Systems and methods for emission and continuous monitoring of analyte values

Abstract

Systems and methods are provided for continuously monitoring analyte values received from an analyte sensor system. A method for wireless data communication between an analyte sensor system and a mobile device involves storing identification information associated with a transceiver of the analyte sensor system, the identification information being entered by a user of the mobile device via a custom application running on the mobile device; causing the custom application to enter a background mode; searching for an advertisement signal; receiving an advertisement signal from the transceiver; authenticating the transceiver based on the identification information; prompting the user to bring the custom application to a foreground mode; causing the custom application to request confirmation from the user that a data connection with the transceiver is desired; receiving the confirmation from the user; and completing the data connection with the transceiver.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202010138849.0, filed on November 5, 2014, entitled "System and Method for Analyzing Emissions and Continuous Monitoring of Material Values".

[0002] By incorporating reference to relevant applications

[0003] Any and all priority claims identified in the application data sheet or any amendment thereof are hereby incorporated by reference in accordance with 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 61 / 901,358, filed November 7, 2013. The entire contents of the above application are incorporated herein by reference and are hereby expressly formed part of this specification. Technical Field

[0004] A system and method are provided for continuously monitoring the values ​​of analytes received from an analyte sensor system. Background Technology

[0005] Diabetes is a condition in which the pancreas cannot produce enough insulin (type 1 or insulin-dependent) and / or insulin is ineffective (type 2 or non-insulin-dependent). In diabetes, the patient suffers from high blood sugar, which causes a group of physiological disorders associated with the breakdown of small blood vessels (kidney failure, skin ulcers, or vitreous hemorrhage). Hypoglycemic reactions (hypoglycemia) can be triggered by an accidental overdose of insulin, or by a normal dose of insulin or a glucose-lowering agent accompanied by abnormal exercise or insufficient food intake.

[0006] Conventionally, diabetic patients carry self-monitoring blood glucose (SMBG) devices, which typically require the uncomfortable finger-prick method. Due to this lack of comfort and convenience, diabetic patients usually only measure their glucose levels two to four times a day. Unfortunately, these intervals are too widely spaced, potentially leading to delayed detection of high or low blood sugar symptoms, sometimes resulting in dangerous side effects. In fact, diabetic patients not only cannot obtain timely SMBG values, but they also cannot determine whether their blood sugar levels are rising (higher) or falling (lower) using conventional methods.

[0007] Therefore, various non-invasive transdermal (e.g., percutaneous) and / or implantable electrochemical sensors are being developed for the continuous detection and / or quantification of blood glucose levels. These devices typically emit raw or minimally processed data for subsequent analysis at a remote device, which may include a display. Summary of the Invention

[0008] The accompanying drawings and the following description illustrate details of one or more embodiments of the subject matter described in this specification. Other features, aspects, and advantages will become apparent from the description, drawings, and claims. It should be noted that the relative dimensions in the following drawings may not be drawn to scale.

[0009] In a first aspect, a method is provided for wireless data communication between an analyte sensor system and a mobile device, the mobile device being capable of wirelessly receiving analyte values ​​from the analyte sensor system. The method may include: storing identification information associated with a transceiver of the analyte sensor system, the identification information being entered by a user of the mobile device via a custom application running on the mobile device; causing the custom application to enter a background mode; searching for advertising signals; receiving advertising signals from the transceiver; authenticating the transceiver based on the identification information; prompting the user to bring the custom application to a foreground mode; causing the custom application to request confirmation from the user of a desired data connection with the transceiver; receiving confirmation from the user; and completing the data connection with the transceiver.

[0010] In certain embodiments of the first aspect, which are generally applicable and particularly applicable to any other embodiments of the first aspect, the method may further include: receiving analytical values ​​from the transceiver; terminating the data connection with the transceiver; entering an inactive mode; exiting the inactive mode after a predetermined time; and searching for advertising signals from the transceiver.

[0011] In some embodiments of the first aspect that are generally applicable, particularly to any other embodiments of the first aspect, the authentication steps may include: requesting a query value from the transceiver; receiving the query value from the transceiver; generating a hash value based on the query value and identification information; transmitting the hash value to the transceiver; and receiving an acknowledgment from the transceiver indicating successful authentication.

[0012] In certain embodiments of the first aspect, which are generally applicable and particularly applicable to any other embodiments of the first aspect, the method may further include: determining that the custom application is using excessive memory; causing the custom application to enter a paused state; determining that the custom application is expected to search for advertising signals from the transceiver at the next scheduled time; and causing the custom application to exit the paused state before the next scheduled time.

[0013] In a second aspect, a mobile device configured for wireless data communication with an analyte sensor system is provided, comprising: a user interface; a radio unit for transmitting and receiving wireless signals; a memory for storing identification information associated with one or more transceivers, and a custom application configured to interact with a user of the mobile device via the user interface; and a processor operatively coupled to the user interface, the radio unit, and the memory, and configured to perform the following operations: causing the custom application to enter a background mode; causing the radio unit to search for advertising signals; performing an authentication procedure for the transceiver based on user-inputted identification information associated with the transceiver upon receiving an advertising signal from a transceiver of the analyte sensor system; issuing a first notification to the user to bring the custom application to a foreground mode; causing the custom application to issue a second notification to the user requesting confirmation of a desired data connection with the transceiver; and completing the data connection with the transceiver upon receiving confirmation.

[0014] In some embodiments of the second aspect, which are generally applicable and particularly applicable to any other embodiments of the second aspect, the analyte sensor system may be a continuous glucose sensor system.

[0015] In some embodiments of the second aspect, which are generally applicable and particularly applicable to any other implementation of the second aspect, the user interface may include a voice user interface.

[0016] In some embodiments of the second aspect, which are generally applicable and particularly applicable to any other implementation of the second aspect, the user interface may include a touchscreen display.

[0017] In some embodiments of the second aspect, which are generally applicable and particularly applicable to any other implementation of the second aspect, the first notification may be a pop-up menu displayed on a touchscreen display.

[0018] In some embodiments of the second aspect, which are generally applicable and particularly applicable to any other implementation of the second aspect, wireless data communication may employ a communication protocol designed for short-range and low-power wireless communication.

[0019] In certain embodiments of the second aspect, which are generally applicable and particularly applicable to any other embodiments of the second aspect, the processor may be further configured to perform the following operations: determine that the custom application has used excessive memory space, cause the custom application to enter a paused state, cause the custom application to exit the paused state before the scheduled time when the mobile device is expected to search for the next advertising signal from the transceiver, and cause the custom application to search for the next advertising signal in background mode.

[0020] In certain embodiments of the second aspect, which are generally applicable and particularly applicable to any other embodiments of the second aspect, the processor may be further configured to perform the following operations: determining that the custom application is using excess memory, causing the custom application to enter a paused state, determining the next scheduled time when the transceiver is expected to begin transmitting a series of advertising signals, causing the custom application to exit the paused state before the next scheduled time, and causing the radio unit to search for advertising signals.

[0021] In certain embodiments of the second aspect, which are generally applicable and particularly applicable to any other embodiments of the second aspect, the processor may be further configured to perform the following operations: determine that the custom application is using excess memory, causing the custom application to enter a paused state, determine the next scheduled time when the transceiver is expected to begin transmitting a series of advertising signals, and cause the radio to search for advertising signals at the next scheduled time while the custom application is still in a paused state.

[0022] In a third aspect, a method is provided for wireless data communication between an analyte sensor system and a mobile device, the mobile device being able to wirelessly receive analyte values ​​from the analyte sensor system, the method comprising: initiating the transmission of a first series of advertising signals at a first time; receiving a data connection request from the mobile device at a second time; establishing a data connection with the mobile device; transmitting to the mobile device a connection interval indicating the difference between the second time and the first time; transmitting analyte values; terminating the data connection with the mobile device; and causing the transceiver of the analyte sensor system to enter a sleep state.

[0023] In some embodiments of the third aspect, which are generally applicable and particularly applicable to any other embodiments of the third aspect, the method may further include: causing the transceiver to exit sleep mode after a predetermined time; and transmitting a second series of advertising signals.

[0024] In some embodiments of the third aspect, which are generally applicable, especially to any other implementation of the third aspect, the predetermined time may be between about 200 seconds and 400 seconds.

[0025] In some embodiments of the third aspect, which are generally applicable, and especially applicable to any other implementation of the third aspect, the analytical values ​​may be based on analytical measurements taken when the transceiver was in a previous sleep mode.

[0026] In a fourth aspect, a method is provided for wireless data communication between an analyte sensor system and a mobile device, the mobile device being able to wirelessly receive analyte values ​​from the analyte sensor system, the method comprising: searching for advertising signals; receiving advertising signals from a transceiver of the analyte sensor system; transmitting a data connection request to the transceiver; establishing a data connection with the transceiver if the data connection request is accepted; receiving a connection interval between a first time indicating that the transceiver begins transmitting a series of advertising signals and a second time that the transceiver receives the data connection request from the mobile device; receiving analyte values ​​from the transceiver; terminating the data connection with the transceiver, thereby causing the transceiver to enter a sleep mode; entering an inactive mode, during which the mobile device does not communicate with the transceiver; calculating an exit time at least partially based on the connection interval at which the mobile device will exit the inactive mode; exiting the inactive mode at the exit time; and searching for advertising signals after exiting the inactive mode.

[0027] In some embodiments of the fourth aspect, which are generally applicable and particularly applicable to any other implementation of the fourth aspect, the analyte values ​​may be based on analyte measurements taken when the transceiver was in a previous sleep mode.

[0028] In some embodiments of the fourth aspect, which are generally applicable and particularly applicable to any other implementation of the fourth aspect, the exit time may be given by the following formula: current time + update interval - connection interval - notification delay - protection measures, where the update interval may be the duration between two consecutive wireless communication sessions between the transceiver and the mobile device.

[0029] In some embodiments of the fourth aspect, which are generally applicable, and especially applicable to any other implementation of the fourth aspect, the update interval may be between about 200 seconds and 400 seconds.

[0030] In some embodiments of the fourth aspect, which are generally applicable and particularly applicable to any other implementation of the fourth aspect, the connection interval may be between approximately 90 milliseconds and 300 milliseconds.

[0031] In some embodiments of the fourth aspect, which are generally applicable, particularly to any other implementation of the fourth aspect, the notification delay may be between about 100 milliseconds and 300 milliseconds, and the protection measures are generally between about 300 milliseconds and 700 milliseconds.

[0032] In a fifth aspect, an analyte sensor system configured for wireless data communication with a mobile device is provided, comprising: an analyte sensor; a transceiver configured to transmit and receive wireless signals; and a processor operatively coupled to the analyte sensor and the transceiver and configured to perform the following operations: causing the transceiver to transmit a series of advertising signals; receiving a data connection request from the mobile device; causing the transceiver to establish a data connection with the radio unit of the mobile device; causing the transceiver to transmit a connection interval for the mobile device to use to calculate the exit time when the mobile device will exit inactive mode and begin searching for advertising signals; causing the transceiver to transmit an analyte value; causing the transceiver to terminate the data connection; and causing the transceiver to enter a sleep mode.

[0033] In certain embodiments of the fifth aspect, which are generally applicable and particularly applicable to any other implementation of the fifth aspect, the processor may be further configured to perform the following operations: cause the transceiver to exit sleep mode after a predetermined period of time; and cause the transceiver to transmit a second series of advertising signals.

[0034] In some embodiments of the fifth aspect that are generally applicable, and especially applicable to any other implementation of the fifth aspect, the connection interval may vary with the difference between the first time when the transceiver begins to transmit a series of advertising signals and the second time when the transceiver receives a data connection request from the mobile device.

[0035] In some embodiments of the fifth aspect, which are generally applicable and particularly applicable to any other embodiments of the fifth aspect, the analyte sensor may be a continuous glucose sensor.

[0036] In a sixth aspect, a mobile device configured for wireless data communication with an analyte sensor system is provided. The mobile device includes: a memory for storing a customized application; a radio unit for transmitting and receiving wireless signals; and a processor operatively coupled to the memory and the radio unit and configured to perform the following operations: causing the radio unit to search for advertising signals; receiving advertising signals from a transceiver associated with the analyte sensor system; causing the radio unit to transmit a data connection request to the transceiver; receiving consent to the data connection request from the transceiver; causing the radio unit to establish a data connection with the transceiver; receiving a connection interval of an amount of time elapsed between an instruction for the transceiver to begin transmitting a series of advertising signals and the transceiver receiving the data connection request; causing the radio unit to terminate the data connection with the transceiver; causing the radio unit to enter an inactive mode during which the radio unit does not communicate with the transceiver; calculating an exit time at least in part based on the connection interval; causing the radio unit to exit the inactive mode at the exit time; and causing the radio unit to search for advertising signals after exiting the inactive mode.

[0037] In some embodiments of the sixth aspect, which are generally applicable and particularly applicable to any other embodiments of the sixth aspect, the analyte sensor system may be a continuous glucose sensor system.

[0038] In some embodiments of the sixth aspect, which are generally applicable and particularly applicable to any other embodiments of the sixth aspect, the mobile device may be a mobile phone.

[0039] In some embodiments of the sixth aspect, which are generally applicable and particularly applicable to any other implementation of the sixth aspect, the exit time may be given by the following formula: current time + update interval - connection time - notification delay - protection measures, where the update interval may be the duration between two consecutive wireless communication sessions between the transceiver and the mobile device.

[0040] In a seventh aspect, a method is provided for wireless data communication between an analyte sensor system and a plurality of display devices, the display devices being capable of displaying analyte values ​​received wirelessly from the analyte sensor system, the method comprising: transmitting a first series of advertising signals; receiving a first data connection request from a first display device; determining whether the first display device is identified in a list containing a single permitted display device; and, if the first display device is not identified in the list, rejecting the first data connection request from the first display device at the radio hardware level.

[0041] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the method further includes agreeing to a first data connection from the first display device at the radio hardware level if the first display device is identified in the list.

[0042] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the method further includes establishing a first data connection with the first display device and transmitting analytical values ​​to the first display device.

[0043] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the analyte value may indicate a blood glucose value.

[0044] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other implementation of the seventh aspect, information identifying one or more display devices that have been paired with the transceiver may also be stored in a list.

[0045] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, information identifying one or more display devices paired with the transceiver may be stored in different lists.

[0046] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the method may further include continuing to accept data connection requests from one or more display devices when no other display device has been paired with the analyte sensor system.

[0047] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other implementation of the seventh aspect, the method may further include clearing the list upon satisfaction of predetermined conditions.

[0048] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the predetermined condition may be that a data connection request is not received from a listed display device identified in the list within a predetermined number of communication sessions.

[0049] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the predetermined condition may be receiving a clear signal from a list of listed display devices identified in the list, the clear signal indicating that the listed display devices will be removed from the list.

[0050] In some embodiments of the seventh aspect, which are generally applicable and particularly applicable to any other embodiments of the seventh aspect, the method may further include: receiving a second data connection request from the second display device; determining that the list has been cleared; agreeing to the second data connection request; and writing data identifying the second display device into the list.

[0051] In an eighth aspect, an analyte sensor system is provided configured for wireless data communication with a plurality of display devices, the display devices being capable of displaying analyte values ​​received wirelessly from the analyte sensor system. The analyte sensor system includes: an analyte sensor; a memory for storing a list identifying individual allowed display devices; a transceiver configured to transmit and receive wireless signals; and a processor operatively coupled to the analyte sensor, the memory, and the transceiver, and configured to perform the following operations: causing the transceiver to transmit a first series of advertising signals; receiving a first data connection request from a first display device; determining that the first display device is not identified in the list; and rejecting the data connection request from the first display device at the radio hardware level.

[0052] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other embodiments of the eighth aspect, the analyte sensor may be a continuous glucose sensor.

[0053] In some embodiments of the eighth aspect, which are generally applicable, and particularly applicable to any other embodiments of the eighth aspect, one of the plurality of display devices may be a custom analyte monitoring device, and another of the plurality of display devices may be a mobile device.

[0054] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other implementation of the eighth aspect, wireless data communication may employ a short-range and low-power wireless communication protocol.

[0055] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other implementation of the eighth aspect, the processor may be a link layer (LL) controller.

[0056] In some embodiments of the eighth aspect, which are generally applicable and especially applicable to any other implementation of the eighth aspect, the list may be a whitelist maintained in the LL controller.

[0057] In certain embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other embodiments of the eighth aspect, the processor may be further configured to perform the following operations: cause the transceiver to continue transmitting one or more advertising signals after rejecting the first data connection request, receive a data connection request from the second display device, and establish a data connection with the second display device if the second display device is identified in the list.

[0058] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other embodiments of the eighth aspect, the processor may be further configured to perform the following operations: participate in data communication with the second display device after establishing a data connection, terminate the data connection after completing the data communication, and cause the transceiver to enter a sleep mode.

[0059] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other implementation of the eighth aspect, the processor may be further configured to clear the list if predetermined conditions are met.

[0060] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other embodiments of the eighth aspect, the predetermined conditions may include the failure to receive a data connection request from a listed display device identified in the list within a predetermined number of communication sessions.

[0061] In some embodiments of the eighth aspect, which are generally applicable and particularly applicable to any other embodiments of the eighth aspect, the predetermined conditions may include receiving a clear signal from a list of display devices that can be identified in the list, the clear signal indicating that the listed display devices will be removed from the list.

[0062] In some embodiments of the eighth aspect, particularly those applicable to any other embodiments of the eighth aspect, the processor may be further configured to perform the following operations: receive a second data connection request from a second display device, determine that a list has been cleared, cause a transceiver to agree to the second data connection request, and write data identifying the second display device into the list. In a ninth aspect, a method is provided for wireless data communication between an analyte sensor system and a plurality of display devices, the display devices being capable of displaying analyte values ​​received wirelessly from the analyte sensor system, the method comprising: transmitting a first series of advertising signals; receiving a first data connection request from a first display device; determining that the first display device is identified in a first list containing one or more allowed display devices; establishing a first data connection with the first display device; transmitting to the first display device a first signal indicating that different display devices are identified in a second list containing a single currently active display device; receiving from the first display device a second signal indicating that the first display device is the most recently selected active display device; changing the second list to indicate that the first display device is the currently active display device; and terminating the first data connection with the first display device.

[0063] In some embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the method may further include determining that the first display device is not identified in the second list.

[0064] In some embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the method may further include receiving a request from the first display device to transmit the first signal.

[0065] In some embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the method may further include: reading first data from a second list that identifies different display devices as the currently active display device; and including the first data in a first signal transmitted to the first display device.

[0066] In some embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the second signal may include a request to write second data identifying the first display device as the currently active display device to a second list.

[0067] In certain embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the method may further include: transmitting a second series of advertising signals; receiving a second data connection request from the first display device; establishing a second data connection with the first display device; determining that the first display device is identified in a second list; transmitting analytical values ​​to the first display device; and terminating the second data connection with the first display device.

[0068] In certain embodiments of the ninth aspect, which are generally applicable and particularly applicable to any other embodiments of the ninth aspect, the method may further include: transmitting a third series of advertising signals; receiving a third data connection request from the second display device; establishing a third data connection with the second display device if it is determined that the second display device is identified in the first list; transmitting a third signal to the second display indicating that a different display device is identified in the second list; receiving a fourth signal from the second display device indicating that the third display device is not the most recently selected active display device; and terminating the third data connection with the second display device without changing the second list.

[0069] In a tenth aspect, an analyte sensor system is provided configured for wireless data communication with a plurality of display devices, the display devices being capable of displaying analyte values ​​from an analyte sensor module. The analyte sensor system includes: an analyte sensor; a transceiver configured to transmit and receive wireless signals; and a processor operatively coupled to the analyte sensor and the transceiver and configured to perform the following operations: causing the transceiver to transmit a first series of advertising signals; receiving a first data connection request from a first display device; determining that the first display device is identified in a first list containing one or more allowed display devices; establishing a first data connection with the first display device; reading first data from a second list identifying different display devices as currently active display devices; transmitting the first data to the first display device; receiving a request to write second data to the second list identifying the first display device as currently active display devices; writing the second data to the second list; and terminating the first data connection with the first display device.

[0070] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the analyte sensor may be a continuous glucose sensor.

[0071] In some embodiments of the tenth aspect, which are generally applicable, especially to any other embodiments of the tenth aspect, at least one of the first display device and different display devices may be a custom analyte monitoring device, and the other of the first display device and different display devices may be a mobile device.

[0072] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the mobile device may be a mobile phone.

[0073] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the processor may be configured to deny data connection requests from display devices not identified in the first list at the radio hardware level.

[0074] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other implementation of the tenth aspect, the processor may include a link layer (LL) controller.

[0075] In some embodiments of the tenth aspect, which are generally applicable and especially applicable to any other implementation of the tenth aspect, the first list may be a whitelist maintained in the LL controller.

[0076] In certain embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the processor may be further configured to perform the following operations: cause the transceiver to transmit a second series of advertising signals, receive a second data connection request from the first display device, cause the transceiver to establish a second data connection with the first display device, determine that the first display device is identified in a second list, cause the transceiver to transmit analytical values ​​to the first display device, and cause the transceiver to terminate the second data connection with the first display device.

[0077] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the processor may be further configured to perform the following operations: cause the transceiver to enter a sleep mode and cause the transceiver to exit the sleep mode after a predetermined time.

[0078] In some embodiments of the tenth aspect, which are generally applicable, especially to any other embodiments of the tenth aspect, the predetermined time may be between about 200 seconds and 300 seconds.

[0079] In some embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the processor may be further configured to measure the output of the analyte sensor when the transceiver is in sleep mode.

[0080] In certain embodiments of the tenth aspect, which are generally applicable and particularly applicable to any other embodiments of the tenth aspect, the processor may be further configured to perform the following operations: cause the transceiver to transmit a third series of advertising signals after exiting; receive a third data connection request from the second display device; cause the transceiver to establish a third data connection with the second display device if it is determined that the second display device is identified in the first list; cause the transceiver to transmit a third signal to the second display indicating that a different display device is identified in the second list; receive a fourth signal from the second display device indicating that the third display device is not the most recently selected active display device; and cause the transceiver to terminate the third data connection with the second display device without changing the second list.

[0081] In an eleventh aspect, a method is provided for wireless data communication between an analyte sensor system, a passive device, and an active display device, wherein the passive device is configured to receive data from a transceiver without establishing a data connection with the analyte sensor system, and the active display device is configured to display analyte data from the analyte sensor system after establishing a data connection with the analyte sensor system, the method comprising: the passive device receiving a first advertising signal from the analyte sensor system, the first advertising signal containing data to be used by the passive device; and the passive device extracting data from the first advertising signal.

[0082] In certain embodiments of the eleventh aspect, which are generally applicable and particularly applicable to any other embodiments of the eleventh aspect, the data that may be included in the first advertising signal includes analytical values.

[0083] In some embodiments of the eleventh aspect, which are generally applicable and particularly applicable to any other embodiments of the eleventh aspect, the analytical value may be a coded analytical value.

[0084] In some embodiments of the eleventh aspect, which are generally applicable and particularly applicable to any other embodiments of the eleventh aspect, the method may further include: the active display device receiving a second advertising signal from a transceiver; the active display device establishing a data connection with the transceiver in response to the second advertising signal; and the active display device receiving analytical values ​​to be displayed on the active display device.

[0085] In some embodiments of the eleventh aspect, which are generally applicable and particularly applicable to any other embodiments of the eleventh aspect, the second advertising signal may be the same as the first advertising signal.

[0086] In some embodiments of the eleventh aspect, which are generally applicable and particularly applicable to any other embodiments of the eleventh aspect, the second advertising signal may be different from the first advertising signal.

[0087] In a twelfth aspect, a system for wireless data communication is provided, comprising: an analyte sensor system configured to transmit a series of advertising signals; a passive device configured to perform the following operations: receiving a first advertising signal from the analyte sensor system, the first advertising signal being one of a series of advertising signals transmitted by the analyte sensor system and containing data to be used by the passive device; and extracting data from the first advertising signal without establishing a data connection with the analyte sensor system; and an active display device configured to perform the following operations: receiving a second advertising signal from the analyte sensor system, the second advertising signal being one of a series of advertising signals transmitted by the analyte sensor system; establishing a data connection with the analyte sensor system in response to the second advertising signal; receiving analyte values ​​from the analyte sensor system; terminating the data connection; and displaying the analyte values.

[0088] In some embodiments of the twelfth aspect, which are generally applicable and particularly applicable to any other embodiments of the twelfth aspect, the data to be used by the passive device may include coded analytical values.

[0089] In some embodiments of the twelfth aspect, which are generally applicable and particularly applicable to any other embodiments of the twelfth aspect, the analyte sensor system may be a continuous glucose sensor system and the passive device may be an insulin pump configured for insulin administration.

[0090] In some embodiments of the twelfth aspect, which are generally applicable and particularly applicable to any other embodiments of the twelfth aspect, the data contained in the first advertising signal may indicate a glucose level, and additionally wherein the insulin pump is configured to suspend insulin administration if the glucose level drops below a threshold.

[0091] Any of the features of the aspects specified herein applies to all other aspects and embodiments identified herein. Furthermore, any of the features of one aspect may be combined independently, in any manner, partially or entirely, with the other aspects described herein; for example, one, two, or three or more aspects may be combined entirely or partially. Additionally, any of the features of one aspect may be optional with respect to the other aspects. Any aspect of the method may be performed by a system or apparatus of another aspect, and any aspect of the system may be configured to perform the method of another aspect. Attached Figure Description

[0092] Figure 1 These are diagrams illustrating certain embodiments of a continuous analyzer sensor system according to certain aspects of this disclosure.

[0093] Figure 2A This is a perspective view of an exemplary sensor system that embodies certain aspects of the analyte sensor system according to this disclosure.

[0094] Figure 2B This is a side view of an exemplary sensor system that embodies certain aspects of the analyte sensor system according to this disclosure.

[0095] Figure 3 This is an exemplary block diagram illustrating various elements of certain embodiments of a continuous analytical substance monitoring system, including an analytical substance sensor system and multiple display devices, according to certain aspects of this disclosure.

[0096] Figure 4 This is a flowchart illustrating an exemplary wireless data communication procedure between an analyte sensor system and a display device according to certain aspects of this disclosure, wherein the display device is capable of wirelessly receiving analyte values ​​from the analyte sensor system.

[0097] Figure 5 This is a flowchart illustrating an exemplary process for facilitating the initial setup procedure between an analyte sensor system and a mobile device, according to certain aspects of this disclosure.

[0098] Figure 6 This is a flowchart illustrating an exemplary process for facilitating wireless data communication between an analyte sensor system and a mobile device according to certain aspects of this disclosure, wherein the mobile device is able to wirelessly receive analyte values ​​from the analyte sensor system by causing a custom application to exit a paused state before the next scheduled data communication event.

[0099] Figure 7 This is a flowchart illustrating an exemplary process for minimizing the number of advertising signals transmitted by the transceiver of an analyte sensor system before establishing a data connection with a display device, according to certain aspects of this disclosure.

[0100] Figure 8A and Figure 8B The flowchart illustrates an exemplary system and method for rejecting data connection requests from display devices not identified in a list containing a single permitted display device, according to certain aspects of this disclosure.

[0101] Figure 9A and Figure 9B A flowchart illustrating an exemplary procedure for facilitating switching between two display devices utilizing two separate lists, according to certain aspects of this disclosure.

[0102] Figure 10 This is a diagram illustrating a wireless data communication system including an analytical material sensor system, an active display device, and a passive display device, according to certain aspects of this disclosure.

[0103] Figure 11This is a flowchart illustrating an exemplary process according to certain aspects of this disclosure for allowing a passive device to receive desired data from an analyte sensor system without pairing or connection. Detailed Implementation

[0104] The following description and examples illustrate in detail some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that numerous variations and modifications of the invention exist within its scope. Therefore, the description of a particular exemplary embodiment should not be considered as limiting the scope of the invention.

[0105] Overview

[0106] In some embodiments, a system is provided for continuously measuring an analyte in a host, comprising: a continuous analyte sensor configured to continuously measure the concentration of the analyte in the host; and a sensor electronics module physically connected to the continuous analyte sensor during sensor use. In some 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 tailored to a corresponding display device, such that different display devices can receive different sensor information.

[0107] As used herein, the term "analyte" is a broad term and will be given its common and conventional meaning (and not limited to a specific or customary meaning) by those skilled in the art, and further refers without limitation to a substance or chemical component in an analyzable biological fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine). An analyte may comprise naturally occurring substances, artificial substances, metabolites, and / or reaction products. In some embodiments, the analyte used for measurement by a sensor head, device, and method is the analyte. However, other analytes are also expected, including but not limited to: non-carboxylic acid prothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (tricarboxylic acid cycle), histidine / imidazolylacrylic acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinose enantiomers; arginase; benzoyl succinate (cocaine); biotinylate; biopterin; C-reactive protein; carnitine; carnosine; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β-hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporine A; d-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylation polymorphism, alcohol dehydrogenase, α-... 1-Antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab hemoglobin, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); debutylhalogenated pantoxygenase; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycine; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3) Fumaryl acetylacetase; Galactose / galactose-1-phosphate; Galactose-1-phosphate uridine transferase; Gentamicin; Analyte-6-phosphate dehydrogenase; Glutathione; Glutathione peroxidase; Glycinecholic acid; Glycosylated hemoglobin; Halopanthone; Hemoglobin variants; Aminohexosidase A; Human erythrocyte carbonic anhydrase I; 17-α-hydroxyprogesterone; Hypoxanthine phosphoribosyltransferase; Immunoreactive trypsin; Lactate; Lead; Lipoproteins ((a), β / A-1, β); Lysozyme; Mefloquine; Netilmycin; Phenobarbital; Phenytoin; Phytanic acid / norphytanic acid; Progesterone; Prolactin; Aminoacylproline dipeptidase; Purine nucleoside phosphorylase; Quinine; Reverse triiodothyronine (rT3); Selenium; Serum pancreatic lipase; Sisomicin; Somatostatin C;Specific antibodies (adenovirus, antinuclear antibody, anti-ζ antibody, arbovirus, pseudorabies virus, dengue virus, dracunculia vesicanthus, echinococcosis, entomophobia, enterovirus, giardia lamblia, Helicobacter pylori, hepatitis B virus B, herpesvirus, HIV-1, IgE) (Atopic diseases), influenza virus, Leishmania donovani, Leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, myoglobin, filariasis var. spinosa, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, Rickettsia (jungle typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma krusei / Treatisena lentigines, herpestostomosis virus, Wuch. var. shans, yellow fever virus); specific antigens (hepatitis B virus B, HIV-1); succinylacetone; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transfer; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; leukocytes; and zinc protoporphyrin. In some embodiments, naturally occurring salts, sugars, proteins, fats, vitamins, and hormones in blood or interstitial fluid may also constitute analytes. Analytes may be naturally present in biological fluids, such as metabolites, hormones, antigens, antibodies, and the like. Alternatively, analytes may be introduced into the body, such as contrast agents for imaging, radioactive isotopes, chemical reagents, synthetic blood based on fluorocarbons, or pharmaceutical products or pharmaceutical compositions, including but not limited to: insulin; ethanol; cannabis products (cannabis, tetrahydrocannabinol, cannabis powder); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (quick cocaine); stimulants (amphetamine, methamphetamine, methylphenidate, pemoline, benzylpheniramine hydrochloride, prestate, o-chlorophenbutylamine hydrochloride, Sandrex). Benzomorpholine; sedatives (barbiturates, methaqualone, tranquilizers such as diazepam, nitrazepam, sildenafil, senna, chlorpheniramine, chlorpheniramine, chlorpheniramine, chlorpheniramine, chlorpheniramine, chlorpheniramine); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, phytohexidine); narcotics (heroin, codeine, morphine, opium, meperidine, acetaminophen, acetaminophen, hydrocodone, fentanyl, dalfool, analgesic, antidiarrheal); synthetic drugs (fentanyl, meperidine, amphetamine, methamphetamine, and analogues of phencyclidine, e.g., hallucinogens); anabolic steroids;And nicotine. Metabolites of pharmaceuticals and drug compositions are also expected analytes. Analytes generated in vivo, such as neurochemicals and other chemicals, such as, for example, ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), serotonin (5HT), and 5-hydroxyindoleacetic acid (FHIAA), can also be analyzed.

[0108] Warning

[0109] In some embodiments, one or more alerts are associated with a sensor electronics module. For example, each alert may include one or more alert conditions indicating when the corresponding alert has been triggered. For example, a hypoglycemia alert may include alert conditions indicating a minimum glucose level. Alert conditions may also be based on transformed sensor data, such as trend data, and / or sensor data from multiple different sensors (e.g., an alert may be based on sensor data from both a glucose sensor and a temperature sensor). For example, a hypoglycemia alert may include alert conditions indicating a minimum required trend of host glucose levels that must be present before the alert is triggered. As used herein, the term "trend" generally refers to data indicating a property of data acquired over time, such as calibrated or screened data from a continuous glucose sensor. A trend may indicate the amplitude, rate of change, acceleration, direction, etc., of data such as sensor data (including transformed or raw sensor data).

[0110] In some embodiments, each of the alerts is associated with one or more actions to be performed in response to the triggering of the alert. 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 vibration 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 will be transmitted, the time at which the data will be transmitted, and / or the communication protocol used for data delivery.

[0111] In some embodiments, multiple delivery actions (each with a corresponding delivery option) may be associated with a single alert, such that displayable sensor information (e.g., with different content and formats) is transmitted to a corresponding display device in response to triggering a single alert. For example, a mobile phone may receive a data packet containing a minimum amount of displayable sensor information (which may be specifically formatted for display on the mobile phone), while a desktop computer may receive a data packet containing most (or all) of the 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 confined to a single display device but is configured to communicate directly, systematically, simultaneously (e.g., via broadcast), periodically, cyclically, randomly, on demand, in response to queries, based on alerts or alarms, and / or the like, with multiple different display devices.

[0112] In some embodiments, clinical risk alerts are provided that include alert conditions that combine intelligent and dynamic estimation algorithms for estimating current or predicted hazards with greater accuracy, more timely resolution of pending hazards, avoidance of false alarms, and less patient annoyance. Generally, clinical risk alerts incorporate dynamic and intelligent estimation algorithms based on analytical values, rates of change, acceleration, clinical risk, statistical probability, known physiological constraints, and / or individual physiological patterns, thereby providing more appropriate, clinically safer, and patient-friendly alerts. Co-pending U.S. Patent Publication No. 2007 / 0208246 describes some systems and methods associated with the clinical risk alerts (or alarms) described herein, the entire contents of which are incorporated herein by reference. In some embodiments, a clinical risk alert may be triggered for a predetermined period of time to allow a user to monitor his / her symptoms. Additionally, a clinical risk alert may be deactivated upon leaving a clinical risk area so as not to annoy the patient with repetitive clinical alarms (e.g., visual, auditory, or vibrational) as the patient's symptoms are improving. In some embodiments, dynamic and intelligent estimation determines the likelihood of a patient avoiding clinical risks based on analyte concentration, rate of change, and other aspects of the dynamic and intelligent estimation algorithm. If the likelihood of avoiding a clinical risk is minimal or nonexistent, a clinical risk alert is triggered. However, if the likelihood of avoiding a clinical risk exists, the system is configured to wait a predetermined amount of time and re-analyze the likelihood of avoiding the clinical risk. In some embodiments, when the likelihood of avoiding a clinical risk exists, the system is further configured to provide goals, treatment recommendations, or other information that can help the patient proactively avoid clinical risks.

[0113] In some embodiments, the sensor electronics module is configured to search for one or more display devices within its communication range and wirelessly transmit sensor information (e.g., data packets containing displayable sensor information, one or more alarm conditions, and / or other alarm information) to them. Therefore, the display devices are configured to display at least some of the sensor information and / or issue alarms (and / or alerts) to the host, wherein the alarm mechanism is located on the display device.

[0114] In some embodiments, the sensor electronics module is configured to provide one or more distinct alarms via the sensor electronics module and / or via the transmission of data packets indicating that an alarm should be initiated by one or more display devices (e.g., sequentially and / or simultaneously). In some embodiments, the sensor electronics module provides only a data field indicating the presence of an alarm condition, and the display device can determine to trigger an alarm after 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 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 indicating activation of an alarm on the display to a monitoring device, 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, mobile phone, pager device, and / or similar device, and the text message contains displayable sensor information indicating the host's symptoms (e.g., "severe hypoglycemia").

[0115] In some embodiments, the sensor electronics module is configured to wait for a period of time for the host to respond to a triggered alert (e.g., by pressing or selecting a doze and / or shut-off function and / or button on the sensor electronics module and / or display device), after which additional alerts (e.g., in a progressively escalating manner) are triggered 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 associated with an alarm condition (e.g., hypoglycemia), such as an insulin pump, wherein the stop alert triggers the cessation of insulin delivery via the pump.

[0116] In some embodiments, the sensor electronics module is configured to transmit alarm information directly, systematically, simultaneously (e.g., via broadcast), periodically, cyclically, randomly, on demand, in response to queries (from a display device), based on alerts or alarms, and / or the like. In some embodiments, the system further includes a repeater that increases the wireless communication range of the sensor electronics module to, for example, 10, 20, 30, 50, 75, 100, 150, or 200 meters or more, wherein the repeater is configured to relay wireless communication from the sensor electronics module to a display device located remotely from the sensor electronics module. The repeater can be useful for families with children who have diabetes. For example, it allows parents to carry the display device or place it in a fixed location, such as when parents sleep in a large house some distance from the child.

[0117] Display device

[0118] In some embodiments, the sensor electronics module is configured to search for and / or attempt wireless communication with display devices in a list of display devices. In some embodiments, the sensor electronics module is configured to search for and / or attempt (e.g.) wireless communication with the list of display devices in a predetermined and / or programmable order (e.g., tiered and / or progressively escalating), wherein a failure to attempt to communicate with a first display device and / or to issue an alarm with the first display device triggers an attempt to communicate with a second display device and / or to issue an alarm with the second display device, and so on. In an exemplary embodiment, the sensor electronics module is configured to search for and attempt to issue alarms to the host or care provider in sequence from the list of display devices, such as: 1) a default display device or a custom analyte monitoring device; 2) a mobile phone via auditory and / or visual methods, such as sending text messages to the host and / or care provider, sending voice messages to the host and / or care provider, and / or 911; 3) a tablet; 4) a smartwatch.

[0119] Depending on the embodiment, one or more display devices that receive data packets from the sensor electronics module are “dummy displays” that display displayable sensor information received from the sensor electronics module without additional processing (e.g., the expected algorithmic processing necessary for real-time display of the sensor information). In some embodiments, the displayable sensor information includes sensor data that has undergone transformations that do not require processing by the display device prior to the displayable sensor information being displayed. Some display devices may include software containing display instructions configured to display displayable sensor information thereon (including software programming of instructions configured to display displayable sensor information and / or optionally query the sensor electronics module to obtain displayable sensor information). In some embodiments, the display device is programmed with display instructions at the manufacturer and may include security and / or authentication features to prevent display device theft. In some embodiments, the display device is configured to display displayable sensor information via a downloadable program (e.g., JavaScript downloadable via the Internet), such that any display device that supports program downloading (e.g., any display device that supports Java applets) can therefore be configured to display displayable sensor information (e.g., mobile phones, tablets, PDAs, PCs, and the like).

[0120] In some embodiments, certain display devices may communicate directly with the sensor electronics module; however, intermediate network hardware, firmware, and / or software may be included within the direct wireless communication. In some embodiments, a repeater (e.g., a Bluetooth repeater) may be used to retransmit transmitted displayable sensor information to a location farther than the direct range of the telemetry module of the sensor electronics module, wherein the repeater enables direct wireless communication even when actual processing of the displayable sensor information does not occur. In some embodiments, a receiver (e.g., a Bluetooth receiver) may be used to retransmit transmitted displayable sensor information, possibly in a different format (e.g., as a text message), to a TV screen, wherein the receiver enables direct wireless communication even when actual processing of the sensor information does not occur. In some embodiments, the sensor electronics module directly and wirelessly transmits displayable sensor information to one or more display devices, such that the displayable sensor information transmitted from the sensor electronics module is received by the display devices without any intermediate processing of the displayable sensor information.

[0121] In some embodiments, one or more display devices include a built-in authentication authority, wherein communication between the sensor electronics module and the display device requires authentication. In some embodiments, to authenticate data communication between the sensor electronics module and the display device, a query-response protocol, such as password authentication, is provided, wherein a query is a request for a password and a valid response is a correct password, such that pairing of the sensor electronics module and the display device can be accomplished by a user and / or manufacturer via a password.

[0122] In some embodiments, one or more display devices are configured to query displayable sensor information in a sensor electronics module, wherein the display devices act as master devices, requesting sensor information from the sensor electronics module (e.g., a slave device) as needed (e.g., in response to a query). In some embodiments, the sensor electronics module is configured to periodically, systematically, periodically, and / or periodically transmit sensor information to one or more display devices (e.g., every 1, 2, 5, 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 above-described data transmission scenarios can be implemented using any combination of paired sensor electronics modules and display devices. For example, one or more display devices may be configured to query a sensor electronics module database and receive alert information triggered by one or more satisfied alert conditions. Additionally, the sensor electronics module may be configured to periodically transmit sensor information to one or more display devices (the same or different display devices described in the foregoing examples), thereby allowing the system to include display devices that function differently regarding how they acquire sensor information.

[0123] In some embodiments, as described in more detail elsewhere herein, the display device is configured to query certain types of data content in the data storage of the sensor electronics module, including directly querying a database in the sensor electronics module's storage and / or requesting configured or configurable packages of data content from it; that is, the data stored in the sensor electronics module is configurable, queryable, predetermined, and / or pre-packaged based on the display device communicating with the sensor electronics module. 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. Additionally, some display devices are capable of obtaining calibration information and wirelessly transmitting calibration information to the sensor electronics module, such as through manual input of calibration information, automatic delivery of calibration information, and / or through an integrated reference analyzer monitor incorporated into the display device. U.S. Patent Publications 2006 / 0222566, 2007 / 0203966, 2007 / 0208245, and 2005 / 0154271 describe systems and methods for providing an integrated reference analyte monitor incorporated into a display device and / or other calibration methods that can be implemented using the embodiments disclosed herein, all of which are incorporated herein by reference in their entirety.

[0124] Generally, multiple display devices (e.g., custom analyte monitoring devices, mobile phones, tablets, smartwatches, reference analyte monitors, drug delivery devices, medical devices, and personal computers) are configured to wirelessly communicate with a sensor electronics module, wherein one or more display devices are configured to display at least some of the displayable sensor information transmitted wirelessly from the sensor electronics module, wherein the displayable sensor information includes 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.

[0125] Exemplary configuration

[0126] Figure 1 The diagram illustrates an exemplary continuous analyte monitoring system 100 according to certain aspects of this disclosure. System 100 includes an analyte sensor system 8 and multiple display devices 110, 120, 130, and 140. The analyte sensor system 8 includes a sensor electronics module 12 and a continuous analyte sensor 10 associated with the sensor electronics module 12. The sensor electronics module 12 communicates directly and wirelessly with one or more of the shown display devices 110, 120, 130, and / or 140.

[0127] In some embodiments, the sensor electronics module 12 includes electronic circuitry associated with measuring and processing continuous analyte sensor data, and includes anticipated algorithms associated with the processing and calibration of the sensor data. The sensor electronics module 12 may be physically connected to the continuous analyte sensor 10 and may be integrally (non-releasably attached) or releasably attached to the continuous analyte sensor 10. The sensor electronics module 12 may include hardware, firmware, and / or software enabling the measurement of analyte levels via a glucose sensor. For example, the sensor electronics module 12 may include a potentiostat, a power supply for providing power to the sensor, other components for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronics module to one or more display devices. The electronics may be attached to a printed circuit board (PCB) or the like, and may take various forms. For example, the electronics may take the form of an integrated circuit (IC), such as an application-specific integrated circuit (ASIC), a microcontroller, and / or a processor. The sensor electronics module 12 includes sensor electronics configured to process sensor information, such as sensor data, and to 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 6,931,327 and U.S. Patent Publications 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.

[0128] See again Figure 1Multiple display devices (110, 120, 130, and / or 140) are configured to display (and / or alarm) displayable sensor information transmitted by the sensor electronics module 12 (e.g., in custom data packets transmitted to the display devices based on their respective preferences). Each of the display devices 110, 120, 130, or 140 may include a display, such as a touchscreen display 112, 122, 132, and / or 142, for displaying sensor information to a user and / or receiving input from the user. In some embodiments, instead of a touchscreen display or in addition to a touchscreen display, the display device may also 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 when it is communicated from the sensor electronics module (e.g., in data packets transmitted to the respective display device), and the calibration and real-time display of the sensor data do not require any additional expected processing.

[0129] exist Figure 1 In some embodiments, the plurality of display devices include a custom display device 110 specifically designed to display certain types of displayable sensor information associated with analytical values ​​(e.g., numerical values ​​and arrows in some embodiments) received from the sensor electronics module 12. In some embodiments, one of the plurality of display devices is a mobile phone 120, a handheld computer, and / or the like based on an Android or iOS operating system, wherein the display device includes a relatively large display 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 130, a smartwatch 140, an insulin delivery device, a blood glucose meter, and / or a desktop or laptop computer.

[0130] Because different display devices offer different user interfaces, the content of data packets (e.g., the amount, format, and / or type of data to be displayed, alarms, and the like) can be customized for each specific display device (e.g., programmed differently by the manufacturer and / or end user). Therefore, in Figure 1 In some embodiments, multiple different display devices may communicate directly with the sensor electronics module during a sensor session (e.g., such as an on-dermal sensor electronics module 12 physically connected to the continuous analyte sensor 10) to enable multiple different types and / or levels of display and / or functionality associated with displayable sensor information, which are described in more detail elsewhere herein.

[0131] Continuous sensor

[0132] In some embodiments, Figure 1 The analyte sensor 10 includes a continuous glucose sensor, such as a subcutaneous device, a transdermal (e.g., percutaneous) device, or an intravascular device. In some embodiments, the device can analyze multiple intermittent blood samples. The glucose sensor can use any glucose measurement method, including enzymatic, chemical, physical, electrochemical, spectrophotometric, optical rotation, calorimetric, iontophoresis, radiometric, immunochemical, and similar methods.

[0133] Glucose sensors can use any known method, including invasive, minimally invasive, and non-invasive sensing technologies (e.g., fluorescence monitoring), to provide a data stream indicating glucose concentration in the host. The data stream is typically a raw data signal that has been converted into a calibrated and / or filtered data stream to provide useful glucose values ​​to users, such as patients or caregivers (e.g., patients, relatives, guardians, teachers, doctors, nurses, or any other individual interested in the host's well-being).

[0134] A glucose sensor can be any device capable of measuring glucose concentration. An exemplary embodiment utilizing an implantable glucose sensor is described below. However, it should be understood that the apparatus and methods described herein can be applied to any device capable of detecting glucose concentration and providing an output signal representing that glucose concentration.

[0135] In some embodiments, the analyte sensor is an implantable glucose sensor such as that described in U.S. Patent 6,001,067 and U.S. Patent Publication No. US-2005-0027463-A1. In another embodiment, the analyte sensor is a transdermal glucose sensor such as that described in U.S. Patent Publication No. US-2006-0020187-A1. In other embodiments, the sensor is configured to be implanted in or outside a host blood vessel, as described in U.S. Patent Publication No. US-2007-0027385-A1, co-pending U.S. Patent Publication No. US-2008-0119703-A1 (filed October 4, 2006), co-pending U.S. Patent Publication No. US-2008-0108942-A1 (filed March 26, 2007), and co-pending U.S. Patent Publication No. US-2007-0197890-A1 (filed February 14, 2007). In one alternative embodiment, the continuous glucose sensor includes, for example, a percutaneous sensor as described in U.S. Patent 6,565,509 to Say et al. In another alternative embodiment, the continuous glucose sensor includes, for example, a subcutaneous sensor as described in U.S. Patent 6,579,690 to Bonnecaze et al. or U.S. Patent 6,484,046 to Say et al. In another alternative embodiment, the continuous glucose sensor includes, for example, a refillable subcutaneous sensor as described in U.S. Patent 6,512,939 to Colvin et al. In another alternative embodiment, the continuous glucose sensor includes, for example, an intravascular sensor as described in U.S. Patent 6,477,395 to Schulman et al. In another alternative embodiment, the continuous glucose sensor includes, for example, an intravascular sensor as described in U.S. Patent 6,424,847 to Mastrototaro et al.

[0136] Figure 2A and Figure 2B It is possible to have certain aspects of this disclosure. Figure 1The illustrated analyte sensor system 8 is shown in perspective and side views. In some embodiments, the sensor system includes a mounting unit 214 and a sensor electronics module 12 attached to the mounting unit 214. The sensor system is shown in its functional position as including the mounting unit and sensor electronics module matingly engaged therein. In some embodiments, the mounting unit 214, also referred to as a housing or sensor housing, includes a base 234 adapted to be fastened to the host's skin. The base may be formed of a variety of hard or soft materials and may include a low profile to minimize protrusions from the device to the host during use. In some embodiments, the base 234 is at least partially formed of a flexible material, believed to provide numerous advantages over conventional transdermal sensors, which unfortunately suffer from motion-related artifacts associated with host movement when the host is using the device. The mounting unit 214 and / or sensor electronics module 12 may be located above the sensor insertion site to protect the site and / or provide minimal occupancy (utilization of the host's skin surface area).

[0137] In some embodiments, a detachable connection is provided between the mounting unit 214 and the sensor electronics module 12. This improves manufacturability, meaning that the relatively inexpensive mounting unit 214 can be disposed of when the sensor system is replaced after its usable lifespan, while the relatively expensive sensor electronics module 12 can be reused in multiple sensor systems. In some embodiments, the sensor electronics module 12 is configured for signal processing (programming), for example, configured for screening, calibration, and / or other algorithms for calibrating and / or displaying sensor information. However, an integrated (non-detachable) sensor electronics module can be configured.

[0138] In some embodiments, contact 238 is mounted on or in a subassembly, hereinafter referred to as contact subassembly 236, which is configured to engage within the base 234 of mounting unit 214, and hinge 248 allows contact subassembly 236 to pivot relative to mounting unit 214 between a first position (for insertion) and a second position (for use). The term “hinge” as used herein is a broad term and is used in its ordinary sense, including but not limited to referring to any of a variety of pivoting, hinged, and / or articulating mechanisms, such as adhesive hinges, sliding joints, and the like; the term hinge does not necessarily imply a fulcrum or fixed point around which the hinge occurs. In some embodiments, contact 238 is formed of a conductive elastomeric material (such as carbon black elastomeric material), through which analyte sensor 10 extends.

[0139] In some embodiments, the mounting unit 214 includes an adhesive pad 208 disposed on the back surface of the mounting unit and comprises a releasable backing layer. Therefore, removing the backing layer and pressing the base portion 234 of the mounting unit onto the host's skin will adhesively attach the mounting unit 214 to the host's skin. Alternatively, the adhesive pad may be placed over some or all of the sensor system after sensor insertion is complete to ensure adhesion and optionally ensure an airtight or waterproof seal around the wound exit site (or sensor insertion site) (not shown). Appropriate adhesive pads can be selected and designed to stretch, elongate, conform to the area (e.g., the host's skin), and / or ventilate the area. See U.S. Patent No. 7,310,544 for a more detailed description. Figure 2A and Figure 2B The embodiments described herein, and the full text of the U.S. patent, are incorporated herein by reference. Configurations and arrangements may provide water-resistant, waterproof, and / or fully sealed properties associated with the mounting unit / sensor electronics module embodiments described herein.

[0140] U.S. Patent Publication No. US-2009-0240120-A1 discloses various methods and apparatuses suitable for use in conjunction with aspects of some embodiments, the entire contents of which are incorporated herein by reference for all purposes.

[0141] Figure 3 This is an exemplary block diagram illustrating various elements of certain embodiments of a continuous analyte monitoring system 300, which includes an analyte sensor system 8 and display devices 110, 120, 130, and 140. The analyte sensor system 8 may include an analyte sensor 312 (in... Figure 1 Also designated as 10), it is coupled to sensor measurement circuitry 310 for processing and managing sensor data. Sensor measurement circuitry 310 may be coupled to processor 314 ( Figure 1 (Part of the sensor electronics module 12 in the sensor). In some embodiments, the processor 314 may perform some or all of the functions of the sensor measurement circuit 310 for obtaining and processing sensor measurement values ​​from the sensor 312. The processor may be further coupled to a radio unit or transceiver 316. Figure 1 The sensor electronics module 12 is a portion thereof for transmitting sensor data and receiving requests and commands from external devices, such as display devices 110, 120, 130, 140, for displaying or otherwise providing sensor data to a user. As used herein, the terms “radio unit” and “transceiver” are used interchangeably and generally refer to devices capable of transmitting and receiving data wirelessly. The analyte sensor system 8 may further include a memory 318 ( Figure 1The sensor electronics module 12 and the real-time clock (RTC) 320 (part of the sensor electronics module 12) Figure 1 The sensor electronics module 12 is part of the sensor data storage and tracking module.

[0142] Wireless communication protocols can be used to transmit and receive data between the analyte sensor system 8 and display devices 110, 120, 130, and 140. The wireless protocols used are designed for use in wireless sensor networks and are optimized for periodic and small-data transmissions (which may be performed at low rates if necessary) to and from multiple devices at close range (e.g., in a personal area network (PAN)). For example, the protocol can be optimized for periodic data transmission, where transceivers can be configured to transmit data at short intervals and then enter a low-power mode for longer intervals. The protocol can have low overhead requirements for both normal data transmission and initial setup of the communication channel (e.g., by reducing header overhead) to reduce power consumption. In some embodiments, burst broadcast schemes (e.g., one-way communication) can be used. This eliminates the overhead required for acknowledgment signals and allows for periodic transmissions consuming very little power.

[0143] The protocol can be further configured to establish communication channels with multiple devices when implementing interference avoidance schemes. In some embodiments, the protocol may use an adaptive isochronous network topology that defines various time slots and frequency bands for communicating with multiple devices. The protocol can therefore modify the transmission window and frequency in response to interference with multiple devices and in response to supporting communication with multiple devices. Thus, the wireless protocol can use schemes based on time division and frequency division multiplexing (TDMA). The wireless protocol can also employ direct sequence spread spectrum (DSSS) and frequency hopping spread spectrum schemes. Various network topologies can be used to support short-range and / or low-power wireless communications, such as peer-to-peer, start-up, tree, or mesh network topologies, such as WiFi, Bluetooth, and Bluetooth Low Energy (BLE). The wireless protocol can operate in various frequency bands, such as open ISM bands (e.g., 2.4 GHz). Furthermore, to reduce power consumption, the wireless protocol can adaptively configure the data rate according to power consumption.

[0144] Display devices 110, 120, 130, and 140 can be used to alert users and provide sensor information, and may include a processor 330 for processing and managing sensor data. Display devices 110, 120, 130, and 140 may include a display 332, a memory 334, and a real-time clock 336 for displaying, storing, and tracking sensor data, respectively. Display devices 110, 120, 130, and 140 may further include a radio unit or transceiver 338 for receiving sensor data and for sending requests, instructions, and data to the analyte sensor system 8. The transceiver 338 may further employ a communication protocol. The memory 334 may also be used to store the operating system of the display device and / or a custom (e.g., proprietary) application designed for wireless data communication between the transceiver and the display device. The memory 334 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 software programs and applications. Instructions can be executed by processor 330 to control and manage transceiver 338.

[0145] In some embodiments, when using standardized communication protocols, commercially available transceiver circuitry can be utilized, which includes processing circuitry to handle low-level data communication functions such as managing data encoding, transmission frequency, handshake protocols, and the like. In these embodiments, processors 314, 330 do not need to manage these activities; instead, they provide the desired data values ​​for transmission and manage higher-level functions such as power-on or power-off, setting the rate of transmitted messages, and the like. Instructions and data values ​​for performing these higher-level functions can be provided to the transceiver circuitry via a data bus and a transmission protocol established by the manufacturer of the transceiver circuitry 316.

[0146] Components of the analyte sensor system 8 may require periodic replacement. For example, the analyte sensor system 8 may include an implantable sensor 312 and a battery (not shown) attachable to a sensor electronics module, which includes sensor measurement circuitry 310, a processor 314, a memory 318, and a transceiver 316. The sensor 312 may require periodic replacement (e.g., every 7 to 30 days). The sensor electronics module may be configured to be powered and active for a much longer period than the sensor 312 (e.g., three months, six months, or more) until the battery needs replacement. Replacing these components can be difficult and requires specialized personnel. Reducing the need to replace such components, especially the battery, significantly improves the user convenience of the analyte sensor system 8. In some embodiments, a sensor session, as defined above, may correspond to the lifespan of the sensor 312 (e.g., in the range of 7 to 30 days). When the sensor electronics module is first used (or, in some cases, reactivated after a battery replacement), it can be connected to the sensor 312, and a sensor session can be established. As will be further described below, there may be a process for initially establishing communication between the display devices 110, 120, 130, 140 and the sensor electronics module upon first use or reactivation of the sensor electronics module (e.g., battery replacement). Once communication is established between the display devices 110, 120, 130, 140 and the sensor electronics module, they may communicate periodically and / or continuously over the lifetime of the sensors 312 until, for example, the battery needs to be replaced. Each time a sensor 312 is replaced, a new sensor session can be established. A new sensor session can be initiated using a process performed by the display devices 110, 120, 130, 140, which can be triggered by notification of a new sensor via communication between the sensor electronics module and the display devices 110, 120, 130, 140, and this communication may persist within the sensor session.

[0147] The analyte sensor system 8 collects analyte data from sensor 312 and periodically transmits the analyte data to display devices 110, 120, 130, and 140. Data points are collected and transmitted over the lifetime of the sensor (e.g., within a range of 1 to 30 days or more). New measurements may need to be transmitted frequently enough to adequately monitor glucose levels. Instead of continuous communication between the transmitting and receiving circuits of each of the analyte sensor system 8 and the display devices 110, 120, 130, and 140, the analyte sensor system 8 can establish communication channels with the display devices 110, 120, 130, and 140 via periodic and recurring transmissions. Therefore, the analyte sensor system 8 can communicate wirelessly with the display devices 110, 120, 130, and 140 (e.g., handheld computing devices) at predetermined time intervals. The duration of the predetermined time interval can be selected to be long enough that the analyte sensor system 8 does not consume excessive power by transmitting data more frequently than necessary, but the frequency is sufficient to provide substantially real-time sensor information (e.g., measured glucose values) to the display devices 110, 120, 130, 140 for output (display) to the user. Although in some embodiments the predetermined time interval is every five minutes, it should be understood that this time interval can be changed to any desired length of time.

[0148] Figure 4 This is a flowchart illustrating an exemplary wireless data communication procedure between the analyte sensor system 8 and display devices 110, 120, 130, and 140 according to certain aspects of this disclosure, wherein the display devices 110, 120, 130, and 140 are capable of wirelessly receiving analyte values ​​from the analyte sensor system 8. (In conjunction with...) Figure 4 The various tasks performed by the described program can be executed by a processor that executes instructions embodied in a non-transitory computer-readable medium. For example, the tasks performed by the program can be performed by one or more hardware, software, firmware, or any combination thereof incorporated in a computing device (such as...). Figure 1 and / or Figure 3 The analysis is performed by the analyte sensor system 8 and one or more of the display devices 110, 120, 130 and 140. It should be understood that the program may include any number of additional or alternative tasks. Figure 4 The tasks shown do not need to be performed in the order described, and the program can be incorporated into a more comprehensive program or process with additional functionality not described in detail in this document.

[0149] In the examples described below, for illustrative purposes, the analyte value is based on one or more measurements of glucose level taken by the analyte sensor 312. However, it should be understood that the analyte value can be any other analyte value described herein. Wireless data communication between the analyte sensor system 8 and the display device can be periodically denoted by "T". interval The update interval T occurs at intervals that separate the time intervals. interval This can correspond to the duration between two consecutive wireless communication sessions between transceiver 316 of the analyte sensor system 8 and transceiver 338 of the display devices 110, 120, 130, 140. Alternatively, the update interval can be viewed as the period for acquiring and transmitting the most recently measured glucose value. Transmitting advertising signals, establishing data connections (e.g., communication channels), and requesting and sending data can occur during a wireless communication session, with each session lasting for an update interval T. interval The inner part is represented as "T" Active The activity time or period of "T". Between two consecutive wireless communication sessions, transceiver 316 in the "T" period... Inactive During inactive periods, the system enters an inactive or sleep mode to (for example) save battery life and / or reduce peak voltage requirements.

[0150] Figure 4 Two such wireless communication sessions are shown: a first wireless communication session 410 and a second wireless communication session 420. Each wireless communication session 410, 420 begins with the establishment of a data connection between the analyzer sensor system 8 and the display devices 110, 120, 130, 140. To establish a data connection with the display devices 110, 120, 130, 140, the transceiver 316 of the analyzer sensor system 8 transmits a series of advertising signals 412 during the first wireless communication session 410. Each advertising signal can be viewed as an invitation for the display devices 110, 120, 130, 140 to establish a data connection with the transceiver 316.

[0151] exist Figure 4In the illustrated example, it is assumed that the analyte sensor system 8 needs to participate in initial system setup because the analyte sensor system 8 has just been connected for the first time and / or is not currently paired with display devices 110, 120, 130, 140. Typically, users of display devices 110, 120, 130, 140 identify the new or unused analyte sensor system 8 by entering identification information (e.g., serial number) associated with the new / unpaired analyte sensor system 8 through a user interface (e.g., a touchscreen display) via a custom application running on the display device. During the first wireless communication session 410, an authentication procedure needs to be performed as part of the data connection process 414. To establish a data connection with the analyte sensor system 8, display devices 110, 120, 130, 140 continuously listen until they receive an advertising signal transmitted by the transceiver 316 of the analyte sensor system 8. Once transceiver 316 begins transmitting advertising signal 412, it may use one, two, or more advertising signals to enable display devices 110, 120, 130, and 140 to receive and respond to the advertising signals. In some embodiments, transceiver 316 stops transmitting additional advertising signals once a display device receives an advertising signal and (for example) responds to it via an acknowledgment. In other embodiments, transceiver 316 may continue transmitting additional advertising signals even after receiving a response from a display device, enabling another display device to receive and respond to one of the additional advertising signals.

[0152] After the advertising signal is successfully received by display devices 110, 120, 130, and 140, the display devices and the analytical substance sensor system 8 participate in a first data connection process 414. During the first data connection process 414, the display devices request a query value from the analytical substance sensor system 8, and the analytical substance sensor system 8 sends a change value to the display devices in response. Upon receiving the query value, the display devices calculate a hash value based on the query value and the identification information associated with the analytical substance sensor system 8 and / or transceiver 316, and send the hash value to the transceiver 316. The transceiver 316 receives the hash value from the display devices 110, 120, 130, and 140, decodes the identification information based on the hash value, and verifies that the received identification information matches the identification information previously stored in the memory 318 of the analytical substance sensor system 8 (such as during the manufacturing of the analytical substance sensor system 8) associated with the analytical substance sensor system 8 and / or transceiver 316. After verification, transceiver 316 sends a signal confirming successful authentication to display devices 110, 120, 130, and 140. Once authenticated, the analyte sensor system 8 and display devices 110, 120, 130, and 140 can exchange information to determine how data will be exchanged (e.g., specific frequency, time slot assignment, encryption, etc.).

[0153] After the first data connection process 414 is completed, the analyte sensor system 8 and the connected display devices 110, 120, 130, and 140 participate in a first data communication 416. During the first data communication, the connected display devices request and receive desired information (e.g., analyte data, control information, identification information, and / or instructions) from the analyte sensor system 8. When the first data communication 416 is completed, the data connection is terminated (e.g., by closing the established communication channel), and can be disabled by causing the transceiver 316 and / or processor 314 of the analyte sensor system 8 to enter a sleep or inactive mode (or possibly the transceiver 338 and / or processor 330 of the display devices 110, 120, 130, and 140, depending on implementation preference). In some embodiments, the transceiver 316 is completely powered off during the sleep mode. In other embodiments, the transceiver 316 is in a low-power mode, using only a small fraction of the normal current / power (e.g., 1% to 10%).

[0154] The activity period T corresponding to the duration of each wireless communication session Active The update interval T can be the period corresponding to the time interval between two consecutive wireless communication sessions. interval Small fractions. For example, T interval It can be between approximately 200 and 400 seconds, and T Active The time can be between 20 and 40 seconds. Therefore, the transceiver 316 of the analyte sensor system 8 can be fully powered for only five minutes. interval 10% (e.g., 30 seconds). This significantly reduces power consumption and peak voltage requirements. In some cases, the transceiver 316 does not completely power down when not transmitting, but instead enters a low-power mode. During inactive periods or cycles T... Inactive Subsequently, the second wireless communication session 420 begins when transceiver 316 (and transceiver 338) is powered on again, and begins transmitting a second series of advertising signals 422, participating in the second data connection process 424 and the second data communication process 426 with the transceiver 338 of display devices 110, 120, 130, and 140, as follows. Figure 4 As shown. However, unlike the first data connection process 414, the second data connection process 424 does not involve authentication because the analyzer sensor system 8 and the display devices 110, 120, 130, 140 have been successfully paired or combined during the first wireless communication session 410, as described above. This process can continue, with new data connections and communications completed at predetermined intervals. During each inactive cycle T when the transceiver 316 is in sleep mode. InactiveDuring all or part of the process, the processor 314 may use the analyte sensor 312 and sensor measurement circuitry 310 to measure one or more analyte values. For example, the processor 314 may take multiple analyte value measurements and average them to produce a single average analyte value that will be transmitted in the next wireless communication session.

[0155] In each update interval T interval Continuously re-establishing new communication channels during this period allows for partial or complete power-off of transceiver 316, providing significant power savings and enabling sensor electronics module 12 ( Figure 1 It can operate continuously for six months or more without battery replacement. Furthermore, it is not at the update interval T. interval Instead of blindly transmitting glucose data points, establishing specific data connections (e.g., communication channels) only with the desired display devices 110, 120, 130, 140 prevents unauthorized use and interception of glucose measurements. In some embodiments, only a subset of the multiple display devices 110, 120, 130, 140 can be configured to receive different data, such as glucose measurements and / or alarm conditions. This has the benefit of preventing multiple display devices from issuing alarms, thus avoiding user confusion and / or frustration. Furthermore, by establishing a secure two-way communication channel, requests for specific glucose measurements or the transmission of calibration or configuration information can be transmitted between the analyte sensor system 8 and the display devices 110, 120, 130, 140 based on need / request.

[0156] Moreover, in some embodiments, it may not be every update interval T interval All transceivers 316 are activated for data communication. Instead, updates can be performed (for example) every two, three, or four intervals T. interval Activate transceiver 316 to make communication between the analyte sensor system 8 and the display devices 110, 120, 130, 140 less than every update interval T. interval This occurs so frequently. Doing so further reduces power consumption. Activation can also be dependent on sensor data. For example, the transceiver can be activated only if the data meets certain thresholds, this current rate of change, the current high value, the current low value, the absolute difference from the previously exchanged value, the percentage difference from the previously exchanged value, and the like. In some embodiments, instead of skipping certain fixed update intervals, the length of each interval can be varied based on sensor data. For example, if sensor data indicates a low glucose level and / or a hypoglycemic response is detected, the update interval value can be shortened from the normal update interval value, resulting in more frequent taking and transmitting of readings.

[0157] In some embodiments, the update interval T interval Activity cycle T Active and the frequency F of activating the transceiverActivation (For example, every two, three, or four update intervals) can be variable. In some embodiments, the parameters identified above can be user-configurable (e.g., by inputting variable values ​​through a user interface of display devices 110, 120, 130, 140) and / or automatically varied by the analyte sensor system 8 or display devices 110, 120, 130, 140 based on one or more criteria. The criteria may include: (i) the battery level monitored by the analyte sensor system 8; (ii) the currently measured, previously measured, and / or predicted glucose concentrations that meet or exceed a predetermined threshold; (iii) the glucose concentration trend of the host based on the currently measured, previously measured, and / or predicted glucose concentrations; (iv) the rate of change of the host's glucose concentration based on the currently measured, previously measured, and / or predicted glucose concentrations that meet or exceed a predetermined threshold; (v) determining whether the host is in or near hyperglycemia based on the currently measured, previously measured, and / or predicted glucose concentrations; (vi) determining whether the host is in or near hypoglycemia based on the currently measured, previously measured, and / or predicted glucose concentrations; (vii) the host activity entered by the user (e.g., exercise or sleep); (viii) the time since the start of the sensor session (e.g., when a new analyte sensor 10 is used); (ix) one or more errors detected by the analyte sensor system 8 or display devices 110, 120, 130, 140; and (x) the type of display device.

[0158] T interval T Active F Activation And / or other configuration items described herein may form part of a communication protocol profile, which may be stored on any device implementing the basic communication protocol to allow for customized use of the protocol for communicating analyte measurements in the analyte sensor system 8 and display devices 110, 120, 130, 140.

[0159] Facilitating the initial data connection process

[0160] When a user wishes to pair display devices 110, 120, 130, and 140 with a new analyte sensor system 8, they type identification information (e.g., a serial number or other unique identifier) ​​associated with the analyte sensor system 8 (or its transceiver 316) in the display device (e.g., via the user interface, such as a touchscreen). For example, depending on the programmed update interval T... intervalAnd / or any sensor system initialization time can take 5 to 10 minutes before transceiver 316 begins transmitting advertising signals. Therefore, pairing the analyte sensor system 8 with display devices 110, 120, 130, and 140 can take up to 10 minutes. In some embodiments, the display device can be a mobile device based on a specific mobile operating system (e.g., Android or iOS), such as mobile phone 120, tablet 130, or smartwatch 140. A custom application running on the mobile device to handle the authentication process for the analyte sensor system 8 may be inactive or in the background, causing the mobile device to fail to complete the authentication process when transceiver 316 begins transmitting advertising signals. This problem can further increase pairing time.

[0161] One solution to the aforementioned problem is to have the mobile device display a message to the user via a user interface, informing them that the analyzer sensor system 8 is ready to connect to the mobile device, thus allowing the custom application to enter foreground mode. Once in foreground mode, the custom application can optionally request the user to confirm their desire to establish a data connection with the transceiver. Figure 5 This is a flowchart illustrating an exemplary process 500 for facilitating the initial setup procedure between the analyte sensor system 8 and the mobile devices 120, 130, and 140, according to certain aspects of this disclosure. (In conjunction with...) Figure 5 The various tasks performed by the described process 500 can be executed by a processor that executes instructions embodied in a non-transitory computer-readable medium. For example, the tasks performed by process 500 can be performed by hardware, software, firmware, or any combination thereof incorporated in one or more computing devices (such as...). Figure 1 and / or Figure 3 The analysis is performed by the analyte sensor system 8 and one or more of the display devices 110, 120, 130 and 140. It should be understood that the program may include any number of additional or alternative tasks. Figure 5 The tasks shown do not need to be performed in the order described, and the program can be incorporated into a more comprehensive program or process with additional functionality not described in detail in this document.

[0162] As indicated above, mobile devices 120, 130, and 140 may be based on a mobile operating system such as Android or iOS. The mobile devices may also be configured to run custom applications for handling communication and management of analyte data from the analyte sensor system 8. In some embodiments, wireless data communication is based on short-range and / or low-power wireless communication protocols such as WiFi, Bluetooth, and Bluetooth Low Energy (BLE). In some embodiments, the mobile device is an iOS-based iPhone, and the wireless communication protocol is BLE.

[0163] Process 500 begins in start state 501 and proceeds to operation 510, where mobile devices 120, 130, and 140 read identification information associated with transceiver 316 of the analyte sensor system 8 to which the user wishes to pair. The identification information may be, for example, a serial number associated with the sensor system. The user may type this information via a customized application using a user interface, such as a touchscreen display 122, 132, and 142 provided in mobile devices 120, 130, and 140. Process 500 proceeds to operation 520, where the user-typed identification information is stored in memory 334 of mobile devices 120, 130, and 140. Process 500 proceeds to operation 530, where processor 330 of mobile devices 120, 130, and 140 causes the customized application to enter background mode. The customized application may enter background mode for various reasons. For example, in some embodiments, background mode is entered after a predetermined inactivity period. Depending on the mobile operating system, the predetermined inactivity period may be between 10 seconds and 100 seconds. In some embodiments, background mode is entered after conditions such as the mobile device's memory usage exceeding a predetermined threshold and the mobile operating system and / or the user deciding to put one or more active applications into background mode are detected.

[0164] Process 500 then proceeds to operation 540, in which mobile devices 120, 130, and 140 search for advertising signals from transceiver 316 until the mobile devices receive the advertising signal. Process 500 then proceeds to operation 550, in which the mobile devices authenticate transceiver 316 based on user-entered identification information and query values. (As mentioned above regarding...) Figure 4 As discussed, the authentication operation 500 may include: the mobile device requesting a query value from the transceiver 316; receiving the query value; generating or calculating a hash value based on the query value and identification information; transmitting the hash value to the transceiver; and receiving confirmation from the transceiver 316 indicating successful authentication.

[0165] Process 500 then proceeds to operation 560, where mobile devices 120, 130, and 140 prompt (e.g., via one or a combination of audible alarms, vibration alarms, and pop-up messages) the user to bring the customized application to the foreground, for example, by touching an icon associated with the customized application and / or causing a pop-up message to appear on the display, prompting the user to touch an optional field corresponding to the customized application. Once the customized application is brought to the foreground, process 500 proceeds to operation 570, where the customized application requests confirmation from the user of the desired data connection with transceiver 316. Process 500 proceeds to query state 575, where it is determined whether this confirmation has been received from the user within a predetermined time. If confirmation (yes) is received, then process 500 proceeds to operation 580, where the data connection with transceiver 316 is completed, for example, by sending a signal indicating confirmation to the transceiver, followed by data communication in which the mobile device requests and receives analytical values ​​from transceiver 316. After completing the data connection and data communication, process 500 proceeds to operation 590, in which the data connection is terminated and then ends in the end state 503. On the other hand, if no acknowledgment is received from the user within a predetermined time (no), then process 500 ends without completing the pairing between the analyzer sensor system 8 and the mobile devices 120, 130, and 140.

[0166] As an example, the process 500 described above can be implemented in an Apple iPhone with the iOS 7 operating system. iOS 7 has a "resume function" that alerts a custom application that has been paused or placed in the background to another Bluetooth event. Prior to this event, iOS 7 can wake up the application and cause it to scan for Bluetooth signals (e.g., advertisements) from transceiver 316.

[0167] Resume a custom application from a paused state

[0168] In some cases, the processor 330 in mobile devices 120, 130, and 140 may suspend custom applications when a certain condition occurs. For example, in some mobile operating systems, when it is determined that one or more applications are using excessive memory, the operating system may decide to disable or otherwise suspend one or more applications containing custom applications in the mobile device that facilitate wireless communication with the analyte sensor system 8. When this disabling or suspension of custom applications occurs, the transceiver 338 in the mobile device may not scan or search for advertising signals frequently or at all, which may in turn impair the mobile device's ability to display updated analyte values ​​and / or provide alerts based on those values.

[0169] This issue can be addressed by using an alert feature available in some mobile operating systems (such as Apple's iOS 7), which alerts the operating system that the custom application has been paused and that the application is anticipating a wireless communication event. In response to the alert, the operating system can either remove the custom application from its inactive state (e.g., paused, closed, in the background, etc.) or simply acknowledge that the BLE radio is active, thereby allowing the custom application to prepare for the upcoming wireless communication event. Figure 6 This is a flowchart illustrating an exemplary process 600 for facilitating wireless data communication between an analyte sensor system 8 and mobile display devices 120, 130, 140 according to certain aspects of this disclosure. The mobile display devices 120, 130, 140 are able to wirelessly receive analyte values ​​from the analyte sensor system 8 by causing a custom application to exit an inactive state before the next scheduled data communication event.

[0170] Process 600 begins in start state 601 and proceeds to operation 610, where it has been determined that a custom application is using excessive memory. Excessive memory usage can occur, for example, when memory usage on mobile display devices 110, 120, 130, and 140 exceeds a preset memory threshold. An example could be multiple applications running on the mobile display device using more memory than desired, which can cause poor overall performance. Process 600 proceeds to operation 610, where processor 330 of mobile display devices 110, 120, 130, and 140 causes, for example, the custom application to enter an inactive state to reduce overall memory usage. As described above, when the custom application is placed in an inactive state, transceiver 338 in the mobile device can be configured to scan or search for advertising signals less frequently or no longer. Process 600 then proceeds to operation 620, where processor 330 determines that transceiver 316 is expected to begin transmitting the next set of advertising signals at the next scheduled time. Process 600 proceeds to operation 630, where processor 330 causes the customized application to exit the inactive state before the next scheduled time. By resuming the customized application from the suspended state before transceiver 316 exits the inactive mode and begins transmitting the next set of advertising signals, the mobile device is able to receive advertising signals and participate in data connection and communication with transceiver 316. Process 600 ends at end state 603 and then proceeds to request connection and exchange data, as described above regarding... Figure 4 Operation 420 is described.

[0171] Minimize the number of advertising signals used to establish data connections.

[0172] As mentioned above Figure 4As described, once transceiver 316 begins transmitting advertising signal sets 412, 422, several advertising signals can be used to enable display devices 110, 120, 130, 140 to receive the advertising signals and establish a data connection with transceiver 316. In some cases, the number can be as high as 10 or more. Transmitting such a high number of advertising signals can consume a significant amount of power from the battery of the analytical sensor system 8. Therefore, minimizing the number of advertising signals transmitted by transceiver 316 can extend the lifespan of analytical sensor system 8. In some aspects of this disclosure, this minimization can be achieved by causing the transceiver or radio unit 338 of display devices 110, 120, 130, 140 to exit inactive mode and actively scan for advertising signals from transceiver 316 of analytical sensor system 8 before the transmission of advertising signals. The specific time when transceiver 338 exits inactive mode can be calculated based on the connection interval received from analytical sensor system 8 in the previous wireless communication cycle. The connection interval indicates the amount of time elapsed between the start of a series of advertising signals transmitted by the transceiver 316 of the analyzer sensor system 8 in the previous wireless communication cycle and the receipt of a data connection request from the display devices 110, 120, 130, and 140 by the transceiver 316. This scheme prevents the transceivers 338 of the display devices 110, 120, 130, and 140 from waking up too late and missing one or more advertising signals at the start of transmission.

[0173] Figure 7 This is a flowchart illustrating an exemplary process 700 for minimizing the number of advertising signals transmitted by the transceiver 316 of the analyte sensor system 8 before establishing a data connection with the display devices 110, 120, 130, and 140, according to certain aspects of this disclosure. The flowchart shows two sets of operations. The set of numbers from 750 to 768 shown on the left corresponds to the operations performed at the display devices 110, 120, 130, and 140; and the set of numbers from 710 to 722 shown on the right corresponds to the operations performed at the analyte sensor system 8. (In conjunction with...) Figure 7 The various tasks performed by the described process 700 can be executed by a processor that executes instructions embodied in a non-transitory computer-readable medium. For example, the tasks performed by process 700 can be performed by hardware, software, firmware, or any combination thereof incorporated in one or more computing devices (such as...). Figure 1 and / or Figure 3 The analysis is performed by the analyte sensor system 8 and one or more of the display devices 110, 120, 130 and 140. It should be understood that the program may include any number of additional or alternative tasks. Figure 7 The tasks shown do not need to be performed in the order described, and the program can be incorporated into a more comprehensive program or process with additional functionality not described in detail in this document.

[0174] Program 700 begins in start state 701 and proceeds to operation 710, during which transceiver 316 exits from sleep or inactive mode at analyzer sensor system 8, during which transceiver 316 does not participate in data communication with display devices 110, 120, 130, 140.

[0175] At display devices 110, 120, 130, and 140, process 700 proceeds to operation 750, wherein the processor 330 of the display device causes the transceiver 338 to search for advertising signals from the analyte sensor system 8. At the analyte sensor system 8, process 700 proceeds to operation 712, wherein the processor 314 of the analyte sensor system 8 causes the transceiver 316 to begin transmitting a first series of advertising signals at a first time T1. The processor 314 of the analyte sensor system 8 uses a real-time clock (RTC) 320 to measure the first time T1 and stores T1 in memory 318.

[0176] At display devices 110, 120, 130, and 140, process 700 proceeds to operation 752, where the processor 330 of the display device receives an advertising signal from the analyte sensor system 8 via transceiver 338. Subsequently, at operation 754, the processor 330 causes the transceiver 338 to transmit a data connection request to the analyte sensor system 8. At the analyte sensor system 8, process 700 proceeds to operation 714, where the processor 314 receives a data connection request from the display device via transceiver 316 at a second time T2. The processor 314 uses RTC 320 to measure the second time T2 and stores T2 in memory 318. At operation 716, the processor 314 approves the data connection request by causing the transceiver 316 to transmit a signal indicating acceptance of the data connection request to the display devices 110, 120, 130, and 140 and establishing a data connection with the display devices. At the display device, the processor 330 of the display device receives signals from the analyte sensor system 8 and causes transceiver 338 to establish a data connection with transceiver 316 at operation 758.

[0177] At the analyte sensor system 8, process 700 proceeds to operation 718, where processor 314 causes transceiver 316 to transmit connection intervals to display devices 110, 120, 130, and 140. The connection interval is used by the display devices to calculate the exit time when the display devices will exit inactive mode and begin searching for advertising signals from the analyte sensor system 8. The connection interval is calculated based on a first time T1 and a second time T2, and indicates the difference between those two times. For example, in some embodiments, the connection interval is the difference, i.e., (T2 – T1). In other embodiments, the connection interval varies with the difference, such as the current time + (T2 – T1).

[0178] At display devices 110, 120, 130, and 140, process 700 proceeds to operation 760, where processor 330 receives a connection interval from analyte sensor system 8. Processor 330 then sends a request for analyte values ​​to analyte sensor system 8 at operation 762. At analyte sensor system 8, processor 314 receives the request and sends the analyte values ​​to the display device at operation 718, causing transceiver 316 to terminate the data connection at operation 720 and enter sleep mode at operation 722. In some embodiments, transceiver 316 is completely powered off. In other embodiments, transceiver 316 enters a low-power mode.

[0179] At display devices 110, 120, 130, and 140, processor 330 receives the analyte value at operation 762 and terminates the data connection with the analyte sensor system 8. At operation 764, processor 330 also causes transceiver 338 to enter an inactive mode. During the inactive mode, transceiver 338 of the display device does not participate in wireless data communication with transceiver 316 of the analyte sensor system 8. At operation 766, processor 330 also calculates the exit time for transceiver 316 to exit the inactive mode based on the connection interval received from the analyte sensor system 8. In some embodiments, the calculated exit time is given by the following formula: current time + update interval (T). interval - Connection Interval - Notification Delay - Protective Measures. As used herein, notification delay is a measure of the time elapsed between the initial connection establishment and the actual transmission of a synchronization notification. The actual duration may vary depending on the device used. Protective measures are a measure of the time that display device transceiver 338 must wake up and begin scanning before the analyte sensor system transceiver 316 wakes up. In some embodiments, the connection interval is from about 90 milliseconds to 300 milliseconds, the notification delay is from about 100 milliseconds to 300 milliseconds, and the protective measures are typically from about 300 milliseconds to 700 milliseconds. At operation 768, processor 330 causes transceiver 338 to exit inactive mode at the calculated exit time, allowing transceiver 338 to begin searching for the next series of advertising signals from transceiver 316 of the analyte sensor system 8.

[0180] As in Figure 7As can be seen, process 700 is subsequently repeated, such that for a given wireless communication session, the transceiver 338 of display devices 110, 120, 130, and 140 can exit from inactive mode at an exit time calculated based on the connection interval received from the analyzer sensor system 8 during the previous wireless communication session. When implemented in a mobile device using the Android operating system, this scheme has been shown to reduce the average number of advertising signals that transceiver 316 needs to transmit from over 50 to 3 to 4. Furthermore, using this scheme, a reduction of up to approximately 68% in power consumption for advertising transmission during the connection process has been achieved.

[0181] Switching between display devices

[0182] In some situations, it may be necessary or desirable for a user to switch between two or more display devices. For example, a user might typically want to check their glucose readings on their mobile phone 120. However, when the battery level of mobile phone 120 is low, they might want to switch to a custom monitoring device 110 to continue checking the glucose readings from there. After charging the mobile phone, the user might want to switch back to mobile phone 120 for a better viewing experience. Therefore, a convenient and efficient way to switch between display devices is needed.

[0183] Additionally, it needs to be able to efficiently reject data connection requests from one or more display devices that are not selected by the user. For example, in a situation where the user selects mobile phone 120 as the only allowed display device, but transceiver 316 can receive data connection requests from other display devices. In such cases, it is necessary to quickly reject data connection requests without wasting significant time and battery power.

[0184] One solution for facilitating switching between two display devices is to identify a single allowed display device in a list (mobile phone 120 in the example above) and reject the request at the radio hardware level rather than the upper software level if a data connection request is received from a display device that is not identified as a single allowed display device in the list. Such a list may be implemented in the memory of a processor that jointly controls the functions of the transceiver 316 at the radio hardware level. Such a processor may be part of the main processor 314 or part of the transceiver 316. In some embodiments, the processor is a link layer (LL) controller in a Bluetooth Low Energy (BLE) architecture. When a data connection request is received from a device, the radio hardware level controller determines whether the requesting device is identified in the list and rejects the request at the radio hardware level rather than the upper software level if it is not identified in the list. This can significantly reduce the time and battery consumption associated with rejecting data connection requests from unwanted devices. In some embodiments, more than one allowed display device may exist. That is, multiple display devices may be simultaneously connected to and communicating with the analyte sensor system 8.

[0185] In some embodiments, the analyzer sensor system 8 may also store information identifying one or more display devices previously paired with the transceiver. In some embodiments, such information is stored in the same list or memory as the list or memory storing information identifying individual authorized display devices. In other embodiments, such information is stored in a different list or memory. By storing this information, the device can establish authenticated communications more quickly and efficiently.

[0186] Figure 8A and Figure 8B The flowchart illustrates an exemplary system and method for rejecting data connection requests from display devices not identified in a list containing a single allowed display device, according to certain aspects of this disclosure. However, in some embodiments, the list may contain multiple allowed display devices. Figure 8A The diagram illustrates an analyte sensor system 801, a first display device (DD1) 803, and a second display device (DD2) 805. The vertical arrows on the left side of Figure 8, indicating "Device Identified in the List," identify the display devices currently stored in a list containing a single allowed list. In the illustrated example, DD2 805 is... Figure 8A The display device identified in the list. Figure 8B In the middle, the content of the list changed from DD2 805 to none to DD1 803.

[0187] This disclosure is intended solely for ease of explanation and is not intended to limit the scope of this disclosure in any way. See also: Figure 4 The described analyte sensor system 8 Figure 8A and Figure 8B The analyte sensor system 801. Similarly, see... Figure 4 The depicted display devices 110, 120, 130, and 140 describe a first display device 8031 ​​and a second display device 805.

[0188] Combination Figure 4 To explain why DD1 and DD2 have been authenticated and paired. At the start of the first communication session 810, the analyzer sensor system 801 begins transmitting the first series of advertising signals 812. During this phase, both DD1 803 and DD2 805 have been authenticated and paired according to the above description. Figure 4 The described pairing operations 414 and 416 are for pairing with the analyte sensor system 8. However, currently only DD2 805 is on the list containing a single allowed display device. The advertising signal 812 can be received by both DD1 803 and DD2 805, with DD2 805 being the display device identified in the list containing a single allowed display device. In the illustrated example, DD1 803 receives the advertising signal from the analyte sensor system 8 and responds first by transmitting a first data connection request 813. DD2 805 may also have received the advertising signal, but cannot respond to the signal until DD1 803 responds. Therefore, the transceiver 316 of the analyte sensor system 8 does not receive or recognize the response signal from DD2 805. By comparing the ID of DD1 803 contained in the first data connection request 813 with identification information stored in a list containing a single allowed display device, a processor (e.g., a link layer (LL) controller) controlling the radio hardware-level functions of transceiver 316 determines that DD1 803 is not a display device identified in the list and rejects the first connection request 813 at the radio hardware level. In some embodiments, the analyzer sensor system 8 transmits a signal that causes DD1 803 to stop sending additional connection requests. In other embodiments, if DD1 803 does not receive a response to the first advertising signal within a predetermined time, then DD1 803 stops sending additional connection requests.

[0189] In the illustrated example, after rejecting the first data connection request 813 from DD1 802, the transceiver 316 of the analyzer sensor system 801 continues to transmit additional advertising signals during the first wireless communication session 810, such as... Figure 8AAs shown. In response to one of the additional advertising signals, DD2 805 transmits a second data connection request 815. The processor determines that DD2 805 is a display device identified in a list containing a single permitted device and agrees to the request. After the data connection is established, DD2 805 transmits a request for data 817 (e.g., analyte data) from the analyte sensor system 801, and the analyte sensor system 801 transmits the requested data 818 to DD2 805. After completing the data communication processes 817, 818, the data connection between the analyte sensor system 801 and DD2 805 is terminated / closed and disabled by causing the transceiver 316 of the analyte sensor system 801 to enter sleep mode.

[0190] During the inactivity time T Inactive (During this period, analyte measurements can be performed by analyte sensor 312, as described above.) Figure 4 Following the inactivity period indicated (as described), a second communication session 820 begins, in which the transceiver 316 of the analyzer sensor system 801 begins transmitting a second series of advertising signals 822. At this time, DD2 805 receives the advertising signals and responds first by transmitting a second data connection request 815. By comparing the ID of DD2 805 contained in the second data connection request 815 with the identification information stored in a list containing a single allowed display device, the processor of the analyzer sensor system 801 determines that DD2 805 is the currently allowed display device and agrees to the request, for example, by transmitting an indication of consent signal 826. After the data connection is established, DD2 805 transmits a request for data 827, and the analyzer sensor system 801 transmits the requested data 828. After completing the data communication process, including transmitting a request for data 827 and transmitting the requested data 828, the data connection between the analyte sensor system 801 and DD2 805 is terminated / closed and the analyte sensor system 801 is disabled by causing its transceiver 316 to enter a sleep / power-down mode.

[0191] If a predetermined condition is met, the list of devices allowed with a single permitted display can be cleared, allowing another display to connect to the analyte sensor system 8 without being rejected at the radio hardware level. This feature addresses the problem of attempting to connect to a new display when the current display on the list is missing or malfunctioning. Figure 8B This indicates that a predetermined number (N) of wireless communication sessions 8301 to 830 are possible. N This is an exemplary procedure for clearing the list when a display device not recognized in the list receives a data connection request. For example, in... Figure 8B As can be seen from this, the advertising signal sets 8321 to 832 are being transmitted. NThe transceiver 316 is among the N sets of devices that have not received a data connection request from DD2 805, which is a list of devices that contain a single permitted display device. When this occurs, the processor controlling the radio function of the transceiver 316 erases the information storing the identification of DD2 805 from the list.

[0192] In subsequent communication session 840, transceiver 316 transmits advertising signal set 842, and at this time receives a third data connection request 845 from DD1 803. Note that at this stage, the list containing a single permitted display device is empty. Upon receiving the third data connection request 845, the processor controlling the radio functions of transceiver 316 agrees to the request 845 and writes information identifying DD1 803 into the list. As long as DD1 803 is identified in the list, subsequent data connection requests received from DD1 803 will be agreed to without being rejected at the radio hardware level.

[0193] Another predetermined condition that could cause the list to be cleared is receiving a signal from the listed display device (i.e., the display device identified in the list) instructing that the listed display device will be cleared from the list. This could occur, for example, when a user who wants to switch to another display device (e.g., from mobile phone 120 to custom display device 120 or vice versa) explicitly types a command to clear the listed display device from the list on the currently listed display device. Another possibility is that the listed device automatically transmits a clear signal when it determines that the device will be turned off due to, for example, a low battery level.

[0194] As described above, the analyte sensor system 8 is also configured to store information identifying one or more display devices that have been paired with the transceiver in the same list or different lists. If such information is not stored in the analyte sensor system 8, meaning that no other display device has been paired with the transceiver, the transceiver continues to accept data connection requests from one or more display devices until at least one display device has been paired with the transceiver, and stores information identifying the paired display device in a list used to store one or more previously paired display devices.

[0195] Figure 9A and Figure 9BThe flowchart illustrates an exemplary procedure for facilitating switching between two display devices utilizing two separate lists, according to certain aspects of this disclosure. The first list contains information identifying one or more permitted display devices, and the second list contains information identifying a single currently active display device, i.e., a display device selected to receive and display analyte values ​​from the analyte sensor system. The first list is preferably implemented in the memory of a processor functioning at the radio hardware level for the joint control transceiver described above. The second list may be implemented in the same memory as the first list or in a different memory.

[0196] This disclosure is intended solely for ease of explanation and is not intended to limit the scope of this disclosure in any way. See also: Figure 4 The described analyte sensor system 8 Figure 9A and Figure 9B The analyte sensor system 901. Similarly, see... Figure 4 The depicted display devices 110, 120, 130, and 140 describe a first display device 903 and a second display device 905.

[0197] At this stage, both DD1 903 and DD2 905 have been based on the above-mentioned... Figure 4 The described pairing operations 414 and 416 are for pairing with the analyte sensor system 901 and are listed in the list of permitted display devices. However, currently only DD2 905 is listed in the list of single active display devices. In the illustrated example, it is assumed that the user has decided to select DD1 903 as the new active display device to receive and display analyte values ​​from the analyte sensor system 901. Figure 9AAt the start of the first communication session 910 shown, the transceiver 316 of the analyte sensor system 801 begins transmitting a first series of advertising signals 912. The advertising signals 812 can be received by both DD1 903 and DD3 905. As indicated by the two vertical arrows on the left side of the figure, at this stage, both DD1 903 and DD2 905 are identified in a first list containing information identifying one or more permitted display devices, and only DD2 905 is identified in a second list containing information identifying a single active display device. DD1 903, the most recently selected active display device, receives the advertising signals from the analyte sensor system 901 and responds first by transmitting a data connection request 913 to the analyte sensor system 901. By comparing the ID of DD1 903 contained in the first data connection request 913 with data stored in a first list containing one or more permitted display devices, a processor (e.g., a link layer (LL) controller) that controls the transceiver 316 at the radio hardware level determines that DD1 903 is identified in the first list and agrees to the data connection request 913 by transmitting a signal 914 indicating consent to DD1 903.

[0198] DD1 903 then transmits a request 915 for the identification of a display device identified in the second list. Analyte sensor system 901 responds to request 915 by transmitting a signal 916 indicating that DD2 905 is identified in the second list. Upon receiving signal 916, DD1 903 transmits a signal 917 indicating that it has been selected as a new active display device. In response, analyzer sensor system 901 changes the second list to indicate that DD1 903 is the currently active display device. In some embodiments, analyzer sensor system 901 also transmits a signal 918 indicating that DD1 903 is now identified in the second list. According to signal 919, DD2 905 may be notified that display device 905 is no longer an active display device, and this may cause display device 905 to stop responding to advertising signals and / or enter an inactive state during the next communication session. After transmitting signal 917 (and possibly signal 918), the data connection is terminated and transceiver 316 is disabled, thereby completing the first wireless communication session 910.

[0199] During the inactivity time T InactiveAfter a predetermined inactivity period indicated by the analyte sensor 312 (during which one or more analyte measurements can be taken) the second wireless communication session 920 begins, wherein the transceiver 316 of the analyte sensor system 901 begins transmitting a second series of advertising signals 922. DD1 903 receives the advertising signals and responds first by transmitting a second data connection request 923. Upon receiving the second data connection request 923, the analyte sensor system 901 determines that DD1 903 is identified in the first list and transmits a signal 924 to DD1 903 indicating agreement to the second data connection request 923. DD1 903 then transmits a data request 925, and the analyte sensor system 901 responds to request 925 by transmitting the requested data 926. After data communication including transmitting the data request 925 and the requested data 926, the data connection is terminated and the transceiver 316 is deactivated, thereby completing the second wireless communication session 920.

[0200] Figure 9B This describes a scenario where a display device that is not currently the active display device sends a data connection request to the analytical substance sensor system 901, according to certain aspects of this disclosure. In the illustrated example, in a third wireless communication session 930, DD2 905 transmits a third data connection request 933 in response to a series of advertising signals 932 transmitted from the analytical substance sensor system 901. In response to the third data connection request 933, the analytical substance sensor system 901, after determining that DD2 905 is identified in a first list, agrees to the third data connection request 933 and transmits a signal 924 indicating agreement to DD2 905. DD2 905 then transmits a request 936 for the identification of a display device identified in a second list. The analytical substance sensor system 901 responds to request 936 by transmitting a signal 937 indicating that DD1 902 is identified in the second list. Upon receiving the identification information in signal 937, DD2 905 transmits a signal 938 indicating that the display device 905 is not the most recently selected active display device. In response, the analyzer sensor system 901 terminates / closes the data connection, and in some embodiments, the transceiver 316 may be deactivated (i.e., put into sleep mode) without altering the second list. Because the second list remains unchanged during the third communication session 930 and therefore still identifies DD1 903 as the currently active display device, the data connection processes 943 and 945 and the data communication processes 946, 947 are... Figure 9B The fourth wireless communication session 940 shown occurred normally.

[0201] exist Figure 9A and Figure 9BIn the system and method, only one active display device is allowed to establish a data connection with the analyte sensor system 901 and receive sensor information such as analyte data from the sensor system 901. Generally, more than one display device can be allowed to establish a data connection with the analyte sensor system 901. However, for ease of explanation, in... Figure 9A and Figure 9B In some instances, only one active display device is allowed to establish a data connection. In some embodiments, if no connection request is received from a display device on the list within a predetermined number of wireless communication sessions, the list containing one or more allowed display devices and / or the list containing one or more active display devices may be erased. In some cases, it is necessary to allow passive devices to receive analyte data and / or other information from the analyte sensor system without pairing and / or connecting to the analyte sensor system. Figure 10 This is a diagram illustrating a wireless data communication system 1000 comprising an analyte sensor system 1010, an active display device 1020, and a passive device 1050 according to certain aspects of this disclosure. In the illustrated example, the analyte sensor system 1010 is a continuous glucose sensor system including a sensor electronics module 1012 and a continuous glucose sensor 1014; the active display device 1020 is a mobile phone; and the passive device 1050 is an insulin pump for administering insulin to a user. For various reasons, it may be necessary for the insulin pump 1050 to receive and track glucose values ​​emitted from the continuous glucose sensor system 1010. One reason is to provide the insulin pump 1050 with the ability to pause insulated administration when the glucose value drops below a threshold. One solution that allows the passive device (e.g., the insulin pump 1050) to receive desired data (e.g., glucose values) without establishing an authorized communication channel with the analyte sensor system (e.g., the glucose sensor system 1010) is to include the desired data in an advertising signal emitted from the analyte sensor system. The data contained in the advertising signal can be encoded so that only a device with identification information associated with the analyzer sensor system 1010 can decode the data. In some embodiments, the active display device 1020 extracts and uses the data contained in the advertising signal. In other embodiments, the active display device 1020 does not extract the data contained in the advertising signal, but instead uses the data contained in the advertising signal in the display device 1020 as described above. Figure 4 The described method involves establishing a data connection with the analyte sensor system 1010 to obtain data.

[0202] Figure 11This is a flowchart illustrating an exemplary process 1100, according to certain aspects of this disclosure, for allowing a passive device to receive desired data from an analyte sensor system without pairing or connection. Process 1100 begins in a start state 1101 and proceeds to operation 1110, where the transceiver of the analyte sensor system 1010 exits sleep mode and begins transmitting a series of advertising signals containing analyte values ​​(or other information to be used by the passive device). Process 1100 proceeds to operation 1120, where the passive device 1050 receives a first advertising signal containing the analyte values. In some embodiments, the analyte values ​​contained in the advertising signals are encoded such that the analyte values ​​can only be read or decoded by having identification information associated with the analyte sensor system 1010. As an example, a user previously entered a serial number associated with the analyte sensor system 1010 into the passive display device. Process 1100 proceeds to operation 1130, where the passive device 1050 extracts the analyte values ​​from the first advertising signal. In embodiments where the analyte values ​​contained in the advertising signal are encoded, the extraction process involves decoding the encoded analyte values ​​using a key or code generated by using identification information associated with the analyte sensor system 1010. The passive device 1050 can use the extracted analyte values ​​for various purposes. For example, in embodiments where the passive device 1050 is an insulin pump, the extracted glucose values ​​can be displayed on the interface of the device 1050 for calculating the optimal insulin dosing rate and / or pausing insulin dosing when the glucose values ​​drop below a threshold.

[0203] Process 1100 proceeds to operation 1140, where the active display device 1020 receives an advertising signal from the transceiver of the analyte sensor system 1010. This advertising signal may be the same as or a different advertising signal received by the passive device. Process 1100 proceeds to operation 1150, where the active display device 1020 establishes a data connection with the transceiver using one or more data connection procedures, as described above regarding... Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8A , Figure 8B , Figure 9A , Figure 9B An example of a data connection process is described. Process 1100 proceeds to operation 1170, in which the active display device 1020 uses one or more data communication processes to request and receive analyte values ​​or other information from the analyte sensor system 1010, as described above. Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8A , Figure 8B , Figure 9A , Figure 9B An example of a data communication process is described. Process 1100 proceeds to operation 1180, in which the analyte sensor system 1010 terminates its data connection with the active display device 1020 and causes the transceiver of the analyte sensor system 1010 to enter sleep mode. Process 1100 is repeated by looping back to operation 1110.

[0204] Various embodiments of the subject matter described herein can be implemented in digital electronic circuits, integrated circuits, specially designed ASICs (Application-Specific Integrated Circuits), computer hardware, firmware, software, and / or combinations thereof. As noted, the circuits may be attached to a printed circuit board (PCB) or the like, and may take many forms. These various embodiments may be included in one or more non-transitory computer programs executable and / or interpretable on a programmable system, the programmable system including at least one programmable processor, which may be dedicated or general-purpose, coupled to receive data and instructions from a storage system, at least one input device, and at least one output device, and to transmit data and instructions to the storage system, at least one input device, and at least one output device.

[0205] These computer programs (also referred to as programs, software, software applications, or code) contain machine instructions for a programmable processor and can be implemented using high-level programming and / or object-oriented programming languages ​​and / or assembly / machine languages. As used herein, the term "machine-readable media" refers to any non-transitory computer program product, device, and / or apparatus (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including machine-readable media that receive machine instructions.

[0206] Although this disclosure has been detailed and described in the accompanying drawings and the foregoing description, such description and illustration should be considered illustrative or exemplary, not restrictive. This disclosure is not limited to the disclosed embodiments. Those skilled in the art can understand and implement variations of the disclosed embodiments from a study of the drawings, the disclosure, and the appended claims when practicing the claimed disclosure.

[0207] All references cited herein are incorporated herein by reference in their entirety. If any cited publication or patent or patent application contradicts any disclosure contained in this specification, this specification shall supersede and / or take precedence over any such contradictory material.

[0208] Unless otherwise defined, all terms (including technical and scientific terms) will be given their common and conventional meanings to those skilled in the art, and will not be limited to specific or particular meanings unless expressly defined herein. It should be noted that the use of specific terms in describing certain features or aspects of the disclosure should not be construed as implying that the terms are redefined herein as limited to any specific characteristic of the feature or aspect of the disclosure to which the term is associated. Unless otherwise expressly stated, terms and phrases used in this application and its variations, particularly in the appended claims, should be interpreted as open-ended rather than restrictive. As an example from the preceding text, the term 'comprising' should be interpreted as meaning 'including but not limited to', 'including but not limited to', etc.; as used herein, the term 'comprising' is synonymous with 'including', 'containing', or 'characterized in', and is inclusive or open-ended, and does not exclude additional unstated elements or method steps; the term 'having' should be interpreted as 'having at least'; the term 'comprising' should be interpreted as 'including but not limited to'; the term 'example' is used to provide illustrative examples of the items discussed, not an exhaustive or limiting list thereof; adjectives such as 'known', 'normal', 'standard', and similar terms should not be interpreted as limiting the described items to items available up to a given time period or time, but should be interpreted as covering known, normal, or standard techniques that may be available now or at any time in the future; and the use of terms such as 'preferred', 'ideal', 'desired', or 'expected', and similar terms should not be construed as implying that certain features are critical, necessary, or even important to the structure or function of the invention, but are only intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Similarly, unless otherwise explicitly stated, a group of items connected by the conjunction 'and' should not be interpreted as requiring that every item in that group be present, but rather as 'and / or'. Likewise, unless otherwise explicitly stated, a group of items connected by the conjunction 'or' should not be interpreted as requiring that items in that group be mutually exclusive, but rather as 'and / or'.

[0209] When a range of values ​​is provided, it should be understood that the upper and lower limits, as well as each intermediate value between the upper and lower limits of the range, are covered in the embodiment.

[0210] Regarding the use of virtually any plural and / or singular terms herein, those skilled in the art can convert plural to singular and / or from singular to plural where appropriate for the context and / or application. For clarity, various singular / plural arrangements may be explicitly stated herein. The indefinite article “a” does not exclude plural. A single processor or other unit may perform the functions of several items recited in the claims. The mere fact that certain measures are recited in dissimilar subsidiary claims does not indicate that combinations of these measures cannot be advantageously used. Any reference marks in the claims should not be construed as limiting the scope.

[0211] Those skilled in the art will further understand that if the intention is to introduce a specific number of claim statements, then such an intention will be explicitly stated in the claims, and where such a statement is absent, such an intention does not exist. For example, as an aid to understanding, the appended claims may contain the use of the introductory phrases “at least one” and “one or more” to introduce claim statements. However, the use of such phrases should not be construed as implying that the introduction of the indefinite article “a” limits any particular claim containing such an introductory claim statement to an embodiment containing only one such statement, even when the same claim contains the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” (e.g., “a” should generally be interpreted as meaning “at least one” or “one or more”); the same applies to the use of definite articles used to introduce claim statements. Furthermore, even when the specific number of claim statements introduced is explicitly stated, those skilled in the art will recognize that such statements should generally be interpreted as meaning at least the number stated (e.g., a simple statement of “two statements” without other modifiers generally means at least two statements or two or more statements). Furthermore, in examples using idioms such as "at least one of A, B, and C," generally, such idioms are intended to be understood by a person skilled in the art for their meaning (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C). In examples using idioms such as "at least one of A, B, or C," generally, such idioms are intended to be understood by a person skilled in the art for their meaning (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C). A person skilled in the art will further understand that any antonyms and / or phrases presenting two or more alternative items, whether in the description, claims, or drawings, should be understood to cover the possibility of including one, any, or both of the items. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B".

[0212] All numbers of expressed components, reaction conditions, etc., used in this specification will be understood to be modified by the term 'about' in all instances. Therefore, unless otherwise indicated, the numerical parameters set forth herein are approximate values ​​that may vary depending on the desired properties sought to be obtained. At least, and without attempt to limit the application of the equivalence principle to the scope of any claim in any application that claims priority to this application, each numerical parameter should be interpreted according to the number of significant figures and general rounding methods.

[0213] Furthermore, although the foregoing has been described in considerable detail with the aid of illustrations and examples for clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the descriptions and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather encompass all modifications and alternatives that fall within the true scope and spirit of the invention.

Claims

1. A method for wireless data communication between an analyte sensor system and a plurality of display devices, the display devices being capable of displaying analyte values ​​received wirelessly from the analyte sensor system, the method comprising: The first series of advertising signals were launched; Receive a first data connection request from the first display device; Determine that the first display device is identified in a first list containing one or more permitted display devices; Establish a first data connection with the first display device; A request is received from the first display device, wherein the request is used to identify the first display device in a second list, and the second list stores information about a current active display device configured to receive and display analyte values ​​from the analyte sensor system; In response to the request, a first signal is transmitted to the first display device indicating that a second display device different from the first display device is identified in the second list instead of the first display device; Receive a second signal from the first display device indicating that the first display device is the most recently selected active display device; In response to the second signal, the second list is changed, wherein changing the second list includes indicating that the second display device is no longer the active display device, and selecting the first display device as the single current active display device for receiving and displaying analyte values ​​from the analyte sensor system; as well as Terminate the first data connection with the first display device.

2. The method of claim 1, further comprising transmitting from the analyte sensor system to the first display device a third signal indicating that the first display device is a newly selected single currently active display device.

3. The method according to claim 1, further comprising: Read first data from the second list that identifies the second display device as the currently active display device; The change includes replacing the first data with second data that identifies the first display device.

4. The method of claim 3, wherein the second signal includes a request to write to the second list the second data identifying the first display device as the currently active display device.

5. The method of claim 1, further comprising: Launch the second series of advertising signals; Receive a second data connection request from the first display device; Establish a second data connection with the first display device; It is determined that the first display device is identified in the second list; The analytical values ​​are transmitted to the first display device; as well as Terminate the second data connection with the first display device.

6. The method of claim 5, further comprising: Launch the third series of advertising signals; Receive a third data connection request from the second display device; A third data connection is established with the second display device if it is determined that the second display device is identified in the first list; A fourth signal is transmitted to the second display device, indicating that different display devices are identified in the second list; A fifth signal is received from the second display device, the fifth signal indicating that the second display device is not the most recently selected active display device; as well as Terminate the third data connection with the second display device without changing the second list.

7. An analyte sensor system configured for wireless data communication with a plurality of display devices, the display devices being capable of displaying analyte values ​​from an analyte sensor module, the analyte sensor system comprising: Analyte sensor; A transceiver, which is configured to transmit and receive wireless signals; as well as A processor, operatively coupled to the analyte sensor and the transceiver, is configured to perform the following operations: This causes the transceiver to transmit the first series of advertising signals. Receives a first data connection request from the first display device. It is determined that the first display device is identified in a first list containing one or more permitted display devices. Establish a first data connection with the first display device. A request is received from the first display device, wherein the request is used to identify the first display device in a second list, and the second list stores information about a current active display device configured to receive and display analyte values ​​from the analyte sensor system; In response to the request, first data identifying the second display device as the currently active display device is read from the second list. The first data is transmitted to the first display device. In response to the transmission of the first data, a request is received to write second data to the second list, wherein the second data selects the first display device as the current active display device for receiving and displaying analyte values ​​from the analyte sensor system, and indicates that the second display device is no longer the active display device. Write the second data to the second list, and Terminate the first data connection with the first display device.

8. The analyte sensor system according to claim 7, wherein the analyte sensor is a continuous glucose sensor.

9. The analyte sensor system of claim 7, wherein the first display device and the second display device are selected from the group consisting of a custom analyte monitoring device and a moving device.

10. The analyte sensor system according to claim 9, wherein the mobile device is a mobile phone.

11. The analyte sensor system of claim 7, wherein the processor is configured to reject data connection requests from display devices not identified in the first list at the radio hardware level.

12. The analyte sensor system of claim 11, wherein the processor includes a link layer (LL) controller.

13. The analyte sensor system of claim 12, wherein the first list is a whitelist maintained in the LL controller.

14. The analyte sensor system of claim 7, wherein the processor is further configured to perform the following operations: This causes the transceiver to transmit a second series of advertising signals. Receive a second data connection request from the first display device. This causes the transceiver to establish a second data connection with the first display device. It is determined that the first display device is identified in the second list. This causes the transceiver to transmit the analyzed values ​​to the first display device, and This causes the transceiver to terminate the second data connection with the first display device.

15. The analyte sensor system of claim 14, wherein the processor is further configured to perform the following operations: This causes the transceiver to enter sleep mode, and This causes the transceiver to exit the sleep mode after a predetermined time.

16. The analyte sensor system of claim 15, wherein the predetermined time is between 200 seconds and 300 seconds.

17. The analyte sensor system of claim 15, wherein the processor is further configured to measure the output of the analyte sensor when the transceiver is in the sleep mode.

18. The analyte sensor system of claim 15, wherein the processor is further configured to perform the following operations: This causes the transceiver to transmit a third series of advertising signals after exiting the sleep mode. Receive a third data connection request from the second display device. If the transceiver is determined to be identified in the first list, it causes the transceiver to establish a third data connection with the second display device. This causes the transceiver to transmit a third signal to the second display device, indicating that different display devices are identified in the second list. A fourth signal is received from the second display device, the fourth signal indicating that the third display device is not the most recently selected active display device, and This causes the transceiver to terminate the third data connection with the second display device without changing the second list.

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