204 and / or a remote computing device 210. The polling request may be transmitted at 228 in response to a triggering event. For example, the polling request may be transmitted at 228 in response to an expiration of a period of time (e.g., since a previously received set of calibration values or calibration value), an indication of an update at the peripheral medical monitoring device 202, a message received from another device, an input from a user at the mobile device 204, after detection of a disconnection and / or establishment (e. , re-establishment) of communication between the mobile device 204 and the peripheral medical monitoring device 202, after receipt of a measurement after transmission of a calibration value, and / or in response to input from the user. The message triggering the request at 228 may include an indication of an update at the peripheral medical monitoring device 202, for example. The indication of the update may be included in a message from the peripheral medical monitoring device 202, which may include a calibration data record number of the latest calibration at the peripheral medical monitoring device 202.Matter No. P39495 -WO

[0050] In one example, the peripheral medical monitoring device 202 may operate in different states that prevent or allow adjustments to the calibration values on which the peripheral medical monitoring device 202 is configured to operate. For example, the peripheral medical monitoring device 202 may enter a state in which updates or changes to the calibration values, or a subset of the calibration values, are prevented from being made (e.g., by the mobile device 204 and / or other computing devices). The peripheral medical monitoring device 202 may enter another state in which updates or changes to the calibration values, or a subset of the calibration values, are permitted.

[0051] In one example, peripheral medical monitoring device 202 may enter the state in which a calibration value is permitted to be accepted by, or even requested (e.g., via the mobile device 204) by, the peripheral medical monitoring device 202. The calibration value may be stored at the peripheral medical monitoring device 202 and calibration may be performed therefrom. The calibration value may be accepted at the peripheral medical monitoring device 202 a predefined period of time (e.g., an hour, two hours, etc.) after establishing the communication at 220 with the mobile device 204. After accepting the calibration value, the peripheral medical monitoring device 202 enter a state in which updates or changes to the calibration value is prevented for a period of time (e.g., twelve hours, twenty four hours, etc.). The peripheral medical monitoring device may wait the predefined period of time before accepting another calibration value (e.g., of the same type or a different type). The period of time may be configured to cause a certain delay between analyte measurement values for purposes of calibration or recalibration of the peripheral medical monitoring device. The peripheral medical monitoring device 202 may also, or alternatively, enter the state in which updates or changes to the calibration value are permitted based on the operation of the peripheral medical monitoring device (e.g., the state may be changed in response to sensor measurements outside of a predefined threshold or other types of sensor performance).

[0052] The peripheral medical monitoring device 202 may enter the state for permitting updates or changes to the calibration values stored thereon for operation in response to one or more triggering events. For example, the triggering events may include an expiration of a period of time, a message received from another device, analyte values or changes thereof (e.g., analyte values reaching a high-end or low end threshold, analyte values rising or falling with at least a predefined rate within a predefined period of time, etc.), temperature or temperature changes,Matter No. P39495 -WO and / or an input from a user at the mobile device 204. The mobile device 204 may be aware of the triggering events for enabling the peripheral medical monitoring device 202 to enter the state for permitting updates or changes to the calibration values stored thereon and these triggering events may dictate the transmission of the requests for calibration values from the peripheral medical monitoring device 202. For example, the mobile device 204 may prevent requests from being transmitted for calibration values when the peripheral medical monitoring device 202 is in the state in which updates or changes to the calibration values, or a subset of the calibration values, are prevented from being made. This may prevent the mobile device 204 from utilizing processing resources by generating request messages and / or the peripheral medical monitoring device 202 from utilizing processing resources by processing and / or responding to request messages during periods of time for which changes to the calibration values at the peripheral medical monitoring device 202 are prevented or unlikely. This may also prevent the mobile device 204 and / or the peripheral medical monitoring device 202 from utilizing network / communication resources by communicating request / response messages during periods of time for which changes to the calibration values at the peripheral medical monitoring device 202 are prevented or unlikely. Further, this may allow the mobile device 204 and / or the peripheral medical monitoring device 202 to remain in a sleep state or otherwise conserve battery power during periods of time for which changes to the calibration values at the peripheral medical monitoring device 202 are prevented or unlikely. The mobile device 204 may transmit a request a predefined period of time after determining that the peripheral medical monitoring device 202 has entered, or is expected to have entered, the state for permitting updates or changes to the calibration values stored thereon.

[0053] The request transmitted at 228 may identify information to be received in response. For example, the request transmitted at 228 may include a request for current calibration records stored at the peripheral medical monitoring device 202. The request may indicate one or more calibration values being requested, a record type being requested, the device type and / or device identifier of the peripheral medical monitoring device 202, a calibration data record number (e.g., a unique identifier indicating a value of the latest calibration record updated at the peripheral medical monitoring device 202), and / or a date / time or range within which the calibration values were stored and / or updated at the peripheral medical monitoring device 202. In another example, the peripheral medical monitoring device 202 may transmit each calibrationMatter No. P39495 -WO value or be preconfigured to identify the calibration values to be sent in response to the request at 228. The request transmitted at 228 may include a device identifier of the mobile device 204 and / or authentication information (e.g., a security key or other security information, such as a username and / or password) that authorizes the mobile device 204 to receive the requested information.

[0054] The mobile device 204 may receive a response at 232. The response may include information related to one or more calibration values. The information related to the one or more calibration values may include each of the calibration values stored thereon, a predefined subset of the calibration values stored thereon, and / or the calibration values being requested. For example, the peripheral medical monitoring device 202 may maintain a local set of calibration records that include calibration values for operation of the peripheral medical monitoring device 202. The local set of calibration records may include one or more calibration values on which the peripheral medical monitoring device is currently operating, a source device from which the calibration value was received, and / or a calibration data record number, which may be a unique identifier of the latest calibration record updated e.g., for a given record type or for any record types) at the peripheral medical monitoring device 202. In an example, the response at 232 may include the calibration data record number, which the mobile device 204 may use (e.g., by comparing the calibration data record number received in response to calibration records transmitted to the peripheral medical monitoring device 202) to determine whether the latest calibration record updated at the peripheral medical monitoring device 202 was updated by the mobile device 204.

[0055] The response at 232 may include a record type associated with the calibration values, the device type and / or device identifier of the peripheral medical monitoring device 202, and / or a date / time at which each calibration value was last updated or stored at the peripheral medical monitoring device 202. The response may indicate a change in a calibration value since a prior transmission of the calibration value to the mobile device 204 and / or a reason for the change in calibration value. The peripheral medical monitoring device 202 may be calibrated at manufacture, such that updates may be unnecessary or unexpected during the operational life of the peripheral medical monitoring device 202. In another example, the peripheral medical monitoring device 202 may receive updates to one or more calibration values during the operational life (e.g., regularly or in response to updates being generated). Thus, updates to theMatter No. P39495 -WO calibration values stored at the peripheral medical monitoring device 202 may be unexpected, or may be expected and managed by input from the user and / or updating the calibration record 230 stored at the mobile device 204.

[0056] Though the message at 232 is described as being a response to a request at 228, a message may be sent to the mobile device 204 in response to another triggering event. For example, the peripheral medical monitoring device 202 may transmit a message at 232 in response to a detected change or difference in calibration values on which the peripheral medical monitoring device 202 is operating, after an expiration of a period of time, in response to a message from another computing device, and / or another triggering event. The transmission of the message at 232 in response to a change in calibration values may be based on a threshold amount of change. For example, the peripheral medical monitoring device 202 may detect a change in analyte values or other values operating as thresholds on the peripheral medical monitoring device by more than a threshold, changes that cause greater than a threshold amount of power utilization, changes that cause less than a threshold amount of communications with the mobile device 204 or another computing device, and / or another threshold amount of change.

[0057] The mobile device 204 may compare the information related to the one or more calibration values received in the message at 232 with the corresponding information related to the one or more calibration values locally stored in the calibration record 230 at 234. The comparison may include a comparison of the latest calibration value or values transmitted to the peripheral medical monitoring device 202 from the mobile device 204. The comparison at 234 may include a comparison of the calibration data record number associated with the latest calibration value or values transmitted to the peripheral medical monitoring device 202. The mobile device 204 may store the calibration record 230 at one or more remote computing devices 210 and may retrieve the calibration record 230 from the one or more remote computing devices 210 prior to performing the comparison. The comparison may be performed at 234 to validate the one or more calibration values stored at the peripheral medical monitoring device 202 and on which the peripheral medical monitoring device is operating.

[0058] The mobile device 204 may determine that the information related to the one or more calibration values received in the message at 232 is acceptable at 234 and / or continue to monitor the calibration values at the peripheral medical monitoring device 202. For example the mobile device 204 may determine that the one or more calibration values and / or the calibrationMatter No. P39495 -WO data record number received in the message at 232 are acceptable at 234 and / or continue to monitor the calibration values at the peripheral medical monitoring device 202. If the calibration value includes an analyte value that is used for calibration, any variation in the analyte value may be unacceptable. In another example, variation within a defined range (e.g., a range of less than 0.5mg / dl, less than l.Omg / dl, less than 2.0mg / dl, less than 5.0mg / dl, or less than lO.Omg / dl) may be acceptable. The mobile device 204 may determine that the information related to the one or more calibration values received in the message at 232 is acceptable at 234 if they are the same as the corresponding calibration value locally stored in the calibration record 230. The mobile device 204 may determine that the one or more calibration values received in the message at 232 are acceptable at 234 when they are different, but expected or determined to be acceptable from input from the user and / or other information indicating a reason for the change. For example, the message received at 232 may indicate a source of the change in calibration values. The source may be determined to be a trusted source (e.g., the mobile device 204, the remote computing devices 210, a trusted user of the mobile device 204, a trusted user of the peripheral medical monitoring device, and / or another trusted source). The message received at 232 may indicate a date / time at which the change was made and / or stored at the peripheral medical monitoring device 202. The date / time may be determined to be a date / time that is acceptable, as it may be understood to be a permitted date / time for updates to be accepted at the peripheral medical monitoring device 202 (e.g., when the peripheral medical monitoring device 202 is in a state in which updates or changes to the calibration values, or a subset of the calibration values, are permitted). The message received at 232 may indicate a reason for a change in a calibration value at the peripheral medical monitoring device 202. The reason may be an acceptable reason, such as an update from a trusted source (e.g, device and / or user), at a trusted date / time, or another acceptable reason for the change. Each portion of the data considered in evaluating whether the one or more calibration values received in the message at 232 are acceptable may be weighted equivalently or differently and compared to a threshold in making a determination as to whether the calibration values that are received are acceptable. The message received at 232 may trigger a notification to the user that includes information related to the one or more calibration values received in the message at 232, and the mobile device 204 may determine that the change in information related to the one or more calibration value is acceptable based on a user input.Matter No. P39495 -WO

[0059] In an example, the peripheral medical monitoring device 202 may receive a message at 236a from one or more other computing devices at 212. The one or more other computing devices 212 may include one or more other computing device with which the peripheral medical monitoring device 202 has established a communication session (e.g., another wireless communication session). In another example, the peripheral medical monitoring device 202 may receive a message at 236b initiated by one or more applications operating on the mobile device 204. For example, the message at 236b may be initiated by a third party application that is different from the application from which the calibration values may be configured and / or that may be maintaining the calibration record 230. The one or more other computing devices 212 and / or the third-party applications may or may not be authorized to change the calibration values at the peripheral medical monitoring device 202. The one or more other computing devices 212 and / or the third-party applications may be unrecognized or unauthorized (e.g, untrusted) devices for making changes to the calibration values of the peripheral medical monitoring device 202. In one example, the one or more remote computing devices 210 may be included in the computing devices 212 that change the calibration values at the peripheral medical monitoring device 202 (e.g., via an update). In another example, the computing devices may include another mobile device or computing device capable of changing the calibration values at the peripheral medical monitoring device 202. In response to the message at 236a, 236b, the peripheral medical monitoring device may update the calibration data record number stored thereon.

[0060] The mobile device 204 may send a request to the peripheral medical monitoring device 202 at 238 for information relate to one or more of the calibration values stored at the peripheral medical monitoring device 202. The request at 238 may be another polling request to confirm the authenticity and reliability of the calibration values configured for the operation of the peripheral medical monitoring device 202. The polling request may be transmitted at 238 in response to another triggering event. For example, the polling request may be transmitted at 238 in response to an expiration of a period of time (e.g, since a previously received set of calibration values or calibration value, an indication of an update at the peripheral medical monitoring device 202, a message received from another device, and / or an input from a user at the mobile device 204. The message triggering the request at 238 may include an indication of an update at the peripheral medical monitoring device 202, for example. The request at 238 mayMatter No. P39495 -WO be triggered in response to receiving a message indicating calibration data record number has been updated at the peripheral medical monitoring device 202.

[0061] The request transmitted at 238 may identify information to be received in response. For example, the request transmitted at 238 may include a request for information related to current calibration records stored at the peripheral medical monitoring device 202. The request may indicate one or more calibration values being requested, a record type being requested, the device type and / or device identifier of the peripheral medical monitoring device 202, a calibration data record number (e.g., a unique identifier indicating a value of the latest calibration record updated at the peripheral medical monitoring device), and / or a date / time or range within which the calibration values were stored and / or updated at the peripheral medical monitoring device 202. In another example, the peripheral medical monitoring device 202 may transmit each calibration value or be preconfigured to identify the calibration values to be sent in response to the request at 238. The request transmitted at 238 may include the device identifier of the mobile device 204 and / or authentication information (e.g, a security key or other security information, such as a username and / or password) that authorizes the mobile device 204 to receive the requested information.

[0062] The mobile device 204 may receive a response at 240. The response may include information related to each of the calibration values stored thereon, a predefined subset of the calibration values stored thereon, and / or the calibration values being requested. The response may include a record type associated with the calibration values, the device type and / or device identifier of the peripheral medical monitoring device 202, and / or a date / time at which each calibration value was last updated or stored at the peripheral medical monitoring device 202. The response may indicate a change in a calibration value since a prior transmission of the calibration value to the mobile device 204. For example, the response may include a different calibration data record number than stored at the mobile device 204. Though the message at 240 is described as being a response to a request at 238, a message may be sent to the mobile device 204 in response to another triggering event, such as the detection in the change of calibration values due to the message received at 236.

[0063] The mobile device 204 may compare information associated with the one or more calibration values by the peripheral medical monitoring device 202 received in the message received at 240 with the corresponding information in the latest calibration record 230 locallyMatter No. P39495 -WO stored thereon at 242. The comparison may be performed at 242 to, again (e.g., at a later period in time), validate the one or more calibration values stored at the peripheral medical monitoring device 202 and on which the peripheral medical monitoring device is operating. Prior to performing the comparison at 234 or 242, the mobile device 204 may communicate with one or more remote computing devices 210 (e.g., which may be trusted computing devices for updating the calibration values at the peripheral medical device 202) to determine whether the one or more remote computing devices 210 have updated any calibration values at the peripheral medical monitoring device 202 (e.g., which may be updated in the calibration record 230). In another example, the mobile device 204 may store the calibration record 230 at one or more remote computing devices 210 and may retrieve the calibration record 230 from the one or more remote computing devices 210 prior to performing the comparison.

[0064] The mobile device 204 may detect that the there has been a change in the information related to one or more calibration values. For example, the mobile device 204 may detect that the one or more calibration values received in the message at 240 have changed or been modified by another source (e.g., to be different than the corresponding calibration value locally stored in the calibration record 230). The mobile device 204 may also, or alternatively, detect that the calibration data record number of the latest calibration recorded by the peripheral medical monitoring device 202 does not match that of the one or more calibration values stored in the calibration record 230 at the mobile device 204 and display the one or more calibration values to the user of the mobile device. The changes in calibration values may include calibration values and / or records added to and / or removed from the calibration record 230. The changed or modified calibration values may be indicated as being accepted by the peripheral medical monitoring device 202 for being a calibration value upon which the peripheral medical monitoring device 202 is configured to operate. The difference in the information related to the one or more calibration values received in the message received at 240 and the corresponding calibration value locally stored in the calibration record 230 may indicate that the calibration values stored at the peripheral medical monitoring device 202 are unreliable or compromised.

[0065] The mobile device 204 may determine that the information related to the one or more calibration values received in the message at 240 is unacceptable at 240 if the change is unexpected or determined to be unacceptable from other information indicating a reason for the change. The difference in the information related to the one or more calibration values receivedMatter No. P39495 -WO in the message at 240 and the corresponding information locally stored in the calibration record 230 may indicate that the calibration values stored at the peripheral medical monitoring device 202 may include calibration values that did not originate from a trusted source. The calibration record 230 may include values that were transmitted from the mobile device 204 for storage at the peripheral medical monitoring device 202 for calibrating operation of the peripheral medical monitoring device 202. The calibration values received in the message at 240 may be determined to be unacceptable when they are different from the calibration values communicated from the mobile device 204 for calibrating operation at the peripheral medical monitoring device 202. The response received at 240 may indicate a source of the change in calibration values. The source may be determined to be an untrusted source, such as the one or more other computing devices 212; an untrusted or unidentified user of the one or more other computing devices; an unauthorized application or software operating on the mobile device 204, the remote computing devices 210, or the other computing devices 212; or another unacceptable source. The message received at 240 may indicate a date / time at which the change was made and / or stored at the peripheral medical monitoring device 202. The date / time may be determined to be a time that is unacceptable, as it may be understood to be outside of a permitted date / time for updates to be accepted at the peripheral medical monitoring device 202 (e.g., when the peripheral medical monitoring device 202 is in a state in which updates or changes to the calibration values, or a subset of the calibration values, are not permitted). The message received at 240 may indicate a reason for a change in a calibration value at the peripheral medical monitoring device 202. The reason may be an unacceptable reason, such as an update from an untrusted source e.g., device and / or user), at an untrusted date / time, or another unacceptable reason for the change. Each portion of the data considered in evaluating whether the one or more calibration values received in the message at 240 are acceptable may be weighted equivalently or differently and compared to a threshold in making a determination as to whether the calibration values that are received are acceptable.

[0066] After the mobile device 204 determines that the information related to the one or more calibration values received in the message at 240 are unacceptable, the mobile device 204 may provide a notification to the user at 244. The notification may be an audible notification, a visual notification, and / or a haptic notification. The notification may be provided via an application on the mobile device 204 and / or an operating system notification. The notificationMatter No. P39495 -WO provided via the application may be an overlay notification provided over a graphical user interface of the application. The application may include a medical application configured to assist in the treatment of the user’s medical condition and the overlay notification may be a medical overlay notification provided when the mobile device 204 presents the user interface of the medial application in the foreground on the display of the mobile device 204. The notification may be provided in a notification portion of the application, such that the notification is provided in a list of notifications to be provided to the user related to the application, the peripheral medical monitoring device 202, or the medical condition of the user. The notification may be provided via the operating system as an overlay notification on a graphical user interface provided by the operating system of the mobile device 204, such as a lock screen, a home screen, a call screen, and / or other graphical user interface.

[0067] The notification may include information related to the triggering of the notification. For example, the notification may include information related to the calibration values stored in the calibration records 230 and the calibration values stored at the peripheral medical monitoring device 202. The notification may indicate the determined changes to or differences in one or more calibration values at the peripheral medical monitoring device 202, which may even include an identification of the change in the calibration values to the user. The notification may identify the type of record that has been changed (e.g., analyte value, communication value, etc ). The notification may identify the device type and / or device identifier of the peripheral medical monitoring device 202. The notification may identify a source of the changed calibration value (e.g., source device and / or user). The notification may identify a source of the date and / or time of the change at the peripheral medical monitoring device 202 or when identified / stored at the mobile device 204. The notification may identify a reason for the change in the calibration value for a given record from a previous value, such as a user input at the mobile device 204, a user input at the peripheral medical monitoring device 202, an update received in a message from another device, etc. The information in the notification may allow the user to determine a subsequent action to be performed in response to the notification.

[0068] The notification provided at 244 may include actuators e.g., buttons) for allowing the user to take action related to the notification of the potentially untrustworthy or compromised peripheral medical monitoring device 202. The notification provided at 244 may also, orMatter No. P39495 -WO alternatively, be configured to receive an input from the user of the mobile device 204 to display the medical monitoring application in the foreground via a graphical user interface for allowing for the user to provide input on subsequent actions. The notification and / or the medical monitoring application may provide an option for the user to provide input to indicate whether the detected difference or change in calibration values (e.g., added or removed calibration value) is acceptable or unacceptable for maintaining the wireless communication session and / or future wireless communication sessions with the peripheral medical monitoring device. The notification provided at 244 and / or the medical monitoring application may provide a dismiss actuator configured to allow the user to dismiss the notification and the mobile device 204 may maintain the communication with the peripheral medical monitoring device 202. The notification provided at 244 and / or the medical monitoring application may provide an actuator configured to allow the user to identify that the change in the calibration values was acceptable (e.g., performed by a trusted source, such as the user themselves or another trusted user, a trusted device, and / or another trusted source; for a trustworthy reason, and / or at a trusted date / time), and the mobile device 204 may maintain the communication with the peripheral medical monitoring device 202 at 246.

[0069] The notification provided at 244 and / or the medical monitoring application may provide an actuator configured to allow the user to identify that the change in the calibration values is unacceptable (e.g., performed by an untrusted source, for an untrustworthy reason, and / or at an untrusted date / time), and the mobile device 204 may terminate the communication with the peripheral medical monitoring device 202 at 246. The notification and / or the medical monitoring application may include an option to terminate the wireless communication session. The mobile device 204 may receive an indication from the user (e.g., via the graphical user interface) to terminate the wireless communication session and terminate the wireless communication session with the peripheral medical monitoring device 202 at 246.

[0070] The mobile device 204 may set a flag in memory that identifies the peripheral medical monitoring device 202 as compromised or potentially compromised and prevents the mobile device 204 from discovering and / or connecting with the peripheral medical monitoring device 202 while the flag is stored. The indication to terminate the wireless communication session may also cause the mobile device 204 to transmit a message to the peripheral medical monitoring device 202 to enter an end of life state. This message may be configured to cause theMatter No. P39495 -WO peripheral medical monitoring device 202 to store an indicator locally thereon that the peripheral medical monitoring device 202 is compromised or potentially compromised. During subsequent establishments of a communication session with the mobile device 204 and / or other mobile devices, the peripheral medical monitoring device 202 may be configured to transmit the indication that the peripheral medical monitoring device 202 is compromised or potentially compromised, which may prevent the establishment of the communication session from occurring. For example, a communication request or discovery message from the peripheral medical monitoring device 202 may indicate the end of life state or that the peripheral medical monitoring device 202 is compromised or potentially compromised, which may prevent the establishment of the communication session from occurring.

[0071] The notification provided at 244 and / or another notification provided by the medical monitoring application may provide an actuator that allows the user to select an option to perform another calibration at the peripheral medical monitoring device 202. For example, the user may input a change to the calibration values received from the peripheral medical monitoring device 202 or indicate that the peripheral medical monitoring device 202 should revert back to prior calibration values (e.g., the calibration values stored in the calibration records 230). The change in calibration values may be communicated to the peripheral medical monitoring device 202 for performing the update and / or being stored thereon for operation of the peripheral medical monitoring device 202. In one example, the mobile device 204 or a user may perform a restoration procedure at the peripheral medical monitoring device 202 by causing the calibration values to be restored to prior values, factory values, and / or values of a prior update. The restoration may also, or alternatively, cause the peripheral medical monitoring device 202 to remove the software stored thereon and reinstall the software (e.g., locally or from one or more remote computing devices 210). However, the changes to the calibration values may not resolve the fact that the peripheral medical monitoring device 202 may potentially be untrustworthy or compromised allowing for future potential changes in the calibration values stored at the peripheral medical monitoring device 202. As such, the mobile device 204 may flag the peripheral medical monitoring device 202 as being compromised and / or prevent the mobile device 204 from establishing future communication sessions. The mobile device 204 may establish a subsequent communication session with another peripheral medical monitoring device that has not been determined to be untrustworthy or compromised.Matter No. P39495 -WO

[0072] In one example, the mobile device 204 may perform a restoration procedure (e.g., upon removing / downloading the mobile medical application on the device mobile device 204 and / or changing users at the mobile device 204), which may cause the mobile device to restore the calibration values in the calibration records 230 (e.g., based on user input or messages received from the peripheral medical monitoring device 202 and / or the one or more remote computing devices). The mobile device 204 may compare the restored calibration values in the calibration records 230 to the calibration values stored at the peripheral medical monitoring device 202 by transmitting one or more requests for the calibration values and / or receiving one or more responses.

[0073] FIG. 3 is a flow diagram illustrating an example process 300 for checking an authenticity or reliability of calibration values being used to operate one or more peripheral medical monitoring devices. One or more portions of the process 300 may be implemented by a central medical monitoring device, such as the mobile device 104, 204 shown in FIGs. 1 and 2, respectively, the remote computing device 122, 210 shown in FIGs. 1 and 2, respectively, and / or one or more other central medical monitoring devices. An example central medical monitoring device may be described herein as a mobile device, but other types of central medical monitoring devices or computing devices may be implemented to perform one or more portions of the process 300 described herein. For example, the process 300 may be implemented on the mobile device and / or one or more portions thereof may be distributed across other central medical monitoring devices or other computing devices. The central medical monitoring device may include software and / or hardware operating on the central medical monitoring device to perform one or more portions of the process 300. The software may include an application (c. ., a medical application, such as a diabetes-related application, an exercise-related application, a nutrition or mealtime-related application, another health-related application, or another type of application). The central medical monitoring device may have stored thereon in memory computer-executable instructions for implementing one or more portions of the process 300. Though the process 300 may illustrate a sequence of steps or events in a particular order, the sequence of steps or events may be performed in another order.

[0074] As shown in FIG. 3, the central medical monitoring device may establish a wireless communication session with a peripheral medical monitoring device at 302. For example, the communication session may be established via one or more wirelessMatter No. P39495 -WO communication protocols, such as BLUETOOTH®, BLUETOOTH® low energy (BLE), near field communication (NFC), THREAD®, WIFI®, ZIGBEE®, WLMAX®, or another radio frequency (RF) communication protocol. During or after the establishment of the communication session, the central medical monitoring device may store an identifier of the peripheral medical monitoring device, which may be used for identifying calibration values that may be used for operation of the peripheral medical monitoring device.

[0075] At 304, the central medical monitoring device may receive information related to one or more calibration values associated with the peripheral medical monitoring device. The information related to the calibration values may be stored in calibration records maintained at the central medical monitoring device and / or one or more remote computing devices. The information related to the calibration values may include the calibration values themselves and / or other information related to the calibration values, as described herein. The calibration values stored in the calibration records may include different types of calibration values in different records, such as analyte values that may be measured at the peripheral medical monitoring device, parameter values of the communication parameter set for communicating with the central medical monitoring device and / or other computing devices, timing values, values configuring the settings of an operating system on the peripheral medical monitoring device, power management values for managing power usage on the peripheral medical monitoring device, values configuring the settings of a particular application on the peripheral medical monitoring device, user-specific values associated with one or more particular users, and / or values configured to change a mode of operation. The calibration values may be received in response to a user input on a graphical user interface at the central medical monitoring device, in response to a request from or a negotiation with the peripheral medical monitoring device, and / or in response to a request from a remote computing device (e. ., a trusted remote computing device configured to store the calibration values at manufacture and / or updates to the calibration values that may be used to operate the peripheral medical monitoring device). The information related to the calibration values may be stored in the calibration record at the central medical monitoring device and / or one or more remote computing devices for later comparison with calibration values on which the peripheral medical monitoring device is currently operating or has stored for operation.Matter No. P39495 -WO

[0076] At 306, the central medical monitoring device may detect a triggering event to request information related to the calibration values on which the peripheral medical monitoring device is currently operating or has received for operation. For example, the triggering event may be an expiration of a period of time for transmitting the request as a polling message. The triggering event may be a message received from another device, such as the peripheral medical monitoring device or another remote computing device. The message from the peripheral medical monitoring device may indicate a change to or difference in calibration values locally thereon. The message from the peripheral medical monitoring device may indicate an update from a trusted source or an update from an unknown source. The message from another remote computing device may indicate updates transmitted to the peripheral medical monitoring device for updating the calibration values locally thereon. The triggering event may be received in response to a user input on a graphical user interface. In another example, as described herein, the calibration values may be received from the peripheral medical monitoring device without transmission of a request from the central medical monitoring device.

[0077] At 308, the central medical monitoring device may transmit a request for information related to the calibration values from the peripheral medical monitoring device and / or another remote computing device based on the detection of the triggering event. The request may be transmitted to request the calibration values currently being used for operation of the peripheral medical monitoring device or for which the peripheral medical monitoring device has received for operation. The request may be transmitted to the peripheral medical monitoring device or a trusted remote computing device configured for updating and / or maintaining the calibration values at the peripheral medical monitoring device. The request may identify information to be received in response or predefined information may be provided based on the request. For example, the request may indicate one or more calibration values being requested, a record type being requested, the device type and / or device identifier of the peripheral medical monitoring device, a calibration data record number (e.g., a unique identifier indicating a value of the latest calibration record updated at the peripheral medical monitoring device), and / or a date / time or range within which the calibration values were stored and / or updated at the peripheral medical monitoring device. The peripheral medical monitoring device, and / or another remote computing device from which the calibration values are being requested, may transmit each calibration value and / or other information associated therewith in a calibration record storedMatter No. P39495 -WO locally thereon, or may be preconfigured to identify the calibration values and / or other information to be sent in response to the request.

[0078] The central medical monitoring device may receive the information related to the calibration values at 310 from in response to the request at 310. The response may include a record type associated with the calibration values, the device type and / or device identifier of the peripheral medical monitoring device, a calibration data record number, and / or a date / time at which each calibration value was last updated or stored at the peripheral medical monitoring device. The response may indicate a change or difference in information related to a calibration value (e.g., including a difference in a calibration value) since a prior transmission of the calibration value to the central medical monitoring device.

[0079] At 312, the central medical monitoring device may compare the information related to the calibration values to the calibration record stored thereon. The comparison may be performed to validate the one or more calibration values on which the peripheral medical monitoring device is currently operating. At 314, the central medical monitoring device may determine whether the one or more calibration values on which the peripheral medical monitoring device is currently operating are acceptable. For example, the central medical monitoring device may determine that the calibration values on which the peripheral medical monitoring device is currently operating are acceptable at 314 if they are the same as the corresponding calibration values previously stored in the calibration record. The central medical monitoring device may determine that the calibration values are acceptable when they are different, but expected or determined to be acceptable from other information indicating a reason for the change or difference. For example, the central medical monitoring device may determine that a source of the change or difference is a trusted source (e.g., the central medical monitoring device itself or another trusted computing device or user). The date / time at which the change or difference was made to the calibration values may be determined to be a date / time that is acceptable, as it may be understood to be a permitted date / time for updates to be accepted at the peripheral medical monitoring device (e.g., when the peripheral medical monitoring device is in a state in which updates or changes to the calibration values, or a subset of the calibration values, are permitted). In response to detecting a potentially unacceptable difference in the information associated with one or more calibration values, the central medical monitoring device may provide an alert to the user with one or more types of information related to the calibrationMatter No. P39495 -WO values for soliciting input as to whether the difference in the information is acceptable. For example, in response to a difference in a calibration data record number received from the peripheral medical monitoring device and a locally stored calibration data record, the central medical monitoring device may display the different calibration values to the user for soliciting input as to whether the difference in the calibration values is acceptable. Multiple portions of information may be considered in evaluating whether a change or difference in the information related to a calibration value on which the peripheral medical device is operating is an acceptable change or difference. Each portion of information may be weighted equivalently or differently and compared to a threshold in making a determination as to whether changes or differences in calibration values are acceptable. If the changes or differences in the calibration values are determined to be acceptable at 314, the central medical monitoring device may await another triggering event for requesting and / or comparing calibration values.

[0080] The central medical monitoring device may determine that a change or difference in the information related to one or more calibration values on which the peripheral medical monitoring device is currently operating are unacceptable. The central medical monitoring device may detect that the calibration values on which the peripheral medical monitoring device is currently operating have changed or been modified from the previously stored values in the calibration record. For example, the central medical monitoring device may detect that the calibration values have changed or been modified by another source or an untrusted source. The difference in the calibration values may indicate that the calibration values on which the peripheral medical monitoring device is operating may be unreliable or compromised.

[0081] The central medical monitoring device may determine that the calibration values on which the peripheral medical monitoring device is operating are unacceptable if the changes or differences are unexpected or determined to be unacceptable from other information indicating a reason for the change or difference. For example, the central medical monitoring device may determine that the calibration values on which the peripheral medical monitoring device is currently operating are unacceptable at 314 if they are originated from an untrusted or unknown source or user. The central medical monitoring device may determine that the calibration values on which the peripheral medical monitoring device is operating are unacceptable if there is a difference in a calibration data record number received from the peripheral medical monitoring device and a locally stored calibration data record. The date / timeMatter No. P39495 -WO at which the change or difference was made to the calibration values may be determined to be a date / time that is unacceptable, as it may be understood to be outside of a permitted date / time for updates to be accepted at the peripheral medical monitoring device. The central medical monitoring device may determine that the calibration values on which the peripheral medical monitoring device is operating are unacceptable in response to user input.

[0082] If the change or difference in the calibration values are determined to be unacceptable at 314, the central medical monitoring device may notify the user and / or perform a subsequent action at 316. The notification may be an audible notification, a visual notification, and / or a haptic notification. The notification may be provided via an application on the central medical monitoring device and / or an operating system notification. The notification provided via the application may be an overlay notification provided over a graphical user interface of the application. The application may include a medical application configured to assist in the treatment of the user’s medical condition. The notification may be provided in a notification portion of the application, such that the notification is provided in a list of notifications to be provided to the user related to the application, the peripheral medical monitoring device, and / or the medical condition of the user. The notification may be provided via the operating system as an overlay notification on a graphical user interface provided by the operating system of the central medical monitoring device, such as a lock screen, a home screen, a call screen, and / or other graphical user interface.

[0083] The notification may include information related to the triggering of the notification. For example, the notification may indicate the determined changes to or differences in the information relate to the one or more calibration values (e. , including the changed to the one or more calibration values themselves) at the peripheral medical monitoring device from previously stored information related to calibration values in the calibration record. The notification may identify the type of calibration value (e.g., analyte value, communication value, etc.) that has been changed, including an added or removed calibration value. The notification may identify the device type and / or device identifier of the peripheral medical monitoring device for which the change or difference is detected. The notification may identify a source of the changed calibration value (e.g., source device and / or user). The notification may identify a source of the date and / or time of the change at the peripheral medical monitoring device. The notification may identify a reason for the change or difference in the calibration value for a givenMatter No. P39495 -WO record from a previous value, such as a user input at the central medical monitoring device, a user input at the peripheral medical monitoring device, an update received in a message from another device, etc. The information in the notification may allow the user to determine a subsequent action to be performed in response to the notification.

[0084] The central medical monitoring device may perform remedial action in response to the detection of the unacceptable change or difference in the calibration values on which the peripheral medical monitoring device is operating. For example, the central medical monitoring device may automatically end the communication session with the peripheral medical monitoring device. The central medical monitoring device may set a flag in memory that identifies the peripheral medical monitoring device as compromised or potentially compromised and prevents the central medical monitoring device from discovering and / or connecting with the peripheral medical monitoring device while the flag is stored. The central medical monitoring device may transmit a message to the peripheral medical monitoring device to cause the peripheral medical monitoring device to enter an end of life state. This message may be configured to cause the peripheral medical monitoring device to store an indicator locally thereon that the peripheral medical monitoring device is compromised or potentially compromised. During subsequent establishments of a communication session with the central medical monitoring device and / or another central medical monitoring device, the peripheral medical monitoring device may transmit the indication that the peripheral medical monitoring device is compromised or potentially compromised, which may prevent the establishment of the communication session from occurring. For example, a communication request or discovery message from the peripheral medical monitoring device may indicate the end of life state or that the peripheral medical monitoring device is compromised or potentially compromised, which may prevent the establishment of the communication session from occurring.

[0085] In another example, the central medical monitoring device may provide options to the user for providing input regarding the subsequent action to be taken. The user may provide input instructing the central medical monitoring device to dismiss the alert, accept the change or difference that has been identified in the calibration values, and / or continue the communication session with the peripheral medical monitoring device. In another example, the user may provide input instructing the central medical monitoring device to discontinue the communication session, establish a communication session with another device, and / orMatter No. P39495 -WO recalibrate or restore calibration values at the peripheral medical monitoring device. The subsequent action may be provided as options via the notification or in a separate user interface provided by the central medical monitoring device.

[0086] FIGs. 4A-4C are graphical representations of example user interfaces that may be implemented for providing notifications to a user and / or receiving user input for performing an action related to a peripheral medical monitoring device. The example user interfaces may be generated and / or displayed using one or more computing devices. For example, the user interfaces may be generated and / or displayed via a local application on a central medical monitoring device. In another example, the user interfaces may be generated via information from a remote application or service that is accessed via a local application, such as a web browser or other local application enabling a web interface, executed at the central medical monitoring device.

[0087] FIG. 4A shows an example user interface 400a that may be displayed to a user. The user interface 400a may be displayed via an application, such as a medical application, such as a diabetes-related application, an exercise-related application, a nutrition or mealtime-related application, another health-related application, or another type of application. The application may display information 402a related to the health of the user and / or based on information received from the peripheral medical monitoring device. For example, the information 402a may include analyte values (e. ., blood glucose values) and / or other health-related information (e.g., heartrate, etc.) measured by one or more sensors on the peripheral medical monitoring device.

[0088] The user interface 400a may provide a notification 404. The notification 404 may be overlay ed on or displayed with the other information 402a being provided by the application in response to detection of a change or difference in calibration values being used to operate the peripheral medical monitoring device. In another example, the notification 404 may be accessed via actuation of an actuator 405 configured to display notifications related to the application. For example, the notification 404 may provide information 407 indicating a reason for the notification 407 being generated and / or displayed, such as the detected changes to or differences in one or more calibration values operating the peripheral medical monitoring device. The user may actuate the notification 404 and / or an actuator 406 (e.g., button, link, or other actuator) to perform a subsequent action related to the notification 404. For example, the notification 404 and / or the actuator 406 may allow the user to review additional information related to theMatter No. P39495 -WO calibration values and / or take action related to the potentially untrustworthy or compromised peripheral medical monitoring device.

[0089] The notification 404 may provide an option for the user to provide input to indicate whether the detected change or difference in calibration values at the peripheral medical monitoring device is acceptable for maintaining the wireless communication session and / or future wireless communication sessions with the peripheral medical monitoring device. For example, in response to actuation of the notification 404 or the actuator 406 shown in FIG. 4A, the user interface 400a may display an actuator 410, shown in FIG. 4B, that is configured to allow the user to identify that the change or difference in the calibration values was acceptable (e.g., performed by a trusted source, such as the user themselves or another trusted user, a trusted device, and / or another trusted source; for a trustworthy reason, and / or at a trusted date / time), and the central medical monitoring device may maintain the communication session with the peripheral medical monitoring device. In response to actuation of the notification 404 or the actuator 406, the user interface 400a may display an actuator 412a configured to allow the user to identify that the change or difference in the calibration values was unacceptable (e.g, performed by an untrusted or unknown source device or user, for an untrustworthy reason, and / or at an untrusted date / time), and the central medical monitoring device may end the communication session with the peripheral medical monitoring device and / or allow the user to establish another communication session with a different peripheral medical monitoring device.

[0090] The user interface 400a may display additional information 407a (e.g., in response to the actuation of the actuator 406 shown in FIG. 4A) related to the reason for the change or difference in the calibration values at the peripheral medical monitoring device. For example, the additional information may include a source device and / or user that caused the change or difference in calibration values, a date / time at which the change in calibration values was performed or detected, a calibration value type or record type, and / or other information associated with the change or difference in calibration values to allow the user to review the information prior to providing input regarding subsequent action to be performed.

[0091] FIG. 4C shows another example user interface 400b that may be displayed to a user. The user interface 400b may be displayed via an application, such as a medical application, such as a diabetes-related application, an exercise-related application, a nutrition or mealtime- related application, another health-related application, or another type of application. TheMatter No. P39495 -WO application may display information 402b related to the health of the user and / or based on information received from the peripheral medical monitoring device. For example, the information 402b may include analyte values (e. ., blood glucose values) and / or other health- related information (e.g., heartrate, etc.) measured by one or more sensors on the peripheral medical monitoring device.

[0092] The user interface 400b may provide a notification 404a. The notification 404a may be overlayed on or displayed with the information 402b being provided by the application in response to detection of a change or difference in calibration values being used to operate the peripheral medical monitoring device. In another example, the notification 404a may be accessed via actuation of the actuator 405 configured to display notifications related to the application. The notification 404a may provide information 407b indicating a reason for the notification 404a being generated and / or displayed, such as the detected changes to or differences in one or more calibration values operating the peripheral medical monitoring device, a source device and / or user that caused the change or difference in calibration values, a date / time at which the change or difference in calibration values was performed or detected, a calibration value type or record type, and / or other information associated with the change or difference in calibration values to allow the user to review the information prior to providing input regarding subsequent action to be performed. The notification 404a may include an actuator 420 (e.g., button, link, or other actuator) configured to dismiss the notification 404a.

[0093] The user interface 400b may provide a notification 404b. The notification 404b may be overlayed on the other information 402b being provided by the application in response to detection of a change or difference in calibration values being used to operate the peripheral medical monitoring device. In another example, the notification 404b may be accessed via actuation of the actuator 405 configured to display notifications related to the application. The notification 404b may be displayed to allow the user to perform subsequent remedial action after the central medical monitoring device detects a change or difference in calibration values operating at the peripheral medical monitoring device. For example, the notification 404b may be displayed after the central medical monitoring device automatically terminates a communication session with the peripheral medical monitoring device or to allow the user to provide input to cause the central medical monitoring device terminate the communication session. The notification 404b may include an actuator 412b (e.g., button, link, or other actuator)Matter No. P39495 -WO configured to terminate the terminate the communication session with the peripheral medical monitoring device and / or establish a communication session with another peripheral medical monitoring device.

[0094] FIG. 5 is a block diagram of an example computing device 500. The computing device 500 may be a mobile computing device, such as a tablet, a cellular phone, a wearable device, a medical monitoring device, such as an analyte monitoring device, a remote computing device, or another computing device, for example. As shown in FIG. 5, the computing device 500 may include a processor 502 for controlling the functionality of the computing device 500. The processor 502 may include one or more circuits, such as general-purpose processors, special purpose processors, conventional processors, digital signal processors (DSPs), microprocessors, integrated circuits, a programmable logic device (PLD), application specific integrated circuits (ASICs), or the like. The processor 502 may perform signal coding, data processing, power control, image processing, input / output processing, or any other functionality that enables the computing device 500 to perform as described herein.

[0095] The processor 502 may store information in or retrieves information from the memory 516. The memory 516 includes a non-removable memory or a removable memory. The non-removable memory includes random-access memory (RAM), read-only memory (ROM), a hard disk, or any other type of non-removable memory storage. The removable memory includes a subscriber identity module (SIM) card, a memory stick, a memory card (e.g., a digital camera memory card), or any other type of removable memory. The processor 502 may access the memory 516 for executable instructions or other information that is used by the computing device 500. For example, the memory 516 may include computer-readable or machine-readable instructions that may be executed by the processor 502 for performing one or more methods, processes, or procedures, or portions thereof, as described herein.

[0096] The computing device 500 may include a camera 506 that is in communication with the processor 502. The camera 506 may be a digital camera or other optical device capable of generating images or videos (e.g., image sequences) for being captured at the computing device 500. The camera 506 may include a lighting device capable of flashing to in response to signals from the processor 502.

[0097] The computing device 500 may include one or more communication circuits 518. The processor 502 may be in electrical communication with the communication circuit 518 forMatter No. P39495 -WO sending or receiving information. The communication circuit 518 may be capable of performing wired and / or wireless communications. For example, the communication circuit 518 may include one or more radio frequency (RF) transceivers for transmitting and receiving RF signals (e.g., BLUETOOTH®, BLE, NFC, WIFI®, WI-MAX®, cellular, or other RF signals) via an antenna, or other communications module capable of performing wireless communications. In some embodiments, one or more communication circuits 518 are capable of performing infrared (IR) communications.

[0098] The processor 502 may be in electrical communication with a keypad 524 for providing input to the processor 502. The keypad 524 may include one or more keys for receiving input from a user. The keypad 524 may include hard or soft keys for which the function of the keys changes as a user performs selections.

[0099] Other input into the processor 502 may be provided by one or more sensors 526. The sensors 526 include a motion sensor, a proximity sensor, a heartrate monitoring sensor, an accelerometer, a gyroscope, and / or another sensor on the computing device 500. The motion sensor may transmit infrared signals or use image processing to sense movement. The proximity sensor may transmit infrared signals to detect when an object is within a predefined proximity. The heartrate monitoring sensor may implement photoplethysmography to detect the amount of blood flow in the user. The heartrate monitoring sensor may include one or more LED or photodiodes to detect the amount of blood flow in the user. The heartrate monitoring sensor may implement infrared technology to detect the amount of blood flow in the user. The heartrate monitoring sensor may take an electrocardiogram (ECG) and detect information about the user’s heartrate from the ECG. The accelerometer may measure the non-gravitational acceleration of the computing device 500 in a given direction. The accelerometer may respond to vibrations associated with movement in a given direction. The measurements from the accelerometer may be used by the processor 502 to determine the magnitude or direction of the relative movement of the computing device 500, or the user’s relative position (e.g., standing, sitting, or lying down). The gyroscope may be used to determine the orientation of the computing device 500.

[0100] The processor 502 may be in electrical communication with or generate images on a display 520 for providing information to a user. The communication between the display 520 and the processor 502 may be a two-way communication, as the display 520 may include a touch screen module capable of receiving information from a user and providing suchMatter No. P39495 -WO information to the processor 502. For example, the display 520 may provide soft buttons for selection by a user that are recognized by the touch screen module and provided to the processor 502 as input.

[0101] The processor 502 may be in electrical communication with or control a speaker 508. The speaker 508 may provide an audible sound (e.g., tone, beep, or buzz) in response to a triggering event detected by the processor 502.

[0102] The computing device 500 may include an electric motor 510 that is in electrical communication with or controlled by the processor 502. The electric motor 510 may rotate and causes the computing device 500 to vibrate (e.g., to indicate a notification) or provide haptic feedback in response to a triggering event detected by the processor 502.

[0103] The processor 502 may be in electrical communication with or receive information from a microphone 514. For example, the processor 502 may receive audio signals via the microphone 514.

[0104] The computing device 500 may include a global positioning system (GPS) circuit 504. The GPS circuit 504 may be capable of receiving GPS information. The processor 502 may be capable of determining the GPS coordinates (e.g., latitude and longitude) of the computing device 500 based on the GPS information received via the GPS circuit.

[0105] The computing device 500 may include a visual indicator, such as one or more light-emitting diodes (LEDs) 512. In some embodiments, one or more LEDs 512 are illuminated or flashed to provide a notification, alert, or communicate other information to the user (e.g., low battery or turning on of the device).

[0106] FIG. 6 is a block diagram of an example continuous monitoring device 600. In some embodiments, the continuous monitoring device 600 is a CGM or FGM, for example. The continuous monitoring device 600 may include a subcutaneous sensor 626 that is used to sense and monitor the amount of glucose in interstitial fluid of the user. Data is transmitted from the sensor 626 to a transmitting device 604. When the continuous monitoring device 600 is a CGM, the transmitting device 604 is located directly over the sensor 626 and wirelessly powers the data transfer from the sensor 626 via power supply 620. When the continuous monitoring device 600 is an FGM, the transmitting device 604 is a mobile device or other reader device that instantaneously receives the information from the sensor 626 when the device is within the RF range of the sensor 626.Matter No. P39495 -WO

[0107] The transmitting device 604 receives data communications from the sensor 626 via a communication circuit 618. The communication circuit 618 may be in electrical communication with a processor 602. The processor 602 may include one or more circuits, such as general-purpose processors, special purpose processors, conventional processors, digital signal processors (DSPs), microprocessors, integrated circuits, a programmable logic device (PLD), application specific integrated circuits (ASICs), or the like. The processor 602 may perform signal coding, data processing, power control, input / output processing, or any other functionality that enables the transmitting device 604 to perform as described herein.

[0108] The transmitting device 604 may include another communication circuit 616 for communicating with other devices. The processor 602 may be in electrical communication with the communication circuit 616 for sending or receiving information. The communication circuits 616, 618 are capable of performing wired or wireless communications. For example, the communication circuits 616, 618 may include one or more radio frequency (RF) transceivers for transmitting and receiving RF signals (e g., BLUETOOTH®, BLE, near field communication (NFC), WIFI®, WLMAX®, cellular, or other RF signals) via an antenna, or other communications module capable of performing wireless communications. The communication circuits 616, 618 may communicate using the same RF protocol or a different RF protocol.

[0109] The processor 602 may store information in or retrieve information from the memory 612. The memory 612 may include a non-removable memory or a removable memory. The non-removable memory may include random-access memory (RAM), read-only memory (ROM), a hard disk, or any other type of non-removable memory storage. The removable memory may include a subscriber identity module (SIM) card, a memory stick, a memory card (e.g., a digital camera memory card), or any other type of removable memory. For example, the memory 612 may include computer-readable or machine-readable instructions that may be executed by the processor 602 for performing one or more methods, processes, or procedures, or portions thereof, as described herein. The processor 602 may access the memory 612 for executable instructions or other information that is used by the transmitting device 604. The processor 602 is in electrical communication with one or more input keys 624 for providing input to the processor 602.Matter No. P39495 -WO

[0110] The processor 602 may be in electrical communication with or control a speaker 614. The speaker 614 may provide an audible sound e.g., tone, beep, or buzz) in response to a triggering event detected by the processor 602.[0U1] The continuous monitoring device 600 may include an electric motor 610 that is in electrical communication with or controlled by the processor 602. The electric motor 610 may rotate and causes the continuous monitoring device 600 to vibrate (e.g., to indicate a notification) or provide haptic feedback in response to a triggering event detected by the processor 602. The electric motor 610 may provide an alert to supplement the audible alarm or replace the audible alarm provided by the speaker 614.

[0112] FIG. 7 is a block diagram of an example blood glucose meter (BGM) device 700. As shown in FIG. 7, the BGM device 700 may include a processor 702 for controlling the functionality of the BGM device 700. The processor 702 may include one or more circuits, such as general-purpose processors, special purpose processors, conventional processors, digital signal processors (DSPs), microprocessors, integrated circuits, a programmable logic device (PLD), application specific integrated circuits (ASICs), or the like. The processor 702 may perform signal coding, data processing, power control, image processing, input / output processing, and / or any other functionality that enables the BGM device 700 to perform as described herein.

[0113] The processor 702 may store information in or retrieve information from the memory 716. The memory 716 may include a non-removable memory or a removable memory. The non-removable memory may include random-access memory (RAM), read-only memory (ROM), a hard disk, and / or any other type of non-removable memory storage. The removable memory may include a subscriber identity module (SIM) card, a memory stick, a memory card (e.g., a digital camera memory card), and / or any other type of removable memory. The memory 716 may include computer-readable or machine-readable instructions that may be executed by the processor 702 for performing one or more methods, processes, or procedures, or portions thereof, as described herein. The processor 702 may access the memory 716 for executable instructions or other information that is used by the BGM device 700.

[0114] The BGM device 700 may include one or more communication circuits 718. The processor 702 may be in electrical communication with the communication circuit 718 for sending or receiving information. The communication circuit 718 may be capable of performing wired and / or wireless communications. For example, the communication circuit 718 may includeMatter No. P39495 -WO one or more radio frequency (RF) transceivers for transmitting and receiving RF signals (e.g., BLUETOOTH®, BLE, near field communication (NFC), WIFI®, WI-MAX®, cellular, or other RF signals) via an antenna, or other communications module capable of performing wireless communications. In some embodiments, one or more communication circuits 718 may be capable of performing infrared (IR) communications.

[0115] The processor 702 may be in electrical communication with a keypad 724 for providing input to the processor 702. The keypad 724 may include one or more keys for receiving input from a user. The keypad 724 may include hard or soft keys for which the function of the keys changes as a user performs selections.

[0116] Other input into the processor 702 may be provided by the BGM sensor module 704. The BGM sensor module 704 may include a blood glucose measuring engine that may analyze blood samples provided by a patient on a blood glucose measurement strip and measure the amount of blood glucose in the samples.

[0117] The processor 702 may be in electrical communication with or generate images on a display 706 for providing information to a user. The communication between the display 706 and the processor 702 may be a two-way communication, as the display 706 may include a touch screen module capable of receiving information from a user and providing such information to the processor 702. For example, the display 706 may provide soft buttons for selection by a user that are recognized by the touch screen module and provided to the processor 702 as input.

[0118] The processor 702 may be in electrical communication with or control a speaker 708. The speaker 708 may provide an audible sound (e.g., tone, beep, or buzz) in response to a triggering event detected by the processor 702.

[0119] The BGM device 700 may include an electric motor 710 that is in electrical communication with or controlled by the processor 702. The electric motor 710 may rotate and cause the BGM device 700 to vibrate (e.g., to indicate an notification) or provide haptic feedback in response to a triggering event detected by the processor 702. The electric motor 710 may provide a notification or an alert to supplement the audible alarm or replace the audible alarm provided by the speaker 708.Matter No. P39495 -WO

[0120] The processor 702 may be in electrical communication with or receive information from a microphone 722. For example, the processor 702 may receive audio signals via the microphone 722.

[0121] The BGM device 700 may include a visual indicator, such as one or more one or more light-emitting diodes (LEDs) 728. In some embodiments, one or more LEDs 728 are illuminated or flashed to provide a notification, an alert, or communicate other information to the user (e.g., low battery or turning on of the device).

[0122] Although features, elements, and functions are described above in particular combinations, a feature, element, or function is used alone or in any combination with the other features, elements, or functions. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements may be subsequently made that are also intended to be encompassed by the following claims.

[0123] The methods described herein are implemented in a computer program, software, or firmware incorporated in a computer-readable medium for execution by a computer or processor. Examples of computer-readable media include electronic signals (transmitted over wired or wireless connections) and computer-readable storage media. Examples of computer- readable storage media include, but are not limited to, a read only memory (ROM), a randomaccess memory (RAM), removable disks, and optical media such as CD-ROM disks, and digital versatile disks (DVDs).

Claims

Matter No. P39495 -WOCLAIMSWhat is claimed is:

1. A method comprising: establishing, at a central medical monitoring device, a wireless communication session with a peripheral medical monitoring device, wherein during or after the establishment of the wireless communication session the central medical monitoring device receives first information related to at least one calibration value associated with the peripheral medical monitoring device; transmitting, from the central medical monitoring device, a polling message to the peripheral medical monitoring device, wherein the polling message comprises a request for updated information related to the at least one calibration value associated with the peripheral medical monitoring device; receiving, in response to the polling message, second information related to the at least one calibration value associated with the peripheral medical monitoring device; comparing the first information related to the at least one calibration value with the second information related to the at least one calibration value; detecting that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value; and based on the detected unacceptable difference in the first information and the second information related to the at least one calibration value associated with the peripheral medical monitoring device, providing a notification via a user interface.

2. The method of claim 1, wherein the polling message is transmitted periodically or a period of time after a scheduled update at the peripheral medical monitoring device.

3. The method of claim 1, wherein the notification is configured to provide the first information related to the at least one calibration value and the second information related to at least one calibration value indicating the unacceptable difference, and wherein the notification provides an option for user input to indicate whether the detected difference is acceptable forMatter No. P39495 -WO maintaining the wireless communication session or future wireless communication sessions with the peripheral medical monitoring device.

4. The method of claim 3, wherein the notification comprises an option to terminate the wireless communication session, the method further comprising: receiving an indication via user input to terminate the wireless communication session; and terminating the wireless communication session with the peripheral medical monitoring device.

5. The method of claim 4, further comprising: in response to receiving the indication to terminate the wireless communication session, transmitting a message to the peripheral medical monitoring device to cause the peripheral medical monitoring device to enter an end of life state.

6. The method of claim 1, wherein detecting that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value further comprises detecting that the at least one calibration value has changed.

7. The method of claim 6, wherein detecting that the change in the at least one calibration value is unacceptably different comprises detecting that the change was not caused by a communication from the central medical monitoring device.

8. The method of claim 1, wherein detecting that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value further comprises detecting that a calibration data record number has changed, wherein the calibration data record number comprises a unique identifier indicating a value for the latest calibration record updated at the peripheral medical monitoring device.Matter No. P39495 -WO9. The method of claim 1, wherein the at least one calibration value comprises at least one communication parameter, sensor measurement interval for measuring analyte values, or analyte value.

10. The method of claim 1, wherein the peripheral medical monitoring device is a continuous glucose monitoring device, and wherein the at least one calibration value comprises a blood glucose value configured to calibrate at least one sensor on the continuous glucose monitoring device.

11. At least one computer-readable storage medium comprising computer-executable instructions stored thereon that are configured, when executed by at least one processor, cause the at least one processor to: establish a wireless communication session with a peripheral medical monitoring device, wherein the instructions are configured to cause the at least one processor to receive, during or after the establishment of the wireless communication session, first information related to at least one calibration value associated with the peripheral medical monitoring device; transmit a polling message to the peripheral medical monitoring device, wherein the polling message comprises a request for updated information related to the at least one calibration value associated with the peripheral medical monitoring device; receive, in response to the polling message, second information related to the at least one calibration value associated with the peripheral medical monitoring device; compare the first information related to the at least one calibration value with the second information related to the at least one calibration value; detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value; and based on the detected unacceptable difference in the first information and the second information related to the at least one calibration value associated with the peripheral medical monitoring device, provide a notification via a user interface.Matter No. P39495 -WO12. The at least one computer-readable storage medium of claim 11 , wherein the instructions are configured to cause the at least one processor to transmit the polling message periodically or a period of time after a scheduled update at the peripheral medical monitoring device.

13. The at least one computer-readable storage medium of claim 11, wherein the notification is configured to provide the first information related to the at least one calibration value and the second information related to at least one calibration value indicating the unacceptable difference, and wherein the notification provides an option for user input to indicate whether the detected difference is acceptable for maintaining the wireless communication session or future wireless communication sessions with the peripheral medical monitoring device.

14. The at least one computer-readable storage medium of claim 13, wherein the notification comprises an option to terminate the wireless communication session, the instructions being further configured to cause the at least one processor to: receive an indication via user input to terminate the wireless communication session; and terminate the wireless communication session with the peripheral medical monitoring device.

15. The at least one computer-readable storage medium of claim 14, the instructions being further configured to cause the at least one processor to: in response to receiving the indication to terminate the wireless communication session, transmit a message to the peripheral medical monitoring device to cause the peripheral medical monitoring device to enter an end of life state.

16. The at least one computer-readable storage medium of claim 11, wherein the instructions being configured to cause the at least one processor to detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value further comprises the instructions being configured to cause the at least one processor to detect that the at least one calibration value has changed.Matter No. P39495 -WO17. The at least one computer-readable storage medium of claim 15, wherein the instructions being configured to cause the at least one processor to detect that the change in the at least one calibration value is unacceptably different comprises the instructions being configured to cause the at least one processor to detect that the change was not caused by a communication from a central medical monitoring device.

18. The at least one computer-readable storage medium of claim 11, the instructions being configured to cause the at least one processor to detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value further comprises the instructions being configured to cause the at least one processor to detect that a calibration data record number has changed, wherein the calibration data record number comprises a unique identifier indicating a value for the latest calibration record updated at the peripheral medical monitoring device.

19. The at least one computer-readable storage medium of claim 11, wherein the at least one calibration value comprises at least one communication parameter, sensor measurement interval for measuring analyte values, or analyte value.

20. The at least one computer-readable storage medium of claim 11, wherein the peripheral medical monitoring device is a continuous glucose monitoring device, and wherein the at least one calibration value comprises a blood glucose value configured to calibrate at least one sensor on the continuous glucose monitoring device.

21. An apparatus comprising: a transceiver; and at least one processor configured to: establish, via the transceiver, a wireless communication session with a peripheral medical monitoring device, wherein the instructions are configured to cause the at least one processor to receive, during or after the establishment of the wireless communication session, first information related to at least one calibration value associated with the peripheral medical monitoring device;Matter No. P39495 -WO transmit a polling message to the peripheral medical monitoring device, wherein the polling message comprises a request for updated information related to the at least one calibration value associated with the peripheral medical monitoring device; receive, in response to the polling message, second information related to the at least one calibration value associated with the peripheral medical monitoring device; compare the first information related to the at least one calibration value with the second information related to the at least one calibration value; detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value; and based on the detected unacceptable difference in the first information and the second information related to the at least one calibration value associated with the peripheral medical monitoring device, provide a notification via a user interface.

22. The apparatus of claim 21, wherein the at least one processor is configured to transmit, via the transceiver, the polling message periodically or a period of time after a scheduled update at the peripheral medical monitoring device.

23. The apparatus of claim 21, wherein the notification is configured to provide the first information related to the at least one calibration value and the second information related to at least one calibration value indicating the unacceptable difference, and wherein the notification provides an option for user input to indicate whether the detected difference is acceptable for maintaining the wireless communication session or future wireless communication sessions with the peripheral medical monitoring device.

24. The apparatus of claim 23, wherein the notification is configured to comprise an option to terminate the wireless communication session, wherein the at least one processor is configured to: receive an indication via user input to terminate the wireless communication session; and terminate the wireless communication session with the peripheral medical monitoring device.Matter No. P39495 -WO25. The apparatus of claim 24, wherein the at least one processor is configured to: in response to receiving the indication to terminate the wireless communication session, transmit, via the transceiver, a message to the peripheral medical monitoring device to cause the peripheral medical monitoring device to enter an end of life state.

26. The apparatus of claim 21, wherein the at least one processor being configured to detect that the change in the at least one calibration value is unacceptably different further comprises the at least one processor being configured to detect that the at least one calibration value has changed.

27. The apparatus of claim 26, wherein the at least one processor being configured to detect that the change in the at least one calibration value is unacceptably different comprises the at least one processor being configured to detect that the change was not caused by a communication from the central medical monitoring device.

28. The method of claim 21, wherein the at least one processor being configured to detect that the first information related to the at least one calibration value is unacceptably different from the second information related to the at least one calibration value further comprises the at least one processor being configured to detect that a calibration data record number has changed, wherein the calibration data record number comprises a unique identifier indicating a value for the latest calibration record updated at the peripheral medical monitoring device.

29. The apparatus of claim 21, wherein the at least one calibration value comprises at least one communication parameter, sensor measurement interval for measuring analyte values, or analyte value.

30. The apparatus of claim 21, wherein the peripheral medical monitoring device is a continuous glucose monitoring device, and wherein the at least one calibration value comprises a blood glucose value configured to calibrate at least one sensor on the continuous glucose monitoring device.

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