Systems and methods for wireless communication of analyte data

Abstract

Systems, methods, devices, and apparatuses for wireless communication of analyte data are provided. In some embodiments, methods and calibration stations for calibrating continuous analyte sensor systems are provided. Methods and test systems for testing continuous analyte sensor systems are provided. Continuous analyte sensor systems, display devices, and peripheral devices configured for wireless communication of analyte, connectivity, alert, and / or alarm data, and associated methods are provided.

Description

[0001] Related Applications Incorporated by Reference

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 853,957, filed May 29, 2019. The foregoing application is incorporated herein by reference in its entirety and is expressly made a part of this specification. Technical Field

[0003] The present disclosure generally relates to continuous monitoring of analyte values ​​received from an analyte sensor system. More particularly, the present disclosure relates to systems, methods, devices, and apparatus for wireless communication of analyte data. Background Art

[0004] Diabetes mellitus is a condition in which the pancreas fails to produce enough insulin (Type 1 or insulin-dependent) and / or is insulin-ineffective (Type 2 or non-insulin-dependent). In the diabetic state, the patient suffers from high blood sugar levels, which can cause a series of physiological disturbances associated with the degeneration of small blood vessels (kidney failure, skin ulcers, or bleeding into the vitreous humor of the eye). A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agents followed by heavy exercise or inadequate food intake.

[0005] Conventionally, people with diabetes wear self-monitoring blood glucose (SMBG) monitors, which often require an uncomfortable finger-prick procedure. Due to the lack of comfort and convenience, diabetics will typically only measure their glucose levels two to four times a day. Unfortunately, these intervals are spaced so far apart that diabetics may be alerted to hyperglycemic or hypoglycemic conditions too late, sometimes with dangerous side effects. In fact, due to the limitations of conventional methods, diabetics are not only unlikely to obtain SMBG values ​​in a timely manner, but also will not know whether their blood glucose values ​​are rising (higher) or falling (lower).

[0006] Therefore, various non-invasive, transdermal (e.g., percutaneous) and / or implantable electrochemical sensors are being developed for continuously detecting and / or quantifying blood glucose levels. These devices typically transmit raw or minimally processed data for subsequent analysis at a remote device that may include a display. The transmission to a wireless display device may be wireless.

[0007] With respect to wireless transmission of glucose and other analyte data collected using implanted sensors, the battery life of the transmitters used in conjunction with the sensors is often an issue. To conserve battery life or improve the efficiency associated with the transmission of glucose and other analyte data, transmission may, for example, need to be intermittent. However, intermittent transmission of monitored data can introduce reliability issues. In some cases, reliability is sacrificed due to battery life in conventional sensor systems. Summary of the Invention

[0008] A method for calibrating a continuous analyte sensor system is provided. The method includes scanning an identification tag encoding information identifying an analyte sensor system. The method includes retrieving calibration data for a sensor of the analyte sensor system based at least in part on the information identifying the analyte sensor system. The method includes positioning the analyte sensor system sufficiently close to a calibration station for a short-range communication controller of the calibration station to cause a short-range antenna of the analyte sensor system to transition at least a portion of the analyte sensor system to an operational mode. The method includes transmitting at least the sensor calibration data from the calibration station to the continuous analyte sensor system via short-range communication in response to a command, thereby facilitating calibration of the continuous analyte sensor system.

[0009] In some embodiments, the method includes causing the analyte sensor system to return to sleep mode after storing the sensor calibration data in a storage device of the analyte sensor system. In some embodiments, the identification tag is a 2-dimensional (2D) barcode that encodes at least the batch number of the applicator and the serial number of the sensor of the analyte sensor system in a single string. In some embodiments, the sensor calibration data includes an initial slope determined for the sensor, a final slope determined for the sensor, and an indication of the date on which the initial slope and the final slope are determined. In some embodiments, the command includes a 0x7a near field communication command configured to transmit each of the batch number of the applicator, the serial number of the sensor, the initial slope, the final slope, and the indication of the date in a single message. In some embodiments, the sensor calibration data is retrieved from a database, wherein the sensor calibration data is indexed according to the batch number of the applicator and the serial number of the sensor.

[0010] A calibration station configured for calibrating a continuous analyte sensor system is provided. The calibration station includes an identification tag scanner configured to scan an identification tag encoding information identifying the analyte sensor system. The calibration station includes a processor configured to retrieve calibration data for a sensor of the analyte sensor system based at least in part on the information identifying the analyte sensor system. The calibration station includes a short-range communication controller configured to cause a short-range antenna of the analyte sensor system to transition at least a portion of the analyte sensor system to an operational mode when the analyte sensor system is positioned sufficiently close to the calibration station, and to transmit at least sensor calibration data to the analyte sensor system via short-range communication in response to a command, thereby facilitating calibration of the analyte sensor system.

[0011] In some embodiments, the short-range communication controller is further configured to send at least one signal to the analyte sensor system, the at least one signal causing the analyte sensor system to return to sleep mode after the sensor calibration data is stored in the storage device of the analyte sensor system. In some embodiments, the identification tag is a 2-dimensional (2D) barcode that encodes at least the batch number of the applicator and the serial number of the sensor of the analyte sensor system in a single string. In some embodiments, the sensor calibration data includes an initial slope determined for the sensor, a final slope determined for the sensor, and an indication of the date on which the initial slope and the final slope are determined. In some embodiments, the command includes a 0x7a NFC command configured to transmit each of the batch number of the applicator, the serial number of the sensor, the initial slope, the final slope, and the indication of the date in a single message. In some embodiments, the sensor calibration data is retrieved from a database, wherein the sensor calibration data is indexed according to the batch number of the applicator and the serial number of the sensor.

[0012] A method for testing a continuous analyte sensor system is provided. The method includes waking at least a portion of the analyte sensor system from a sleep mode. The method includes receiving, using a first transceiver chip, a data packet transmitted from a second transceiver chip, the data packet including a request for the analyte sensor system to perform one or more tasks designed to verify the intended operation of the analyte sensor system. The method includes processing the request. The method includes transmitting, using the first transceiver chip, a response returning a result of the request to the second transceiver chip. The method includes receiving, using the first transceiver chip, a message transmitted from the second transceiver chip, the message including an instruction to cause one or more components of the analyte sensor system to return to a sleep mode.

[0013] In some embodiments, the first transceiver chip is embedded in the analyte sensor system and the second transceiver chip is embedded in a factory test bench configured to test the operation of the analyte sensor system. In some embodiments, each of the request, the response, and the message is communicated on a channel preprogrammed into each of the first and second transceiver chips. In some embodiments, the request, the response, and the message are communicated without any prior connection or authentication process occurring between the first and second transceiver chips.

[0014] A method for testing a continuous analyte sensor system is provided. The method includes transmitting, using a second transceiver chip, a data packet to a first transceiver chip, the data packet including a request for the analyte sensor system to perform one or more tasks designed to verify the intended operation of the analyte sensor system. The method includes receiving, using the second transceiver chip, a response from the first transceiver chip conveying the result of the request. The method includes transmitting, using the second transceiver chip, a message to the first transceiver chip, the message including an instruction to restore one or more components of the analyte sensor system to a sleep mode.

[0015] In some embodiments, the first transceiver chip is embedded in the analyte sensor system and the second transceiver chip is embedded in a factory test bench configured to test the operation of the analyte sensor system. In some embodiments, each of the request, the response, and the message is communicated on a channel preprogrammed into each of the first and second transceiver chips. In some embodiments, the request, the response, and the message are communicated without any prior connection or authentication process occurring between the first and second transceiver chips.

[0016] A test system for testing a continuous analyte sensor system is provided. The test system includes an analyte sensor system including a first transceiver chip. The test system includes a factory test bench including a second transceiver chip. The analyte sensor system is configured to wake up at least a portion of the analyte sensor system from a sleep mode. The analyte sensor system is configured to receive, using the first transceiver chip, a data packet transmitted from the second transceiver chip, the data packet including a request for the analyte sensor system to perform one or more tasks designed to verify the intended operation of the analyte sensor system. The analyte sensor system is configured to process the request. The analyte sensor system is configured to transmit, using the first transceiver chip, a response returning the result of the request to the second transceiver chip. The analyte sensor system is configured to receive, using the first transceiver chip, a message transmitted from the second transceiver chip, the message including an instruction to restore one or more components of the analyte sensor system to a sleep mode. The factory test bench is configured to transmit, using the second transceiver chip, the data packet to the first transceiver chip. The factory test bench is configured to receive, using the second transceiver chip, a response from the first transceiver chip. The factory test bench is configured to transmit the message to the first transceiver chip using the second transceiver chip.

[0017] In some embodiments, each of the first transceiver chip and the second transceiver chip is preprogrammed to communicate each of the request, the response, and the message on a predetermined channel. In some embodiments, the first transceiver chip and the second transceiver chip communicate the request, the response, and the message without any prior connection or authentication process.

[0018] A continuous analyte sensor system configured for wireless communication of analyte data is provided. The system includes a sensor comprising a plurality of terminals, the sensor configured to generate a current through the plurality of terminals based on an analyte concentration in a subject. The system includes a short-circuit element configured to electrically short-circuit the plurality of terminals when the sensor is disposed in a package. The system includes a sensor electronics module configured to periodically wake up, measure the current through the plurality of terminals, determine if the measured current is below a predetermined threshold, and generate a signal configured to wake up at least one additional component of the analyte sensor system based on the determination.

[0019] In some embodiments, the shorting element comprises at least one of a conductive wire, a conductive sheet, or a conductive foam comprising at least a portion of the package.

[0020] A method for wireless communication of continuous analyte data is provided. The method includes generating a pairing key. The method includes initializing a transceiver radio having a first peripheral instance and a second peripheral instance. The method includes generating and transmitting a first advertisement message associated with the first peripheral instance. The method includes generating and transmitting a second advertisement message associated with the second peripheral instance and including the pairing key. The method includes determining that a pairing request corresponding to the first peripheral instance has been received. The method includes determining that the pairing request includes a pairing key. The method includes generating and transmitting a pairing request acceptance message based on the pairing request including the pairing key.

[0021] In some embodiments, the method includes encrypting the pairing key, wherein the second advertisement message includes the encrypted pairing key and the pairing request includes a decrypted version of the encrypted pairing key. In some embodiments, the first advertisement message includes one or more of an indication of the manufacturer of the analyte sensor system, an address identifying the analyte sensor system, an indication that the first peripheral instance is connectable, and an indication of out-of-band authentication. In some embodiments, the second advertisement message includes one or more of an indication of the manufacturer of the analyte sensor system, an address identifying the analyte sensor system, an indication that the second peripheral instance is not connectable, and a payload including the pairing key. In some embodiments, the first peripheral instance and the second peripheral instance are both associated with the same analyte sensor system. In some embodiments, the first advertisement message and the second advertisement message are transmitted during the same pairing session.

[0022] A continuous analyte sensor system is provided. The system includes an analyte sensor. The system includes a transceiver radio. The system includes one or more processors configured to generate a pairing key. The one or more processors are configured to initialize the transceiver radio in the presence of a first peripheral instance and a second peripheral instance. The one or more processors are configured to generate and transmit, via the transceiver radio, a first advertisement message associated with the first peripheral instance. The one or more processors are configured to generate and transmit, via the transceiver radio, a second advertisement message associated with the second peripheral instance and including the pairing key. The one or more processors are configured to determine that a pairing request corresponding to the first peripheral instance has been received, via the transceiver radio. The one or more processors are configured to determine that the pairing request includes the pairing key. The one or more processors are configured to generate and transmit, via the transceiver radio, a pairing request acceptance message based on the pairing request including the pairing key.

[0023] A method for wireless communication of continuous analyte data is provided. The method includes monitoring one or more communication channels for one or more advertisement messages indicating that an analyte sensor system has initiated a pairing operation with a peripheral device. The method includes determining that a first advertisement message has been received from the analyte sensor system, the first advertisement message including an indication of a predetermined manufacturer of the analyte sensor system and an address identifying the analyte sensor system. The method includes determining that a second advertisement message has been received from the analyte sensor system including the indication of the predetermined manufacturer, the address identifying the analyte sensor system, and a pairing key. The method includes extracting the pairing key from the second advertisement message. The method includes generating and transmitting a pairing request message including the extracted pairing key. The method includes receiving a pairing request acceptance message based on the pairing request message.

[0024] In some embodiments, the pairing key within the second advertisement message is encrypted and the pairing request includes a decrypted version of the encrypted pairing key, the method comprising decrypting the pairing key to obtain the decrypted version of the encrypted pairing key. In some embodiments, the first advertisement message further includes one or more of an indication that the first peripheral instance of the analyte sensor system is connectable and an indication of out-of-band authentication. In some embodiments, the second advertisement message further includes an indication that the second peripheral instance of the analyte sensor system is not connectable, the pairing key being disposed in a payload of the second advertisement message. In some embodiments, the first advertisement message and the second advertisement message are received during the same pairing session.

[0025] A peripheral device is provided. The device includes a display, a transceiver radio, and one or more processors configured to monitor one or more communication channels for one or more advertisement messages instructing an analyte sensor system to initiate a pairing operation with the peripheral device. The one or more processors are configured to determine that a first advertisement message has been received from the analyte sensor system, the first advertisement message including an indication of a predetermined manufacturer of the analyte sensor system and an address identifying the analyte sensor system. The one or more processors are configured to determine that a second advertisement message including an indication of a predetermined manufacturer, an address identifying the analyte sensor system, and a pairing key has been received from the analyte sensor system. The one or more processors are configured to extract the pairing key from the second advertisement message. The one or more processors are configured to generate and transmit a pairing request message including the extracted pairing key via the transceiver radio. The one or more processors are configured to receive a pairing request acceptance message based on the pairing request message via the transceiver radio.

[0026] A method for wireless communication of continuous analyte data is provided. The method includes transmitting an advertisement message for establishing a communication channel. The method includes receiving, via the communication channel, a random number encrypted using a first public key. The method includes decrypting the encrypted random number using a first private key associated with the first public key. The method includes re-encrypting the decrypted random number using a second public key. The method includes transmitting the re-encrypted random number via the communication channel. The method includes transmitting sensor data encrypted using the second public key.

[0027] In some embodiments, the first private key is one of a first plurality of unique private keys configured to decrypt data previously encrypted using the first public key, and the second private key is one of a second plurality of unique private keys configured to decrypt data previously encrypted using the second public key. In some embodiments, the first public key and the second public key are publicly available keys, and the first private key and the second private key are not publicly available keys. In some embodiments, the method includes receiving at least one of the first private key and the second public key from a server.

[0028] A continuous analyte sensor system is provided. The system includes an analyte sensor, a transceiver radio, and one or more processors, the one or more processors being configured to transmit an advertisement message for establishing a communication channel. The one or more processors are configured to receive a random number encrypted using a first public key via the communication channel. The one or more processors are configured to decrypt the encrypted random number using a first private key associated with the first public key. The one or more processors are configured to re-encrypt the random number using a second public key. The one or more processors are configured to transmit the re-encrypted random number via the communication channel. The one or more processors are configured to transmit sensor data encrypted using the second public key.

[0029] A method for wireless communication of continuous analyte data is provided. The method includes receiving an advertisement message for establishing a communication channel. The method includes generating a random number. The method includes encrypting the random number using a first public key. The method includes transmitting the encrypted random number using a communication channel. The method includes receiving the random number re-encrypted using a second public key. The method includes decrypting the re-encrypted random number using a second private key. The method includes comparing the decrypted random number with an initially generated random number. The method includes authenticating a communication session based on a determination that the decrypted random number and the initially generated random number are identical. The method includes receiving sensor data encrypted using a second public key.

[0030] In some embodiments, the first private key is one of a first plurality of unique private keys configured to decrypt data previously encrypted using the first public key, and the second private key is one of a second plurality of unique private keys configured to decrypt data previously encrypted using the second public key. In some embodiments, the first public key and the second public key are publicly available keys, and the first private key and the second private key are not publicly available keys.

[0031] A peripheral device is provided. The device includes a display, a transceiver radio, and one or more processors configured to receive an advertisement message for establishing a communication channel. The one or more processors are configured to generate a random number. The one or more processors are configured to encrypt the random number using a first public key. The one or more processors are configured to transmit the encrypted random number using a communication channel. The one or more processors are configured to receive the random number re-encrypted using a second public key. The one or more processors are configured to decrypt the re-encrypted random number using a second private key. The one or more processors are configured to compare the decrypted random number with the originally generated random number. The one or more processors are configured to authenticate the communication session based on a determination that the decrypted random number is the same as the originally generated random number. The one or more processors are configured to receive sensor data encrypted using the second public key.

[0032] A method for wireless communication of continuous analyte data is provided. The method includes sequentially coupling each of a plurality of filter circuits to an antenna, each of the filter circuits being configured to transmit a respective signal received by the antenna in a respective frequency channel. The method includes measuring a respective amount of power received on each respective frequency channel when the analyte sensor system is not communicating wirelessly. The method includes comparing the respective measured amounts of power received on each respective frequency channel. The method includes selecting the respective frequency channel with the lowest measured amount of power for the antenna to transmit one or more signals.

[0033] In some embodiments, each of the plurality of filtering circuits comprises a bandpass filter. In some embodiments, sequentially coupling each of the plurality of filtering circuits to the antenna comprises sequentially closing a respective switch that couples the respective one of the filtering circuits to the antenna. In some embodiments, selecting the respective frequency channel having the lowest measured amount of power for transmission of one or more signals by the antenna comprises sending at least one signal that causes a frequency selection circuit of a transmitter to select the respective frequency channel.

[0034] A continuous analyte sensor system is provided. The system includes an antenna and a plurality of filter circuits that are coupleable to the antenna, each of the filter circuits being configured to transmit a respective signal received by the antenna in a respective frequency channel. The system includes one or more processors configured to sequentially couple each of the plurality of filter circuits to the antenna. The one or more processors are configured to measure a respective amount of power received on each respective frequency channel when the analyte sensor system is not communicating wirelessly. The one or more processors are configured to compare the measured respective amounts of power received on each respective frequency channel. The one or more processors are configured to select the respective frequency channel with the lowest measured amount of power for the antenna to transmit one or more signals.

[0035] A method for wirelessly communicating analyte data via a continuous analyte sensor system is provided. The method includes preconfiguring the analyte sensor system to periodically wake up from a low-power passive monitoring mode according to a predetermined interval for waking up the analyte sensor system. The method includes, while the analyte sensor system is in the low-power passive monitoring mode, receiving a wake-up signal from a display device before the predetermined interval expires, thereby causing the analyte sensor system to wake up before the predetermined interval expires. The method includes transmitting an advertising message in response to the wake-up signal. The method includes receiving a pairing request from the display device. The method includes transmitting a pairing request acceptance message to the display device. The method includes transmitting sensor data to the display device.

[0036] In some embodiments, transmitting the sensor data to the display device occurs before a predetermined interval for waking up the analyte sensor system has expired. In some embodiments, the wake-up signal has a predetermined pattern, magnitude, or modulation configured to cause the analyte sensor system to wake up from the low-power passive monitoring mode.

[0037] A continuous analyte sensor system is provided. The system includes an analyte sensor and a transceiver radio. The system includes one or more processors configured to preconfigure the analyte sensor system to periodically wake up from a low-power passive monitoring mode according to a predetermined interval for waking up the analyte sensor system. The one or more processors are configured to receive a wake-up signal from a display device before the predetermined interval expires while the analyte sensor system is in the low-power passive monitoring mode, thereby causing the analyte sensor system to wake up before the predetermined interval expires. The one or more processors are configured to cause an advertising message to be transmitted in response to the wake-up signal. The one or more processors are configured to receive a pairing request from the display device. The one or more processors are configured to cause a pairing request acceptance message to be transmitted to the display device and cause sensor data to be transmitted to the display device.

[0038] A method for wirelessly communicating continuous analyte data via a display device is provided. The method includes transmitting a wake-up signal to an analyte sensor system in a low-power passive monitoring mode. The method includes receiving an advertisement message in response to the wake-up signal. The method includes transmitting a pairing request to the analyte sensor system. The method includes receiving a pairing request acceptance message in response to the pairing request. The method includes receiving sensor data from the analyte sensor system.

[0039] In some embodiments, receiving sensor data from the analyte sensor system occurs before a predetermined interval for waking up the analyte sensor system has expired. In some embodiments, the wake-up signal has a predetermined pattern, magnitude, or modulation configured to cause the analyte sensor system to wake up from the low-power passive monitoring mode.

[0040] A display device is provided. The device includes a display and a transceiver radio. The device includes one or more processors configured to transmit a wake-up signal to an analyte sensor system in a low-power passive monitoring mode. The one or more processors are configured to receive an advertisement message in response to the wake-up signal. The one or more processors are configured to transmit a pairing request to the analyte sensor system. The one or more processors are configured to receive a pairing request acceptance message in response to the pairing request. The one or more processors are configured to receive sensor data from the analyte sensor system.

[0041] A method for wireless communication of continuous analyte data is provided. The method includes physically moving a display device supporting a short-range wireless communication protocol into close proximity to a sticker physically disposed on an analyte sensor system or one of the packages for the analyte sensor system, the sticker including a short-range wireless communication tag preprogrammed with a pairing key, such that the display device can retrieve the pairing key from the tag via the short-range wireless communication protocol. The method includes pairing the display device with the analyte sensor system using the retrieved pairing key for a wireless protocol different from the short-range wireless communication protocol.

[0042] In some embodiments, the pairing key is associated with the analyte sensor system.In some embodiments, physically moving the NFC enabled display device sufficiently close to the sticker comprises touching the display device to rest on the sticker.

[0043] A display device is provided. The device includes a display, a radio supporting a short-range wireless communication protocol, and a radio enabling wireless communication using a wireless protocol different from the short-range wireless communication protocol. The device includes one or more processors configured to retrieve a pairing key from a short-range wireless communication tag embedded in a sticker based on physically moving the display device close enough to the sticker, the tag being pre-programmed with the pairing key and associated with an analyte sensor system. The one or more processors are configured to perform a pairing operation with the analyte sensor system using the retrieved pairing key for the wireless communication protocol different from the short-range wireless communication protocol.

[0044] In some embodiments, physically moving the display device close enough to the sticker includes touching the display device to rest on the sticker.

[0045] A method for wireless communication of continuous analyte data is provided. The method includes detecting an advertisement message from an analyte sensor system. The method includes attempting to establish a connection with the analyte sensor system in response to the advertisement message. The method includes determining that the attempt to establish a connection with the analyte sensor system has failed. The method includes generating an alert indicating that the analyte sensor system has been detected but the attempt to establish a connection with the analyte sensor system has failed.

[0046] In some embodiments, the alert includes at least one proposed user intervention to improve the probability of establishing a connection with the analyte sensor system in a subsequent connection attempt.

[0047] A display device is provided. The device includes a display and a transceiver radio. The device includes one or more processors configured to detect an advertising message from an analyte sensor system. The one or more processors are configured to attempt to establish a connection with the analyte sensor system in response to the advertising message. The one or more processors are configured to determine that the attempt to establish a connection with the analyte sensor system has failed. The one or more processors are configured to generate an alert indicating that an analyte sensor system has been detected but the attempt to establish a connection with the analyte sensor system has failed.

[0048] A method for wireless communication of continuous analyte data is provided. The method includes transmitting a wake-up signal to an analyte sensor system. The method includes receiving a transmitter ID corresponding to the analyte sensor system. The method includes comparing the received transmitter ID to a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The method includes establishing a wireless connection with the analyte sensor system based on a determination that the received transmitter ID is within the range of transmitter IDs corresponding to currently deployed analyte sensor systems. The method includes receiving at least recorded analyte concentration data from the analyte sensor system. The method includes generating one or more reports based on at least the recorded analyte concentration data from the analyte sensor system.

[0049] In some embodiments, the wake-up signal is transmitted using an electromagnet.

[0050] A device is provided comprising a transceiver radio and an electromagnet. The device comprises one or more processors configured to cause the electromagnet to transmit a wake-up signal to an analyte sensor system. The one or more processors are configured to receive a transmitter ID corresponding to the analyte sensor system. The one or more processors are configured to compare the received transmitter ID with a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The one or more processors are configured to establish a wireless connection with the analyte sensor system based on a determination that the received transmitter ID is within a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The one or more processors are configured to receive at least analyte concentration data recorded by the analyte sensor system during a previous sensor session. The one or more processors are configured to generate one or more reports based on at least the recorded analyte concentration data.

[0051] A method for wireless communication of continuous analyte data is provided. The method includes receiving a wake-up signal from a healthcare provider device. The method includes transmitting a transmitter ID corresponding to an analyte sensor system. The method includes establishing a wireless connection with the healthcare provider device based on the transmitted transmitter ID being within a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The method includes transmitting at least recorded analyte concentration data to the healthcare provider device.

[0052] In some embodiments, the method includes generating analyte concentration data during a sensor session. In some embodiments, the method includes recording analyte concentration data during a sensor session. In some embodiments, the wake-up signal is received by the magnetic sensor at a time after the sensor session has ended.

[0053] A continuous analyte sensor system is provided. The system includes an analyte sensor configured to generate analyte concentration data during a sensor session. The system includes a storage device configured to record the analyte concentration data during the sensor session. The system includes a magnetic sensor configured to receive a wake-up signal from a healthcare provider device. The system includes a transceiver radio. The system includes one or more processors configured to cause the transceiver radio to transmit a transmitter ID corresponding to the analyte sensor system. The one or more processors are configured to establish a wireless connection with the healthcare provider device based on the transmitted transmitter ID being within a range of transmitter IDs corresponding to the currently deployed analyte sensor system. The one or more processors are configured to cause the transceiver radio to transmit at least the recorded analyte concentration data to the healthcare provider device.

[0054] In some embodiments, the magnetic sensor receives the wake-up signal at a time after the sensor session has ended.

[0055] A method for wireless communication of continuous analyte data is provided. The method includes periodically collecting raw data from an analyte sensor for the duration of a sensor session. The method includes storing the raw data. The method includes delaying conversion of the raw data into an estimated analyte value until at least after the sensor session has ended.

[0056] In some embodiments, a sensor session corresponds to an expected useful life of the analyte sensor system.

[0057] A continuous analyte sensor system is provided. The system includes an analyte sensor configured to periodically generate raw data for the duration of a sensor session. The system includes a storage device configured to store the raw data during the sensor session. The system includes one or more processors configured to delay conversion of the raw data into an estimated analyte value until at least after the sensor session has ended.

[0058] A method for wireless communication of continuous analyte data is provided. The method includes measuring at least one analyte concentration value by an analyte sensor system during a sensor session. The method includes transmitting the at least one analyte concentration value to a device associated with a healthcare provider using a cellular network connection.

[0059] In some embodiments, the at least one analyte concentration value is not displayed to a user of the analyte sensor system. In some embodiments, the at least one analyte concentration value is transmitted to a device associated with a healthcare provider after the sensor session has ended.

[0060] A continuous analyte sensor system is provided. The system includes an analyte sensor configured to measure at least one analyte concentration value during a sensor session. The system includes a cellular network-enabled transceiver radio. The system includes one or more processors configured to cause the cellular network-enabled transceiver radio to transmit the at least one analyte concentration value to a device associated with a healthcare provider using a cellular network connection.

[0061] A method for wireless communication of data is provided. The method includes receiving power from a first device via near-field communication by an analyte sensor system. The method includes powering at least a portion of the analyte sensor system using the received power. The method includes transmitting data from the analyte sensor system to the first device using a first communication protocol for troubleshooting a suspected failure of the analyte sensor system.

[0062] In some embodiments, the first communication protocol comprises a Bluetooth Low Energy protocol.

[0063] A continuous analyte sensor system is provided. The system includes near-field communication circuitry configured to receive power from a first device via near-field communication. The system includes a transceiver radio configured to be powered by the received power. The system includes one or more processors configured to cause the transceiver radio to transmit data to the first device using a first communication protocol for troubleshooting a suspected failure of the analyte sensor system.

[0064] A method for wireless communication of continuous analyte data is provided. The method includes positioning a display device sufficiently proximate to an analyte sensor system for a short-term wireless communication protocol controller of the display device to transmit power to the analyte sensor system using the short-term wireless communication protocol, thereby energizing at least a portion of the analyte sensor system. The method includes receiving data from the analyte sensor system via a first communication protocol. The method includes retransmitting the data via a second communication protocol to a second device accessible by a customer service representative for troubleshooting a suspected malfunction of the analyte sensor system.

[0065] In some embodiments, the first communication protocol comprises Bluetooth Low Energy protocol. In some embodiments, the second communication protocol is Wi-Fi.

[0066] A display device is provided. The device includes a short-term communication protocol controller configured to transmit power to an analyte sensor system using the short-term communication protocol when the display device is positioned sufficiently close to the analyte sensor system, thereby powering at least a portion of the analyte sensor system. The device includes a transceiver radio configured to receive data from the analyte sensor system via a first communication protocol. The device includes one or more processors configured to cause the transceiver radio to retransmit the data via a second communication protocol to a second device accessible by a customer service representative for use in troubleshooting a suspected malfunction of the analyte sensor system.

[0067] A method for wireless communication of continuous analyte concentration data is provided. The method includes transmitting at least one of a wake-up signal and a first security code as modulated visible light to an analyte sensor system. The method includes receiving, from the analyte sensor system, a second security code encrypted using the first security code. The method includes verifying the encrypted second security code. The method includes establishing a secure communication channel with the analyte sensor system in response to the verification. The method includes receiving analyte concentration data from the analyte sensor system via the secure communication channel.

[0068] In some embodiments, the encrypted second security code is received using a communication protocol different from modulated visible light. In some embodiments, the communication protocol is Bluetooth Low Energy. In some embodiments, analyte concentration data is received and encrypted using the second security code, and the secure communication channel comprises a Bluetooth Low Energy communication channel. In some embodiments, the wake-up signal and the first security code are transmitted as modulated visible light using a display. In some embodiments, the modulated visible light comprises one or more color patterns, brightness, or contrast displayed on the display.

[0069] A display device is provided. The device includes a display configured to transmit at least one of a wake-up signal and a first security code to an analyte sensor system as modulated visible light. The device includes a transceiver radio configured to receive a second security code encrypted using the first security code from the analyte sensor system. The device includes one or more processors configured to verify the encrypted second security code. The one or more processors are configured to establish a secure communication channel with the analyte sensor system in response to the verification. The one or more processors are configured to receive analyte concentration data from the analyte sensor system via the secure communication channel.

[0070] A method for wireless communication of continuous analyte concentration data is provided. The method includes receiving at least one of a wake-up signal and a first security code from a display device as modulated visible light. The method includes transmitting a second security code encrypted using the first security code from an analyte sensor system. The method includes establishing a secure communication channel with the display device. The method includes transmitting analyte concentration data via the secure communication channel.

[0071] In some embodiments, the encrypted second security code is transmitted using a communication protocol different from the modulated visible light. In some embodiments, the communication protocol is Bluetooth Low Energy. In some embodiments, the analyte concentration data is transmitted, encrypted using the second security code, and the secure communication channel comprises a Bluetooth Low Energy communication channel. In some embodiments, the wake-up signal and the first security code are received as modulated visible light using a light sensor. In some embodiments, the modulated visible light comprises one or more color patterns, brightness, or contrast displayed on a display of a display device.

[0072] A continuous analyte sensor system is provided. The system includes a light sensor configured to receive at least one of a wake-up signal and a first security code from a display device as modulated visible light. The system includes a transceiver radio configured to transmit a second security code encrypted using the first security code. The system includes one or more processors configured to establish a secure communication channel with the analyte sensor system. The one or more processors are configured to cause the transceiver radio to transmit analyte concentration data via the secure communication channel.

[0073] A method for wirelessly communicating with a continuous analyte sensor system is provided. The method includes receiving input from a user on a first display device indicating a request to pair a second display device with the analyte sensor system. The method includes transmitting a first signal to the analyte sensor system indicating that the second display device has requested pairing. The method includes receiving a second signal from the second display device indicating that the user has initiated a pairing process between the second display device and the analyte sensor system. The method includes transmitting a transmitter ID corresponding to the analyte sensor system to the second display device in response to receiving the second signal from the second display device.

[0074] In some embodiments, the first display device comprises a smartphone and the second display device comprises a smartwatch. In some embodiments, the second display device is configured to pair with the analyte sensor system using the transmitter ID.

[0075] A first display device is provided. The device includes an input interface configured to receive input from a user indicating a request to pair a second display device with an analyte sensor system. The device includes a transceiver radio configured to transmit a first signal to the analyte sensor system indicating that the second display device has requested pairing. The device includes one or more processors configured to receive a second signal from the second display device indicating that the user has initiated a pairing process between the second display device and the analyte sensor system. The one or more processors are configured to, in response to receiving the second signal from the second display device, cause the transceiver radio to transmit a transmitter ID corresponding to the analyte sensor system to the second display device.

[0076] A method for wirelessly communicating with a continuous analyte sensor system is provided. The method includes receiving one or more advertising messages from the analyte sensor system in response to a user selection on a first display device to pair a second display device with the analyte sensor system. The method includes displaying a notification of a pairing process in response to receiving the one or more advertising messages. The method includes transmitting a signal to the first display device indicating that input has been received from the user in response to receiving input from the user to initiate the pairing process. The method includes receiving a transmitter ID corresponding to the analyte sensor system from the first display device. The method includes establishing a secure connection with the analyte sensor system using the transmitter ID corresponding to the analyte sensor system.

[0077] In some embodiments, the first display device comprises a smartphone and the second display device comprises a smartwatch. In some embodiments, the second display device is configured to pair with the analyte sensor system using the transmitter ID.

[0078] A display device is provided. The device includes a transceiver radio configured to receive one or more advertising messages transmitted from an analyte sensor system in response to a user selection on another display device to pair the display device with the analyte sensor system. The device includes a display configured to display a notification of a pairing process in response to the transceiver radio receiving the one or more advertising messages. The device includes one or more processors configured to, in response to receiving an input from the user for initiating a pairing process, cause the transceiver radio to transmit a signal indicating that an input has been received from the user to the other display device. The one or more processors are configured to receive a transmitter ID corresponding to the analyte sensor system from a first display device. The one or more processors are configured to establish a secure connection with the analyte sensor system using the transmitter ID corresponding to the analyte sensor system.

[0079] A method for wireless communication of continuous analyte concentration data is provided. The method includes transmitting one or more first advertisement messages using a first set of parameters during a predetermined communication interval if a whitelist of previously authenticated devices has at least one unpopulated entry. The method includes transmitting one or more second advertisement messages using a second set of parameters during the predetermined communication interval if the whitelist lists at least one device. The method includes establishing a first communication session between an analyte sensor system and a first device and establishing a second communication session between the analyte sensor system and a second device based on at least one of the first advertisement message and the second advertisement message during the predetermined communication interval. The method includes transmitting analyte concentration data to the first device and the second device using at least one of the first communication session and the second communication session during the predetermined communication interval.

[0080] In some embodiments, one or more first advertisement messages advertise the availability of the analyte sensor system for connection with one or more devices not currently listed on the whitelist and one or more second advertisement messages advertise the availability of the analyte sensor system for connection with one or more devices currently listed on the whitelist.

[0081] In some embodiments, one or more first advertisement messages are transmitted after one or more second advertisement messages. In some embodiments, one or more first advertisement messages are transmitted before one or more second advertisement messages. In some embodiments, the method includes not transmitting one or more first advertisement messages during a predetermined communication interval if the whitelist does not have at least one unpopulated entry. In some embodiments, the method includes not transmitting one or more second advertisement messages during a predetermined communication interval if the whitelist does not currently list any devices. In some embodiments, the method includes not transmitting the one or more second advertisement messages during the predetermined communication interval if all devices currently listed on the whitelist connect to the analyte sensor system in response to the one or more first advertisement messages.

[0082] In some embodiments, a first set of parameters defines one or more of a first duration of a first advertising interval for transmitting one or more first advertising messages, a first periodic interval for transmitting one or more first advertising messages, and a first power for transmitting the one or more first advertising messages. In some embodiments, a second set of parameters defines one or more of a second duration of a second advertising interval for transmitting one or more second advertising messages, a second periodic interval for transmitting one or more second advertising messages, and a second power for transmitting the one or more second advertising messages. In some embodiments, the first power for transmitting the one or more first advertising messages is lower than the second power for transmitting the one or more second advertising messages. In some embodiments, both devices utilized by consumers and devices utilized by healthcare professionals are eligible for inclusion in a whitelist. In some embodiments, the whitelist includes three or more entries.

[0083] A continuous analyte sensor system configured for wireless communication of analyte concentration data is provided. The system includes a transceiver radio configured to transmit one or more first advertisement messages using a first set of parameters during a predetermined communication interval if a whitelist of previously authenticated devices has at least one unpopulated entry. The transceiver radio is configured to transmit one or more second advertisement messages using a second set of parameters during the predetermined communication interval if the whitelist lists at least one device. The system includes one or more processors configured to establish a first communication session between the analyte sensor system and a first device and a second communication session between the analyte sensor system and a second device based on at least one of the first advertisement message and the second advertisement message. The one or more processors are configured to cause the transceiver radio to transmit analyte concentration data to the first device and the second device using at least one of the first communication session and the second communication session during the predetermined communication interval.

[0084] In some embodiments, the one or more processors are configured to cause the transceiver radio to not transmit the one or more first advertisement messages during the predetermined communication interval if the whitelist does not have at least one unpopulated entry. In some embodiments, the one or more processors are configured to cause the transceiver radio to not transmit the one or more second advertisement messages during the predetermined communication interval if no devices are currently listed on the whitelist. In some embodiments, the one or more processors are configured to cause the transceiver radio to not transmit the one or more second advertisement messages during the predetermined communication interval if all devices currently listed on the whitelist connect to the analyte sensor system in response to the one or more first advertisement messages.

[0085] A method for communicating continuous analyte sensor data is provided. The method includes establishing a first communication session with a first display device and establishing a second communication session with a second display device, the second display device becoming unavailable for communication with the first device and the analyte sensor system for a period of time after establishing the second communication session. The method includes transmitting the analyte sensor data to the first display device via the first communication session. The method includes storing the analyte sensor data for at least the period of time. The method includes transmitting the stored analyte sensor data to the second display device using the second communication session in response to the second display device becoming available for communication with the analyte sensor system after the period of time.

[0086] A continuous analyte sensor system is provided. The system includes a transceiver radio configured to establish a first communication session with a first display device and a second communication session with a second display device. The transceiver radio is configured to transmit analyte sensor data to the first display device via the first communication session. The system includes a storage device configured to store the analyte sensor data for at least a period of time after the second communication session is established, during which the second display device becomes unavailable for communication with the first device and the analyte sensor system. The system includes one or more processors configured to cause the transceiver radio to transmit the stored analyte sensor data to the second display device using the second communication session in response to the second display device becoming available for communication with the analyte sensor system after the period of time.

[0087] A method for communicating continuous analyte sensor data is provided. The method includes establishing a first communication session between a first display device and an analyte sensor system and establishing a third communication session between the first display device and a second display device, the second display device having established a second communication session with the analyte sensor. The method includes receiving analyte sensor data from the analyte sensor system via the first communication session, wherein the second display device becomes unavailable for communication with the first display device and the analyte sensor system for a period of time after establishing the second communication session. The method includes storing the analyte sensor data for at least the period of time. The method includes transmitting the stored analyte sensor data to the second display device using the third communication session in response to the second display device becoming available for communication via the third communication session after the period of time.

[0088] A first display device is provided. The device includes a transceiver radio configured to establish a first communication session with an analyte sensor system and a third communication session with a second display device, the second display device having established a second communication session with the analyte sensor. The transceiver radio is configured to receive analyte sensor data from the analyte sensor system via the first communication session, wherein the second display device becomes unavailable for communication with the first device and the analyte sensor system for a period of time after establishing the second communication session. The device includes a memory configured to store analyte sensor data for at least the period of time. The device includes one or more processors configured to transmit the stored analyte sensor data to the second device using the third communication session in response to the second device becoming available for communication via the third communication session after the period of time.

[0089] A method for communicating continuous analyte sensor data is provided. The method includes establishing a first communication session with an analyte sensor system and establishing a second communication session with a first display device. The method includes becoming unavailable for communication with the first display device and the analyte sensor system for a time period after establishing the first communication session. The method includes receiving analyte sensor data previously stored by at least one of the first display device and the analyte sensor system during the time period via at least one of the first communication session and the second communication session in response to becoming available for communication via at least one of the first communication session and the second communication session after the time period.

[0090] A first display device is provided. The device includes a transceiver radio configured to establish a first communication session with an analyte sensor system and a second communication session with the first display device, wherein the first display device becomes unavailable for communication with the first device and the analyte sensor system for a period of time after establishing the first communication session. The transceiver radio is configured to receive analyte sensor data previously stored by at least one of the first device and the analyte sensor system during the period of time via at least one of the first communication session and the second communication session in response to becoming available for communication via at least one of the first communication session and the second communication session after the period of time.

[0091] A method for communicating continuous analyte sensor data is provided. The method includes determining that a first communication session between an analyte sensor system and a display device is to be closed. The method includes delaying closing of the first communication session until at least after an advertising message has been transmitted.

[0092] In some embodiments, the determination that the first communication session will be closed is generated in response to the first communication session being inactive for a predetermined period of time. In some embodiments, the determination that the first communication session will be closed is generated in response to a mode change of the analyte sensor system. In some embodiments, the mode change of the analyte sensor includes the analyte sensor system transitioning from performing an active glucose monitoring session to ending the active glucose monitoring session. In some embodiments, the method includes, in response to the determination, preventing the first communication session from being closed based on receiving a plurality of heartbeat signals via the first communication session after the determination. In some embodiments, the plurality of heartbeat signals are separated from each other by a first interval and the method includes receiving a second plurality of heartbeat signals via the first communication session before the determination, the second plurality of heartbeat signals being separated from each other by a second interval longer than the first interval.

[0093] A continuous analyte sensor system is provided. The system includes one or more processors configured to determine that a first communication session with a display device is to be closed and delay closing the first communication session until at least after one or more advertising messages have been transmitted. BRIEF DESCRIPTION OF THE DRAWINGS

[0094]

[0011] Further aspects of the present disclosure will become more readily apparent after reviewing the following detailed description of the various disclosed embodiments, which is described in conjunction with the accompanying figures.

[0095] Figure 1A Describe aspects of example systems that may be used in conjunction with implementing embodiments of the present disclosure;

[0096] Figure 1B Describe aspects of example systems that may be used in conjunction with implementing embodiments of the present disclosure;

[0097] Figure 2A is a perspective view of an example enclosure that may be used in conjunction with implementing embodiments of an analyte sensor system;

[0098] Figure 2B is a cross-sectional view of an example enclosure that may be used in conjunction with implementing embodiments of an analyte sensor system;

[0099] Figure 3A Describe aspects of an example system that may be used in conjunction with implementing embodiments of the present disclosure;

[0100] Figure 3B Describe aspects of an example system that may be used in conjunction with implementing embodiments of the present disclosure;

[0101] Figure 3C Describe aspects of example systems that may be used in conjunction with implementing embodiments of the present disclosure;

[0102] Figure 3Ddescribes aspects of an example factory calibration system that may be used in conjunction with implementing embodiments of the present disclosure;

[0103] Figure 3E describes aspects of an example factory test system that may be used in conjunction with implementing embodiments of the present disclosure;

[0104] Figure 4 is a block diagram illustrating aspects of an example analyte sensor system according to an embodiment of the present disclosure;

[0105] Figure 5 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0106] Figure 6A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0107] Figure 6B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0108] Figure 7 A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0109] Figure 8A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0110] Figure 8B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0111] Figure 9 A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0112] Figure 10A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0113] Figure 10B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0114] Figure 11 illustrates a schematic circuit diagram illustrating aspects of a portion of an example analyte sensor system according to an embodiment of the present disclosure;

[0115] Figure 12 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0116] Figure 13 A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0117] Figure 14 A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0118] Figure 15A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0119] Figure 15B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0120] Figure 16 An NFC tag embedded in a sticker according to an embodiment of the present disclosure is described;

[0121] Figure 17 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0122] Figure 18 Describe aspects of example systems that may be used in conjunction with implementing embodiments of the present disclosure;

[0123] Figure 19A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0124] Figure 19B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0125] Figure 20 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0126] Figure 21A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0127] Figure 21B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0128] Figure 22A A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0129] Figure 22B A signaling diagram illustrating various operations that may be performed according to an embodiment of the present disclosure;

[0130] Figure 23 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0131] Figure 24A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0132] Figure 24BOperational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0133] Figure 24C Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0134] Figure 25 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0135] Figure 26 Describe aspects of an example system that may be used in conjunction with implementing embodiments of the present disclosure;

[0136] Figure 27A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0137] Figure 27B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0138] Figure 28 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0139] Figure 29 Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0140] Figure 30A Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0141] Figure 30B Operational flow charts for illustrating various operations that may be performed according to embodiments of the present disclosure;

[0142] Figure 31 An example computing module according to an embodiment of the present disclosure is described.

[0143] The accompanying drawings, which are described in more detail in the following description and examples, are provided for illustrative purposes only and depict only typical or example embodiments of the present disclosure. The drawings are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. It should also be understood that the present disclosure may be practiced through modification or alteration and that the present disclosure may be limited only by the claims and their equivalents. DETAILED DESCRIPTION

[0144] Embodiments of the present disclosure relate to systems, methods, and devices for wireless communication of analyte data. In the various deployments described herein, the analyte data may be glucose data generated by an analyte sensor system that is configured to be connected to a display device, etc. As described in detail herein, aspects of implementing the present disclosure may reduce the power consumption of the analyte sensor system by improving its efficiency relative to wireless communication between the analyte sensor system and other devices. In addition, aspects of implementing the present disclosure may also allow for reduced power consumption while maintaining and / or improving performance relative to the reliability, speed, and accuracy of wireless communication and the connection protocols associated therewith. Specifically, some such aspects of the present disclosure relate to, for example, authentication and encryption, connection protocols, advertising message structure and content, device pairing, data transmission, data logging, etc.

[0145] Details of some example embodiments of the systems, methods, and apparatus of the present disclosure are set forth in this specification and, in some cases, in other parts of this disclosure. Other features, objects, and advantages of the present disclosure will be apparent to those skilled in the art upon examination of the present disclosure, specification, drawings, examples, and claims. It is intended that all such additional systems, methods, apparatus, features, and advantages be included within this specification (whether explicitly or by reference), be within the scope of the present disclosure, and be protected by one or more of the following claims.

[0146] Overview

[0147] In some embodiments, a system for continuous measurement of an analyte in a subject is provided. The system may include: a continuous analyte sensor configured to continuously measure the concentration of an analyte in a subject, and a sensor electronics module physically connected to the continuous analyte sensor during use of the sensor. In certain embodiments, the sensor electronics module includes electronics configured to process a data stream associated with the analyte concentration measured by the continuous analyte sensor to generate sensor information including, for example, raw sensor data, transformed sensor data, and / or any other sensor data. The sensor electronics module may be further configured to generate sensor information customized for a corresponding display device so that different display devices can receive different sensor information.

[0148] As used herein, the term "analyte" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and further refers to, but is not limited to, a substance or chemical constituent in a biological fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine) that can be analyzed. An analyte can include naturally occurring substances, man-made substances, metabolites, and / or reaction products. In some embodiments, the analyte measured by the sensor head, device, and method is an analyte. However, other analytes are also contemplated, including but not limited to acarbose prothrombin; acylcarnitines; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (Krebs cycle), histidine / urine, homocysteine, phenylalanine / tyrosine tryptophan); andrenostrobinone; antipyrine; arabinoside enantiomers; arginase; benzoylchlorguanidine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugates. 1-beta-hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; desethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetyltransferase polymorphism, alcohol dehydrogenase, alpha-1 antitrypsin, cystic fibrosis, Duchenne / Berkshire muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy vivax, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofatrin; dihydropterin reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3); fumarate acetylesterase; galactose / galactose-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione Peptide; glutathione perioxidase; glycocholic acid; glycated hemoglobin; halogenated thyroxine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; guide; lipoprotein ((a), B / A-1, beta); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin sodium; phytic acid / n-heptanoic acid; progesterone; prolactin; prolinase; purine nucleoside phosphorylase; quinine; reverse triiodothyronine (rT3); selenium; serum pancreatic lipase; cytoxan; growth factor C;Specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Ojecki disease virus, dengue virus, Guinea worm, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalis, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, Leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, polio virus, Pseudomonas aeruginosa) analytes include: serovar Typhimurium, Trichomonas, Respiratory Syncytial Virus, Rickettsia (tsutsugamushi), Schistosoma mansoni, Toxoplasma gondii, Cladosporium pallidus, Trypanosoma cruzi / T. langleyi, Vesicular Stomatitis Virus, Uchella bancrofti, Yellow Fever Virus); specific antigens (Hepatitis B Virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyroid stimulating hormone (TSH); thyroxine (T4); thyroxine binding globulin; trace elements; transport; UDP-galactose-4-epimerase; uroporphyrinogen I synthase; vitamin A; leukocytes; and zinc protoporphyrin. In certain embodiments, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluid may also constitute analytes. Analytes may be naturally present in biological fluids, for example, metabolites, hormones, antigens, antibodies, etc. Alternatively, the analyte may be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical reagent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to: insulin; ethanol; inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine; depressants (barbiturates, methaqualone, sedatives such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); phencyclidine, lysergic acid; acid, mescaline, peyote, psilocybin; anesthetics (meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil);Designer drugs (fentanyl, meperidine, and phencyclidine analogs; anabolic steroids; and nicotine. Metabolites of drugs and pharmaceutical compositions are also considered analytes. Analytes such as neurochemicals and other chemicals produced in the body, for example, ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 7-hydroxytryptamine (5HT), and 7-hydroxyindoleacetic acid (FHIAA) can also be analyzed.

[0149] Warning

[0150] In certain embodiments, one or more alerts are associated with a sensor electronics module. For example, each alert may include one or more alert conditions that indicate when the corresponding alert has been triggered. For example, a hypoglycemia alert may include an alert condition that indicates a minimum glucose level. The alert condition may also be based on transformed sensor data, such as trend data, and / or sensor data from multiple different sensors (for example, the alert may be based on sensor data from both a glucose sensor and a temperature sensor). For example, a hypoglycemia alert may include an alert condition that indicates a minimum required trend in the subject's glucose level, which trend must exist before the alert is triggered. As used herein, the term "trend" generally refers to data that indicates some attribute of data acquired over time, such as calibrated or filtered data from a continuous glucose sensor. A trend may indicate, for example, the amplitude, rate of change, acceleration, direction, etc. of data such as sensor data, wherein the sensor data includes transformed or raw sensor data.

[0151] In certain embodiments, each of the alerts is associated with one or more actions to be performed in response to the triggering of the alert. The alert actions may include, for example, activating an alarm, such as displaying information on a display of the sensor electronics module or activating an audible or vibrating alarm coupled to the sensor electronics module, and / or transmitting data to one or more display devices external to the sensor electronics module. For any delivery action associated with a triggered alert, one or more delivery options define the content and / or format of the data to be transmitted, the device to which the data is to be transmitted, when the data is to be transmitted, and / or the communication protocol used for data delivery.

[0152] In certain embodiments, multiple delivery actions (each with corresponding delivery options) can be associated with a single alert, such that displayable sensor information having different content and formatting is transmitted to respective display devices, e.g., in response to the triggering of a single alert. For example, a mobile phone can receive a data packet containing minimal displayable sensor information (which can be specifically formatted for display on the mobile phone), while a desktop computer can receive a data packet containing most (or all) displayable sensor information generated by the sensor electronics module in response to the triggering of a common alert. Advantageously, the sensor electronics module is not tied to a single display device, but rather is configured to communicate with multiple different display devices directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on-demand, in response to a query, based on an alert or alarm, and / or the like.

[0153] In some embodiments, clinical risk alerts are provided that include alert conditions that combine intelligent and dynamic estimation algorithms that estimate current or predicted risk with greater accuracy, provide more timely information about impending risk, avoid false alarms, and reduce patient annoyance. Generally speaking, clinical risk alerts include dynamic and intelligent estimation algorithms based on analyte values, rate of change, acceleration, clinical risk, statistical probability, known physiological constraints, and / or individual physiological patterns, thereby providing more appropriate, clinically safe, and patient-friendly alerts. U.S. Patent Publication No. 2007 / 0208246, incorporated herein by reference in its entirety, describes some systems and methods associated with the clinical risk alerts (or alarms) described herein. In some embodiments, clinical risk alerts can be triggered for a predetermined period of time to allow the user to care for their condition. Additionally, clinical risk alerts can be deactivated upon leaving the clinical risk zone so that the patient is not disturbed by repeated clinical alerts (e.g., visual, audible, or vibrational) as their condition improves. In some embodiments, dynamic and intelligent estimation determines the patient's likelihood of avoiding clinical risk based on analyte concentration, rate of change, and other aspects of the dynamic and intelligent estimation algorithm. If the likelihood of avoiding the clinical risk is minimal or nonexistent, a clinical risk alert is triggered. However, if there is a likelihood of avoiding the clinical risk, the system is configured to wait a predetermined amount of time and re-evaluate the likelihood of avoiding the clinical risk. In some embodiments, when there is a likelihood of avoiding the clinical risk, the system is further configured to provide goals, therapy recommendations, or other information that can assist the patient in proactively avoiding the clinical risk.

[0154] In some embodiments, the sensor electronics module is configured to search for one or more display devices within communication range of the sensor electronics module and wirelessly communicate sensor information (e.g., data packets containing displayable sensor information, one or more alarm conditions, and / or other alarm information) to the display devices. Thus, the display devices are configured to display at least some of the sensor information and / or issue an alert to the subject (and / or caregiver), wherein the alert mechanism is located on the display devices.

[0155] In some embodiments, the sensor electronics module is configured to provide one or more different alerts via the sensor electronics module and / or via the transmission of a data packet indicating that an alert should be initiated (e.g., sequentially and / or simultaneously) via one or more display devices. In certain embodiments, the sensor electronics module only provides a data field indicating the presence of an alarm condition, and the display device can determine to trigger an alarm upon reading the data field indicating the presence of an alarm condition. In some embodiments, the sensor electronics module determines which of the one or more alarms to trigger based on the one or more triggered alerts. For example, when an alert trigger indicates severe hypoglycemia, the sensor electronics module may perform multiple actions, such as activating an alarm on the sensor electronics module, transmitting a data packet to a monitoring device indicating the activation of the alarm on a display, and transmitting the data packet as a text message to a care provider. As an example, the text message may appear on a custom monitoring device, a cellular phone, a pager device, etc., containing displayable sensor information indicating the subject's condition (e.g., "Severe Hypoglycemia").

[0156] In some embodiments, the sensor electronics module is configured to wait a period of time for the subject to respond to a triggered alert (e.g., by pressing or selecting a snooze and / or disconnect function and / or button on the sensor electronics module and / or display device), after which additional alerts are triggered (e.g., in an incremental manner) until one or more alerts are responded to. In some embodiments, the sensor electronics module is configured to send a control signal (e.g., a stop signal) to a medical device, such as an insulin pump, associated with an alarm condition (e.g., hypoglycemia), wherein the stop alert triggers cessation of insulin delivery via the pump.

[0157] In some embodiments, the sensor electronics module is configured to transmit alarm information directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to a query (from a display device), based on a warning or alarm, and / or the like. In some embodiments, the system further comprises a repeater so that the wireless communication distance of the sensor electronics module can be increased, for example, to 10, 20, 30, 70, 75, 100, 150, or 200 meters or more, wherein the repeater is configured to forward the wireless communication from the sensor electronics module to a display device located away from the sensor electronics module. The repeater can be used in families with children suffering from diabetes. For example, to allow parents to carry the display device or to place the display device in a fixed location, such as in a large house where parents and children sleep at a distance.

[0158] Display device

[0159] In some embodiments, the sensor electronics module is configured to search for and / or attempt wireless communication with a list of display devices. In some embodiments, the sensor electronics module is configured to search for and / or attempt wireless communication with the list of display devices in a predetermined and / or programmable order (e.g., hierarchical and / or escalating), e.g., where a failed attempt and / or alarm regarding communication with a first display device triggers an attempt and / or alarm regarding communication with a second display device, and so on. In one example embodiment, the sensor electronics module is configured to sequentially search and attempt to alert a subject or care provider using a list of display devices, e.g., (1) a default display device or a customized analyte monitoring device; (2) a mobile phone via auditory and / or visual methods, e.g., a text message to the subject and / or care provider, a voice message to the subject and / or care provider, and / or 911); (3) a tablet computer; (4) a smartwatch.

[0160] Depending on the embodiment, one or more display devices that receive data packets from the sensor electronics module are "dummy displays," wherein the display devices display the displayable sensor information received from the sensor electronics module without additional processing (e.g., proactive algorithmic processing necessary for real-time display of the sensor information). In some embodiments, the displayable sensor information includes transformed sensor data that does not require processing by the display device prior to display of the displayable sensor information. Some display devices may include software including display instructions (including software programming configured to display the displayable sensor information and optionally query the sensor electronics module for instructions to obtain the displayable sensor information), the display instructions being configured to enable display of the displayable sensor information on the display device. In some embodiments, the display device is programmed with the display instructions at the manufacturer and may include security and / or authentication to prevent plagiarism of the display device. In some embodiments, the display device is configured to display the displayable sensor information via a downloadable program (e.g., a Java script, application, etc. downloadable via the Internet, such as but not limited to AppStore or Google Play), so that any display device that supports downloading of the program (e.g., any display device that supports Java applets) can therefore be configured to display the displayable sensor information (e.g., a mobile phone, tablet computer, PDA, PC, etc.).

[0161] In some embodiments, certain display devices can communicate wirelessly directly with the sensor electronics module, but intermediate network hardware, firmware, and / or software may be included in the direct wireless communication. In some embodiments, a repeater (e.g., a Bluetooth repeater) can be used to retransmit the transmitted displayable sensor information to a location further away than the immediate vicinity of the sensor electronics module's telemetry module, wherein the repeater enables direct wireless communication when no substantial processing of the displayable sensor information occurs. In some embodiments, a receiver (e.g., a Bluetooth receiver) can be used to retransmit the transmitted displayable sensor information to a TV screen, possibly in a different format, such as a text message, wherein the receiver enables direct wireless communication when no substantial processing of the sensor information occurs. In some embodiments, the sensor electronics module wirelessly transmits the displayable sensor information directly to one or more display devices, such that the displayable sensor information transmitted from the sensor electronics module is received by the display device without intermediate processing of the displayable sensor information.

[0162] In some embodiments, one or more display devices include a built-in authentication mechanism, wherein authentication is required for communication between the sensor electronics module and the display device. In some embodiments, in order to authenticate data communication between the sensor electronics module and the display device, a challenge-response protocol is provided, such as key authentication, wherein the challenge is a request for a key or a hash or other value based on or derived from the key, and the valid response is the correct key or a hash or other value based on or derived from the key, so that pairing of the sensor electronics module and the display device can be achieved by the user and / or the manufacturer via the key. In some cases, this can be referred to as two-way authentication. The key can be a software or hardware-level key. In addition, the key can be a password (e.g., randomly generated or set by the user or other entity) and / or can be derived from a unique identification feature (e.g., fingerprint or retinal information) or information.

[0163] In some embodiments, one or more display devices are configured to query the sensor electronics module for displayable sensor information, with the display device acting as a master device, for example, requesting sensor information from the sensor electronics module (e.g., a slave device) on demand in response to the query. While in some cases, the display device acts as the master device and the sensor electronics module acts as the slave device, in other cases, these roles may be reversed. For example, the roles may be reversed depending on the nature of the communication, among other things. In some embodiments, the sensor electronics module is configured for periodic, systematic, regular, and / or cyclical transmission of sensor information to the one or more display devices (e.g., every 30 seconds, 1 minute, 2 minutes, 7 minutes, or 10 minutes, or more). In some embodiments, the sensor electronics module is configured to transmit data packets associated with triggered alerts (e.g., triggered by one or more alert conditions). However, any combination of the aforementioned data transmission modes may be implemented using any combination of paired sensor electronics modules and display devices, or between the display devices themselves. For example, one or more display devices may be configured to query the sensor electronics module database and receive alert information triggered by satisfying one or more alert conditions. Additionally, the sensor electronics module may be configured for periodic transmission of sensor information to one or more display devices (the same or different display devices as described in the previous examples), whereby the system may include display devices that function in different ways with respect to how the sensor information is obtained.

[0164] In some embodiments, the display device is configured to query the data storage memory in the sensor electronics module for certain types of data content, including direct queries of a database in the memory of the sensor electronics module and / or requests for configured or configurable packages of data content therefrom; that is, the data stored in the sensor electronics module is configurable, queryable, predetermined, and / or pre-packaged based on the display device with which the sensor electronics module is communicating. In some additional or alternative embodiments, the sensor electronics module generates displayable sensor information based on its knowledge of which display device will receive a particular transmission. In addition, some display devices are capable of obtaining calibration information and wirelessly transmitting the calibration information to the sensor electronics module, for example, through manual entry of calibration information, automatic delivery of calibration information, and / or an integrated reference analyte monitor incorporated into the display device. U.S. Patent Publication Nos. 2006 / 0222566, 2007 / 0203966, 2007 / 0208245, and 2005 / 0154271, all of which are incorporated herein by reference in their entirety, describe systems and methods for providing an integrated reference analyte monitor incorporated into a display device and / or other calibration methods that may be implemented with the embodiments disclosed herein. In some embodiments, such sensor electronics modules may be factory calibrated such that calibration information does not need to be transferred to the sensor electronics module.

[0165] In general, a plurality of display devices (e.g., a custom analyte monitoring device (also referred to as an analyte display device), a mobile phone, a tablet computer, a smart watch, a reference analyte monitor, a drug delivery device, a medical device, and a personal computer) can be configured to communicate wirelessly with the sensor electronics module. The plurality of display devices can be configured to display at least some of the displayable sensor information wirelessly communicated from the sensor electronics module. The displayable sensor information can include sensor data, such as raw data and / or transformed sensor data, such as analyte concentration values, rate of change information, trend information, warning information, sensor diagnostic information, and / or calibration information.

[0166] Continuous Sensor

[0167] refer to Figure 1A In some embodiments, analyte sensor 10 comprises a continuous glucose sensor, such as a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device. In some embodiments, such a sensor or device can analyze multiple intermittent blood samples. The glucose sensor can use any glucose measurement method, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarization, calorimetric, iontophoresis, radiometric, immunochemical, and the like.

[0168] The glucose sensor may use any known method including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring) to provide a data stream indicative of the glucose concentration in the subject. The data stream is typically a raw data signal that is converted into a calibrated and / or filtered data stream to provide a useful glucose value to a user, such as a patient or a caregiver (e.g., a parent, relative, guardian, teacher, physician, nurse, or any other individual concerned with the subject's health).

[0169] A glucose sensor can be any device capable of measuring the concentration of glucose. According to one example embodiment described below, an implantable glucose sensor can be used. However, it should be understood that the devices and methods described herein can be applied to any device capable of detecting a glucose concentration and providing an output signal representative of the glucose concentration (e.g., in the form of analyte data).

[0170] In certain embodiments, analyte sensor 10 is an implantable glucose sensor, such as described in US Pat. No. 8,001,067 and US Patent Publication No. US-2005-0027463-A1. In an embodiment, analyte sensor 10 is a transcutaneous glucose sensor, such as described in US Patent Publication No. US-2006-0020187-A1. In an embodiment, the analyte sensor 10 is configured to be implanted in a subject's blood vessel or externally, such as described in U.S. Patent Publication No. US-2007-0027385-A1, co-pending U.S. Patent Publication No. US-2008-0119703-A1 filed on October 4, 2006, U.S. Patent Publication No. US-2008-0108942-A1 filed on March 26, 2007, and U.S. Patent Application No. US-2007-0197890-A1 filed on February 14, 2007. In an embodiment, the continuous glucose sensor comprises a transcutaneous sensor, such as described in U.S. Patent No. 8,565,509 to Say et al. In an embodiment, the analyte sensor 10 is a continuous glucose sensor comprising a subcutaneous sensor, such as described in U.S. Patent No. 8,579,690 to Bonnecaze et al. or U.S. Patent No. 8,484,046 to Say et al. In an embodiment, the continuous glucose sensor comprises a refillable subcutaneous sensor such as described in U.S. Patent 8,512,939 to Colvin et al. The continuous glucose sensor may comprise an intravascular sensor such as described in U.S. Patent 8,477,395 to Schulman et al. The continuous glucose sensor may comprise an intravascular sensor such as described in U.S. Patent 8,424,847 to Mastrototaro et al.

[0171] Figure 2A and 2B Figures 200 and 200 illustrate perspective and cross-sectional views of an enclosure 200 that may be used in conjunction with embodiments implementing the analyte sensor system 8 according to certain aspects of the present disclosure. In certain embodiments, the enclosure 200 includes a mounting unit 214 and the sensor electronics module 12 attached thereto. The enclosure 200 is shown in a functional position, including the mounting unit 214 and the sensor electronics module 12 matingly engaged therein. In some embodiments, the mounting unit 214, also referred to as a housing or sensor capsule, includes a base 234 adapted to be fastened to the subject's or user's skin. The base 234 can be formed from a variety of rigid or soft materials and can include a low-profile surface for minimal protrusion of the device from the subject during use. In some embodiments, the base 234 is at least partially formed from a flexible material, which can provide numerous advantages over other transcutaneous sensors that, unfortunately, may be subject to motion-related artifacts associated with the subject's movement while using the device. The mounting unit 214 and / or the sensor electronics module 12 can be positioned above the sensor insertion site to protect the site and / or provide a minimal footprint (utilization of the subject's skin surface area).

[0172] In some embodiments, a detachable connection between the mounting unit 214 and the sensor electronics module 12 is provided, which improves manufacturability. Specifically, the potentially relatively inexpensive mounting unit 214 can be discarded when the analyte sensor system 8 is repaired or maintained, while the relatively more expensive sensor electronics module 12 can be reused for multiple sensor systems. In some embodiments, the sensor electronics module 12 is configured with signal processing (programming), for example, to filter, calibrate, and / or execute other algorithms that may be used for calibration and / or display of sensor information. However, an integral (non-detachable) sensor electronics module may also be configured.

[0173] In some embodiments, the contact member 238 is mounted on or in a subassembly, hereinafter referred to as the contact subassembly 236, which is configured to fit within the base 234 of the mounting unit 214 and the hinge 248, which allows the contact subassembly 236 to pivot relative to the mounting unit 214 between a first position (for insertion) and a second position (for use). As used herein, the term "hinge" is a broad term and is used in its ordinary sense to include, but is not limited to, any of a variety of pivoting, articulating, and / or hinged mechanisms, such as adhesive hinges, sliding joints, etc.; the term hinge does not necessarily imply a fulcrum or fixed point about which the articulation occurs. In some embodiments, the contact member 238 is formed of a conductive elastic material, such as a carbon black elastomer, through which the sensor 10 extends.

[0174] Further references Figure 2AIn certain embodiments, the mounting unit 214 is provided with an adhesive pad 208 disposed on a back surface of the mounting unit and comprising a releasable backing layer. Thus, removing the backing layer and pressing at least a portion of the base 234 of the mounting unit 214 against the subject's skin adheres the mounting unit 214 to the subject's skin. Additionally or alternatively, an adhesive pad may be placed over some or all of the analyte sensor system 8 and / or sensor 10 after sensor insertion is complete to ensure adhesion, and optionally to ensure an airtight or watertight seal around the wound exit site (or sensor insertion site) (not shown). An appropriate adhesive pad may be selected and designed to stretch, elongate, conform to, and / or ventilate the area (e.g., the subject's skin). Reference is made to U.S. Patent No. 7,310,544, which is incorporated herein by reference in its entirety, for a more detailed description of the invention. Figure 2A and 2B Described Embodiments. Configurations and arrangements may provide for the water-resistant, waterproof, and / or hermetically sealed properties associated with the mounting unit / sensor electronics module embodiments described herein.

[0175] Various methods and apparatus suitable for use with aspects of some embodiments are disclosed in U.S. Patent Publication No. US-2009-0240120-A1, which is incorporated herein by reference in its entirety for all purposes.

[0176] Instance Configuration

[0177] Reference again Figure 1A , depicts a system 100 that can be used in conjunction with aspects of implementing an analyte sensor system. In some cases, the system 100 can be used to implement the various systems described herein. According to certain aspects of the present disclosure, the system 100 includes an analyte sensor system 8, display devices 110, 120, 130, and 140 in an embodiment. The analyte sensor system 8 in the illustrated embodiment includes a sensor electronics module 12 and a continuous analyte sensor 10 associated with the sensor electronics module 12. The sensor electronics module 12 can wirelessly communicate (e.g., directly or indirectly) with one or more of the display devices 110, 120, 130, and 140. In an embodiment, the system 100 further includes a medical device 136, a healthcare provider device 150, a server system 134, a factory test station 351, and a factory calibration station 381. The sensor electronics module 12 can also wirelessly communicate (e.g., directly or indirectly) with the medical device 136, the healthcare provider device 150, and the server system 134. Likewise, in some examples, display devices 110 - 140 may also communicate wirelessly (eg, directly or indirectly) with medical device 136 , healthcare provider device 150 , or server system 134 . Figure 1AThe various couplings shown in FIG. 1 may be facilitated using a wireless access point 138 as also mentioned below.

[0178] In certain embodiments, the sensor electronics module 12 includes an electronic circuit system associated with measuring and processing continuous analyte sensor data, including a prospective algorithm associated with the processing and calibration of sensor data. The sensor electronics module 12 can be physically connected to the continuous analyte sensor 10, and can be formed into a whole (attached in a non-detachable manner) with the continuous analyte sensor 10 or be attached to the continuous analyte sensor in a detachable manner. The sensor electronics module 12 can include hardware, firmware and / or software that enable measurement of analyte levels via a glucose sensor. For example, the sensor electronics module 12 can include a potentiostat, a power source for providing power to the sensor, other components that can be used for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronics module to one or more display devices. Electronics can be attached to a printed circuit board (PCB) etc., and can take various forms. For example, electronics can be in the form of an integrated circuit (IC), such as an application specific integrated circuit (ASIC), a microcontroller and / or a processor.

[0179] The sensor electronics module 12 may include sensor electronics configured to process sensor information, such as sensor data, and generate transformed sensor data and displayable sensor information. Examples of systems and methods for processing sensor analyte data are described in more detail herein and in U.S. Patent Nos. 7,310,544 and 8,931,327 and U.S. Patent Publication Nos. 2005 / 0043598, 2007 / 0032706, 2007 / 0016381, 2008 / 0033254, 2005 / 0203360, 2005 / 0154271, 2005 / 0192557, 2006 / 0222566, 2007 / 0203966, and 2007 / 0208245, all of which are incorporated herein by reference in their entirety for all purposes.

[0180] Reference again Figure 1A, the display devices 110, 120, 130, and / or 140 are configured to display (and / or alert) displayable sensor information that can be transmitted by the sensor electronics module 12 (e.g., in a customized data packet transmitted to the display device based on the display device's corresponding preferences). Each of the display devices 110, 120, 130, or 140 may include a display, such as a touch screen display 112, 122, 132, or 142, for displaying sensor information and / or analyte data to a user and / or receiving input from the user. For example, a graphical user interface may be presented to the user for such purposes. In some embodiments, instead of or in addition to the touch screen display, the display device may include other types of user interfaces, such as a voice user interface, for communicating sensor information to the user of the display device and / or receiving user input. In some embodiments, one, some, or all of the display devices are configured to display or otherwise communicate sensor information as if it were transmitted from the sensor electronics module (e.g., in a data packet transmitted to the corresponding display device), without requiring any additional proactive processing required for calibration and real-time display of the sensor data.

[0181] In an example embodiment of the present disclosure, the medical device 136 may be a passive device. For example, the medical device 136 may be an insulin pump for administering insulin to a user, such as Figure 1B As shown. For a variety of reasons, it may be necessary for this insulin pump to receive and track the glucose value transmitted from the analyte sensor system 8. One reason is to provide the ability of the insulin pump to suspend / activate insulin administration based on glucose value being lower than / higher than a threshold value. A solution that allows passive devices (e.g., medical devices 136) to receive analyte data (e.g., glucose value) without being incorporated into the analyte sensor system 8 is to include analyte data in the advertising message transmitted from the analyte sensor system 8. The data included in the advertising message can be encoded so that the device with only the identification information associated with the analyte sensor system 8 can decode the analyte data. The medical device 136 can include an input / output portion 136a, wherein, for example, glucose and other values ​​can be displayed and input can be received via a button, wireless connection or other mechanism. The medical device 136 can also include an attachment portion 136b, which interfaces with the user to administer insulin in response to the input received at the input / output portion 136a. In some cases, the attached portion 136b may provide sensory alerts or other notifications to the user based on, for example, inputs received and / or values ​​calculated at the input / output portion 136a.

[0182] The healthcare provider device 150 may be used by a healthcare provider to track, record, and / or otherwise analyze data provided by one or more analyte sensor systems, as disclosed herein. Figures 26 to 27BSeveral example embodiments of the healthcare provider device 150 are described in further detail.

[0183] The factory calibration station 381 can be used to calibrate one or more analyte sensor systems, as disclosed herein. Figure 3D and 5 Several example embodiments of the factory calibration stand 381 are described in greater detail.

[0184] The factory test station 351 can be used to test one or more analyte sensor systems, as disclosed herein. Figure 3E 、 6A 6B describe several example embodiments of the factory test stand 351 in more detail.

[0185] Further references Figure 1A , the plurality of display devices may include a custom display device specifically designed to display certain types of displayable sensor information (e.g., in some embodiments, digital values ​​and arrows) associated with the analyte data received from the sensor electronics module 12. The analyte display device 110 is an example of such a custom device. In some embodiments, one of the plurality of display devices is a smartphone, such as a mobile phone 120 based on Android, iOS, or other operating systems, and is configured to display a graphical representation of continuous sensor data (e.g., including current and historical data). Other display devices may include other handheld devices, such as a tablet computer 130, a smart watch 140, a medical device 136 (e.g., an insulin delivery device or a blood glucose meter), and / or a desktop or laptop computer.

[0186] Because different display devices provide different user interfaces, the contents of the data packets (e.g., the amount, format, and / or type of data, alerts, etc. to be displayed) may be customized (e.g., programmed differently by the manufacturer and / or by the end user) for each specific display device. Figure 1A In embodiments, multiple different display devices may communicate directly wirelessly with a sensor electronics module (e.g., an on-skin sensor electronics module 12 physically connected to the continuous analyte sensor 10) during a sensor session to enable multiple different types and / or levels of displays and / or functionality associated with displayable sensor information, as described in more detail elsewhere herein.

[0187] like Figure 1AAs further described in

[0045] , the system 100 may also include a wireless access point (WAP) 138 that can be used to couple one or more of the analyte sensor system 8, the plurality of display devices, the server system 134, and the medical device 136 to one another. For example, the WAP 138 can provide Wi-Fi and / or cellular connectivity within the system 100. Near field communication (NFC) can also be used among the devices of the system 100. The server system 134 can be used to collect analyte data from the analyte sensor system 8 and / or the plurality of display devices to, for example, perform analysis thereon, generate general or individualized models of glucose levels and profiles, and the like.

[0188] Reference Figure 3A , depicting a system 300. System 300 can be used in conjunction with embodiments of the disclosed systems, methods, and apparatus. For example, Figure 3A The various below-described components may be used, for example, to provide wireless communication of glucose data between an analyte sensor system and a plurality of display devices, medical devices, servers, and the like.

[0189] like Figure 3A As shown in , system 100 can include an analyte sensor system 308 and one or more display devices 310. Additionally, in the illustrated embodiment, system 300 includes a server system 334, which in turn includes a server 334a coupled to a processor 334c and a storage device 334b. Analyte sensor system 308 can be coupled to display device 310 and / or server system 334 via communication medium 305.

[0190] As will be described in detail herein, the analyte sensor system 308 and the display device 310 can exchange messages via the communication medium 305, and the communication medium 305 can also be used to deliver analyte data to the display device 310 and / or the server system 334. The display device 310 can include various electronic computing devices, such as smart phones, tablet computers, laptop computers, wearable devices, such as smart watches, etc. The display device 310 can also include an analyte display device 110, a medical device 136, a healthcare provider device 150, a server system 134, a factory test bench 351, and a factory calibration bench 381. It should be noted here that the graphical user interface (GUI) of the display device 310 can perform such functions, such as accepting user input and displaying menus and information derived from the analyte data. The GUI can be provided by various operating systems known in the art, such as iOS, Android, Windows Mobile, Windows, Mac OS, Chrome OS, Linux, Unix, gaming platform OS (e.g., Xbox, PlayStation, Wii), etc. In various embodiments, the communication medium 305 may be based on one or more wireless communication protocols, such as Bluetooth, Bluetooth Low Energy (BLE), ZigBee, Wi-Fi, 802.11 protocols, infrared (IR), radio frequency (RF), 2G, 3E, 4G, 7G, etc., and / or wired protocols and media.

[0191] In various embodiments, the elements of system 300 can be used to perform the various processes described herein and / or can be used to perform the various operations described herein with respect to one or more disclosed systems and methods. After studying this disclosure, one skilled in the art will appreciate that system 300 can include multiple analyte sensor systems, communication media 305 for communicating using the same or different communication protocols, and / or server system 334.

[0192] As mentioned, the communication medium 305 can be used to connect or communicatively couple the analyte sensor system 308, the display device 310, and / or the server system 334 to each other or to a network, and the communication medium 305 can be implemented in a variety of forms. For example, the communication medium 305 can include an Internet connection, such as a local area network (LAN), a wide area network (WAN), a fiber optic network, Internet over power lines, a hard-wired connection (e.g., a bus), etc., or any other type of network connection. The communication medium 305 can be implemented using any combination of routers, cables, modems, switches, optical fibers, wires, radio (e.g., microwave / RF links), etc. In addition, the communication medium 305 can be implemented using various wireless standards, such as BLE, Wi-Fi, 3EPP standards (e.g., 2G GSM / GPRS / EDGE, 3E UMTS / CDMA2000, 4G LTE / LTE-U, 5G), etc. After reading this disclosure, those skilled in the art will recognize other ways to implement the communication medium 305 for communication purposes.

[0193] The server 334a may receive, collect, or monitor information including analyte data and related information from the analyte sensor system 308 and / or the display device 310, such as in response to input of analyte data or input received in conjunction with an analyte monitoring application running on the analyte sensor system or the display device 310. In such cases, the server 334a may be configured to receive such information via the communication medium 305. Such information may be stored in the storage device 334b ​​and may be processed by the processor 334c. For example, the processor 334c may include an analysis engine capable of performing analysis on information that the server 334a has collected, received, etc. via the communication medium 305. In an embodiment, the server 334a, the storage device 334b, and / or the processor 334c may be implemented as a distributed computing network (e.g., network) or relational database, etc.

[0194] The server 334a can include, for example, an internet server, a router, a desktop or laptop computer, a smart phone, a tablet computer, a processor, a module, etc., and can be implemented in various forms, including, for example, an integrated circuit or its collection, a printed circuit board or its collection, or in a discrete housing / package / rack or a plurality thereof. In an embodiment, the server 334a at least partially guides the communication carried out on the communication medium 305. Such communication includes delivery and / or messaging (for example, advertising, commands or other messaging) and analyte data. For example, the server 334a can process and exchange messages related to frequency band, transmission timing, security, alarms, etc. between the analyte sensor system 308 and the display device 310. The server 334a can, for example, update and / or provide information stored on the analyte sensor system and / or the display device by delivering an application, a security code, a transmitter ID, a pairing key, etc. to the analyte sensor system 308 and / or the display device 310. The server 334a can send / receive information to / from the analyte sensor system 308 and / or the display device 310 in real time or sporadically. Additionally, server 334 a may implement cloud computing capabilities for analyte sensor system 308 and / or display device 310 .

[0195] Figure 3B A system 302 is depicted that includes examples of additional aspects of the present disclosure that can be used in conjunction with implementing an analyte sensor system. Figure 3B, system 302 may include an analyte sensor system 308. As shown, the analyte sensor system 308 may include an analyte sensor 375 coupled to a sensor measurement circuit system 370 for processing and managing sensor data (e.g., in FIG. Figure 1A 10). The sensor measurement circuitry 370 may be coupled to a processor / microprocessor 380 (e.g., which may be Figure 1A In some embodiments, the processor 380 may perform some or all of the functions of the sensor measurement circuitry 370 for obtaining and processing sensor measurements from the sensor 375. The processor 380 may be further coupled to a radio unit or transceiver 360 (e.g., which may be a Figure 1A 310) for sending sensor data and receiving requests, commands and / or temporary power from an external device, such as a display device 310, which can be used to display or otherwise provide sensor data (or analyte data) to a user. As used herein, the terms "radio", "radio unit", "transceiver", "radio transceiver" and "transceiver radio" are used interchangeably and generally refer to a device, circuit system or module that can transmit and receive data wirelessly. In addition, according to some embodiments, the transceiver 360 may further include an NFC antenna and associated circuit system that is configured to receive power from another device, such as the display device 310, via near field communication, and the analyte sensor system 308 can be used to temporarily power one or more of its components necessary for communicating with another device, for example, when the internal battery of the analyte sensor system 308 (not shown) has insufficient power or is originally unable to fully power such components. The analyte sensor system 308 may further include a storage device 365 (for example, which may be Figure 1A part of the sensor electronics module 12 in the ) and a real time clock (RTC) 380 (which may be, for example, Figure 1A Part of the sensor electronics module 12 in the sensor module 12) for storing and tracking sensor data.

[0196] As mentioned above, wireless communication protocols can be used to transmit and receive data between analyte sensor system 308 and display device 310 via communication media 305. Such wireless protocols can be designed for periodic and small data transmission (can be transmitted at a low rate when necessary) to and from multiple devices in a close range (e.g., personal area network (PAN)) and optimized wireless networks. For example, a type of such protocol can be optimized for periodic data transmission, wherein the transceiver can be configured to transmit data in a short interval and then enter a low power mode in a long interval. The protocol can have a low overhead requirement for normal data transmission and for initially setting a communication channel (e.g., by reducing overhead) to reduce power consumption. In some embodiments, a burst broadcast scheme (e.g., one-way communication) can be used. This can eliminate the overhead required for confirmation signal and allow periodic transmissions that consume very little power. In other embodiments, a passive or active proximity-based protocol can be used to reduce overhead (e.g., overhead associated with typical pairing operations) and / or increase security, wherein NFC is a specific instance.

[0197] The protocol may further be configured to establish a communication channel with a plurality of devices while implementing an interference avoidance scheme. In some embodiments, the protocol may utilize an adaptive isochronous network topology that defines various time slots and frequency bands for communication with a plurality of devices. The protocol may therefore modify the transmission window and frequency in response to interference and support communication with a plurality of devices. Therefore, the wireless protocol may use a scheme based on time and frequency division multiplexing (TDMA). The wireless protocol may also employ direct sequence spread spectrum (DSSS) and frequency hopping spread spectrum schemes. Various network topologies may be used to support short-range and / or low-power wireless communications, such as peer-to-peer, star, tree, or mesh network topologies, such as Wi-Fi, Bluetooth, and Bluetooth Low Energy (BLE). The wireless protocol may operate in a variety of frequency bands, such as an open ISM band, such as 2.4 GHz. In addition, in order to reduce power usage, the wireless protocol may adaptively configure the data rate based on power consumption.

[0198] Further references Figure 3B , system 302 may include a display device 310 communicatively coupled to an analyte sensor system 308 via a communication medium 305. In the illustrated embodiment, the display device 310 includes a connectivity interface 315 (which in turn includes a transceiver 320), a storage device 325 (which in turn stores an analyte sensor application 330 and / or additional applications), a processor / microprocessor 335, a graphical user interface (GUI) 340 that may be presented using a display 345 of the display device 310, and a real-time clock (RTC) 350. A bus (not shown here) may be used to interconnect the various elements of the display device 310 and transfer data between these elements.

[0199] The display device 310 can be used to alert and provide sensor information or analyte data to the user, and can include a processor / microprocessor 335 for processing and managing sensor data. The display device 310 can include a display 345, a storage device 325, an analyte sensor application 330, and a real-time clock 350 for displaying, storing, and tracking sensor data. The display device 310 can further include a radio unit or transceiver 320 coupled to other elements of the display device 310 via a connectivity interface 315 and / or a bus. The transceiver 320 can be used to receive sensor data and for sending requests, instructions, data, and / or power to the analyte sensor system 308. The transceiver 320 can further adopt a communication protocol. The storage device 325 can also be used to store an operating system for the display device 310 and / or a custom (e.g., proprietary) application designed for wireless data communication between the transceiver and the display device 310. The storage device 325 can be a single memory device or multiple memory devices and can be a volatile or non-volatile memory for storing data and / or instructions of software programs and applications. The instructions may be executed by the processor 335 to control and manage the transceiver 320 .

[0200] In some embodiments, when standardized communication protocols are used, commercially available transceiver circuits may be utilized that incorporate processing circuitry to handle low-level data communication functions, such as management of data encoding, transmission frequency, handshake protocols, etc. In these embodiments, the processor 335, 380 does not need to manage these activities, but rather provides the required data values ​​for transmission and manages higher-level functions such as powering on or off, setting the rate at which messages are transmitted, etc. The instructions and data values ​​for performing these higher-level functions may be provided to the transceiver circuitry via a data bus and transmission protocol established by the manufacturer of the transceiver 320, 360.

[0201] The components of the analyte sensor system 308 may need to be replaced periodically. For example, the analyte sensor system 308 may include an implantable sensor 375, which can be attached to a sensor electronic module, such as a sensor electronic module 12, which includes a sensor measurement circuit system 370, a processor 380, a storage device 365, a transceiver 360, and a battery (not shown). The sensor 375 may need to be replaced periodically (e.g., every 7 to 30 days). The sensor electronic module can be configured to be powered and in effect for much longer than the sensor 375 (e.g., up to three to six months or more) until the battery needs to be replaced. Replacing these components may be difficult and require the help of trained personnel. Reducing the need to replace these components, specifically batteries, significantly improves the convenience and cost of using the analyte sensor system 308, including for users. In some embodiments, when the sensor electronic module is used for the first time (or in some cases, reactivated once the battery has been replaced), it can be connected to the sensor 375 and a sensor session can be established. As will be described further below, there may be a process for initially establishing communication between the display device 310 and a sensor electronics module, such as sensor electronics module 12, when the module is first used or reactivated (e.g., when the battery is replaced). Once the display device 310 and the sensor electronics module have established communication, the display device 310 and the sensor electronics module may be in communication periodically and / or continuously over the life of the number of sensors 375, until, for example, a battery replacement is required. Each time a sensor 375 is replaced, a new sensor session may be established. A new sensor session may be initiated by a process completed using the display device 310, and the process may be triggered by notification of a new sensor via communication between the sensor electronics module and the display device 310, which may be persistent across sensor sessions.

[0202] The analyte sensor system 308 typically collects analyte data from the sensor 375 and transmits it to the display device 310. Data points about analyte values ​​can be collected and transmitted over the life of the sensor 375 (e.g., in the range of 1 to 30 days or more). New measurements can be transmitted frequently enough to adequately monitor glucose levels. Rather than having the transmission and receiving circuitry of each of the analyte sensor system 308 and the display device 310 communicate continuously, the analyte sensor system 308 and the display device 310 can regularly and / or periodically establish a communication channel between them. Therefore, the analyte sensor system 308 can, in some cases, communicate at predetermined time intervals via wireless transmission with the display device 310 (e.g., a handheld computing device, a medical device, or a proprietary device). The duration of the predetermined time interval can be selected to be long enough so that the analyte sensor system 308 does not consume excessive power by transmitting data more frequently than necessary, but frequently enough to provide substantially real-time sensor information (e.g., measured glucose values ​​or analyte data) to the display device 310 for output to the user (e.g., via the display 345). While in some embodiments the predetermined time interval is every five minutes, it will be appreciated that this time interval can be varied to any desired length of time.

[0203] Continue to refer Figure 3B As shown in the figure, connectivity interface 315 interfaces display device 310 to communication medium 305 so that display device 310 can be coupled to analyte sensor system 308 in a communication manner via communication medium 305. The transceiver 320 of connectivity interface 315 may include multiple transceiver modules and / or circuit systems that can operate by different wireless standards. Transceiver 320 can be used to receive analyte data and associated commands and messages from analyte sensor system 308. In some embodiments, transceiver 320 may include a near field communication (NFC) controller, which is configured to transmit NFC signals for communicating with another device, such as analyte sensor system 308 and / or temporarily providing power to the other device, as described in more detail below in conjunction with one or more embodiments. In addition, connectivity interface 315 may include additional components for controlling radio and / or wired connections in some cases, such as baseband and / or Ethernet modem, audio / video codec, BLE, Bluetooth, and / or cellular connection, etc.

[0204] The storage device 325 may include volatile memory (e.g., RAM) and / or non-volatile memory (e.g., flash memory), and may include any of EPROM, EEPROM, cache memory, or a combination / variation thereof. In various embodiments, the storage device 325 may store user input data and / or other data collected by the display device 310 (e.g., input from other users collected via the analyte sensor application 330). The storage device 325 may also be used to store a large amount of analyte data received from the analyte sensor system 308 for later retrieval and use, such as for determining trends and triggering alerts. In addition, the storage device 325 may store the analyte sensor application 330, which receives input (e.g., via conventional hard / soft keys or a touch screen, voice detection, or other input mechanisms) when executed using, for example, the processor 335, and allows the user to interact with the analyte data and related content via the GUI 340, as will be described in further detail herein.

[0205] In various embodiments, a user can interact with the analyte sensor application 330 via a GUI 340, which can be provided by a display 345 of the display device 310. For example, the display 345 can be a touch screen display that accepts various gestures as input. The application 330 can process and / or present analyte-related data received by the display device 310 according to various operations described herein and present such data via the display 345. In addition, the application 330 can be used to obtain, access, display, control, and / or interface with analyte data and related signaling and processes associated with the analyte sensor system 308, as further described herein.

[0206] The application 330 can be downloaded, installed, and initially configured / set up on the display device 310. For example, the display device 310 can obtain the application 330 from the server system 334 or from another source accessed via a communication medium (e.g., communication medium 305), such as an application store or the like. After installation and setup, the application 330 can be used to access and / or interface analyte data (e.g., whether stored on the server system 334, locally from the storage device 325, or from the analyte sensor system 308). By way of illustration, the application 330 can present a menu comprising various controls or commands that can be executed in conjunction with the operation of the analyte sensor system 308 and one or more display devices 310. The application 330 can also be used to interface or control other display devices 310, such as to deliver analyte data or make analyte data available thereto, including, for example, by directly receiving / sending analyte data to another display device 310 and / or sending instructions for the analyte sensor system 308 and another display device 310 to connect, as will be described herein. Additionally, application 330 may, in some embodiments, interact with one or more additional applications supported by display device 310 to, for example, retrieve or supply relevant data. Such applications may include, for example, health / lifestyle monitoring applications, social media applications, and the like.

[0207] The analyte sensor application 330 may include various code / functional modules, such as a display module, a menu module, a list module, and the like, as will become clear from the description of the various functionalities herein (e.g., in conjunction with the disclosed method). These modules may be implemented individually or in combination. Each module may include a computer-readable medium and computer executable code stored thereon, so that the code can be operatively coupled to a processor 335 and / or executed by it (the processor, for example, may include a circuit system for such execution) to perform specific functions (e.g., as described herein with respect to various operations and flow charts, etc.) relative to interfacing with analyte data and performing tasks related thereto. As will be further described below, the display module may present various screens to the user (e.g., via a display 345), wherein the screen contains a graphical representation of the information provided by the application 330. In other embodiments, the application 330 may be used to display to the user an environment for viewing various display devices that can be connected to the analyte sensor system 308 and interacting therewith, as well as interacting with the analyte sensor system 308 itself. Sensor applications 330 may include native applications that are modified with a software design kit (eg, depending on the operating system) in order to implement the functionality / features described herein.

[0208] Reference again Figure 3BDisplay device 310 also includes a processor / microcontroller 335. Processor 335 may include processor submodules, including, for example, an application processor that interfaces with and / or controls other components of display device 310 (e.g., connectivity interface 315, application 330, GUI 340, display 345, RTC 350, etc.). Processor 335 may include a controller and / or microcontroller that provides various controls related to device management (e.g., interfaces with buttons and switches), such as a list of available or previously paired devices, information related to measurements, information related to network conditions (e.g., link quality, etc.), information related to the timing, type, and / or structure of signaling exchanged between analyte sensor system 308 and display device 310, and the like. Additionally, the controller may include various controls related to the collection of user input, such as a user's fingerprint (e.g., to authorize user access to data or to be used for authorization / encryption of data, including analyte data), as well as analyte data.

[0209] The processor 335 may include circuit systems, such as logic circuits, memory, battery and power circuit systems, and other circuit system drivers for peripheral components and audio components. The processor 335 and any of its sub-processors may include logic circuits for receiving, processing and / or storing data received and / or input to the display device 310 and data to be transmitted or delivered by the display device 310. The processor 335 can be coupled to the display 345 as well as the connectivity interface 315 and the storage device 325 (including the application 330) via a bus. Therefore, the processor 335 can receive and process the electrical signals generated by these respective elements and thus perform various functions. For example, the processor 335 can access stored content from the storage device 325 under the instruction of the application 330, and process the stored content for display and / or output by the display 345. In addition, the processor 335 can process the stored content for transmission to other display devices 310, analyte sensor systems 308 or server systems 334 via the connectivity interface 315 and the communication media 305. The display device 310 may be included in Figure 3B Other peripheral components not shown in detail.

[0210] In other embodiments, the processor 335 may further obtain, detect, calculate, and / or store data input by the user via the display 345 or GUI 340 or data received from the analyte sensor system 308 (e.g., analyte sensor data or related signaling) over a period of time. The processor 335 may use this input to gauge the user's physiological and / or mental response to the data and / or other factors (e.g., time of day, location, etc.). In various embodiments, the user response or other factors may indicate a preference for use of certain display devices 310 under certain conditions and / or the use of certain connection / transmission schemes under various conditions, as will be described in further detail herein.

[0211] It should be noted at this time that similarly named elements between the display device 310 and the analyte sensor system 308 may include similar features, structures, and / or capabilities. Thus, the description of the display device 310 above with respect to such elements may in some cases apply to the analyte sensor system 308.

[0212] Now turn Figure 3C , depicts a system 304 according to an embodiment of the present disclosure. As shown, system 304 includes an analyte sensor system 308 communicatively coupled to display devices 310a, 310b via a communication medium 305a. Display device 310a is also communicatively coupled to display device 310b via a communication medium 305b. By way of example, Figure 3C Description In an example embodiment of the present disclosure, the display device 310a can be connected to the analyte sensor system 308 using a first connection scheme and a first wireless protocol (e.g., BLE or any other preferred communication protocol and / or scheme). In an embodiment, the display device 310b can also be connected to the analyte sensor system 308 using the first connection scheme and the first wireless protocol (e.g., BLE) and / or utilizing a second connection scheme and a second wireless protocol that are different from the first connection scheme and the first wireless protocol. Subsequently, the display device 310a can also be connected to the display device 310b using any of the first connection scheme and the first wireless protocol, the second connection scheme and the second wireless protocol, and / or the third connection scheme and the third wireless protocol (e.g., Wi-Fi, NFC, etc.). In addition, for example, the display devices 310a and 310b can exchange analyte data with each other via the communication medium 305b, wherein each display device 310a, 310b receives the analyte data via the communication medium 305a, i.e., receives the analyte data from the analyte sensor system 308. After studying the entirety of the present disclosure, by Figure 3C Additional aspects and features of the representation will become apparent.

[0213] Factory calibrated and tested

[0214] Before a user can utilize the analyte sensor system 308, it may first be programmed and / or factory calibrated using sensor calibration data. Such programming may include at least the sensor 375 and / or sensor measurement circuitry 370 ( Figure 3B ) onto the storage device 365 so that the sensor measurement circuit system 370 can accurately measure, estimate, or otherwise determine the user's analyte concentration based on the signal from the sensor 375. However, because such programming must be performed for many analyte sensor systems (in some cases, thousands of units or more), it is desirable to simplify the programming and / or factory calibration process as much as possible. Therefore, some embodiments described below provide simplified factory calibration of the sensor 375 and / or sensor measurement circuit system 370 by minimizing the amount of communication required to initiate and verify the connection between the factory calibration system and the analyte sensor system 308 and by minimizing the amount of communication utilized when performing factory calibration.

[0215] Figure 3D Aspects of an example factory calibration system 399 that can be used in conjunction with implementing embodiments of the present disclosure are described. The system 399 can include one or more of a factory calibration station 381, a sensor calibration database 392, a server 391, and an analyte sensor kit box 398. Several components of the factory calibration station 381, the sensor calibration database 392, the server 391, and the analyte sensor kit box 398 are described below. However, it should be understood that the factory calibration station 381, the sensor calibration database 392, the server 391, and the analyte sensor kit box 398 can include more, fewer, or different components than those discussed.

[0216] In some embodiments, the analyte sensor system 308 can be packaged together with at least one applicator (not shown) within an analyte sensor kit box 398. An identification tag 397 (e.g., a barcode, QR code, etc.) can be disposed on the analyte sensor system 308, the applicator, the analyte sensor kit box 398, or anywhere else such that the identification tag 397 is easily accessible by the factory calibration station 381, e.g., without having to modify, open, or disassemble the analyte sensor kit box 398. The identification tag 397 can be encoded to identify a specific sensor 375 disposed within the analyte sensor system 308. For example, in some embodiments, the identification tag 397 can be encoded with at least one applicator lot number corresponding to the applicator disposed within the analyte sensor kit box 398 and a sensor serial number corresponding to the sensor 375 disposed within the analyte sensor system 308, as will be described in more detail below.

[0217] The factory calibration station 381 may include a processor 386 and a memory 387 configured to communicate with the factory calibration station 381, a server 391, a sensor calibration database 392, and / or one or more other components of the analyte sensor system 308. In some embodiments, the memory 387 may be loaded with non-transitory computer-readable instructions that, when executed by the processor 386, implement at least the functionality described in this disclosure.

[0218] The factory calibration stand 381 may include a load sensor 382 configured to sense when the analyte sensor kit case 398 is properly positioned on or near the factory calibration stand 381 for factory calibration of the analyte sensor system 308. In some embodiments, the load sensor 382 may include a scale, and proper positioning of the analyte sensor kit case 398 may be sensed based on the load sensor 382 generating a signal indicative of the load on the load sensor 382, ​​which may correspond to the analyte sensor kit case 398.

[0219] The factory calibration station 381 may further include an identification tag scanner 383 configured to read the identification tag 397. The information encoded in the identification tag 397 may then be used by the factory calibration station 381 to retrieve the unique sensor calibration data for the sensor 375 from the sensor calibration database 392. In some embodiments, the sensor calibration data for multiple sensors, including the sensor 375, may be stored in the sensor calibration database 392 in the form of a .CSV lookup table. However, the present disclosure is not limited in this regard, and the sensor calibration data may be stored in any format.

[0220] The factory calibration station 381 may further include a short-range communication controller 384 configured to communicate with the transmitter 360 (which may include a short-range antenna and associated circuitry) to wake up (e.g., transition to an operational mode) one or more components of the analyte sensor system 308 when the analyte sensor system 308 is brought sufficiently close to the controller 384. In some embodiments, the controller 384 may include a near-field communication (NFC) controller. The controller 384 may then transmit at least a portion of the sensor calibration data for the sensor 375 retrieved from the sensor calibration database 392 to the analyte sensor system 308 via the transmitter 360. The transmitted sensor calibration data may be written and / or stored in one or more locations within the storage device 365 of the analyte sensor system 308. In some embodiments, because the NFC communication protocol is utilized, the sensor calibration data may be written to one or more locations within the storage device 365 using a single NFC command (e.g., 0x7A - Get Sensor Parameters), thereby eliminating or at least substantially reducing the use of other time-consuming pairing and authentication protocols during at least this stage of factory calibration.

[0221] The factory calibration station 381 may further include one or more label printers 388 configured to print one or more labels indicative of data associated with the factory calibration process of the analyte sensor system 308 .

[0222] The factory calibration station 381 may be further configured to generate and / or transmit information regarding the factory calibration process of the analyte sensor system 308 to a server 391, which may be configured to generate and / or transmit one or more summary reports regarding the factory calibration process of one or more analyte sensor systems.

[0223] Some embodiments describe an example of information encoding provided by the identification tag 397 below. The identification tag 397 can be a 2-dimensional barcode that encodes the applicator lot number corresponding to the analyte sensing kit box 398 and the sensor serial number corresponding to the sensor 375 of the analyte sensor system 308 in a single string. Therefore, after scanning the identification tag 397, the identification tag scanner 383 can be configured to retrieve the applicator lot number and the sensor serial number in a single string. The example described below is for illustrative purposes only.

[0224] In some embodiments, the applicator batch number may include a numeric string without letters and may be stored as an unsigned 32-bit number (U32). 32 (4,294,967,296) possible unique applicator lot numbers. An example of such an applicator lot number may be 151110428. In other embodiments, the applicator lot number may include another combination of numbers, letters, and / or other symbols.

[0225] In some embodiments, the sensor serial number may include the 8-bit portion of the sensor's universal fixture serial number and a character (e.g., AH) that indicates the starting position of the 8-bit sensor serial number within the complete universal fixture serial number. The 8-bit sensor universal fixture serial number and the character may be encoded together as an unsigned 32-bit number (u32), where the least significant 24 bits (LSBs) of U32 specify the 8-bit sensor serial number and the most significant 8 bits (MSBs) of U32 specify the universal fixture position indicator character, for example, in ASCII format. An example of such a sensor serial number may be 700958B. In other embodiments, the sensor serial number may include another combination of numbers, letters, and / or other symbols.

[0226] Thus, using the above example applicator lot number and sensor serial number, the barcode 397 can be configured to encode the following single string: 151110428 700958B, with bold and underlining used for clarity purposes only. When scanned by the identification tag scanner 383, the identification tag 397 will then provide the following three pieces of information: [Applicator Lot Number][6-digit Serial Number][Universal Fixture Position Character] is [151110428][700958][B], where the applicator lot number 151110428 is encoded directly as U32, and the sensor universal fixture serial number and position are encoded as 700958 decimal = 0x0AB21E hexadecimal and ASCII "B" = 86 decimal = 0x42 hexadecimal, respectively, and then reassembled and / or concatenated (MSB to LSB) to indicate in U32 as: [8]

[24] = [ASCII B = 86][700958] = 1107997214 (66*2 24 +700958); and in hexadecimal notation: [8]

[24] =[0x42][0x0A][0xB2][0x1E]=0x420AB21E.

[0227] An example use of a single 0x7A NFC command for transmitting sensor calibration data from the factory calibration station 381 to the analyte sensor system 308 utilizing the NFC controller 384 and the NFC antenna and / or transmitter circuitry within the transmitter 360 , respectively, will now be described.

[0228] In some embodiments, the factory calibration station 381 can cause sensor calibration data to be written to the storage device 365 of the analyte sensor system 308 using a single NFC command 0x7A, wherein the sensor calibration data includes the following parameters: the initial slope (m0) of the sensor 375, the final slope (mf) of the sensor 375, an applicator lot number associated with the analyte sensor kit box 398, such as described above, a sensor serial number of the sensor 375, such as described above, and a sensor calibration check date (cc). This sensor calibration data can be transmitted to the analyte sensor system 308 in 20 bytes according to the following table, as provided by the NFC command 0x7A.

[0229] Table 1

[0230]

[0231] The sensor initial slope (m0) can be read from the sensor calibration database 392, for example, indexed by the applicator lot number and sensor serial number read from the identification tag 397. The sensor initial slope (m0) can have units of picoamperes per milligram per deciliter (pA / mg / dL) and can be programmed as a floating point number (float) in the transmitter database within the storage device 365 via command 0x7A using 4 bytes (bytes 0 to 3) without encoding in some embodiments. Once written, this value is non-volatile and can remain in the transmitter database of the storage device 365 until overwritten or until the transmitter database is erased.

[0232] The sensor final slope (mf) can be read from the sensor calibration database 392, for example, indexed by the applicator lot number and sensor serial number read from the identification tag 397. The sensor final slope (mf) can have units of pA / mg / dL and can be programmed as a floating point number (float) in the transmitter database within the storage device 365 via command 0x7A using 4 bytes (bytes 4 to 7) without encoding in some embodiments. Once written, this value is non-volatile and will remain in the transmitter database of the storage device 365 until overwritten or until the transmitter database is erased.

[0233] As previously described, the applicator lot number may already be encoded in the identification tag 397 and may be programmed as an unsigned 32-bit number (u32) in the User Information Configuration Register (UICR) memory within the storage device 365 using 4 bytes (bytes 8 through 11) via command 0x7A, as previously encoded. Once written, this value is non-volatile and may remain in the transmitter UICR memory of the storage device 365 until overwritten or until the transmitter UICR memory is erased or refreshed.

[0234] As previously described, the sensor serial number may already be encoded in the identification tag 397 and may be programmed as an unsigned 32-bit number (u32) in the User Information Configuration Register (UICR) memory within the storage device 365 using 4 bytes (bytes 12-15) via command 0x7A, as previously encoded. Once written, this value is non-volatile and may remain in the transmitter UICR memory of the storage device 365 until overwritten or until the transmitter UICR memory is erased or refreshed.

[0235] The sensor calibration check date (cc) can be read from the sensor calibration database 392, for example, indexed by the applicator lot number and sensor serial number read from the identification tag 397. The sensor calibration check date (cc) can be the UTC timestamp of when the sensor calibration check was performed and can be programmed as an unsigned 32-bit number (u32) in the User Information Configuration Register (UICR) memory within the storage device 365 using 4 bytes (bytes 16 to 19) via command 0x7A, as previously encoded. Once written, this value is non-volatile and can remain in the transmitter UICR memory of the storage device 365 until overwritten or until the transmitter UICR memory is erased or refreshed.

[0236] Now it will be combined below Figure 5 Description for calibration against the above factory calibration (e.g. Figure 3D ) method 500 of an analyte sensor.

[0237] At operation 502, method 500 includes scanning an identification tag encoding information that identifies the analyte sensor system. For example, the factory calibration station 381 can scan the identification tag 397 of the analyte sensor kit box 398 using the identification tag scanner 383. As previously described, the identification tag 397 can be a 2-dimensional (2D) barcode that encodes at least one applicator lot number and a sensor serial number corresponding to the analyte sensor system in a single string of characters.

[0238] At operation 504, method 500 includes retrieving sensor calibration data based at least in part on the information identifying the analyte sensor. For example, the factory calibration station 381 may retrieve sensor calibration data specifically corresponding to sensor 375 from the sensor calibration database 392. The sensor calibration data may include an initial slope (m0) determined for the sensor 375, a final slope (mf) determined for the sensor 375, and a date (cc) on which a test procedure was performed to determine the initial and final slopes of the sensor 375. As previously described, in some embodiments, the initial slope (m0), final slope (mf), and date (cc) of the sensor 375 may be indexed in the sensor calibration database 392 based on the applicator lot number and the sensor serial number corresponding to the sensor 375.

[0239] At operation 506, method 500 includes positioning the analyte sensor system sufficiently close to a factory calibration stand for a short-range communication controller of the factory calibration stand to cause a short-range antenna within the analyte sensor system to transition at least a portion of the analyte sensor system to an operational mode. For example, moving the analyte sensor kit case 398 within a predetermined distance (e.g., 10 cm) of the factory calibration stand 381 may allow a near-field communication signal transmitted by the NFC controller 384 to cause an NFC antenna within the transmitter 360 of the analyte sensor system 308 to generate a signal configured to wake up at least one of the connectivity interface 355, the storage device 365, the sensor measurement circuitry 370, the sensor 375, the processor 380, and / or the real-time clock 385 to prepare for receiving sensor calibration data.

[0240] At operation 508, method 500 includes transmitting at least sensor calibration data to the analyte sensor system via short-range communication in response to the command, thereby facilitating calibration of the continuous analyte sensor system. For example, using NFC, the factory calibration station 381 can utilize a single 0x7A NFC command to transmit the initial slope (m0), final slope (mf), test procedure date (cc), applicator batch number, and sensor serial number to the analyte sensor system 308. This sensor calibration data can be stored in one or more memory locations within the analyte sensor system 308, such as the storage device 365.

[0241] In some embodiments, at operation 510, method 500 may further include causing the analyte sensor system to return to a sleep mode after storing the sensor calibration data in a storage device of the analyte sensor system. For example, in some embodiments, the factory calibration station 381 may be configured to further send a sleep command to the analyte sensor system 308, for example, via the NFC controller 384, after receiving confirmation from the analyte sensor system 308 that the 0x7A command was successfully completed. In some other embodiments, the analyte sensor system 308 may be configured to automatically return to a sleep mode after storing the sensor calibration data in one or more locations within the storage device 365. Returning to a sleep mode after storing the sensor calibration data can minimize or at least significantly reduce the power usage of the analyte sensor system 308 during and after the factory calibration process, thereby extending the useful battery life during subsequent use by the patient.

[0242] Steering Figure 3EIn addition to factory calibration, the analyte sensor system 308 may be tested to ensure expected operation. Such testing may include communication between the factory test station 351 and the analyte sensor system 308. However, such communication may include advertising, connection, and authentication processes that occur before any meaningful test communication is performed, thereby achieving a time-saving communication process. This problem is complicated when such test protocols include writing to the user information configuration register (UICR) within the storage device 365 of the analyte sensor system 308, for example, because such writing may cause the analyte sensor system 308 to restart, which may result in repeated advertising, connection, and authentication processes. In addition, some test protocols may require direct communication with the connectivity interface 355 and / or transmitter 360 of the analyte sensor system 308, at least for performing some types of field fault analysis. Because such tests can be performed for many analyte sensor systems (in some cases thousands of units or more), it is necessary to simplify the factory testing process. Therefore, some embodiments described below provide simplified factory testing of the analyte sensor system 308, which avoids advertising, connection, and authentication processes during at least part of such factory testing.

[0243] Figure 3E The system 359 shown in FIG may include a factory test bench 351 and an analyte sensor system 308. In some embodiments, the analyte sensor system 308 may be housed in an analyte sensor kit box 398, as previously described in connection with FIG. Figure 3D However, the present disclosure is not limited in this regard and the analyte sensor system 308 can be tested while outside the analyte sensor kit case 398. In some embodiments, the system 359 can further include an analyte sensor system test database 357 on which can be stored instructions and / or data that can be retrieved, stored, and / or used before, during, and / or after one or more factory test protocols for the analyte sensor system 308.

[0244] Several components of the factory test station 351, the analyte sensor system test database 357, and the analyte sensor system 308 will be described below. However, it should be understood that the factory test station 351, the analyte sensor system test database 357, and the analyte sensor system 308 may include more, fewer, or different components than those discussed.

[0245] In the illustrated embodiment, the factory test stand 351 includes a connectivity interface 352 (which in turn includes a transceiver 353), a storage device 354 (which in turn stores one or more test programs 356 and / or other applications), a processor / microprocessor 357, a real-time clock (RTC) 361, and in some cases a display 359 and a graphical user interface (GUI) 358 that can be presented on the display. A bus (not shown here) can be used to interconnect the various elements of the factory test stand 351 and transfer data between these elements.

[0246] The storage device 354 may also be used to store the operating system of the factory test station 351 and / or a custom (e.g., proprietary) application designed for wireless data communication between the transceiver 360 of the analyte sensing system 308 and the transceiver 353 of the factory test station 351. The storage device 354 may be a single memory device or multiple memory devices and may be volatile or non-volatile memory for storing data and / or instructions for the software programs and applications. The instructions may be executed by the processor 357 to control and manage the test process.

[0247] To facilitate instantaneous wireless communication between the factory test station 351 and the analyte sensor system 308, each of the transceiver 353 (of the factory test station 351) and the transceiver 360 (of the analyte sensor system 308) may include the same or substantially similarly designed and / or programmed radio chip (e.g., a Nordic chip). Utilizing the same or substantially similarly designed and / or programmed radio chip facilitates point-to-point wireless communication between the factory test station 351 and the analyte sensor system 308 without using a commercially standardized communication protocol stack, such as BLE. For example, one or more of transceiver 353, connectivity interface 352, and storage 354, and one or more of transceiver 360, connectivity interface 355, and storage 365 may each include firmware configured to enable transceivers 353, 360 to send and receive raw data packets between each other during a factory testing process, which may allow such testing processes to be completed an order of magnitude faster than using a standardized communication protocol, such as BLE and its associated BLE stack. Such non-standardized communications may be facilitated by directly configuring one or more registers appropriately on transceivers 353, 360, without requiring the activation of, for example, a BLE stack.

[0248] In such embodiments, transceivers 353, 360 can each be pre-configured and / or pre-programmed to communicate with each other (e.g., transmit and / or receive one or more signals) on the same programming frequency (e.g., channel) during the test process. This pre-configuration eliminates any requirement for negotiating channel selection between transceivers 353, 360. For example, after waking up from sleep mode, the transceiver 360 of the analyte sensor system 308 monitors a predetermined frequency channel for a data packet of a predetermined size and format. In such embodiments, during the test process, the factory test bench 351 can be a "master device", and the analyte sensor system 308 can be a "slave device". The transceiver 353 is configured to transmit and the transceiver 360 is configured to receive a data packet, which includes a request (e.g., job code) for the analyte sensor system 308 to execute one or more tasks or programs designed to verify the expected operation of the analyte sensor system 308. After receiving the request packet, one or more of transceiver 360, connectivity interface 355, and processor 380 may process the request. Transceiver 360 then transmits, and transceiver 353 receives, a response conveying the result of the request. After completing the test procedure, transceiver 353 transmits, and transceiver 360 receives, a message instructing one or more components of analyte sensor system 308 to return to sleep mode. In some embodiments, this message may include an "all done" job code.

[0249] In some embodiments, data packet transmission failures and / or conflicts can be alleviated by utilizing conventional timeouts and retries. In some embodiments, multiple test benches can be provided to operate in parallel by utilizing the RF shielding around each test bench including the factory test bench as described above and the tested analyte sensor system. In some other embodiments, multiple test benches can be provided to operate in parallel by preconfigured and / or preprogrammed each analyte sensor system tested to utilize only one of the multiple available frequencies (e.g., channels) for the test process. In such embodiments, each factory test bench can be configured to synchronize with or track a specific analyte sensor system that is preconfigured and / or preprogrammed to utilize the same frequency (e.g., kHz, MHz, or GHz frequency or any frequency suitable for radio frequency communication) during the test process.

[0250] Now it will be combined below Figure 6A Describes the tests used for the above factory tests (e.g. Figure 3E ) is a flowchart 600 of an analyte sensor system. Flowchart 600 may correspond to the operation of analyte sensor system 308.

[0251] At operation 602, flowchart 600 includes waking at least a portion of the analyte sensor system from a sleep mode. For example, analyte sensor system 308 may be configured to wake from a power save, storage, or sleep mode in response to initiation of a test procedure.

[0252] At operation 604, flowchart 600 includes receiving, using a first transceiver chip, a data packet transmitted from a second transceiver chip, the data packet including a request for the analyte sensor system to perform one or more tasks designed to verify the intended operation of the analyte sensor system. For example, transceiver 353 of factory test bench 351 is configured to transmit, and transceiver 360 of analyte sensor system 308 is configured to receive, a data packet including a request (e.g., a job code) for analyte sensor system 308 to perform one or more tasks or programs designed to verify the intended operation of analyte sensor system 308. Transceivers 353 and 360 may include the same or substantially similar transceiver chips (e.g., Nordic chips).

[0253] At operation 606, flowchart 600 includes processing the request. For example, upon receiving the request data packet, one or more of transceiver 360, connectivity interface 355, and processor 380 of analyte sensor system 308 may process the request.

[0254] At operation 608, flowchart 600 includes utilizing the first transceiver chip to transmit a response returning the result of the request to the second transceiver chip. For example, transceiver 360 of analyte sensor system 308 may transmit and transceiver 353 of factory test station 351 may receive a response returning the result of the request.

[0255] At operation 610, flowchart 600 includes receiving, using the first transceiver chip, a message transmitted from the second transceiver chip, the message including instructions for returning one or more components of the analyte sensor system to sleep mode. For example, transceiver 353 of factory test station 351 may transmit and transceiver 360 of analyte sensor system 308 may receive a message including instructions for returning one or more components of analyte sensor system 308 to sleep mode. In some embodiments, this message may include an "all done" job code.

[0256] Now it will be combined below Figure 6A Describes the tests used for the above factory tests (e.g. Figure 3E ) is a flow chart 650 of an analyte sensor system of the present invention. The flow chart 650 may correspond to the operation of the factory test station 351.

[0257] At operation 652, flowchart 650 includes transmitting, using the second transceiver chip, a data packet to the first transceiver chip, the data packet including a request for the analyte sensor system to perform one or more tasks designed to verify the intended operation of the analyte sensor system. For example, transceiver 353 of factory test bench 351 is configured to transmit, and transceiver 360 of analyte sensor system 308 is configured to receive, a data packet including a request (e.g., a job code) for analyte sensor system 308 to perform one or more tasks or programs designed to verify the intended operation of analyte sensor system 308. Transceivers 353 and 360 may include the same or substantially similar transceiver chips.

[0258] At operation 654, flow chart 650 includes receiving a response from the first transceiver chip backing the result of the request using the second transceiver chip. For example, transceiver 360 of analyte sensor system 308 may transmit and transceiver 353 of factory test station 351 may receive a response backing the result of the request.

[0259] At operation 656, flowchart 650 includes transmitting a message to the first transceiver chip using the second transceiver chip, the message including instructions for returning one or more components of the analyte sensor system to sleep mode. For example, transceiver 353 of factory test station 351 may transmit and transceiver 360 of analyte sensor system 308 may receive a message including instructions for returning one or more components of analyte sensor system 308 to sleep mode. In some embodiments, this message may include an "all done" job code.

[0260] Analyte sensor system low power, sleep and / or storage mode and wake-up circuitry

[0261] Figure 4 is a block diagram illustrating potential aspects of an analyte sensor system 408 according to an embodiment of the present disclosure. In some embodiments, the analyte sensor system 408 may correspond to Figure 3B Analyte sensor system 308. Figure 4The aspects of the analyte sensor system 408 shown in FIG4 can be implemented within the subsystem 400 of the analyte sensor system 408 and can generally be used to manage the radio interface between the analyte sensor system 408 and any display device communicatively coupled to the analyte sensor system via one or more wireless protocols (e.g., BLE, Wi-Fi, cellular, and / or NFC). For example, an application programming interface (API) 450 can be provided for the display device to communicate with a processor 420 (e.g., processor 380) via a radio 425, which can include BLE or another RF or microwave transceiver (e.g., transceiver 360). The processor 420 can be used to process analyte data collected by the sensor 405 (e.g., sensor 375).

[0262] As shown, within the analyte sensor system 408, the subsystem 400 may include a sensor 405 (e.g., sensor 10), an analog front end (AFE) 410 (e.g., sensor electronics module 12), a battery 415, a processor 420, and a radio 425. The design of the analyte sensor system 408, including the design of the subsystem 400 and associated software, enables multi-chip operation and management, particularly where such operation and / or management is performed in accordance with the power conservation principles described herein and may involve implementing a system configuration that supports / maximizes power conservation. For example, the design enables system boot-up, inter-chip communication, application task scheduling, storage, and maximization of battery life in active mode, as well as the utilization of control points and indications by the API 450 associated with the radio 425.

[0263] Analyte sensor system 408 can be in storage mode before analyte sensor system 408 has been inserted into main body.In storage mode, radio 425 can be at least partially disabled to save electricity.Similarly, processor 420 can be at least partially disabled by disabling the clock (e.g., RTC 350) used by processor 420. In addition, it is expected that in storage mode, radio 425 can be configured in deep sleep mode. This can advantageously extend / maximize the battery life of analyte sensor system 408. In some embodiments, when interacting with display device 310 via NFC or visible light modulation and emission protocol, analyte sensor system 408 can exit storage mode. In some embodiments, after detecting that sensor 405 has been inserted into main body, analyte sensor system 408 can automatically exit storage mode and enter active mode.

[0264] For example, in some embodiments, during such a storage mode (e.g., storage mode), the AFE 410 may include an ASIC configured to periodically wake up (e.g., every 64 seconds), obtain an analyte current reading from the sensor 405, and send a signal (e.g., wakeup source 435) to the processor 420 when the reading is greater than a predetermined threshold (e.g., configured during manufacturing), thereby waking up the processor 420, which may then perform a secondary sensor confirmation check. In some embodiments, this predetermined threshold (e.g., 20 nA) may be determined based on the average current draw of the sensor 405 during hydration and electrochemical normalization that occurs after the sensor 405 is inserted into the host. If the secondary sensor confirmation check passes, the analyte sensor system 408 may be able to determine that it has been deployed and begin the connection process with one or more display devices. However, if the analyte current reading from the sensor 405 is not greater than the predetermined threshold, the AFE 410 may revert to sleep mode until the next wakeup cycle (e.g., 64 seconds after the previous wakeup cycle), when the procedure can be repeated.

[0265] However, the time period between opening the box containing the analyte sensor system 408 and starting this connection process is not deterministic, as it can be affected by many factors, including but not limited to the time it takes to insert the sensor 405 into the body, and the time it takes for the sensor 405 to properly hydrate once inserted into the body (which can vary from body to body). Due to the unclear timeline associated with the process, the variability of these and other related factors can impair the user experience. In addition, because the triggering event for exiting storage mode is a measured analyte current reading from the sensor 405 exceeding a predetermined threshold, static discharge of the sensor 405 and / or AFE 410 can inappropriately trigger a false positive for exiting storage mode, thereby increasing the risk that the battery 415 will be partially or completely depleted when actually deployed by the host. Therefore, it may be necessary to provide a more defined sequence for initially exiting storage or storage mode that is less sensitive to timeline variability and false wakeups as described above.

[0266] Thus, in some embodiments, during manufacturing and / or factory packaging, a shorting element 455 can be placed in electrical contact with each terminal of the sensor 405, electrically shorting the terminals. In some embodiments, the shorting element 455 can comprise a conductive wire or sheet. In some embodiments, the shorting element 455 comprises a molded or stamped low-resistance and / or conductive foam configured to electrically short the two terminals of the sensor 405 while the sensor 405 is positioned in its package, comprising the low-resistance and / or conductive foam. After the shorting element 455 is positioned across the terminals of the sensor 405, the analyte sensor system 408 can be placed in a storage or stowage mode, during which the AFE 410 is configured to periodically wake up (e.g., every 64 seconds) and obtain analyte current readings from the sensor 405.

[0267] However, in contrast to the embodiments described above, in which the analyte current reading from sensor 405 exceeds a predetermined threshold value to trigger the exit of storage mode, here, the measured analyte current reading from sensor 405 is lower than a different predetermined threshold value to trigger the exit of storage mode. For example, although the short-circuit element 455 short-circuits the terminals of sensor 405, the measured analyte current reading from sensor 405 is a maximum value or close to a maximum value. When the short-circuit element 455 is removed from the terminals of sensor 405, the measured analyte current reading from sensor 405 will be zero or close to zero, thereby signaling that sensor 405 has been removed from its package and is likely in use. After exiting storage mode, analyte sensor system 408 can be configured to immediately start Bluetooth or BLE pairing operation, or another wireless communication protocol pairing operation, to establish a connection with at least one display device, as will be described in more detail below in conjunction with one or more embodiments. In such embodiments, secondary sensor inspection may not be required. After successful pairing, the analyte sensor system 408 may monitor the analyte current readings from the sensor 405 for signal characteristics indicative of sensor break-in and / or hydration to confirm that the analyte sensor system 408 is properly mounted to the body-worn receptacle.

[0268] The embodiment utilizing this short-circuit element 455 provides at least several other benefits. For example, because the action of removing the short-circuit element 455 provides a deterministic time for the process to start and the analyte sensor system 408 does not need to wait for sensor hydration or running-in, the time interval required for pairing is reduced. In addition, there is no longer a risk of false wake-up in static discharge because the triggering event is that the analyte current reading from the sensor 405 is lower than a predetermined value, rather than the analyte current reading from the sensor 405 being higher than the same or another predetermined value. In some embodiments, a light emitting diode (LED) placed in the analyte sensor system 408 (not shown) can be configured to flash steadily or illuminate when the analyte sensor system 408 has entered the Bluetooth pairing operation, thereby providing the user with further confirmation that the system is working as expected. Alternatively, a notification can be displayed on a display device (e.g., display device 310) to indicate that the analyte sensor system 408 has entered the Bluetooth pairing operation.

[0269] In active mode, low power mode (LPM) can still be used (e.g., to extend / maximize battery life), but RTC 350 can be activated / enabled. This allows processor 420 to accurately track time and perform other clock-based functions while still allowing for power conservation. For example, RTC 350 can be used to perform error recovery using time-based counters and interrupts. The following error recovery scenarios are provided by way of illustration. In one example, if a response message is not received from radio 425 within a given amount of time, processor 420 can reset radio 425. In another example, if the logic of RTC 350 fails, analyte sensor system 408 can be reset by hardware logic using periodic interrupts. In other embodiments, if a message or signal associated with wakeup source 435 (or AFE 410) is not received or fails, an interrupt (e.g., RTC interrupt) can be used to bring processor 420 out of LPM and perform communication functions.

[0270] The processor 420 may act as a system controller for the subsystems 400 within the analyte sensor system 408. For example, after initialization, the radio 425 may enter a sleep state and await instructions from the processor 420. The AFE 410 may be initialized to a default state and also await configuration instructions / commands from the processor 420. The processor 420 may control resetting the AFE 410 and / or the radio 425 if an error is detected. The processor 420 may also reset itself if an internal error condition is detected (e.g., using a hardware watchdog).

[0271] The subsystem 400 of the analyte sensor system 8 can utilize a multi-chip (or multi-module) design, in which case a hardware communication bus can be used for data exchange among the various chips (or modules). Examples of viable options for the hardware communication bus include Inter-Integrated Circuit (I2C or I2C) and Serial Peripheral Interface (SPI). SPI can be used to achieve reduced power and increased speed relative to I2C.

[0272] The wakeup source 435 and the raw sensor data 430 can be used to maximize the battery life of the analyte sensor system 408. The AFE 410 can generally be used as a wakeup source for the components of the subsystem 400. However, other wakeup sources can be utilized. During normal operation, the AFE 410 can allow the processor 420 to enter a lower power mode (LPM) for energy saving. The wakeup source 435 can be used to signal the processor 420 to exit the LPM so that, for example, the processor 420 can perform operations that are normally unavailable during the LPM period. The wakeup source 435 can periodically signal the processor 420 in this manner and trigger the processor 420 to start processing or executing an operation. The analyte sensor system 408 may include multiple processors and, in some cases, may implement hierarchical task processing in conjunction with the wakeup source 435 so that not all processors are active at the same time. This technology can reduce power consumption and thus extend battery life. For example, the wakeup source 435 may first signal the processor 420 to exit LPM and begin configuring the relevant hardware and software of the analyte sensor system 408 to initiate the transmission of raw sensor (analyte) data from the AFE 410 .

[0273] Raw sensor data 430 may include hardware that transmits sensor data collected by sensor 405 from AFE 410 to processor 420. Such data may be referred to herein as raw sensor data or raw analyte data. Configuration 440 may be a bidirectional interface between processor 420 and AFE 410. In some cases, configuration 440 may be implemented via I2C, but may also be configured via SPI or another interface. Processor 420 and radio 425 may also use SPI and / or I2C buses for communication and data transfer. In some cases, other hardware and software may be used to create an asynchronous interface between processor 420 and radio 425 when using a synchronous protocol (e.g., SPI, etc.).

[0274] AFE 410 may sample raw analyte data from sensor 405 over a period of time (e.g., 7 minutes). During the sampling period, processor 420 and the processor within radio 425 (e.g., baseband processor) may remain in low power mode (LPM). Once AFE 410 completes sampling, AFE 410 may send a signal to processor 420 indicating that processor 420 should exit LPM (i.e., wake up). AFE 410 may then transmit the raw analyte data to processor 420 via configuration 440. AFE 410 may then re-enter LPM. Processor 420 may then process the raw analyte data (e.g., to generate an estimated glucose value) and store the processed analyte data. Processor 420 may then signal the processor of radio 425 via communication interface 445 to transmit the processed analyte data to radio 425. Processor 420 may then enter LPM while waiting for radio 425 to connect to a display device (e.g., display device 310). Once this connection is made, processor 420 may exit LPM, and the display device and processor 420 may exchange data, commands, and / or messaging via radio 425 .

[0275] The API 450 can be used to connect to a device remote from the analyte sensor system 408 via various wireless protocols. An example of this protocol is BLE. In this regard, the API 450 can allow the analyte sensor system 408 to be configured by a user of a display device (e.g., display device 310) running an application, such as an analyte sensor application 330. The analyte sensor application 330 may have been developed by the manufacturer of the analyte sensor system 408 and / or the display device 310, or may be developed by any individual or entity. In the case where the display device is coupled to the analyte sensor system 408 using the BLE standard, the BLE characteristics can be configured according to system design parameters.

[0276] Having described aspects of systems and methods for wireless communication of analyte data above, a number of specific and other improvements will now be provided. Those skilled in the art, after studying this disclosure, will appreciate that these improvements can be implemented using features and combinations of features of the example configurations described above, whether or not expressly referenced thereto.

[0277] Authentication and pairing

[0278] In scenarios involving the connection of two devices via a network (wireless or otherwise), authentication and pairing can be used to prevent unauthorized devices from connecting. For example, when exchanging sensitive data (e.g., personal analyte concentration data), authentication can be used to prevent unauthorized devices or entities from gaining access to the data. In this regard, authentication and pairing protocols can be used to establish or verify the identity of the connecting device. However, securely pairing an analyte sensor system, such as system 308, with a peripheral device, such as display device 310, can be challenging for the user. Therefore, the following sections describe authentication and pairing protocols, respectively. Figures 7 to 8B and 9 through 10B describe several embodiments for automatically pairing such analyte sensor systems to one or more display devices with minimal user input.

[0279] Figure 7 A message passing diagram illustrating pairing operations between one or more analyte sensor systems 708 and one or more display devices 710 according to some example embodiments. In some embodiments, the analyte sensor system 708 and the display device 710 may correspond to either of the analyte sensor system 308 and the display device 310, respectively, as previously described in connection with Figures 3A to 3E described. Figure 8A 800 is a flowchart illustrating various operations that may be performed according to embodiments of the present disclosure. In some embodiments, Figure 8A Flowchart 800 corresponds to the flowchart of Figure 7 Operations and / or actions performed by the analyte sensor system 708. Figure 8B 850 is a flowchart illustrating various operations that may be performed according to embodiments of the present disclosure. In some embodiments, Figure 8B Flowchart 850 corresponds to the Figure 7 The operations and / or actions performed by the display device 710.

[0280] For example, the combined operations may be performed by respective processors executing instructions embodied in respective non-transitory computer-readable media. Figures 7 to 8B The various tasks performed by the programs described in the description may be performed by hardware, software, firmware, or any combination thereof incorporated into one or more computing devices. It will be appreciated, after studying this disclosure, that such programs may include any number of additional or alternative tasks or operations. Figures 8A to 8B The operations shown in the examples do not need to be performed in the order described, and the procedures may be incorporated into other programs not specifically referenced herein. Figures 8A to 8B A more comprehensive program or process of other functionalities is described in detail.

[0281] Now combine Figure 7Describe an example pairing operation. In some embodiments, prior to the operations described below, for example, a user may download an application for monitoring the user's analyte concentration from an app store to the display device 710 and / or otherwise initialize the application. The user may complete the setup of the application, after which the application may instruct the user to deploy the analyte sensor system 708 to prepare for a pairing operation between the analyte sensor system 708 and the display device 710. The application running on the display device 710 may then begin monitoring for advertising messages, such as BLE advertising messages. After deployment, the analyte sensor system 708 may be configured to wake up from a lower power or sleep mode, such as previously combined with Figure 4 described.

[0282] After waking up, the analyte sensor system 708 can be configured to generate a random pairing key. Two parallel advertising messages (e.g., advertising message A 712 and advertising message B 714) can be generated and the radio of the analyte sensor system 708 can transmit the two parallel advertising messages. In some embodiments, the first advertising message 712 may include one or more of the following: an indication of the manufacturer of the analyte sensor system 708 (e.g., Dexcom), an address identifying the analyte sensor system 708 (e.g., a BLE address identifying the analyte sensor system 708 and / or the radio chip stored inside the radio chip of the analyte sensor system 708), an indication that the device or peripheral instance associated with the advertising message 712 can be connected, and an indication of out-of-band (OOB) authentication. In some embodiments, the peripheral instance can be considered to be a software-based object corresponding to a specific communication device, such as a display device 710. In some embodiments, the indication of OOB authentication may indicate that one or more other messages will be transmitted to authenticate the connection. In some embodiments, the second advertisement message 714 may include one or more of the following: an indication of the manufacturer of the analyte sensor system 708 (e.g., Dexcom), an address identifying the analyte sensor system 708 (e.g., a BLE address stored within the radio chip of the analyte sensor system 708), an indication that the device or peripheral instance associated with the advertisement message 714 is unconnectable, and a payload including a random pairing key. The addresses included in each of the first advertisement message 712 and the second advertisement message 714 may be identical. In some embodiments, the random pairing key may be encrypted prior to insertion into the advertisement message 714 and transmission within the advertisement message. In some embodiments, in addition to or in lieu of encryption, the random pairing key may be further masked by placing nibbles and / or a subset of the random pairing key in a proprietary pattern within the payload of the advertisement message 714. In such embodiments, the display device 710 can be configured to decrypt and / or reconstruct the nibbles and / or subsets of the random pairing key, for example, based on the display device 710 having and / or obtaining a priori programming and / or instructions configured to perform such decryption and / or reconstruction. In one example, such a priori programming and / or instructions can be downloaded from a server (which can, among other things, use a transmitter ID to determine what content to pull from the server, etc.).

[0283] Based on the monitoring, the display device 710 can be configured to detect each of the first advertisement message 712 and the second advertisement message 714. The display device 710 can be configured to determine that the first advertisement message 712 and the second advertisement message 714 are valid based at least in part on each message 712, 714 indicating the same manufacturer (e.g., Dexcom) and / or at least in part on each message 712, 714 indicating the same address (e.g., identifying the analyte sensor system 708). In some embodiments, when the display device 710 detects more than one pair of valid messages that meet the description of the first advertisement message 712 and the second advertisement message 714, the display device 710 can be configured to select the pair of valid messages with the highest received signal strength indicator (RSSI). For example, each of the advertisement messages 712, 714 would be expected to have substantially similar RSSI values ​​because the two messages were transmitted from the same device at a sufficiently close time to each other.

[0284] The display device 710 may be further configured to extract and decrypt the random pairing key from the second advertisement message 714. The display device 710 may be configured to generate and transmit a pairing request 716 addressed to the analyte sensor system 708 as indicated by the address in the first advertisement message 712 and further including the decrypted random pairing key.

[0285] The analyte sensor system 708 may receive the pairing request 716 and determine whether the decrypted random pairing key within the pairing request 716 is the same as the random pairing key that the analyte sensor system 708 originally generated, encrypted, and transmitted within the second advertisement message 714. If the decrypted random pairing key is the same random pairing key, the analyte sensor system 708 may generate and transmit a pairing request acceptance message 718 to the display device 710. The analyte sensor system 708 and the display device 710 may then enter into a secure sensor communication session. In some embodiments, if the decrypted random pairing key is different from the random pairing key that the analyte sensor system 708 originally generated, encrypted, and transmitted within the second advertisement message 714, the analyte sensor system 708 may ignore the pairing request 716.

[0286] The description now turns to Figure 8A 8, which depicts, for example, the operation of the analyte sensor system 708. Block 802 includes waking up the analyte sensor 708. For example, the analyte sensor system 708 may be awakened from a storage mode, a sleep mode, or a low power mode after deployment.

[0287] Block 804 includes generating and encrypting a pairing key. For example, upon waking up, the analyte sensor system 708 can be configured to generate a random pairing key for pairing with another device, such as the display device 710. The analyte sensor system 708 can be further configured to encrypt the random pairing key according to any suitable encryption scheme.

[0288] Block 806 includes initializing the transceiver's radio with the first peripheral instance and the second peripheral instance. For example, the analyte sensor system 708 can be configured to advertise its availability for pairing using two advertisement messages configured to allow automatic authentication and pairing between the analyte sensor system 708 and the display device 710.

[0289] Block 808 includes setting a timeout counter. For example, the pairing process may have a set time interval after which, if pairing has not been successful, the pairing process may be determined to have failed. In some embodiments, the analyte sensor system 708 may be configured to set a timeout counter of 80 minutes. However, the present disclosure is not limited thereto, and any suitable time interval may be utilized.

[0290] Block 810 includes generating and transmitting a first advertisement message associated with a first peripheral instance and a second advertisement message associated with a second peripheral instance. For example, the analyte sensor system 708 may be configured to generate a first advertisement message 712 that includes an indication of the manufacturer of the analyte sensor system 708 (e.g., Dexcom), an address identifying the analyte sensor system 708 (e.g., a BLE address stored within a radio chip of the analyte sensor system 708), an indication that the device or peripheral instance associated with the advertisement message 712 is connectable, and an indication of out-of-band (OOB) authentication. The analyte sensor system 708 may also be configured to generate a second advertisement message 714 ( Figure 7 ), which includes the same indication of the manufacturer of the analyte sensor system 708 (e.g., Dexcom), the same address identifying the analyte sensor system 708 (e.g., a BLE address stored inside the radio chip of the analyte sensor system 708), an indication that the device or peripheral instance associated with the advertisement message 714 is not connectable, and a payload including an encrypted random pairing key. The analyte sensor system 708 can transmit the first advertisement message 712 and the second advertisement message 714 in parallel, e.g., simultaneously, consecutively, and / or in the same pairing session.

[0291] Block 812 includes determining whether a pairing request corresponding to the first peripheral instance has been received. For example, in response to the transmission of the first advertisement message 712 and the second advertisement message 714, a device attempting to pair with the analyte sensor system 708, such as the display device 710, may transmit and the analyte sensor system 708 may receive a pairing request 716. If the determination at block 812 is negative, block 814 includes determining whether a timeout counter has expired. If not, the flowchart loops back to block 810. If so, the flowchart proceeds to block 820, where a manual pairing operation may be performed between the analyte sensor system 708 and the display device 710. Afterwards, at block 822, the flowchart 800 may enter a secure communication session for securely communicating analyte data.

[0292] If the determination at block 812 is positive, the flowchart 800 proceeds to block 816, which includes determining whether the pairing request includes a valid pairing key. For example, the analyte sensor system 708 may be configured to determine whether the decrypted pairing key embedded within the pairing request 716 is the same pairing key that the analyte sensor system 708 encrypted and transmitted in the second advertisement message 714. If the determination at block 816 is negative, the flowchart 800 loops back to block 814. If the determination at block 816 is positive, the flowchart 800 proceeds to block 818, which includes generating and transmitting a pairing request acceptance message. For example, the analyte sensor system 708 may be configured to transmit the pairing request acceptance message 718 back to the display device 710. The flowchart 800 then proceeds to block 822, thereby entering a secure communication session for securely communicating analyte data.

[0293] The description now turns to Figure 8B 850, describing the operation of, for example, the display device 710. At block 852, the display device, for example, the display device 710 ( Figure 7 ) is ready to enter into a pairing operation. Block 854 includes initiating monitoring for a pairable device. For example, the display device 710 may be configured to monitor one or more communication channels for one or more messages indicating that a device is attempting to pair with the display device 710.

[0294] Block 856 includes continuing to monitor for pairable devices.For example, the display device 710 can be configured to continue monitoring the one or more communication channels for one or more messages indicating that a device is attempting to pair with the display device 710 within a predetermined time interval.

[0295] Block 858 includes determining whether a first advertisement message associated with a first peripheral instance has been received. For example, in some embodiments, the display device 710 can be configured to detect and / or recognize the first advertisement message 712 based at least in part on the first advertisement message 712 including any one or more of an indication of a manufacturer of the analyte sensor system 708 (e.g., Dexcom, Inc., San Diego, California), an address identifying the analyte sensor system 708 (e.g., a BLE address stored internally in a radio chip of the analyte sensor system 708), an indication that a device or peripheral instance associated with the advertisement message 712 is connectable, and an indication of out-of-band (OOB) authentication.

[0296] If the determination at block 858 is negative, the flowchart 850 may loop back to block 856 and the display device 710 may continue monitoring. If the determination at block 858 is positive, the flowchart 850 proceeds to block 860, which includes determining whether a second advertisement message has been received that includes the same address as the first advertisement. For example, the display device 710 may be configured to detect and / or identify the second advertisement message 714 based at least in part on the second advertisement message 714 including an indication of the same manufacturer (e.g., Dexcom) as indicated in the first advertisement message 712 and the same address as indicated in the first advertisement message 712.

[0297] If the determination at block 860 is negative, the flowchart 850 may loop back to block 856 and the display device 710 may continue monitoring. In some embodiments, more than one pair of first advertisement message 712 and second advertisement message 714 may be received from more than one analyte sensor system. In such embodiments, if the determination at block 860 is positive, the flowchart 850 proceeds to block 862, where the display device 710 may be configured to select the first and second advertisement messages with the highest received signal strength indicator (RSSI). Selecting the qualified advertisement message pair with the highest RSSI may facilitate authentication and pairing with the correct analyte sensor system.

[0298] Block 864 includes extracting the pairing key from the second advertisement message and decrypting the pairing key. For example, the analyte sensor system 708 previously generated, encrypted, and embedded a random pairing key into the payload of the second advertisement message 714. The display device 710 can be configured to extract this embedded pairing key and decrypt this embedded pairing key.

[0299] Block 866 includes generating and transmitting a pairing request message including the decrypted pairing key. For example, the display device 710 may be configured to generate and transmit a pairing request message 716 with the decrypted pairing key received in the second advertisement message 714 to the analyte sensor system 708 .

[0300] Block 868 includes determining whether the pairing request has been accepted. For example, within a predetermined period of time after transmitting the pairing request message 716, the display device 710 may determine that the pairing request initiated by transmitting the pairing request message 716 was accepted based on receiving the pairing request acceptance message 718 from the analyte sensor system 708, or alternatively, based on not receiving a pairing request rejection or negative confirmation message from the analyte sensor system 708.

[0301] If the determination at block 868 is negative, the flowchart 850 proceeds to block 872, which includes determining whether the timeout counter has expired. If so, the flowchart 850 proceeds to block 874, where manual pairing of the analyte sensor system 708 with the display device 710 may occur, for example, by manually entering the transmitter ID into the display device 710, and a secure communication session may be entered at block 870, for example, to securely communicate encrypted analyte data. If not, the flowchart 850 loops back to block 856. If the determination at block 868 is positive, a secure communication session may be entered at block 870.

[0302] Figures 9 to 10B Embodiments are described that utilize asymmetric encryption keys (eg, using a single public key and multiple corresponding private keys) to automatically establish a secure link between an analyte sensor system and one or more peripheral display devices.

[0303] Figure 9 A message passing diagram illustrating pairing operations between an analyte sensor system 908 and one or more display devices 910 according to some example embodiments. In some embodiments, the analyte sensor system 908 and the display device 910 may correspond to either of the analyte sensor system 308 and the display device 310, respectively, as previously described in connection with Figures 3A to 3E described. Figure 10A 1000 is a flowchart illustrating various operations that may be performed according to embodiments of the present disclosure. In some embodiments, Figure 10A Flowchart 1000 corresponds to the process of Figure 9 Operations and / or actions performed by the analyte sensor system 908. Figure 10B 1050 is a flowchart illustrating various operations that may be performed according to embodiments of the present disclosure. In some embodiments, Figure 10B Flowchart 1050 corresponds to Figure 9 The operations and / or actions performed by the display device 910.

[0304] For example, the combined operations may be performed by respective processors executing instructions embodied in respective non-transitory computer-readable media. Figures 9 to 10B The tasks or operations performed in conjunction with the described procedures may be performed by hardware, software, firmware, or any combination thereof incorporated into one or more of the computing devices. It will be appreciated, after studying this disclosure, that such procedures may include any number of additional or alternative tasks or operations. Figures 10A to 10B The operations shown in the examples do not need to be performed in the order described, and the procedures may be incorporated into other programs not specifically referenced herein. Figures 10A to 10B A more comprehensive program or process of other functionalities is described in detail.

[0305] Now combine Figure 9 Describe an example pairing operation. In some embodiments, before the operations described below, a user may, for example, download an application for monitoring the user's analyte concentration from an application store to the display device 910 and / or initialize the application in other ways. The application on the display device 910 may include a single public key 911 "Pub A", which corresponds to a specific product platform (e.g., analyte sensor system 908). For example, an application configured to run on the display device 910 and receive, monitor and / or display analyte concentration data from an analyte sensor 908 of the same model or model category may be preloaded with or have public access to a public key 911 "Pub A" that can be used to encrypt data. The application on the display device 910 may also include a private key 913 "Priv B", which is configured to decrypt data encrypted using a corresponding different single public key 917 "Pub B" that was previously preloaded on a specific product platform (e.g., analyte sensor system 908) or that is publicly available for the specific product platform.

[0306] The analyte sensor system 908 may include a public key 917 "Pub B" configured to encrypt data and a unique private key 915 "Priv A" configured to decrypt data previously encrypted at the display device 910 using the public key 911 "Pub A." The public key 917 "Pub B" may be pre-loaded at the factory on each analyte sensor system 908 for a given product platform. In some embodiments, the private keys 911, 913 may be obtained via secure download or by any other suitable method.

[0307] A public key is referred to as a "public key" because it is publicly available or generally known to a device, while a private key is referred to as a "private key" because it is not publicly available or known to all devices and is kept secret from all devices except authorized devices. As described herein, each public key can encrypt data using a public algorithm. Multiple unique private keys associated with the same single public key can each include a unique algorithm configured to decrypt data previously encrypted using the public algorithm of the associated public key. Thus, in such embodiments, encryption to decryption is one-to-many, as a single public algorithm is used to encrypt data, while any of multiple unique corresponding algorithms can be used to decrypt the previously encrypted data.

[0308] The user of the display device 910 can complete the setup of the application, after which the user can deploy the analyte sensor system 908 to prepare for pairing operations between the analyte sensor system 908 and the display device 910. The application running on the display device 910 can begin monitoring for advertising messages, such as BLE advertising messages. Upon activation, the analyte sensor system 908 can be configured to wake up from a lower power or sleep mode, such as previously associated with the analyte sensor system 908. Figure 4 described.

[0309] After waking up, the analyte sensor system 908 may utilize the transceiver radio to transmit an advertising message 912, thereby establishing a communication channel 914 with the display device 910. One or more other communications (not shown) between the analyte sensor system 908 and the display device 910 may occur during the establishment of the communication channel 914. Private data, such as an analyte value or indication of private data, has not yet been sent, but the communication channel 914 is now available for conveying encrypted data between the analyte sensor system 908 and the display device 910 for subsequent establishment of a secure communication channel.

[0310] After establishing the communication channel 914 , the display device 910 may generate a random number and encrypt the random number using the public key 911 “Pub A.” The display device 910 may then transmit the encrypted random number 916 to the analyte sensor system 908 using the communication channel 914 .

[0311] Upon receipt, the analyte sensor system 908 may decrypt the encrypted random number using the private key 915 “Priv A.” The analyte sensor system 908 may then re-encrypt the random number using the public key 917 “Pub B.” The analyte sensor system 908 may then transmit the re-encrypted random number to the display device 910 using the communication channel 914.

[0312] After receiving, the display device 910 can decrypt the re-encrypted random number using the private key 913 "Priv B". The display device 910 then compares the decrypted random number with the originally generated random number. If the decrypted random number is the same as the originally generated random number, the communication between the analyte sensor system 908 and the display 910 is authenticated and the data 920 can now be transmitted securely. For example, if the data 920 is transmitted through the display device 910, the data can be encrypted by the display device 910 using the public key 911 "Pub A" and decrypted by the analyte sensor system 908 using the private key 915 "PrivA". Similarly, if the data 920 is transmitted through the analyte sensor system 908, the data can be encrypted by the analyte sensor system 908 using the public key 917 "Pub B" and decrypted by the display device 910 using the private key 913 "Priv B". In some embodiments, the data 920 may include session data including one or more analyte concentration values.

[0313] The description now turns to Figure 10A 1000, for example, describes the operation of the analyte sensor system 908. Block 1002 includes transmitting an advertisement message for establishing a communication channel. For example, the analyte sensor system 908 may transmit the advertisement message 912 for establishing the communication channel 914.

[0314] Block 1004 includes receiving a random number encrypted with a first public key via a communication channel. For example, analyte sensor system 908 may be configured to receive a random number 916 encrypted with public key 911 “Pub A” from display device 910 via communication channel 914 .

[0315] Block 1006 includes decrypting the encrypted random number using a first private key associated with the first public key.For example, the analyte sensor system 908 may be configured to decrypt the encrypted random number 916 using the private key 915 "Priv A."

[0316] Block 1008 includes re-encrypting the random number using the second public key. For example, the analyte sensor system 908 may be configured to re-encrypt the currently decrypted random number from block 1006 using the public key 917 "Pub B."

[0317] Block 1010 includes transmitting the re-encrypted random number via the communication channel. For example, the analyte sensor system 908 may be configured to transmit the re-encrypted random number 918 to the display device 910 via the unsecured communication channel 914.

[0318] Block 1012 includes transmitting sensor data encrypted with the second public key via the communication channel. For example, after authenticating communication between the analyte sensor system 908 and the display device 910, the sensor session data may be encrypted with the public key 917 "Pub B" and transmitted to the display device 910 via the communication channel 914 by the analyte sensor system 908. In some embodiments, the display device 910 may also be configured to securely transmit data via the communication channel 914 by encrypting the data with the public key 911 "Pub A." The analyte sensor system 908 may decrypt this encoded data using the private key 915 "Priv A." Because all communications are now encrypted, communication via the communication channel 914 is now secure.

[0319] The description now turns to Figure 10B 1050, for example, describes the operation of the display device 910. Block 1052 includes receiving an advertisement message for establishing a communication channel. For example, the display device 910 may be configured to receive the advertisement message 912 from the analyte sensor system 908 for establishing a communication channel 914.

[0320] Block 1054 includes generating a random number. For example, display device 910 can be configured to generate a random number using any suitable generation method.

[0321] Block 1056 includes encrypting the random number using the first public key. For example, the display device 910 may be configured to encrypt the random number using the public key 911 “Pub A”.

[0322] Block 1058 includes transmitting the encrypted random number using the communication channel. For example, the display device 910 may be configured to transmit the encrypted random number 916 using the communication channel 914.

[0323] Block 1060 includes receiving the random number re-encrypted using the second public key. For example, the display device 910 may be configured to receive the re-encrypted random number 918 (the encrypted random number 916 that was previously decrypted by the analyte sensor system 908 using the private key 915 "Priv A" and then re-encrypted using the public key 917 "Pub B").

[0324] Block 1062 includes decrypting the re-encrypted random number using the second private key. For example, the display device 910 may be configured to decrypt the re-encrypted random number 918 using the private key 913 "Priv B."

[0325] Block 1064 includes comparing the decrypted random number to the originally generated random number. For example, the display device 910 may be configured to compare the decrypted version of the re-encrypted random number 918 to the original random number generated by the display device 910 at block 1054.

[0326] Block 1066 includes authenticating the communication session based on a determination that the decrypted random number is the same as the random number originally generated. For example, the display device 910 may be configured to verify and / or communicate with a trusted device (i.e., the analyte sensor system 908) based on the above-described comparison and subsequent determination that the decrypted version of the re-encrypted random number 918 is the same number as the original random number generated by the display device 910 at block 1054.

[0327] Block 1068 includes receiving sensor data encrypted using the second public key. For example, after authenticating communication between the analyte sensor system 908 and the display device 910, the display device 910 can be configured to receive sensor session data encrypted using the public key 917 "PubB" and transmit it through the analyte sensor system 908. In some embodiments, the display device 910 can also be configured to securely transmit data by encrypting the data using the public key 911 "Pub A." The analyte sensor system 908 can decrypt this encoded data using the private key 915 "Priv A." Because all communications are now encrypted, communication via the communication channel 914 is now secure.

[0328] Select a low-interference channel for communication

[0329] In some embodiments, the initial advertisement for establishing a communication channel may be performed during an interval in which one or more other devices are communicating in parallel. Such interfering communications may adversely affect the efficiency and / or effectiveness of the desired communications on these channels. Therefore, it may be desirable to select a channel with the least amount of interference among a plurality of predetermined channels for such advertisement and subsequent communications. Figure 11 and 12 A discussion follows regarding implementations that may provide such channel selection.

[0330] Figure 11 A portion of an analyte sensor system 1108 is illustrated according to some example embodiments. In some embodiments, the analyte sensor system 1108 may correspond to the analyte sensor system 1108 as previously described in connection with Figures 3A to 3E. The analyte sensor system 308 described in any one of the preceding claims. The analyte sensor system 1108 includes an antenna 1102 coupled to or included in a transceiver 1160. The transceiver 1160 may include a frequency selection circuit 1162, which is configured to select a channel (e.g., a frequency band) on which the antenna 1102 can transmit and / or receive one or more signals. The antenna 1102 is further coupled to each of a plurality of filters F1, F2, and F3 via corresponding switches S1, S2, and S3. In some embodiments, the filters F1, F2, and F3 can transmit signals on BLE channels 37, 38, and 39 corresponding to 2402MHz, 2426MHz, and 2480MHz, respectively. However, the present disclosure is not limited thereto, and the filters F1, F2, and F3 can be configured to transmit signals on any other frequency and / or channel of any suitable wireless communication protocol. In addition, although three filters are described, the present disclosure is not limited thereto, and any number of filters may be utilized.

[0331] In some embodiments, each filter F1, F2, F3 includes a respective inductor L1, L2, L3, a respective capacitor C1, C2, C3, and a respective diode D1, D2, D3 connected in series. However, the present disclosure is not limited thereto and any filter, analog or digital, may be utilized. Each filter F1, F2, F3 may include a bandpass filter configured to pass signals within a respective frequency band (e.g., tuned to a respective channel for BLE advertising) to a power detection and channel selection circuit 1104 coupled to each filter F1, F2, F3. The channel power detection and channel selection circuit 1104 may also be coupled to a switch controller 1106 and may be configured to send one or more signals to the switch controller 1106, causing the switch controller 1106 to select one of the filters F1, F2, F3 by closing the respective switches S1, S2, S3 and / or causing the switch controller 1106 to cause the frequency selection circuit 1162 to select a channel (e.g., a frequency band) over which the antenna 1102 may transmit and / or receive one or more signals.

[0332] In some embodiments, the analyte sensor system 1108 and / or corresponding display device ( Figure 11During intervals (not shown) when the filters F1, F2, F3 are not scheduled to transmit any signals, the switch controller 1106 can be configured to simultaneously or continuously couple each of the filters F1, F2, F3 to the antenna 1102, and the channel power detection and channel selection circuit 1104 can be configured to measure the amount of power (e.g., noise in this case) received on each channel corresponding to each filter F1, F2, F3. The channel power detection and channel selection circuit 1104 can be configured to compare the power measured on each corresponding channel and select the channel with the lowest measured power. It can be assumed that the channel with the lowest measured power presents the lowest level of interference with signals transmitted and / or received by the transceiver 1160 because all powers measured on the channel are present in the analyte sensor system 1108 and / or corresponding display device ( Figure 11 Intervals (not shown) during which no signal is scheduled for transmission are inherently noise. Channel power detection and channel selection circuitry 1104 can be configured to select the channel corresponding to the lowest measured power and send at least one signal to switch controller 1106, which causes frequency selection circuitry 1162 to select the corresponding channel for antenna 1102 to transmit and / or receive one or more signals thereon. In various embodiments, the interference determination and channel selection described above can be performed once, multiple times, or periodically between each transmission interval to account for dynamic and / or periodic interference. In some embodiments, another processor (e.g., a CPU) can override the channel selection provided by channel power detection and channel selection circuitry 1104 for any number of reasons.

[0333] The description now turns to Figure 12 Flowchart 1200, describing e.g. Figure 11 Block 1202 includes sequentially coupling each of a plurality of filter circuits to an antenna, each of the filter circuits being configured to pass a respective signal received by the antenna in a respective frequency channel. For example, the switch controller 1106 may be configured to sequentially couple each of the filters F1, F2, F3 to the antenna 1102 by closing the respective switches S1, S2, S3.

[0334] Block 1204 includes measuring the respective amount of power received on each respective frequency channel when the analyte sensor system is not communicating wirelessly. For example, the channel power detection and channel selection circuitry 1104 may be configured to measure the respective amount of power received on each respective frequency channel passed through filters F1, F2, F3 when the analyte sensor system 308 is not communicating wirelessly.

[0335] Block 1206 includes comparing the measured respective amounts of power received on each respective frequency channel.For example, the channel power detection and channel selection circuitry 1104 may be configured to compare the measured respective amounts of power received on each respective frequency channel.

[0336] Block 1208 includes selecting the corresponding frequency channel having the lowest measured power for the antenna to transmit one or more signals. For example, the channel power detection and channel selection circuitry 1104 may be configured to select the channel corresponding to the lowest measured power and send at least one signal to the switch controller 1106, causing the switch controller 1106 to cause the frequency selection circuitry 1162 to select the corresponding channel for the antenna 1102 to transmit and / or receive one or more signals thereon.

[0337] Reversing the slave-master roles of the analyte sensor system and display device when establishing a communication session

[0338] In some of the above descriptions (e.g., Figures 7 to 10B ), the analyte sensor system acts as a slave and the display device acts as a master, at least in that the analyte sensor system transmitter (e.g., acting as a BLE peripheral) is configured to periodically wake up (e.g., every 5 minutes) and advertise for a period of time in anticipation of monitoring by the display device (e.g., acting as a BLE master, central). Once the display device has discovered the analyte sensor system, established and authenticated a wireless connection, command and control is achieved via the exchange of control endpoints and attributes. However, such intermittent advertising by the analyte sensor system transmitter may require more power than passively monitoring one or more communication channels for advertising.

[0339] Therefore, the present disclosure also contemplates reversing the roles of the analyte sensor system and the display device at least with respect to establishing a communication session with each other. Figure 13 At least one embodiment is described. However, the present disclosure is not limited thereto and this reversal concept may be applied to any description herein regarding establishing a communication session between an analyte sensor system (or any of its components) and a display device (or any of its components) such that actions, steps, or procedures described as being performed by one may instead be performed by the other and vice versa.

[0340] Figure 13 A diagram illustrating a pairing operation between an analyte sensor system 1308 and one or more display devices 1310 according to some embodiments. In some embodiments, the analyte sensor system 1308 and the display device 1310 may correspond to either the analyte sensor system 308 or the display device 310, respectively, as previously described in connection with FIG. Figures 3A to 3E described.

[0341] The analyte sensor system 1308 can be configured to passively monitor for advertisements from peripheral devices of a desired type (e.g., display device 1310). Such monitoring can consume less power than advertising and has the advantage of being able to be performed continuously while one or more processors within the analyte sensor system 1308 are dormant, such as previously described in conjunction with Figure 4 After the display device 1310 wakes up, it can be configured to turn on its BLE radio and generate and transmit an advertising message 1312 .

[0342] Based on the monitoring, the analyte sensor system 1308 can be configured to detect an advertisement message 1312. In response to detecting, and in some cases verifying, the advertisement message 1312 (e.g., as described elsewhere herein or according to any otherwise known verification and / or authentication procedure), the analyte sensor system 1308 can be configured to generate and transmit a pairing request 1316. The display device 1310 can receive the pairing request 1316 and, in response, generate and transmit a pairing request acceptance message 1318 to the analyte sensor system 1308. The analyte sensor system 1308 and the display device 1310 can then enter into a secure sensor communication session. In some embodiments, the analyte sensor system 1308 can be configured to initiate a switch from serving as a slave device to serving as a master device based on satisfying one or more criteria, such as a determination that a battery charge within the analyte sensor system 1308 has fallen below a predetermined level, as described above.

[0343] Display device-initiated transmission of session data from an analyte sensor system

[0344] To conserve power in an analyte sensor system, some embodiments contemplate intermittent connectivity between the analyte sensor system and one or more display devices, wherein the analyte sensor system periodically (e.g., every 5 minutes) wakes up from a low-power or sleep mode to perform analyte concentration measurements and transmit an indication of the measurement to the display device. However, in such embodiments, data (e.g., measurement data and / or analyte values) may be sent from the analyte sensor system to the display device only during the periodic wake-up intervals, and some users may not want to wait for another interval before transmitting the data to the display device, particularly if the user has not received data for an extended period of time (e.g., when the display device is out of range for an extended period of time).

[0345] Thus, some embodiments contemplate a protocol in which the analyte sensor system is configured to monitor, from a low-power state, a signal configured to wake the analyte sensor system so that it initiates a pairing operation and communicates session data without waiting for the next periodic wake-up interval or otherwise scheduled wake-up interval.

[0346] Figure 14A diagram illustrating the pairing operation between an analyte sensor system 1408 and one or more display devices 1410 according to some embodiments. In some embodiments, the analyte sensor system 1408 and the display device 1410 may correspond to either the analyte sensor system 308 and the display device 310, respectively, as previously described in connection with FIG. Figures 3A to 3E described.

[0347] Figure 14 Illustrated are an analyte sensor system 1408 and one or more display devices 1410. The analyte sensor system 1408 may be in a low power or sleep mode, passively monitoring for a signal configured to wake up the analyte sensor system before a predetermined interval for waking up has expired.

[0348] The display device 1410 can be configured to transmit a wake-up signal 1412 (e.g., RF, IR, optical, audio, or any other suitable signal) having a predetermined pattern, magnitude, or modulation to the analyte sensor system 1408. Upon detecting the wake-up signal 1412, the analyte sensor system 1408 can be configured to wake up from a low power or sleep mode (e.g., as previously described in connection with Figure 4 1410. The display device 1410 may be configured to generate and transmit a pairing request 1416 in response to detecting, and in some cases verifying, the advertising message 1412. The analyte sensor system 1408 may receive the pairing request 1416 and, in response, generate and transmit a pairing request acceptance message 1418 to the display device 1410. The analyte sensor system 1408 and the display device 1410 may then enter into a secure sensor communication session in which the analyte sensor system 1408 may transmit data, such as sensor data, to the display device 1410. In some embodiments, the transmission of such sensor data may include implementing a backfill request for specific data and / or any other data from the display device 1410 before a predetermined interval for waking up the analyte sensor system 1408 has expired.

[0349] The description now turns to Figure 15A Flowchart 1500, describing e.g. Figure 14 Block 1502 includes preconfiguring the analyte sensor system to periodically wake up from the low-power passive monitoring mode according to a predetermined interval for waking up the analyte sensor system. For example, the analyte sensor system 1408 may be preconfigured to periodically wake up from the low-power passive monitoring mode according to a predetermined interval for waking up the analyte sensor system 308.

[0350] Block 1504 includes receiving a wake-up signal from a display device before the predetermined interval expires while in the low-power passive monitoring mode, thereby causing the analyte sensor system to wake up before the predetermined interval expires. For example, the analyte sensor system 1408 may receive a wake-up signal 1412 from the display device 1410 before the predetermined interval expires while in the low-power passive monitoring mode, thereby causing the analyte sensor system 1408 to wake up before the predetermined interval expires.

[0351] Block 1506 includes transmitting an advertisement message in response to the wake-up signal.For example, the analyte sensor system 1408 may be configured to exit the low-power passive monitoring mode and transmit the advertisement message 1414 in response to receiving the wake-up signal 1408.

[0352] Block 1508 includes receiving a pairing request from the display device. For example, the analyte sensor system 1408 may be configured to receive a pairing request 1416 from the display device 1410 .

[0353] Block 1510 includes transmitting a pairing request acceptance message to a display device. For example, the analyte sensor system 1408 may be configured to transmit the pairing request acceptance message 1418 to the display device 1410 .

[0354] Block 1512 includes transmitting the sensor data to the display device. For example, the analyte sensor system 1408 may be configured to enter into a secure sensor communication session based on the aforementioned communication that the analyte sensor system 1408 may transmit data, such as sensor data, to the display device 1410. In some embodiments, such transmission of sensor data may include implementing a backfill request for specific data and / or any other data from the display device 1410 before a predetermined interval for waking up the analyte sensor system 1408 has expired.

[0355] The description now turns to Figure 15B Flowchart 1550, describing e.g. Figure 14 Block 1552 includes transmitting a wake-up signal to the analyte sensor system in the low-power passive monitoring mode. For example, the display device 1410 can be configured to transmit the wake-up signal 1412 to the analyte sensor system 1408 when in the low-power passive monitoring mode.

[0356] Block 1554 includes receiving an advertising message in response to the wake-up signal. For example, the display device 1410 may be configured to receive an advertising message 1414 from the analyte sensor system 1408 in response to the wake-up signal 1408.

[0357] Block 1556 includes transmitting the pairing request to the analyte sensor system. For example, the display device 1410 may be configured to transmit the pairing request 1416 to the analyte sensor system 1408.

[0358] Block 1558 includes receiving a pairing request acceptance message in response to the pairing request. For example, the display device 1410 may be configured to receive a pairing request acceptance message 1418 from the analyte sensor system 1408 in response to the pairing request 1416.

[0359] Block 1560 includes receiving sensor data from the analyte sensor system. For example, the display device 1410 may be configured to enter a secure sensor communication session based on the above-described communication, wherein the display device 1410 receives data, such as sensor data, from the analyte sensor system 1408. In some embodiments, the transmission and reception of such sensor data may include implementing a backfill request for specific data and / or any other data from the display device 1410 before a predetermined interval for waking up the analyte sensor system 1408 has expired.

[0360] Utilizing a sticker including an NFC tag for pairing an analyte sensor system with a display device

[0361] In some embodiments, the initial pairing between the analyte sensor system and the display device requires verification and confirmation that the analyte sensor system and the display device are authorized to connect to and communicate with each other. Some embodiments require the user to manually enter a serial number, etc. from the analyte sensor system and / or its packaging into an application running on the display device as a step to perform such initial verification and confirmation. However, such procedures can be cumbersome for the user. Therefore, the present disclosure contemplates initially pairing the analyte sensor system to one or more display devices without requiring the user to manually enter such serial numbers, etc., thereby providing a simpler, streamlined setup experience for the user.

[0362] Figure 16 16. Illustrated is an NFC tag 1602 embedded in a sticker 1604, which can be used to initially transfer, for example, a previously bonded Figures 3A to 3E The identification information for the analyte sensor system 308 is transmitted to the display device 310. During manufacturing, the NFC tag 1602 can be embedded in the sticker 1604 and pre-programmed with a pairing key (e.g., a BLE encryption key). When the analyte sensor system 308 is equipped, the sticker 1604 can be secured to the analyte sensor kit box 398 (see Figure 3D). When the user is ready to pair the analyte sensor system 308 with a particular NFC-enabled display device 310, the user may physically move the display device 310 close enough to the sticker 1604 (and the NFC tag 1602 therein) (e.g., within a few centimeters) so that the display device 310 can retrieve the pairing key from the NFC tag 1602 within the sticker 1604 via NFC. In some embodiments, physically moving the display device 310 close enough to the sticker 1604 may include pressing the display device 310 against the sticker. Then, using the pairing key, the display device 310 may be further configured to initiate a pairing protocol with the analyte sensor system 308, or alternatively participate in the completion of a pairing protocol initiated by the analyte sensor system 308, according to any embodiment described in the present disclosure or according to any other pairing protocol. For example, in some embodiments, the analyte sensor system 308 may be configured to pair with the display device 310 or initiate pairing with the display device using the pairing key. That is, the display 310 does not need to initiate the pairing process. For example, the analyte sensor system 308 may be configured to advertise while the display 310 completes the pairing process using the pairing key in subsequent communications with the analyte sensor system 308 .

[0363] The description now turns to Figure 17 Flowchart 1700, describing the operation of any display device described herein, for example. Block 1702 includes physically moving a display device that supports a short-range wireless communication protocol close enough to a sticker physically mounted on an analyte sensor system or one of the packages for the analyte sensor system, including a short-range wireless communication tag pre-programmed with a pairing key, so that the display device can retrieve the pairing key from the tag via the short-range wireless communication protocol. In some embodiments, the tag may further include one or more of sensor-related information, sensor expiration date, license information, calibration information, or any other information. In some embodiments, the short-range wireless communication protocol may be an NFC protocol, and the tag may be an NFC tag. For example, during initial pairing of the analyte sensor system 308 with the NFC-enabled display device 310, the user may physically move the display device 310 close enough to the sticker 1604, including the NFC tag 1602 pre-programmed with the pairing key, so that the display device 310 can retrieve the pairing key from the NFC tag 1602 via NFC.

[0364] Block 1704 includes pairing the display device with the analyte sensor system using the retrieved pairing key for a wireless protocol different from the short-range wireless communication protocol. For example, the display device 310 can be paired with the analyte sensor system 308 using the pairing key retrieved from the NFC tag 1602 for a wireless protocol different from the short-range wireless communication protocol (e.g., Wi-Fi, Bluetooth, BLE, cellular, or any other suitable communication protocol) according to any embodiment described in the present disclosure or according to any other pairing protocol.

[0365] Utilizing optical components for initiating establishment of a secure connection with an analyte sensor system

[0366] Some embodiments of establishing secure communication between an analyte sensor system and one or more display devices require the user to read the transmitter ID attached to the analyte sensor system and manually enter the transmitter ID into the one or more display devices to establish a secure connection. Such embodiments may further require the user to remember this transmitter ID to establish future secure connections with one or more other display devices. Establishing secure communication in this manner can be time-consuming (e.g., taking 5 to 30 minutes to establish) and may provide a suboptimal user experience.

[0367] Therefore, some embodiments are disclosed herein in which a display device is configured to utilize a light source to transmit a transmitter ID or another key associated with an analyte sensor system to initiate a secure pairing process between the display device and the analyte sensor system. As will become apparent from the description below, such embodiments provide a solution that does not require the user to read the transmitter ID and manually enter it into the display device, thereby allowing secure communication to be established more quickly and with less user intervention, thereby providing a more streamlined user experience.

[0368] Figure 18 A block diagram illustrating several features of a system for wirelessly communicating analyte sensor data, according to some embodiments. Figure 18 Included is a display device 1810 and an analyte sensor system 1808. The display device 1810 may correspond to any display device described herein, such as Figure 3B 310 of the display device. Thus, the display device 1810 may include any and all elements previously described in conjunction with any such corresponding display device. The analyte sensor system 1808 may correspond to any display device described herein, such as Figure 3B analyte sensor system 308. Thus, analyte sensor system 1808 may include any or all elements previously described in connection with any such corresponding analyte sensor system.

[0369] The display device 1810 is illustrated as further comprising pairing software 1830 configured to execute at least the communication protocol as described herein for establishing secure communications with at least the analyte sensor system 1808. The pairing software 1830 may correspond to Figure 3B The analyte sensor application 330 may be part of the analyte sensor application 330 or may be software configured separately therefrom.

[0370] Display device 1810 further includes a display and / or light source 1845 (e.g., a light emitting diode, a flashlight, an infrared blaster, or any other suitable light emitting source) configured to display a pattern of modulated light that is configured to transmit information related to at least the process of establishing secure communication with display device 1810, as described below, to analyte sensor system 1808. In some cases, the modulated light is light in the spectrum visible to the naked eye. However, the present disclosure is not limited in this regard, and the modulated light can be light in any portion of the electromagnetic spectrum (e.g., infrared light).

[0371] The display device 1810 can further be configured to communicate with at least the analyte sensor system 1808 over a communication channel separate from the modulated light communication, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol, as described in greater detail below. This separate communication channel can provide secure communication between the display device 1810 and the analyte sensor system 1808 once established.

[0372] The analyte sensor system 1808 is illustrated as further including a light sensor 1805 configured to sense and / or receive modulated light encoding at least one of a wake-up signal and a first security code associated with the display device 1810 from a display / light source 1845 of the display device 1810 .

[0373] The analyte sensor system 1808 further includes a processor / ASIC 1890 configured to receive a wake-up signal and an indication of a first security code from the light sensor 1895. The processor / ASIC 1890 may be configured to detect and / or otherwise recognize the wake-up signal and transmit an interrupt or wake-up signal to the second processor 1880 in response to the detection and / or recognition. The interrupt and / or wake-up signal may be configured to wake up at least a portion of the second processor 1880. The processor / ASIC 1890 may be further configured to pass the received first security code to the second processor 1880 for verification, further processing, or further processing of other data. In some embodiments, the processor / ASIC 1890 may correspond to the processor / ASIC described previously in conjunction with Figure 4One or more processors and / or wake-up detection circuits described herein, such as at least a portion of AFE 410, processor 420, or radio 425. In some embodiments, second processor 1880 may correspond to a processor as previously described in connection with Figure 3B Processor 380 is described.

[0374] In response to receiving the first security code, the second processor 1880 can be configured to encrypt the second security code using the first security code and cause the encrypted second security code to be broadcast to the display device 1810 via a method or communication protocol other than modulated light communication, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol. The second security code can be a unique security code corresponding to and / or associated with the analyte sensor system 1808.

[0375] In response to receiving the encrypted second security code, the display device 1810 may be configured to verify the encrypted second security code using any suitable verification method or protocol. Based on the verification, the display device 1810 may be configured to initiate secure communication with the analyte sensor system 1808 via a communication protocol other than modulated light communication, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol. After establishing secure communication with the analyte sensor system 1808, the analyte sensor system 1808 may be configured to transmit analyte concentration data encrypted using at least the second security code or using another security code that the display device 1810 is configured to decrypt. Thus, according to Figure 18 Embodiments of the may advantageously allow secure pairing and subsequent communication between the display device 1810 and the analyte sensor system 1808 without the user having to manually read and / or enter the transmitter ID into the display device 1810 or the analyte sensor system 1808 .

[0376] The description now turns to Figure 19A Flowchart 1900, describing, for example, the present invention with respect to the previous Figure 18 The operation of any display device described in the described embodiments. Block 1902 includes transmitting at least one of a wake-up signal and a first security code to the analyte sensor system as modulated visible light. For example, the display device 1810 can be configured to transmit the wake-up signal and the first security code corresponding to and / or associated with the display device 1810 to the analyte sensor system 1808 via the display / light source 1845.

[0377] Block 1904 includes receiving a second security code encrypted using the first security code from the analyte sensor system. For example, the display device 1810 may be configured to receive the second security code encrypted using the first security code. In some embodiments, the display device 1810 may receive the encrypted second security code in response to transmitting the wake-up signal and the first security code to the analyte sensor system 1808 and / or in response to the analyte sensor system 1808 receiving the wake-up signal and the first security code. In some embodiments, the encrypted second security code may be received via a communication channel and / or using a communication protocol other than modulated visible light, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol.

[0378] Block 1906 includes verifying the encrypted second security code. For example, display device 1810 may be configured to verify that the second security code corresponds to a predetermined, previously known, or otherwise determined security code and / or encrypt the second security code using a first security code corresponding to display device 1810 and / or associated with the display device.

[0379] Block 1908 includes establishing a secure communication channel with the analyte sensor system in response to the verification. For example, after verifying the encrypted second security code, the display device 1810 can be configured to establish a secure communication channel using a communication protocol other than modulated visible light, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol.

[0380] Block 1910 includes receiving analyte concentration data from the analyte sensor system via the secure communication channel. For example, in some embodiments, the display device 1810 may be configured to receive analyte concentration data encoded with a second security code corresponding to and / or associated with the analyte sensor system 1808 from the analyte sensor system 1808 via the BLE communication channel.

[0381] The description now turns to Figure 19B Flowchart 1950, describing, for example, the present invention with respect to the previous combination Figure 18 The operation of any analyte sensor system of the described embodiments. Block 1952 includes receiving at least one of a wake-up signal and a first security code from a display device as modulated visible light. For example, analyte sensor system 1808 can be configured to receive a wake-up signal and a first security code corresponding to and / or associated with display device 1810 from display device 1810 via light sensor 1895.

[0382] Block 1954 includes transmitting, from the analyte sensor system, a second security code encrypted using the first security code. For example, the analyte sensor system 1808 may be configured to transmit the second security code encrypted using the first security code. In some embodiments, the analyte sensor system may transmit the encrypted second security code in response to receiving the wake-up signal and the first security code. In some embodiments, the encrypted second security code may be transmitted via a communication channel and / or using a communication protocol other than modulated visible light, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol.

[0383] Block 1956 includes establishing a secure communication channel with the display device. For example, the analyte sensor system 1808 can be configured to establish or participate in establishing a secure communication channel with the display device 1810 using a communication protocol other than modulated visible light, such as BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol.

[0384] Block 1958 includes transmitting the analyte concentration data via the secure communication channel. For example, in some embodiments, the analyte sensor system 1808 may be configured to transmit the analyte concentration data encoded with a second security code corresponding to and / or associated with the analyte sensor system 1808 to the display device 1810 via the BLE communication channel.

[0385] User Warning Regarding Failure to Connect the Analyte Sensor System to a Tested Display Device

[0386] Several embodiments are disclosed herein in which an analyte sensor system is configured to transmit sensor data to a paired display device (e.g., a smartphone or smartwatch) so that the user can easily view the sensor data on the display device. In some embodiments, the transmission of this sensor data to the display device is performed periodically and / or intermittently to reduce the average power consumption of the analyte sensor system. Therefore, the display device can periodically connect and disconnect with the analyte sensor system. However, there may be situations where the user is wearing the analyte sensor system when the display device is adjacent, but the display device is unable to connect with the analyte sensor system, preventing sensor data and / or other data from being transmitted from the analyte sensor system to the display device or vice versa. A common reason for such an inability to connect is low signal strength (SSI) between the display device and the analyte sensor system. Such low signal strength can have a variety of reasons, including but not limited to radio frequency (RF) obstructions, the user lying on the analyte sensor system, or other RF interference. Therefore, the present disclosure contemplates alerting the user of the display device when the display device detects an advertising message from the analyte sensor system but is unable to connect with the analyte sensor system, thereby allowing the user to perform one or more actions that may increase the probability of establishing a connection during the next attempt.

[0387] Figure 20 A flow chart 2000 is illustrated that describes the operation of any display device, such as described herein, with respect to alerting a user when the display device detects an advertising message from any analyte sensor system described herein but is unable to connect with the analyte sensor system.

[0388] Block 2002 includes detecting an advertising message from an analyte sensor system.For example, any display device described herein can detect an advertising message from any analyte sensor system described herein.

[0389] Block 2004 includes attempting to establish a connection with the analyte sensor system in response to the advertisement message. For example, the display device may be configured to attempt to establish a connection with the analyte sensor system according to any pairing and / or connection protocol disclosed herein or according to any other suitable pairing and / or connection protocol.

[0390] Block 2006 includes determining that an attempt to establish a connection with the analyte sensor system has failed. For example, after a predetermined period of time of attempting but failing to establish a connection with the analyte sensor system, the display device may be configured to determine that an attempt to establish a connection with the analyte sensor system has failed.

[0391] Block 2008 includes generating an alert on the display device indicating that the analyte sensor system has been detected but the attempt to establish the connection with the analyte sensor system has failed. For example, the display device may be configured to generate any appropriate alert, such as, but not limited to, "Hello [user], your [smartphone / smartwatch] can see your [analyte sensor system / transmitter] somewhere near you, but cannot connect to it to receive data. Please try to change your orientation relative to your [smartphone / smartwatch] and other possible RF obstructions within [5 minutes] to increase the chance of success in the next connection attempt." In some embodiments, the alert may further include at least one suggested user intervention to improve the probability of establishing a connection with the analyte sensor system in a subsequent connection attempt.

[0392] Direct pairing of smartwatches or other displays with analyte sensor systems

[0393] In some cases, a user of an analyte sensor system may want to pair the analyte sensor system with more than one display device, such as a smart phone and a smart watch. For example, it may be more convenient to view analyte concentration data on a smaller display device worn by the user, such as a smart watch. However, while it may be easier to view analyte concentration data and / or alerts at a glance, entering information or initiating a pairing process in such a smaller display device may be more cumbersome, at least in part due to more limited user input capabilities, for example, it may be impossible or difficult to provide a full keyboard or numeric keypad on a smaller display. Therefore, several embodiments are considered that allow for direct and secure pairing of a display device, such as a smart watch, with an analyte sensor system without requiring the user to manually enter a transmitter ID, serial number, or code associated with the analyte sensor system into the smart watch for initial pairing or subsequent connection and / or reconnection with the analyte sensor system. Descriptions of such embodiments are provided below with at least reference to Figures 3A to 3C For illustration purposes only, smartphones and smartwatches (as previously combined Figures 3A to 3C 310b.

[0394] Analyte sensor system 308 may already be paired and / or otherwise connected to display device 310a (e.g., a smartphone). To initiate a connection between display device 310b (e.g., a smartwatch) and analyte sensor system 308, a user may select an analyte monitoring application (e.g., a smartwatch) on display device 310a. Figure 3B310b). Selecting the option to add the display device 310b to the application running on the display device 310a may be an easier user interaction because the display on the display device 310a may be larger than the display on the display device 310b. However, the present disclosure is not limited in this regard, and the user may alternatively select the option to add the display device to a similar analyte sensor application 330 running on the display device 310b. In some embodiments, the analyte sensor application 330 may include a filtering option that determines or limits what type of smartwatch or other display device the user can pair with the analyte sensor system 308 based on display device functionality, version, and / or compatibility (e.g., 3E, 4G, LTE, 5G, Wi-Fi, NFC, Bluetooth, BLE support, etc.). For example, the filtering option may also provide an indication of whether the analyte sensor system 308 can support direct view communication with the display device (e.g., a smartwatch). For example, after selecting the option to add a display on the analyte sensor application 330 (e.g., on the display 310a), a signal or feedback message may be presented on the application notifying the user that the analyte sensor system 308 is not compatible with the display device 310b and / or cannot support direct view communication. For example, this may be because the version or model of the analyte sensor system 308 does not support the direct view feature or the firmware running on the analyte sensor system 308 may be outdated. Alternatively, in some examples, if the analyte sensor system 308 can support direct view communication with the display device 310b (e.g., a smartwatch), then the feedback message on the application after selecting the option to add a display (e.g., the display device 310b) may indicate that the analyte sensor system 308 can support direct view communication. In one example, this may be because the analyte sensor system 308 is of the correct version / model and / or has the correct / latest firmware version.

[0395] Furthermore, in some instances, if the analyte sensor system 308 (already in communication with the display 310 a ) is unable to support direct view communication and therefore does not allow the user to select the option to select a display in the analyte sensor application 330 , then this option may be grayed out rather than a signal or feedback message. However, in another instance, the option may not be grayed out if, for example, the analyte sensor system 308 (already in communication with the display 310 a ) can support direct view communication with the new display device 310 b (e.g., a smartwatch).

[0396] In response to a user selection to add a display device, display device 310a or display device 310b may transmit a signal or message to analyte sensing system 308 indicating that a new device has requested pairing.

[0397] In response to a signal or message indicating that a new device has requested pairing, the analyte sensor system 308 may enter a pairing mode in which the analyte sensor system 308 is configured to periodically or continuously transmit an advertising message within a predetermined time interval. In some embodiments, the predetermined time period during which the analyte sensor system 308 periodically advertises for connection to the display device 310b (e.g., a smartwatch) is significantly longer than the predetermined time period otherwise used for another type of display device (e.g., a smart phone, etc.), such as 10 minutes versus 20 seconds. However, the present disclosure is not limited thereto and the predetermined time period may be substantially the same for any other type of display device. In another example, the analyte sensor system 308 may not enter pairing mode in response to a signal or message indicating that a new device has requested pairing. Alternatively, the analyte sensor system 308 may request connection to the new display device until its whitelist is complete. In this example, the predetermined time period may vary (e.g., it may be longer, shorter, or the same).

[0398] In response to detecting, identifying, and / or receiving the advertisement message, the display device 310b may display a "pairing" notification for the user to select to initiate the pairing process. Thus, the display device 310b may be configured to receive input from the user to initiate the pairing process in response to displaying the "pairing notification."

[0399] Optionally, in response to receiving input from the user to initiate the pairing process, display device 310b may transmit a signal to display device 310a indicating that input has been received from the user.

[0400] The display device 310a can transmit pairing and / or authentication information (e.g., a transmitter ID or serial number corresponding to the analyte sensor system 308, and / or one or more pairing and / or encryption keys) to the display device 310b. In this manner, the user does not need to input the transmitter ID corresponding to the analyte sensor system 308 or any other similar identifying information into the display device 310b to allow pairing. In one example, this can be performed in response to receiving a signal from the display device 310b indicating that an input has been received from the user.

[0401] In some other embodiments, the display device 310b may be configured to receive data from a separate server, such as Figure 3A In one embodiment, the server system 334 receives some or all of the pairing and / or authentication information. In such embodiments, the server and display device 310b may be considered to have established a previously authenticated communication channel, which may be based on the authentication information provided by display device 310a. In such embodiments, in response to receiving input from a user to initiate the pairing process, display device 310b may transmit a signal indicating that the input has been received from the user to the server system 334 instead of or in addition to display device 310a.

[0402] In response to receiving pairing and / or authentication information from the display device 310a and / or the server system 334, the display device 310b can be configured to pair with the analyte sensor system 308 according to any pairing protocol described herein or otherwise known. In some embodiments, this pairing process can be performed in the background so that the user is unaware or the steps in the notification process do not require explicit input from the user. Thus, the user can easily pair a smaller display device, such as a smartwatch, with the analyte sensor system 308 without having to enter identification information for the analyte sensor system 308 into the smartwatch, thereby providing a more simplified experience for the user. Once a successful pairing has been performed, it should be understood that the display device 310b will receive analyte-related data from the analyte sensor system 308 and provide such data and / or information related to the analyte data to the user (e.g., estimated glucose values, notifications, alarms, warnings, etc., as described herein).

[0403] The description now turns to Figure 21A 2100, describing the operation of a first display device 310a (e.g., a smartphone), such as previously described above. Block 2102 includes receiving input from a user on the first display device indicating a request to pair a second display device with an analyte sensor system. For example, as previously described, the user may select an analyte monitoring application (e.g., Figure 3B The first display device 310a may already be paired and communicating with the analyte sensor system 308.

[0404] Block 2104 includes transmitting a first signal to the analyte sensor system indicating that the second display device has requested pairing. For example, as previously described, display device 310a may transmit a first signal to analyte sensor system 308 indicating that display device 310b has requested pairing. As previously described, transmitting this signal to analyte sensor system 308 may cause analyte sensor system 308 to optionally enter a pairing mode in which analyte sensor system 308 periodically transmits advertising messages at predetermined time intervals.

[0405] Block 2106 includes receiving a second signal from the second display device indicating that the user has initiated a pairing process between the second display device and the analyte sensor system. For example, as previously described, the user may confirm a "pairing" notification displayed by display device 310b by providing user input to display device 310b, and display device 310b may or may not transmit a second signal to display device 310a indicating that the user has initiated a pairing process.

[0406] Block 2108 includes transmitting a transmitter ID corresponding to the analyte sensor system to the second display device in response to receiving the second signal from the second display device. For example, as previously described, in response to receiving the second signal from display device 310b, display device 310a may transmit pairing and / or authentication information (e.g., a transmitter ID or serial number corresponding to analyte sensor system 308, and / or one or more pairing and / or encryption keys) to display device 310b. Display device 310b may use this pairing and / or authentication information to pair with analyte sensor system 308.

[0407] The description now turns to Figure 21B Flowchart 2150 of FIG. 1 depicts the operation of a second display device 310a (e.g., a smartwatch), such as previously described above. Block 2152 includes receiving one or more advertising messages from the analyte sensor system in response to a user selection on the first display device to pair the second display device with the analyte sensor system. For example, as previously described, the user may select the analyte monitoring application 330 ( Figure 3B ), and the analyte sensor system 308 can be configured to optionally enter pairing mode, thereby periodically transmitting advertising messages at predetermined time intervals. In such embodiments, the first display device 310a can already be paired and communicating with the analyte sensor system 308.

[0408] Block 2154 includes displaying a notification of the pairing process in response to receiving the one or more advertisement messages. For example, as previously described, in response to detecting, identifying, and / or receiving the advertisement message, the display device 310b may display a "pairing" notification to the user.

[0409] Block 2156 includes, in response to receiving input from the user for initiating the pairing process, optionally transmitting a signal to the first display device indicating that the input has been received from the user. For example, as previously described, in response to receiving input from the user to initiate the pairing process, display device 310b may or may not transmit a signal to display device 310a indicating that the input has been received from the user.

[0410] Block 2158 includes receiving a transmitter ID corresponding to the analyte sensor system from the first display device. For example, as previously described, display device 310a may transmit and display device 310b may receive pairing and / or authentication information (e.g., a transmitter ID or serial number corresponding to the analyte sensor system 308, and / or one or more pairing and / or encryption keys).

[0411] Block 2160 includes establishing a secure connection with the analyte sensor system using the transmitter ID corresponding to the analyte sensor system. For example, as previously described, in response to receiving pairing and / or authentication information, the display device 310b can be configured to pair with the analyte sensor system 308 according to any pairing protocol described herein or generally known.

[0412] Data Capture

[0413] The following description / reference components are at least as described in Figures 3A to 3E However, the description is not limited thereto and may correspond to or be applicable to any other components described throughout this disclosure.

[0414] In some cases, a user may want to couple more than one display device to their analyte sensor system (e.g., analyte sensor system 308), such as a smartphone and a wearable smartwatch, or their own personal smartphone or smartwatch and a medical device, such as one used by a healthcare provider in conjunction with managing a medical condition. Because it is desirable to conserve the battery life of analyte sensor system 308, analyte sensor system 308 may be configured to initially pair and connect with a display device, transmit data to the display device, disconnect from the display device to enter a low-power and / or sleep mode to conserve battery, and then periodically reconnect to the display device based on a predetermined connection interval (e.g., every 5 minutes). Although several embodiments described in this disclosure utilize "predetermined" connection intervals, this disclosure also contemplates the use of similar connection intervals that occur at unpredetermined durations and / or frequencies. Therefore, embodiments describing the use of predetermined connection intervals also contemplate the use of such unpredetermined connection intervals. One way that analyte sensor system 308 can manage connections with multiple display devices is to allow one display device to maintain a communication connection with analyte sensor system 308 during a given predetermined connection interval. While this allows for sequential connection of multiple display devices at different predetermined connection intervals, it limits such connections because no two display devices simultaneously maintain a connection with the analyte sensor system 308 during the same predetermined connection interval, which may result in longer periods between reestablishing connections with particular display devices when multiple display devices are ultimately accommodated.

[0415] Another way that the analyte sensor system 308 can manage connections with multiple display devices is to operate using multiple time slots, wherein different categories of devices are allowed to connect and communicate with the analyte sensor system 308; for example, a consumer time slot, wherein display devices commonly used by consumer products (e.g., smartphones, smart watches, user receivers) are allowed to connect to the analyte sensor system 308 one at a time; and a medical or professional time slot, wherein display devices commonly used by medical professionals and / or other proprietary or dedicated medical devices are allowed to connect to the analyte sensor system 308 one at a time. In the case of utilizing such consumer and medical / professional time slots, advertising parameters and protocols can be configured similarly or differently to advertise availability for connection within each time slot. Such examples can further utilize multiple corresponding whitelists, listing corresponding consumer products or medical / professional devices that have previously established and authenticated secure connections with the analyte sensor system 308, to help manage connections for known or trusted display devices. In some embodiments, each such whitelist may contain space for a single entry corresponding to a single preferred consumer device (e.g., a user's smartphone) or a single preferred medical / professional device (e.g., a doctor's associated healthcare provider device). If a user or healthcare professional wishes to pair with a new display device that is not currently on the corresponding whitelist, then upon pairing the new display device, the other display device previously on the whitelist is removed from the whitelist and the newly paired display device is added to the whitelist as a single entry in its place. However, when combined with the restriction that a single device can maintain a connection with the analyte sensor system 308 during any predetermined connection interval, whether in the consumer or medical / professional categories, it may still be necessary for the display device to wait a significant amount of time between connections to the analyte sensor system 308.

[0416] Thus, several embodiments described below allow multiple display devices to connect and maintain their connection in parallel during the same predetermined connection interval. The general concepts described below include (individually or in any combination) eliminating the distinction between consumer and medical / professional categories, whitelists, and time slots and treating each display device as belonging to a similar category, utilizing a single whitelist that can list trusted devices of all types / categories, and providing a single time slot in which one or more compatible display devices can potentially pair and connect with the analyte sensor system 308 during the same predetermined connection interval. In some embodiments, this single whitelist can have increased capacity, from, for example, two entries—one for medical / professional devices and another for consumer devices—to, for example, three or more entries for compatible display devices of any type or category. Because a single time slot is utilized to connect and communicate with the analyte sensor system 308, advertising and maintaining connections can be handled simultaneously or at least in parallel for multiple devices when occurring during the same predetermined connection interval. Because whitelists are still available, advertisements can utilize a first parameter set for general advertisements, such as advertisements to display devices that are not yet listed on the whitelist, and a second parameter set for whitelist advertisements, such as advertisements to trusted display devices currently listed on the whitelist. After establishing a connection with each of one or more compatible display devices at the same predetermined communication interval, each of one or more compatible display devices (e.g., display device 310) can communicate with analyte sensor system 308, and / or in some cases, communicate with each other and / or with another server (e.g., server system 334) during the same predetermined communication interval, as described in any part of this specification or as otherwise known. At a certain moment during the predetermined communication interval, it can be determined that one or more connections should be closed or for any number of reasons. Some embodiments consider maintaining those connections, not immediately closing the one or more connections in response to a command or determination to close one or more connections, even potentially during or for a reduced connection interval, until general advertisements end within a specific predetermined connection interval. Additionally, some embodiments contemplate tuning advertisement parameters, connection parameters, and / or timeout policies to conserve power, improve responsiveness, and / or simplify the operation of one or more devices involved. While malicious devices may hear advertisement messages, such malicious devices are expected to be unauthenticated and, therefore, prevented from establishing communication sessions or being added to a whitelist. Several features of such embodiments will now be described in greater detail below.

[0417] Leverages time-slot agnostic connection / communication with analyte sensor systems

[0418] In some embodiments, a single, repeating or periodic time slot is utilized during which multiple compatible display devices 310 can potentially pair, connect, and communicate with the analyte sensor system 308. This single time slot may not provide any distinction between consumer category display devices and medical / professional category display devices. Classifying all time slots and devices into a single category (e.g., all compatible display devices are treated the same for connection purposes) reduces the complexity and requirements associated with operating, advertising, and connection management protocols for all devices involved. Additionally, because only a single category of display devices 310 is considered, in such embodiments, advertising protocols and / or parameters can also be simplified.

[0419] Utilizing a generalized whitelist for connecting / communicating with an analyte sensor system

[0420] In some embodiments, a single or generalized whitelist is utilized, in which all compatible display devices 310 can potentially be listed once initial pairing and authentication with the analyte sensor system 308 has been performed. For example, while previous consumer and medical / professional whitelists have been utilized, each with space for a single display device entry, in some other embodiments, a single whitelist for all compatible display devices 310 can be utilized, with three or more entries for any type or category of compatible display devices 310. Including three or more entries in the whitelist allows multiple display devices to be listed on the whitelist and easily reconnected as needed for concurrent communication of analyte concentration and / or other data during the same predetermined communication interval, such as a user's smartphone, a user's smartwatch, and even a third display device, such as a healthcare provider device for a medical professional. In some embodiments, the analyte sensor system 308 can be configured to remove or delete a display device from the whitelist based on not receiving data from or transmitting data to the display device within a predetermined time period, or according to any other protocol for managing a whitelist, as described elsewhere in this disclosure or as otherwise known.

[0421] Advertise based on a single whitelist for connection to analyte sensor systems

[0422] The discussion in this chapter will refer to Figures 3A to 3C 、 Figure 22A and 22B as well as Figure 23 . Figure 22A and 22B Illustrate example timing diagrams 2200, 2250 for advertising signaling according to some embodiments, and Figure 23 An example flow diagram is illustrated for advertising signaling by the analyte sensor system 308 according to some embodiments.

[0423] To pair, connect, and / or reconnect with the analyte sensor system 308, advertising may be performed, wherein advertisement messages 2202, 2204 are periodically transmitted during one or more advertisement intervals 2206, 2208 to announce the availability of the advertising device for pairing, connection, and / or reconnection during a given predetermined connection interval 2210. In some embodiments, utilizing a single whitelist, a first advertisement message 2202 may utilize a first set of parameters for discovering and / or advertising to new display devices 310 not currently listed on the whitelist. This first set of parameters may define one or more of a first duration 2212 of the first advertisement interval 2206, a first periodic interval 2214 for transmitting the advertisement message 2202 within the first advertisement interval 2206, a first power 2216 at which the first advertisement message 2202 is transmitted, and any other parameters for transmitting the first advertisement message 2202. This first set of parameters may correspond to general or discovery advertising for devices not currently listed on the whitelist.

[0424] Such advertisements may additionally utilize a second advertisement message 2204 that utilizes a second set of parameters for discovering and / or advertising to display devices 310 currently listed on the whitelist. This second set of parameters may define one or more of a second duration 2222 of a second advertisement interval 2208, a second periodic interval 2224 for transmitting advertisement messages 2204 within the second advertisement interval 2208, a second power 2226 for transmitting the second advertisement message 2204, and any other parameters for transmitting the second advertisement message 2204. This second set of parameters may correspond to a whitelist or reconnect advertisement. Using the first and second sets of advertisement parameters for the respective first and second advertisement messages 2202, 2204 allows for both general and reconnect advertisements within the same communication time slot.

[0425] In some embodiments, the first power 2216 for transmitting a general advertisement message 2202 may be lower than the second power 2226 for transmitting a reconnect advertisement message 2204. For example, a user attempting to pair and connect a new display device 310 (e.g., a smartphone or smartwatch) is likely to place the new display device 310 in close proximity to the analyte sensor system 308 (e.g., within a few feet). At least because the new display device 310 is in close proximity to the analyte sensor system 308, such general advertisements do not need to utilize the maximum (e.g., 30 meters) transmission power. In contrast, it may be necessary to keep the display devices 310 listed on the whitelist connected or reconnect them, even when the distance between those devices listed on the whitelist and the analyte sensor system 308 is significantly greater, such as a smartphone left on a table when the user temporarily walks into another room. However, the present disclosure is not limited thereto and the first power 2216 and / or the second power 2226 may be configurable or reconfigurable to have any suitable absolute value and / or any suitable relative value relative to the other.

[0426] In some embodiments, the first duration 2212 of the first ad interval 2206 for general advertising and / or the first periodic interval 2214 for transmitting the advertisement message 2202 within the first ad interval 2206 may be different from the second duration 2222 of the second ad interval 2208 for reconnection advertising and / or the second periodic interval 2224 for transmitting the advertisement message 2204 within the second ad interval 2208. In addition, the first frequency of occurrence of the first ad interval 2206 may be different from the second frequency of occurrence of the second ad interval 2208. For example, analyte concentration data may be measured, processed, or communicated every 30 seconds or every minute. Therefore, in such embodiments, the second frequency of occurrence of the second ad interval 2208 may correspond to this time frame and associated frequency of occurrence, such as every 30 seconds or every minute. However, it may not be necessary or desirable to attempt to "discover" a new display device that may or may not be currently on the whitelist at this short interval (e.g., at the second frequency of occurrence). Therefore, the first frequency of occurrence of the first ad interval 2206 associated with general advertising may be lower than the second frequency of occurrence of the second ad interval 2208 associated with reconnection advertising. Utilizing longer intervals between typical advertising intervals may conserve power within the analyte sensor system 308 by reducing the number or frequency of typical advertisements.

[0427] Additionally, in some embodiments, the analyte sensor system 308 and / or one or more connected display devices 310 may further include a button or other user input that allows a user to initiate a general advertising session on demand, such as when a user wants to pair and connect a new display device 310 with the analyte sensor system 308, such as the user's smartphone or smartwatch.

[0428] The description now turns to Figure 23 Flowchart 2300 depicts advertising operations of, for example, the analyte sensor system 308, according to some embodiments. Block 2302 includes transmitting one or more first advertisement messages using a first set of parameters during a predetermined communication interval if a whitelist of previously authenticated devices has at least one unpopulated entry. For example, during a predetermined connection interval 2210, based on the absence of a display device on the whitelist or the presence of at least one unpopulated entry, the analyte sensor system 308 may be configured to transmit one or more first advertisement messages 2202 using a first set of parameters, such as one or more of a first duration 2212 defining a first advertisement interval 2206, a first periodic interval 2214 for transmitting the first advertisement message 2202 within the first advertisement interval 2206, a first power 2216 for transmitting the first advertisement message 2202, and any other parameters for such advertisements. This first set of parameters may correspond to discovery or general advertising of devices not currently listed on the whitelist.

[0429] In some embodiments, when the analyte sensor system 308 is first powered on, the analyte sensor system 308 can be configured to perform a pairing advertisement, wherein the duration 2212 of the first advertisement interval 2206 is, for example, 15 minutes or less, but the present disclosure is not limited thereto, and the duration 2212 of the first advertisement interval 2206 can be any suitable interval. Due to the shorter advertisement interval compared to some other possible embodiments, this advertisement can be considered a fast pairing advertisement. In such embodiments, the first periodic interval 2214 can be, for example, 1024 milliseconds, but the present disclosure is not limited thereto, and the first periodic interval 2214 can be any suitable interval. In such embodiments, the "fast pairing advertisement" mode ends after any display device is "completed", for example, after successfully pairing and authenticating with the analyte sensor system 308. After the first advertisement interval 2212 expires or any display device is completed, the advertisement can follow any advertisement protocol described herein or otherwise known.

[0430] Block 2304 includes not transmitting the one or more first advertisement messages during the predetermined communication interval if the whitelist does not have at least one unpopulated entry. For example, in some embodiments, if there are no available entries on the whitelist, there may not be room for other devices to connect. Therefore, in such embodiments, the analyte sensor system 308 may be configured to not perform general advertising to conserve power.

[0431] Block 2306 includes transmitting one or more second advertisement messages during the predetermined communication interval using a second set of parameters if at least one device is listed on the whitelist. For example, during the predetermined connection interval 2210, based on the listing of at least one display device 310 on the whitelist, the analyte sensor system 308 may be configured to transmit one or more second advertisement messages 2204 using a second set of parameters, such as a second duration 2222 defining the second advertisement interval 2208, a second periodic interval 2224 for transmitting the second advertisement message 2204 within the second advertisement interval 2208, a second power 2226 for transmitting the advertisement message, and any other parameters for such advertisements. This second set of parameters may correspond to a reconnection advertisement for a display device currently listed on the whitelist.

[0432] Block 2308 includes not transmitting one or more second advertisement messages during the predetermined communication interval if the whitelist currently does not list any devices or if all devices currently listed on the whitelist connect to the analyte sensor system in response to the one or more first advertisement messages. For example, if there are no devices currently listed on the whitelist, then reconnection advertising will not be required. In some embodiments, for example, Figure 22B As shown in FIG, the analyte sensor system 308 may transmit one or more general advertisement messages (e.g., 2202) using a first parameter set before transmitting one or more reconnect advertisement messages (e.g., 2204) using a second parameter set in the same predetermined connection interval. In such embodiments, performing a general advertisement for a new device before performing a reconnect advertisement may also allow devices currently listed on the whitelist to reconnect with the analyte sensor system 308 during the general advertisement interval (e.g., 2206) and allow other new display devices to be discovered and paired during the general advertisement interval (e.g., 2206) in the same predetermined connection interval. Furthermore, if all such whitelisted devices are within range and have reconnected with the analyte sensor system 308 during the general advertisement interval 2206, the analyte sensor system 308 may be configured to delay or not transmit subsequent reconnect advertisements 2204 during the predetermined connection interval 2210, thereby allowing the analyte sensor system 308 to further conserve power.

[0433] In some embodiments, for example, Figure 22AAs shown in FIG, the analyte sensor system 308 may transmit one or more general advertisement messages (e.g., 2202) using a first parameter set after transmitting one or more reconnect advertisement messages (e.g., 2204) using a second parameter set. In such embodiments, performing a general advertisement on a new device after performing a reconnect advertisement on a device currently listed on the whitelist may allow discovery and pairing of other display devices after connection of the display device currently listed on the whitelist. This is in contrast to some previous embodiments that would not continue advertising after connecting a single whitelisted display device because the previous consumer or medical / professional whitelist would not have another entry that also whitelisted another display device, and because such previous embodiments only provided for connecting a single display device to the analyte sensor system 308 during a specific predetermined connection interval.

[0434] Block 2310 includes establishing a first communication session between the analyte sensor system and a first device and establishing a second communication session between the analyte sensor system and a second device based on at least one of the first advertisement message and the second advertisement message. Figure 22A and 22B As illustrated, based on at least one of the first advertisement message 2202 and the second advertisement message 2204, the analyte sensor system 308 may be configured to communicate with the first device (eg, Figure 3C 310a) establishes a first communication session and communicates with a second device (e.g., Figure 3C Display device 310b) establishes a second communication session.

[0435] Block 2312 includes transmitting analyte concentration data to the first device and the second device using at least one of the first communication session and the second communication session during the predetermined communication interval. Figure 22A and 22B As illustrated, analyte sensor system 308 can be configured to transmit analyte concentration data to first device 310a and second device 310b using at least one of the first communication session and the second communication session during predetermined communication interval 2210. Thus, both the first communication session and the second communication session can remain open in parallel.

[0436] Communicate / backfill data during a communication session

[0437] In some embodiments, on the first display device 310a (e.g., a smartphone, see Figure 3C ) and a second display device 310b (eg, a smart watch, see Figure 3C ) are connected to the analyte sensor system 308 during the same predetermined connection interval, such as above in combination with at least Figures 22A to 23As described, the analyte sensor system 308 can transmit data to and / or receive data from the first display device 310a and the second display device 310b in any manner described elsewhere in this specification or as otherwise known. In some embodiments, alarm data can also be transmitted to one or both of the display devices 310a, 310b along with the sensor data by the analyte sensor system 308.

[0438] In some embodiments, after establishing a connection with the analyte sensor system 308, the connected display devices 310a, 310b can be configured to display an icon, such as an icon on the display 345 indicating that the display devices 310a, 310b are connected. Additionally, the analyte sensing system 308 can transmit one or more alarm indications to the first display device 310a for processing, and the second display device 310b can be configured to display an associated alarm notification to the user based on the alarm indication received from the first display device 310a. In other embodiments, one or more alarm indications can be transmitted directly from the analyte sensor system 308 to the second display device 310b, and the second display device 310b can be configured to display an associated alarm notification to the user based on receiving and / or processing the alarm.

[0439] In some embodiments, multiple display devices 310a, 310b can be connected to the analyte sensor system 308 in parallel and can generally communicate data between the analyte sensor system 308 and the display devices 310a, 310b. However, there may be situations where one of the display devices 310a, 310b is out of range or otherwise unavailable for a period of time during a session in which the analyte sensor system 308 is measuring, collecting, processing, and / or generating data for transmission to o...

Claims

1. A method for wireless communication with an analyte sensor system, characterized in that The method comprises: receiving input from a user on a first display device indicating a request to pair a second display device with the analyte sensor system; transmitting, via the first display device, to the analyte sensor system a first signal indicating that the second display device has requested pairing; receiving, by the first display device, a second signal from the second display device indicating that the user has initiated a pairing process between the second display device and the analyte sensor system; and In response to receiving the second signal from the second display device, a transmitter ID corresponding to the analyte sensor system is transmitted to the second display device via the first display device.

2. The method according to claim 1, characterized in that The first display device comprises a smart phone, and the second display device comprises a smart watch.

3. The method according to claim 1, characterized in that The second display device is configured to utilize the transmitter ID to pair with the analyte sensor system.

4. A first display device, characterized in that: include: an input interface configured to receive input from a user indicating a request to pair a second display device with the analyte sensor system; a transceiver radio configured to transmit a first signal to the analyte sensor system indicating that the second display device has requested pairing; One or more processors configured to: receiving a second signal from the second display device indicating that the user has initiated a pairing process between the second display device and the analyte sensor system; and In response to receiving the second signal from the second display device, the transceiver radio is caused to transmit a transmitter ID corresponding to the analyte sensor system to the second display device.

5. A method for wireless communication with an analyte sensor system, characterized in that The method comprises: receiving, via a second display device, from the analyte sensor system one or more advertising messages transmitted in response to a user selection on a first display device to pair the second display device with the analyte sensor system; displaying a notification of a pairing process via the second display device in response to receiving the one or more advertisement messages; in response to receiving, via the second display device, an input from the user for initiating the pairing process, transmitting, via the second display device, a signal to the first display device indicating that the input has been received from the user; receiving, via the second display device, from the first display device, a transmitter ID corresponding to the analyte sensor system; and A secure connection is established with the analyte sensor system via the second display device using the transmitter ID corresponding to the analyte sensor system.

6. The method according to claim 5, characterized in that The first display device comprises a smart phone, and the second display device comprises a smart watch.

7. The method according to claim 5, characterized in that The second display device is configured to utilize the transmitter ID to pair with the analyte sensor system.

8. A second display device, characterized in that: include: a transceiver radio configured to receive one or more advertising messages from an analyte sensor system transmitted in response to a user selection on a first display device to pair the second display device with the analyte sensor system; a display configured to display a notification of a pairing process in response to the transceiver radio receiving the one or more advertisement messages; One or more processors configured to: in response to receiving input from the user to initiate the pairing process, causing the transceiver radio to transmit a signal to the first display device indicating that the input has been received from the user; receiving a transmitter ID corresponding to the analyte sensor system from the first display device; and A secure connection is established with the analyte sensor system using the transmitter ID corresponding to the analyte sensor system.

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