System and method for transmission and continuous monitoring of analyte values

Abstract

To provide systems and methods for continuous monitoring of analyte values.SOLUTION: A method for wireless data communication between an analyte sensor system and a mobile device comprises: storing identification information associated with a transceiver of the analyte sensor system, the identification information 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 advertisement signals; receiving an advertisement signal from the transceiver; authenticating the transceiver; prompting the user to bring the custom application to a foreground mode; causing the custom application to request a 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.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] Incorporation by reference to related applications Any priority claims or amendments thereto identified in the application datasheet are incorporated herein by reference under 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 61 / 901,358, filed on 7 November 2013. The aforementioned application is incorporated herein by reference in its entirety and expressly forms part herein.

[0002] A system and method are provided for the continuous monitoring of analyte values ​​received from an analyte sensor system. [Background technology]

[0003] Diabetes mellitus is a disorder in which the pancreas is unable to produce enough insulin (Type 1 or insulin-dependent) and / or insulin is ineffective (Type 2 or non-insulin-dependent). In a diabetic state, affected individuals suffer from hyperglycemia, which leads to a range of physiological disorders associated with microvascular deterioration (renal failure, skin ulcers, or vitreous hemorrhage of the eye). Hypoglycemic reactions (hypoglycemia) can be caused by inadvertent overdose of insulin, or by extreme exercise or insufficient food intake after normal administration of insulin or glucose-lowering agents.

[0004] Traditionally, people with diabetes have been using self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger prick. Due to the lack of comfort and convenience, individuals with diabetes usually only measure their glucose levels two to four times a day. Unfortunately, these intervals are so far apart that individuals with diabetes often suffer the dangerous side effects of hyperglycemia or hypoglycemia, often noticing too late. In fact, not only do people with diabetes tend not to take SMBG values ​​in a timely manner, but they may also not know whether their glucose levels are rising (getting higher) or falling (getting lower) based on conventional methods.

[0005] As a result, various non-invasive, transdermal (e.g., transdermal), and / or implantable electrochemical sensors have been developed for the continuous detection and / or quantification of blood glucose levels. These devices generally transmit raw or minimally processed data for subsequent analysis on remote devices, which may include displays. [Overview of the project]

[0006] Details of one or more implementations of the subject matter described herein are shown in the accompanying drawings and the following description. Other features, embodiments, and advantages will become apparent from the description, drawings, and claims. Note that the relative dimensions in the accompanying drawings may not be to scale.

[0007] In a first embodiment, a method is provided for wireless data communication between an analyte sensor system and a mobile device 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, which is entered by a user of the mobile device via a custom application launched on the mobile device; putting the custom application into 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 into foreground mode; prompting the custom application to request user confirmation regarding the desire for a data connection with the transceiver; receiving confirmation from the user; and completing the data connection with the transceiver.

[0008] In particular, in a specific implementation of the first embodiment which is generally applicable to any other implementation of the first embodiment, the method may further include receiving analyte values ​​from a transceiver, terminating a data connection with the transceiver, entering a stop mode, exiting the stop mode after a predetermined time, and retrieving an advertisement signal from the transceiver.

[0009] In particular, in a specific implementation of the first embodiment which is generally applicable to any other implementation of the first embodiment, the authentication step may include requesting a challenge value from the transceiver, receiving a challenge value from the transceiver, generating a hash value from the challenge value and identification information, transmitting the hash value to the transceiver, and receiving confirmation from the transceiver that the authentication was successful.

[0010] In particular, in a specific implementation of the first embodiment that is generally applicable to any other implementation of the first embodiment, the method may further include determining that excessive memory is being used by a custom application, putting the custom application into a suspended state, determining the next scheduled time when the custom application is expected to search for an advertisement signal from a transceiver, and exiting the suspended state before the next scheduled time.

[0011] In a second embodiment, a mobile device is provided configured for wireless data communication with an analyte sensor system, comprising: a user interface; a radio unit for transmitting and receiving radio signals; a memory for storing identification information associated with one or more transceivers and a custom application configured to interact with the user of the mobile device via the user interface; and a processor operably coupled to the user interface, the radio unit, and the memory, configured to put the custom application into background mode, cause the radio unit to search for an advertisement signal, and, when an advertisement signal is received from a transceiver, perform an authentication procedure for the transceiver of the analyte sensor system based on the identification information associated with the transceiver entered by the user, issue a first notification to the user to bring the custom application into foreground mode, and cause the custom application to issue a second notification requesting confirmation from the user that a data connection with the transceiver is desired, and complete the data connection with the transceiver when confirmation is received.

[0012] In particular, in a specific implementation of the second embodiment, which is generally applicable to any other implementation of the second embodiment, the analyte sensor system may be a continuous glucose sensor system.

[0013] In particular, in a specific implementation of the second embodiment that is generally applicable to any other implementation of the second embodiment, the user interface may include a voice user interface.

[0014] In particular, in a specific implementation of the second embodiment that is generally applicable to any other implementation of the second embodiment, the user interface may include a touchscreen display.

[0015] In particular, in a specific implementation of the second embodiment that is generally applicable to any other implementation of the second embodiment, the first notification may be a pop-up menu displayed on a touchscreen display.

[0016] In particular, in a specific implementation of the second embodiment that is generally applicable to any other implementation of the second embodiment, the wireless data communication may use a communication protocol designed for short-range, low-power wireless communication.

[0017] In particular, in a specific implementation of the second embodiment which is generally applicable to any other implementation of the second embodiment, the processor may be configured to determine that excessive memory space is being used by a custom application, to put the custom application into a suspended state, to exit the suspended state before a scheduled time when the mobile device is expected to search for the next advertisement signal from the transceiver, and to have the custom application search for the next advertisement signal in background mode.

[0018] In certain implementations of the second aspect, which are generally applicable to any other implementation of the second aspect, the processor further determines that excess memory is being used by a custom application, suspends the custom application, determines the next schedule time at which the transceiver is predicted to start transmitting a series of advertisement signals, exits the custom application from the suspended state before the next schedule time, and may be configured to cause the wireless unit to search for advertisement signals.

[0019] In certain implementations of the second aspect, which are generally applicable to any other implementation of the second aspect, the processor further determines that excess memory is being used by a custom application, suspends the custom application, determines the next schedule time at which the transceiver is predicted to start transmitting a series of advertisement signals, and may be configured to cause the wireless device to search for advertisement signals at the next schedule time while the custom application remains in the suspended state.

[0020] In a third aspect, a method for wireless data communication between an analyte sensor system and a mobile device capable of wirelessly receiving analyte values from the analyte sensor system is provided. The method includes transmitting a first series of advertisement signals starting 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 the analyte value, terminating the data connection with the mobile device, and putting the transceiver of the analyte sensor system into a sleep state.

[0021] In particular, in a specific implementation of the third embodiment which is generally applicable to any other implementation of the third embodiment, the method may further include causing a transceiver to exit sleep mode after a predetermined time and transmitting a second set of advertisement signals.

[0022] In particular, in a specific implementation of the third embodiment that is generally applicable to any other implementation of the third embodiment, the predetermined time may be about 200 to 400 seconds.

[0023] In particular, in a specific implementation of the third embodiment which is generally applicable to any other implementation of the third embodiment, the analyte value may be based on analyte measurements taken while the transceiver was in a previous sleep mode.

[0024] In a fourth embodiment, a method is provided for wireless data communication between an analyte sensor system and a mobile device capable of wirelessly receiving analyte values ​​from the analyte sensor system, the method comprising: searching for an advertisement signal; receiving an advertisement signal 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 approved; receiving a connection interval indicating the difference between a first time when the transceiver began transmitting a series of advertisement signals and a second time when the transceiver received a data connection request from the mobile device; receiving analyte values ​​from the transceiver; terminating the data connection with the transceiver and thereby causing the transceiver to enter sleep mode; the mobile device entering a stop mode in which it does not communicate with the transceiver; calculating an exit time for the mobile device to exit stop mode, at least in part on the connection interval; exiting stop mode at the exit time; and searching for an advertisement signal after exiting stop mode.

[0025] In particular, in a specific implementation of the fourth embodiment which is generally applicable to any other implementation of the fourth embodiment, the analyte value may be based on analyte measurements taken while the transceiver was in a previous sleep mode.

[0026] In particular, in a specific implementation of the fourth aspect which is generally applicable to any other implementation of the fourth aspect, the exit time can be obtained by current time + update interval - connection interval - notification delay - safeguard, where the update interval may be the period between two consecutive wireless communication sessions between the transceiver and the mobile device.

[0027] In particular, in a specific implementation of the fourth aspect which is generally applicable to any other implementation of the fourth aspect, the update interval may be about 200 to 400 seconds.

[0028] In particular, in a specific implementation of the fourth embodiment that is generally applicable to any other implementation of the fourth embodiment, the connection interval may be about 90 to 300 milliseconds.

[0029] In particular, in a specific implementation of the fourth aspect which is generally applicable to any other implementation of the fourth aspect, the notification delay may be about 100–300 milliseconds, and the safeguard is typically about 300–700 milliseconds.

[0030] In a fifth embodiment, an analyte sensor system is provided configured for wireless data communication with a mobile device, comprising: an analyte sensor; a transceiver configured to transmit and receive wireless signals; and a processor operably coupled to the analyte sensor and the transceiver, configured to cause the transceiver to transmit a series of advertisement signals, to receive data connection requests from a mobile device, to cause the transceiver to establish a data connection with the wireless unit of the mobile device, to cause the transceiver to transmit a connection interval for use by the mobile device to calculate an exit time for the mobile device to exit stop mode and begin searching for advertisement signals, to cause the transceiver to transmit analyte values, to cause the transceiver to terminate the data connection, and to cause the transceiver to enter sleep mode.

[0031] In particular, in a specific implementation of the fifth embodiment which is generally applicable to any other implementation of the fifth embodiment, the processor may be further configured to cause the transceiver to exit sleep mode after a predetermined period of time and to cause the transceiver to transmit a second set of advertisement signals.

[0032] In particular, in a specific implementation of the fifth embodiment which is generally applicable to any other implementation of the fifth embodiment, the connection interval may be a function of the difference between a first time when the transceiver begins transmitting a series of advertisement signals and a second time when the transceiver receives a data connection request from a mobile device.

[0033] In particular, in a specific implementation of the fifth embodiment which is generally applicable to any other implementation of the fifth embodiment, the analyte sensor may be a continuous glucose sensor.

[0034] In a sixth embodiment, a mobile device is provided configured for wireless data communication with an analyte sensor system, the mobile device comprising: a memory for storing a custom application; a wireless unit for transmitting and receiving wireless signals; and a processor operably coupled to the memory and the wireless unit, which is configured to cause the wireless unit to retrieve an advertisement signal, receive an advertisement signal from a transceiver associated with the analyte sensor system, cause the wireless unit to transmit a data connection request to the transceiver, receive acknowledgment of the data connection request from the transceiver, cause the wireless unit to establish a data connection with the transceiver, receive a connection interval indicating the amount of time elapsed between the start of transmission of a series of advertisement signals by the transceiver and the reception of the data connection request by the transceiver, cause the wireless unit to terminate the data connection with the transceiver, cause the wireless unit to enter a stop mode in which it does not communicate with the transceiver, calculate an exit time based at least partially on the connection interval, cause the wireless unit to exit the stop mode at the exit time, and cause the wireless unit to retrieve an advertisement signal after exiting the stop mode.

[0035] In particular, in a sixth specific implementation that is generally applicable to any other implementation of the sixth aspect, the analyte sensor system may be a continuous glucose sensor system.

[0036] In particular, in a sixth specific implementation that is generally applicable to any other implementation of the sixth aspect, the mobile device may be a mobile phone.

[0037] In particular, in a specific implementation of the sixth aspect which is generally applicable to any other implementation of the sixth aspect, the exit time can be obtained by current time + update interval - connection time - notification delay - save guard, where the update interval may be the period between two consecutive communication sessions between the transceiver and the mobile device.

[0038] In a seventh embodiment, a method is provided for wireless data communication between an analyte sensor system and a display device capable of displaying analyte values ​​wirelessly received from the analyte sensor system, the method comprising: transmitting a first set of advertisement signals; receiving a first data connection request from a first display device; determining whether the first display device is specified in a list for which a single authorized display device is included; and, if the first display device is not specified in the list, rejecting the first data connection request from the first display device at the wireless hardware level.

[0039] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, the method further includes authorizing a first data connection from the first display device at the wireless hardware level when the first display device is identified in the list.

[0040] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, the method further includes establishing a first data connection with a first display device and transmitting analyte values ​​to the first display device.

[0041] In particular, in a specific implementation of the seventh embodiment which is generally applicable to any other implementation of the seventh embodiment, the analyte value may represent a blood glucose value.

[0042] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, information identifying one or more display devices paired with a transceiver may also be stored in the list.

[0043] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, information identifying one or more display devices paired with a transceiver may be stored in different lists.

[0044] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, the method may further include continuing to allow data connection requests from one or more display devices when there are no other display devices paired with the analyte sensor system.

[0045] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, the method may further include clearing a list if certain conditions are met.

[0046] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, a given condition may be failure to receive a data connection request from an enumerated display device specified in a list within a given number of communication sessions.

[0047] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, a given condition may be the reception of an erase signal from an enumerated display device identified in the list, indicating that the enumerated display device is removed from the list.

[0048] In particular, in a specific implementation of the seventh aspect which is generally applicable to any other implementation of the seventh aspect, the method may further include receiving a second data connection request from a second display device, determining that the list has been cleared, approving the second data connection request, and writing data identifying the second display device to the list.

[0049] In an eighth embodiment, an analyte sensor system is provided configured for wireless data communication with a plurality of display devices capable of displaying analyte values ​​wirelessly received from the analyte sensor system, the analyte sensor system comprising: an analyte sensor; a memory for storing a list identifying a single permitted display device; a transceiver configured to transmit and receive wireless signals; and a processor operably coupled to the analyte sensor, the memory, and the transceiver, and configured to cause the transceiver to transmit a first set of advertisement signals, receive a first data connection request from a first display device, determine that the first display device is not identified in the list, and reject the data connection request from the first display device at the wireless hardware level.

[0050] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the analyte sensor may be a continuous glucose sensor.

[0051] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, one of the multiple display devices may be a custom analyte monitoring device, and the other of the multiple display devices may be a mobile device.

[0052] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the wireless data communication may use a short-range, low-power wireless communication protocol.

[0053] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the processor may be a link layer (LL) controller.

[0054] In particular, in a specific implementation of the eighth aspect that is generally applicable to any other implementation of the eighth aspect, the list may be a whitelist maintained within the LL controller.

[0055] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the processor may be further configured to cause the transceiver to continue transmitting one or more advertisement signals after rejecting a first data connection request, to receive a data connection request from a second display device, and to establish a data connection with the second display device if the second display device is identified in a list.

[0056] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the processor may be further configured to perform data communication with a second display device after establishing a data connection, and to terminate the data connection and put the transceiver into sleep mode after completing the data communication.

[0057] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the processor may be further configured to clear the list if certain conditions are met.

[0058] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, a given condition may include failure to receive a data connection request from an enumerated display device specified in the list within a given number of communication sessions.

[0059] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, a given condition may include receiving an erase signal from an enumerated display device which may be identified in the list, indicating that the enumerated display device is removed from the list.

[0060] In particular, in a specific implementation of the eighth aspect which is generally applicable to any other implementation of the eighth aspect, the processor may be further configured to receive a second data connection request from a second display device, determine that the list has been cleared, cause a transceiver to approve the second data connection request, and write data identifying the second display device to the list. In a ninth embodiment, a method is provided for wireless data communication between an analyte sensor system and a plurality of display devices capable of displaying analyte values ​​wirelessly received from the analyte sensor system, the method comprising: transmitting a first set of advertisement 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 authorized display devices; establishing a first data connection with the first display device; transmitting a first signal to the first display device indicating that different display devices are identified in a second list containing a single currently active display device; receiving a second signal from the first display device indicating that the first display device is a newly selected active display device; modifying 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.

[0061] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the method may further include determining that the first display device is not specified in the second list.

[0062] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the method may further include receiving a request from a first display device to transmit a first signal.

[0063] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the method may further include reading first data from a second list which identifies a different display device as the currently active display device, and including the first data in a first signal transmitted to the first display device.

[0064] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the second signal may include a request to write second data to a second list which identifies the first display device as the currently active display device.

[0065] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the method may further include transmitting a second set of advertisement signals, receiving a second data connection request from a 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 analyte values ​​to the first display device, and terminating the second data connection with the first display device.

[0066] In particular, in a specific implementation of the ninth aspect which is generally applicable to any other implementation of the ninth aspect, the method may further include transmitting a third set of advertisement signals, receiving a third data connection request from a 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 a 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 a newly selected active display device, and terminating the third data connection with the second display device without changing the second list.

[0067] In a tenth embodiment, an analyte sensor system is provided which is configured for wireless data communication with a plurality of display devices capable of displaying analyte values ​​from an analyte sensor module, the analyte sensor system comprising: an analyte sensor; a transceiver configured to transmit and receive wireless signals; and a processor operably coupled to the analyte sensor and the transceiver, which is configured to cause the transceiver to transmit a first set of advertisement signals, receive a first data connection request from a first display device, determine that the first display device is identified in a first list containing one or more authorized display devices, establish a first data connection with the first display device, read first data from a second list identifying a different display device as the currently active display device, transmit the first data to the first display device, receive a request to write second data identifying the first display device as the currently active display device to a second list, write the second data to the second list, and terminate the first data connection with the first display device.

[0068] In particular, in a specific implementation of the tenth embodiment which is generally applicable to any other implementation of the tenth embodiment, the analyte sensor may be a continuous glucose sensor.

[0069] In particular, in a specific implementation of the 10th embodiment which is generally applicable to any other implementation of the 10th embodiment, at least one of the first display device and the different display device may be a custom analyte monitoring device, and the other of the first display device and the different display device may be a mobile device.

[0070] In particular, in a specific implementation of the 10th embodiment that is generally applicable to any other implementation of the 10th embodiment, the mobile device may be a mobile phone.

[0071] In particular, in a specific implementation of the 10th aspect which is generally applicable to any other implementation of the 10th aspect, the processor may be configured to reject data connection requests from display devices not specified in the first list at the wireless hardware level.

[0072] In particular, in a specific implementation of the tenth embodiment that is generally applicable to any other implementation of the tenth embodiment, the processor may include a link layer (LL) controller.

[0073] In particular, in a specific implementation of the 10th aspect which is generally applicable to any other implementation of the 10th aspect, the first list may be a whitelist maintained within the LL controller.

[0074] In particular, in a specific implementation of the 10th embodiment which is generally applicable to any other implementation of the 10th embodiment, the processor may be configured to cause a transceiver to transmit a second set of advertisement signals, receive a second data connection request from a 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 analyte values ​​to the first display device, and cause the transceiver to terminate the second data connection with the first display device.

[0075] In particular, in a specific implementation of the tenth embodiment which is generally applicable to any other implementation of the tenth embodiment, the processor may be further configured to put the transceiver into sleep mode and exit sleep mode after a predetermined time.

[0076] In particular, in a specific implementation of the 10th embodiment that is generally applicable to any other implementation of the 10th embodiment, the predetermined time may be about 200 to 300 seconds.

[0077] In particular, in a specific implementation of the tenth embodiment which is generally applicable to any other implementation of the tenth embodiment, the processor may be further configured to acquire a measurement of the output of the analyte sensor while the transceiver is in sleep mode.

[0078] In particular, in a specific implementation of the 10th embodiment which is generally applicable to any other implementation of the 10th embodiment, the processor may be configured to cause a transceiver to transmit a third set of advertisement signals after exiting, to receive a third data connection request from a second display device, to cause a transceiver to establish a third data connection with a second display device if the second display device is identified in a first list, to cause a transceiver to transmit a third signal to a second display indicating that a different display device is identified in a second list, to receive a fourth signal from the second display device indicating that the third display device is not a newly selected active display device, and to cause a transceiver to terminate the third data connection with a second display device without changing the second list.

[0079] In an eleventh embodiment, a method is provided for wireless data communication between an analyte sensor system, a passive device for receiving data from a transceiver without establishing a data connection with the analyte sensor system, and an active display device for displaying analyte data from the analyte sensor system after a data connection with the analyte sensor system has been established, the method comprising the passive device receiving a first advertisement signal from the analyte sensor system, the first advertisement signal containing data to be used by the passive device, and the passive device extracting data from the first advertisement signal.

[0080] In particular, in a specific implementation of the 11th embodiment which is generally applicable to any other implementation of the 11th embodiment, the data may be included in a first advertisement signal that includes analyte values.

[0081] In particular, in a specific implementation of the 11th embodiment that is generally applicable to any other implementation of the 11th embodiment, the analytic value may be an encoded analytic value.

[0082] In particular, in a specific implementation of the 11th embodiment which is generally applicable to any other implementation of the 11th embodiment, the method may further include an active display device receiving a second advertisement signal from a transceiver, the active display device establishing a data connection with the transceiver in response to the second advertisement signal, and the active display device receiving an analyte value displayed on the active display device.

[0083] In particular, in a specific implementation of the 11th embodiment that is generally applicable to any other implementation of the 11th embodiment, the second advertisement signal may be the same as the first advertisement signal.

[0084] In particular, in a specific implementation of the 11th embodiment that is generally applicable to any other implementation of the 11th embodiment, the second advertisement signal may differ from the first advertisement signal.

[0085] In a twelfth aspect, a system for wireless data communication is provided, comprising: an analyte sensor system configured to transmit a series of advertisement signals; a passive device configured to receive a first advertisement signal from the analyte sensor system, which is one of the series of advertisement signals transmitted by the analyte sensor system and includes data to be used by a passive device, and to extract data from the first advertisement signal without establishing a data connection with the analyte sensor system; and an active display device configured to receive a second advertisement signal from the analyte sensor system, which is one of the series of advertisement signals transmitted by the analyte sensor system, to establish a data connection with the analyte sensor system in response to the second advertisement signal, to receive an analyte value from the analyte sensor system, to terminate the data connection, and to display the analyte value.

[0086] In particular, in a specific implementation of the 12th embodiment that is generally applicable to any other implementation of the 12th embodiment, the data used by the passive device may include encoded analyte values.

[0087] In particular, in a specific implementation of the 12th embodiment, which is generally applicable to any other implementation of the 12th embodiment, the analyte sensor system may be a continuous glucose sensor system, and the passive device is an insulin pump configured for insulin administration.

[0088] In particular, in a specific implementation of the 12th embodiment, which is generally applicable to any other implementation of the 12th embodiment, the data included in the first advertisement signal may indicate a glucose level, and furthermore, the insulin pump is configured to interrupt insulin delivery when the glucose level falls below a threshold.

[0089] Any feature of the embodiments described herein is applicable to all other embodiments and models specified herein. Furthermore, any feature of any embodiment can be independently combined in part or in whole with any other embodiment described herein by any means, for example, one, two, or three or more embodiments may be combined in whole or in part. Furthermore, any feature of any embodiment may be optional with respect to other embodiments. Any embodiment of a method may be performed by a system or apparatus of another embodiment, and any embodiment of a system may be configured to perform a method of another embodiment. [Brief explanation of the drawing]

[0090] [Figure 1] This figure illustrates a particular embodiment of a continuous analyte sensor system according to a particular aspect of the present disclosure. [Figure 2A] This is a perspective view of an exemplary sensor system that may embody an analyte sensor system according to a particular aspect of the present disclosure. [Figure 2B] This is a side view of an exemplary sensor system that can embody an analyte sensor system according to a particular aspect of the present disclosure. [Figure 3] This is an exemplary block diagram illustrating various elements of a particular embodiment of a continuous analyte monitoring system comprising an analyte sensor system and a plurality of display devices, according to a particular aspect of the present disclosure. [Figure 4] This flowchart illustrates an exemplary wireless data communication procedure between an analyte sensor system and a display device capable of wirelessly receiving analyte values ​​from the analyte sensor system, according to a particular aspect of the present disclosure. [Figure 5] This flowchart illustrates an exemplary process for facilitating the initial setup procedure between an analyte sensor system and a mobile device, according to a particular aspect of the present disclosure. [Figure 6]This flowchart illustrates an exemplary process for facilitating wireless data communication between an analyte sensor device and a mobile device capable of wirelessly receiving analyte values ​​from an analyte sensor system, by exiting a suspend state before the next scheduled data communication event, according to a particular aspect of the present disclosure. [Figure 7] This flowchart illustrates an exemplary process, according to a particular aspect of the present disclosure, for minimizing the number of advertisement signals transmitted by a transceiver of an analyte sensor system before establishing a data connection with a display device. [Figure 8A] This diagram illustrates an exemplary system and method for rejecting data connection requests from display devices not specified in a list containing a single permitted display device, according to a particular aspect of the present disclosure. [Figure 8B] This diagram illustrates an exemplary system and method for rejecting data connection requests from display devices not specified in a list containing a single permitted display device, according to a particular aspect of the present disclosure. [Figure 9A] This diagram illustrates an exemplary procedure for facilitating switching between two display devices that utilize two separate lists according to a particular aspect of this disclosure. [Figure 9B] This diagram illustrates an exemplary procedure for facilitating switching between two display devices that utilize two separate lists according to a particular aspect of this disclosure. [Figure 10] This figure illustrates a wireless data communication system, including an analyte sensor system, an active display device, and a passive display device, according to a particular aspect of the present disclosure. [Figure 11] This flowchart illustrates an exemplary process, according to a particular aspect of the present disclosure, for enabling a passive device to receive desired data from an analyte sensor system without being paired with or connected to the analyte sensor system. [Modes for carrying out the invention]

[0091] The following embodiments and examples illustrate in detail some exemplary embodiments of the disclosed invention. Those skilled in the art will understand that there are numerous variations and modifications that fall within the scope of the invention. Therefore, the description of certain exemplary embodiments should not be considered limiting to the scope of the invention. overview

[0092] In some embodiments, a system is provided for continuous measurement of an analyte in a host, comprising a continuous analyte sensor configured to continuously measure the concentration of an analyte in a host, and a sensor electronics module physically connected to the continuous analyte sensor during sensor use. In certain embodiments, the sensor electronics module includes electronics configured to process a data stream associated with the analyte concentration measured by the continuous analyte sensor in order to generate sensor information, including, for example, raw sensor data, converted sensor data, and / or any other sensor data. The sensor electronics module may further be configured to generate sensor information customized for each display device so that different display devices can receive different sensor information.

[0093] As used herein, the term “analyte” is a broad term, given its ordinary and customary meaning to those skilled in the art (not limited to any special or customized meaning), and further, without limitation, refers to a substance or chemical component in a biological fluid (e.g., blood, intestinal fluid, cerebrospinal fluid, lymph, or urine) that can be analyzed. Analytes may include natural substances, artificial substances, metabolites, and / or reaction products. In some embodiments, the analyte to be measured by a sensor head, device, and method is the analyte. However, acarboxyprothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; α-fetoprotein; amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomer; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; C-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β-hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isozyme; cyclosporine A; d-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylated polymorphism (acetylator Polymorphism), alcohol dehydrogenase, α1-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, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber-dependent optic atrophy, MCAD, RNA, PKU, Plasmodium vivax (Platypleura malaria), sex differentiation, 21-deoxycortisol); desbutylhalofantrin; 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 acetase; galactose / gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrin; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17α-hydroxyprogesterone; hypoxanthine guanine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoprotein ((a), B / A-1, β); lysozyme; mefloquine; netylmycin; phenobarbiton; phenytoin; Phytanic acid / pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; kinin; inverted triiodothyronine (rT3); selenium; serum pancreatic lipase; shisomecin; somatomedin C; specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, guinea pig, tapeworm, amoeba histolytica, enterovirus, Giardia lamblia) Helicobacter pylori, Hepatitis B virus, Herpesvirus, HIV-1, IgE (atopic disease), Influenza virus, Donovan leishmania, Leptospira, Measles / Mumps / Rubella, Mycoplasma pneumoniae, Myoglobin, Irocystitis rotundifolia, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (scrub typhus), Schistosomiasis mansoni, Toxoplasma gondii, Trepenoma palladium, Trypanosoma cruzi / Langer's, Vesicular stomatis virus (virus), Bancroftian filarial parasite, yellow fever virus; specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements;Other analytes, including but not limited to transferors; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; leukocytes; and zinc protoporphyrin, are also intended. Salts, sugars, proteins, lipids, vitamins, and hormones naturally occurring in blood or intestinal fluid may also constitute analytes in certain embodiments. Analytes may be naturally occurring in biological fluids, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, analytes, e.g., contrast agents for imaging, radioisotopes, chemical agents, fluorocarbon-based synthetic blood, or insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, hydrocarbon chlorides, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamine, methamphetamine, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methacarone, tranquilizers, e.g., Valium, Libriu) Drugs or pharmaceutical compositions, including but not limited to m, Miltown, Serax, Equanil, Tranxene; hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidin, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (fentanyl, meperidin, amphetamine, methamphetamine, and analogs of phencyclidine, e.g., Ecstasy); anabolic steroids; and nicotine, may be introduced into the body. Metabolites of drugs and pharmaceutical compositions are also intended analytes. For example, analytes such as neurochemicals and other chemicals produced in the body, including ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA), can also be analyzed. caveat

[0094] In a particular embodiment, one or more warnings are associated with a sensor electronic device module. For example, each warning may include one or more warning conditions indicating when each warning was triggered. For example, a hypoglycemia warning may include a warning condition indicating a minimum glucose level. Warning conditions may also be based on converted sensor data, such as trend data, and / or sensor data from multiple different sensors (for example, a warning may be based on sensor data from both a glucose sensor and a temperature sensor). For example, a hypoglycemia warning may include a warning condition indicating a minimum required trend in the host glucose level that must be present before the warning is triggered. As used herein, the term “trend” generally refers to data that indicates some attribute of data acquired over time, such as calibrated or filtered data from a continuous glucose sensor. Trends may indicate the amplitude, rate of change, acceleration, direction, etc. of data, including converted data or raw sensor data, such as sensor data.

[0095] In a particular embodiment, each warning is associated with one or more actions performed in response to triggering the warning. Warning actions may include, for example, activating an alarm, such as displaying information on the display of a sensor electronic device module, or activating an audible or vibrational alarm connected to the sensor electronic device module, and / or transmitting data to one or more display devices that are external to the sensor electronic device module. For any delivery action associated with a triggered alarm, one or more delivery options define the content and / or format of the data to be transmitted, the device to which the data is transmitted, when the data is transmitted, and / or a communication protocol for the delivery of the data.

[0096] In a particular embodiment, multiple delivery operations (each having its own delivery options) may be associated with a single warning such that displayable sensor information having different content and format is transmitted to each display device, for example, in response to a single alarm trigger. For example, a mobile phone may receive a data package containing minimal displayable sensor information (which may be specially formatted for display on the mobile phone), while a desktop computer may receive a data package containing most (or all) of the displayable sensor information generated by the sensor electronics module in response to a shared alarm trigger. Advantageously, the sensor electronics module is not coupled to a single display device, but is configured to communicate with multiple different display devices directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on-demand, in response to queries, based on warnings or alarms, etc.

[0097] In some embodiments, a clinical hazard alert is provided that includes an intelligent and dynamic estimation algorithm for estimating current or predicted hazards, combined with warning conditions that offer better accuracy, greater timeliness regarding imminent hazards, avoidance of false alarms, and less intrusiveness to the patient. Generally, the clinical hazard alert includes a dynamic and intelligent estimation algorithm that provides a more appropriate, clinically safe, and patient-friendly alert based on analyte values, rates of change, acceleration, clinical hazard, statistical establishment, known physiological constraints, and / or individual physiological patterns. Concurrently pending U.S. Patent Publication 2007 / 0208246, which is incorporated herein in its entirety by reference, describes several systems and methods related to the clinical hazard alert (or alarm) described herein. In some embodiments, the clinical hazard alert may be triggered for a predetermined period of time to allow the user to care for his / her condition. Additionally, the clinical hazard alert may be stopped when the patient leaves the clinical hazard area so as not to disturb the patient with repeated clinical alarms (e.g., visual, auditory, or vibratory) if the patient's condition is improving. In some embodiments, dynamic and intelligent estimation determines the likelihood of a patient avoiding clinical risk based on analyte concentration, rate of change, and other aspects of the dynamic and intelligent estimation algorithm. If the likelihood of avoiding clinical risk is minimal or nonexistent, a clinical risk warning is triggered. However, if there is a possibility of avoiding clinical risk, the system is configured to wait for a predetermined time and re-analyze the likelihood of avoiding clinical risk. In some embodiments, if there is a possibility of avoiding clinical risk, the system is further configured to provide targets, treatment recommendations, or other information that may help the patient proactively avoid clinical risk.

[0098] In some embodiments, the sensor electronic device module is configured to search for one or more display devices within the communication range of the sensor electronic device module and to communicate sensor information (e.g., a data package including displayable sensor information, one or more alarm conditions, and / or alarm information) wirelessly to them. Thus, the display device is configured to display at least some of the sensor information and / or to broadcast an alarm to a host (and / or caregiver), where the alarm mechanism is located on the display device.

[0099] In some embodiments, the sensor electronics module is configured to provide one or more different alarms, indicating that the alarm should be triggered (e.g., sequentially and / or simultaneously) by one or more display devices, via the sensor electronics module and / or via the transmission of a data package. In certain embodiments, the sensor electronics module merely provides a data field indicating the presence of an alarm condition, and a display device may decide to trigger an alarm upon reading the data field indicating the presence of the 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 warnings. For example, if a warning trigger indicates severe hypoglycemia, the sensor electronics module may perform several actions, such as activating an alarm on the sensor electronics module, transmitting a data package indicating the activation of the alarm on a display to a monitoring device, and transmitting the data package to a caregiver as a text message. As an example, a text message containing displayable sensor information indicating the host's status (e.g., "severe hypoglycemia") may appear on a custom monitoring device, mobile phone, pager device, etc.

[0100] In some embodiments, the sensor electronic device 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 the snooze and / or off function and / or button on the sensor electronic device and / or display device), and then to trigger additional alerts (e.g., in an increasing manner) until one or more alerts are responded to. In some embodiments, the sensor electronic device 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, where the stop alert triggers the cessation of insulin delivery via the pump.

[0101] In some embodiments, the sensor electronic device module is configured to transmit alarm information directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to queries (from a display device), based on warnings or alarms, etc. In some embodiments, the system further includes repeaters such that the wireless communication range of the sensor electronic device module is increased to, for example, 10, 20, 30, 50, 75, 100, 150, or 200 meters or more, where the repeaters are configured to repeat wireless communication from the sensor electronic device module to a display device located remotely from the sensor electronic device. Repeaters may be useful for families with children who have diabetes, for example, to allow parents to carry or place the display device in a stationary position, such as in a large house where parents sleep away from their children. Display device

[0102] In some embodiments, the sensor electronic device module is configured to search for a display device from a list of display devices and attempt to communicate with it wirelessly. In some embodiments, the sensor electronic device module is configured to search for a list of display devices and / or attempt to communicate with them in a predetermined and / or programmable order (e.g., graded and / or stepwise), for example, if an attempt to communicate with and / or alarm a first display device fails, an attempt to communicate with and / or alarm a second display device is triggered. In one exemplary embodiment, the sensor electronic device module is configured to search for a host or nurse and attempt to alarm them using a sequential list of display devices, e.g., 1) a default display device or a custom analyte monitoring device, 2) a mobile phone (using auditory and / or visual methods such as text messages to the host and / or nurse, voice messages to the host and / or nurse, and / or 911), 3) a tablet, 4) a smartwatch, etc.

[0103] Depending on the embodiment, one or more display devices that receive data packages from a sensor electronic device module are “dummy displays” that display displayable sensor information received from the sensor electronic device module without further processing (e.g., prospective algorithmic processing required for real-time display of sensor information). In some embodiments, the displayable sensor information includes converted sensor data that does not require processing by the display device before displaying the displayable sensor information. Some display devices may include software including display commands (software programming including commands configured to display the displayable sensor information and optionally query the sensor electronic device module to retrieve the displayable sensor information) configured to enable the display of the displayable sensor information thereon. In some embodiments, the display device may include security and / or authentication at the manufacturer to prevent theft of the display device, with the display commands programmed accordingly. In some embodiments, the display device is configured to display sensor information via a downloadable program (e.g., JavaScript® downloadable over the Internet), thereby enabling any display device that supports program downloads (e.g., any display device that supports Java® applets) to consequently display the sensor information (e.g., mobile phones, tablets, PDAs, PCs, etc.).

[0104] In some embodiments, a particular display device may be in a state of direct wireless communication with the sensor electronic device module, however, intermediate network hardware, firmware, and / or software may be included in the direct wireless communication. In some embodiments, a repeater (e.g., a Bluetooth® repeater) can be used to retransmit the transmitted displayable sensor information to a location away from the direct range of the telemetry module of the sensor electronic device module, where the repeater enables direct wireless communication when no substantial processing of the displayable sensor information occurs. In some embodiments, a receiver (e.g., a Bluetooth® receiver) can be used to retransmit the transmitted displayable sensor information in potentially different forms, e.g., as a text message on a TV screen, where the receiver enables direct wireless communication when no substantial processing of the sensor information occurs. In a particular embodiment, the sensor electronic device module directly wirelessly transmits displayable sensor information to one or more display devices, and as a result, the displayable sensor information transmitted from the sensor electronic device module is received by the display devices without any intermediate processing of the displayable sensor information.

[0105] In certain embodiments, one or more display devices include an integrated authentication mechanism, where authentication is required for communication between the sensor electronic device module and the display device. In some embodiments, a challenge-response protocol, such as password authentication, is provided to authenticate data communication between the sensor electronic device module and the display device, where the challenge is a request for a password and the valid response is a correct password, so that pairing between the sensor electronic device module and the display device can be achieved by the user and / or manufacturer via the password.

[0106] In some embodiments, one or more display devices are configured to query a sensor electronics module for displayable sensor information, where the display device functions as a master device, for example, to request sensor information on demand from the sensor electronics module (e.g., a slave device) in response to the query. In some embodiments, the sensor electronics module is configured for periodic, systematic, regular, and / or periodic transmission (e.g., once every 1, 2, 5, or 10 minutes or more) of sensor information to one or more display devices. In some embodiments, the sensor electronics module is configured to transmit triggered alerts (e.g., those triggered by one or more alert conditions) and associated data packages. However, any combination of the above-described statuses of data transmission can be implemented in 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 to receive alert information triggered by the fulfillment of one or more alarm conditions. Additionally, the sensor electronic device module may be configured for the periodic transmission of sensor information to one or more display devices (the same or different display devices as described in the example above), thereby the system may include display devices that function differently in terms of how the sensor information is acquired.

[0107] In some embodiments, as described in more detail elsewhere in this specification, the display device is configured to query the data storage memory in the sensor electronic device module for certain types of data content, including direct queries to a database in the sensor electronic device module's memory and / or requests for packages of data content composed thereof; that is, the data stored in the sensor electronic device module is configurable, queryable, predetermined, and / or pre-packaged based on the display device with which the sensor electronic device module is communicating. In some additional or alternative embodiments, the sensor electronic device module generates displayable sensor information based on its knowledge of which display device receives a particular transmission. Additionally, some display devices can acquire calibration information and transmit that calibration information wirelessly to the sensor electronic device module, for example, through manual input of the calibration information, automatic delivery of the calibration information, and / or through an integrated reference analyte monitor incorporated into the display device. U.S. Patent Publications 2006 / 0222566, 2007 / 0203966, 2007 / 0208245, and 2005 / 0154271 (all of which are incorporated herein by reference in their entirety) describe systems and methods for providing an integrated reference analyte monitor incorporated into a display device, and / or other calibration methods that can be implemented in embodiments disclosed herein.

[0108] 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 communicate wirelessly with a sensor electronic device module, where one or more display devices are configured to display at least a portion of displayable sensor information communicated wirelessly from the sensor electronic device module, the displayable sensor information including sensor data, e.g., raw data and / or converted sensor data, e.g., analyte concentration values, rate of change information, trend information, warning information, sensor diagnostic information, and / or calibration information. Exemplary configuration

[0109] Figure 1 shows an exemplary continuous analyte monitoring system 100, according to a particular aspect of the present disclosure, which includes an analyte sensor system 8 and a plurality of 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 is in direct wireless communication with one or more of the plurality of display devices 110, 120, 130, and / or 140 shown.

[0110] In a particular embodiment, the sensor electronic device module 12 includes electronic circuits associated with measuring and processing continuous analyte sensor data, including predictive algorithms associated with processing and calibration of sensor data. The sensor electronic device module 12 may be physically connected to the continuous analyte sensor 10 and integrated with the continuous analyte sensor 10 (permanently mounted therein) or detachably mounted therein. The sensor electronic device module 12 may include hardware, firmware, and / or software that enable measurement of analyte levels via the glucose sensor. For example, the sensor electronic device module 12 may include a potentiostat, a power supply for supplying power to the sensor, other components useful for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronic device module to one or more display devices. The electronic device may be attached to a printed circuit board (PCB) or the like and may take various forms. For example, the electronic device 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 electronic device module 12 includes a sensor electronic device configured to process sensor information such as sensor data and generate converted sensor data and displayable sensor information. Examples of systems and methods for processing sensor analyte data are described herein, as well as U.S. Patents Nos. 7,310,544 and 6,931,327, and U.S. Patent Publications 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 any purpose.

[0111] Referring again to Figure 1, the multiple display devices (110, 120, 130, and / or 140) are configured to display (and / or communicate alarms) displayable sensor information (e.g., customized data packages transmitted to the display devices based on individual preferences) transmitted by the sensor electronics module 12. 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 the user and / or receiving input from the user. In some embodiments, the display devices may include other types of user interfaces, such as a voice user interface, instead of, or in addition to, a touchscreen display for communicating sensor information to the user of the display device and / or receiving user input. In some embodiments, one, some, or all of the display devices are configured to display, or otherwise communicate, sensor information as if it were being communicated from the sensor electronics module (e.g., in the data packages transmitted to each display device) without any additional predictive processing required for calibration and real-time display of sensor data.

[0112] In the embodiment shown in Figure 1, the multiple display devices include a custom display device 110 specifically designed to display a certain type of displayable sensor information (e.g., numerical values ​​and arrows in some embodiments) associated with analyte values ​​received from the sensor electronic device module 12. In some embodiments, one of the multiple display devices is a mobile phone 120, palmtop computer, etc., based on an Android or iOS operating system, where the display device has a relatively large display and is configured to display a graphic 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.

[0113] Since different display devices offer different user interfaces, the contents of the data package (e.g., the quantity, format, and / or type of data, alarms, etc., to be displayed) can be customized for each specific display device (e.g., they can be programmed differently by the manufacturer and / or the user). Accordingly, in the embodiment of Figure 1, multiple different display devices may be in direct wireless communication with the sensor electronic device module (e.g., the skin-mounted sensor electronic device module 12, physically connected to the continuous analyte sensor 10) during a sensor session to enable multiple different types and / or levels of display and / or functionality associated with the displayable sensor information, which is described in more detail elsewhere in this specification. Continuous sensor

[0114] In some embodiments, the analyte sensor 10 in Figure 1 includes a continuous glucose sensor, e.g., a subcutaneous, transdermal (e.g., transdermal), or intravascular device. In some embodiments, the device may analyze multiple intermittent blood samples. The glucose sensor may use any method of glucose measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, optical rotatory, calorimetry, ionophoretic, radiometric, immunochemical, etc.

[0115] A glucose sensor may provide a data stream indicating the glucose concentration in a host using any known method, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring). The data stream is typically the raw data signal, which is then converted into a calibrated and / or filtered data stream used to provide a useful glucose value to a user, such as a patient or caregiver (e.g., a patient, relative, guardian, teacher, physician, nurse, or any other individual interested in the host's health).

[0116] A glucose sensor can be any device capable of measuring glucose concentration. One exemplary embodiment is described below, which uses a glucose sensor. However, it should be understood that the devices and methods described herein are applicable to any device capable of detecting glucose concentration and providing an output signal representing glucose concentration.

[0117] In one particular embodiment, the analyte sensor is an implantable glucose sensor, such as that described by reference to U.S. Patent No. 6,001,067 and U.S. Patent Publication No. US-2005-0027463-A1. In another embodiment, the analyte sensor is a transcutaneous glucose sensor, such as that described by reference to U.S. Patent Publication No. US-2006-0020187-A1. In other embodiments, the sensor is configured to be implanted intravascularly or extracorporeally in a host, such as those described in U.S. Patent Publication US-2007-0027385-A1, concurrently pending U.S. Patent Publication US-2008-0119703-A1 filed October 4, 2006, concurrently pending U.S. Patent Publication US-2008-0108942-A1 filed March 26, 2007, and concurrently pending U.S. Patent Application US-2007-0197890-A1 filed February 14, 2007. In one alternative embodiment, the continuous glucose sensor includes a transdermal sensor, such as those described in U.S. Patent No. 6,565,509 to Say et al. In another alternative embodiment, the continuous glucose sensor includes a subcutaneous sensor, such as one described by reference to U.S. Patent No. 6,579,690 to Bonnecaze et al. or U.S. Patent No. 6,484,046 to Say et al. In another alternative embodiment, the continuous glucose sensor includes a refillable subcutaneous sensor, such as one described by reference to U.S. Patent No. 6,512,939 to Colvin et al. In another alternative embodiment, the continuous glucose sensor includes an intravascular sensor, such as one described by reference to U.S. Patent No. 6,477,395 to Schulman et al. In another alternative embodiment, the continuous glucose sensor includes an intravascular sensor, such as one described by reference to U.S. Patent No. 6,424,847 to Mastrototaro et al.

[0118] Figures 2A and 2B are perspective and side views of an exemplary sensor system that may incorporate the analyte sensor system 8 shown in Figure 1, according to a particular aspect of the present disclosure. The sensor system includes a mounting unit 214 and a sensor electronic device module 12 mounted thereon, which, in a particular embodiment, is shown in its functional position and includes a mounting unit and a sensor electronic device module fitted therein. In some embodiments, the mounting unit 214, also referred to as a housing or sensor pod, includes a base 234 adapted to be fixed to the skin of a host. The base may be formed from a variety of rigid or flexible materials and may have a low profile to minimize device protrusion from the host during use. In some embodiments, the base 234 is formed from at least partially flexible material, which is considered to provide numerous advantages over conventional transdermal sensors, which unfortunately may have motion-related drawbacks associated with the host's movements when the host is using the device. The mounting unit 214 and / or the sensor electronic device module 12 may be positioned on the sensor insertion site to protect it and / or to minimize the footprint (utilizing the surface area of ​​the host's skin).

[0119] In some embodiments, a removable connection is provided between the mounting unit 214 and the sensor electronics module 12, thereby improving manufacturability; that is, the relatively inexpensive mounting unit 214 can be used when replacing the sensor system after its service life, while the relatively more expensive sensor electronics module 12 can be reused in multiple sensor systems. In some embodiments, the sensor electronics module 12 is configured with, for example, filtering, signal processing (programming) configured to perform calibration, and / or other algorithms useful for calibrating and / or displaying sensor information. However, an integrated (non-removable) sensor electronics module may also be configured.

[0120] In some embodiments, the contact portion 238 is mounted on or within a hinge 248 that allows the contact portion subassembly 236 to pivot between a first position (for insertion) and a second position (for use) relative to the mounting unit 214, and is configured to fit into the base 234 of the mounting unit 214. The term “hinge” as used herein is a broad term and includes, but is not limited to, any of the various pivoting, joining, and / or hinge fixing mechanisms, such as adhesive hinges and sliding joints, and the term hinge does not necessarily mean a fulcrum or fixing point around which joining occurs. In some embodiments, the contact portion 238 is formed from a conductive elastomer material, such as carbon black elastomer, through which the sensor 10 extends.

[0121] In a particular embodiment, the mounting unit 214 is provided with an adhesive pad 208, which is located on the back surface of the mounting unit and includes a peelable backing layer. The mounting unit 214 is then adhered to the host's skin by removing the backing layer and pressing the base portion 234 of the mounting unit against the host's skin. Additionally or alternatively, the adhesive pad may be installed on part or all of the sensor system after sensor insertion is complete to ensure adhesion and, if applicable, to ensure airtightness or watertightness around the wound exit site (or sensor insertion site) (not shown). Adhesive pads suitable for stretching, elongating, conforming, and / or ventilating the area (e.g., the host's skin) may be selected and designed. Embodiments described with reference to Figures 2A and 2B are described in more detail with reference to U.S. Patent No. 7,310,544, which is incorporated herein by reference in its entirety. Depending on the configuration and arrangement, water resistance, waterproofing, and / or sealing properties associated with the mounting unit and / or sensor electronic device module described herein may be provided.

[0122] Various methods and devices suitable for use in conjunction with aspects of several embodiments are disclosed in U.S. Patent Publication No. US-2009-0240120-A1, which is incorporated herein by reference in whole for all purposes.

[0123] Figure 3 is an exemplary block diagram illustrating various elements of a particular embodiment of a continuous analyte monitoring system 300 comprising an analyte sensor system 8 and display devices 110, 120, 130, and 140. The analyte sensor system 8 may include an analyte sensor 312 (also designated 10 in Figure 1) which is coupled to a sensor measurement circuit 310 for processing and managing sensor data. The sensor measurement circuit 310 may be coupled to a processor 314 (part of item 12 in Figure 1). In some embodiments, the processor 314 may perform some or all of the functions of the sensor measurement circuit 310 to acquire sensor measurements from the sensor 312 and process them. The processor may further be coupled to a radio unit or transceiver 316 (part of item 12 in Figure 1) for transmitting sensor data and receiving requests and commands from external devices such as display devices 110, 120, 130, and 140 used to display or otherwise provide the sensor data to the user. As used herein, the terms “wireless 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 (part of item 12 in Figure 1) and a real-time clock (RTC) 320 (part of item 12 in Figure 1) for recording and tracking sensor data.

[0124] Data can be transmitted and received between the sensor system 8 and the display devices 110, 120, 130, and 140 using a wireless communication protocol. The wireless protocol used may be designed for use in wireless sensor networks optimized for periodic and small data transmission to and from multiple devices over short distances (e.g., a personal area network (PAN)). For example, the protocol may be optimized for periodic data transitions, where the transceiver transmits data at short intervals and then enters a low-power mode at long intervals. The protocol may have low overhead requirements for both normal data transmission and setting up the initial communication channel to reduce power consumption (e.g., by reducing header overhead). In some embodiments, a burst broadcast scheme (e.g., one-way communication) may be used. This eliminates the overhead requirement for recognition signals and enables periodic transmission with little power consumption.

[0125] This protocol can further be configured to implement interference avoidance schemes while simultaneously establishing communication with multiple devices. In some embodiments, the protocol can utilize an adaptive isochronous network topology that defines various time slots and frequency bands for communication with multiple devices. The protocol can therefore modify transmission frames and frequencies in response to interference and to support communication with multiple devices. Thus, the wireless protocol can use a scheme based on time and frequency division multiplexing (TDMA). The wireless protocol can also utilize direct sequence spread spectrum (DSSS) and frequency hopping spread spectrum schemes. Using various network topologies, it can support short-range and / or low-power wireless communication, such as peer-to-peer, start, tree, or mesh network topologies, e.g., WiFi, Bluetooth®, and Bluetooth® Low Energy (BLE). The wireless protocol can operate in various frequency bands, such as the open ISM band, 2.4 GHz, etc. Furthermore, to reduce power consumption, the wireless protocol can be configured to adaptively change the data rate according to power consumption.

[0126] Display devices 110, 120, 130, and 140 may be used to alert and provide sensor information to the user and may include a processor 330 for processing and managing sensor data. Display devices 110, 120, 130, and 140 may each include a display 332, a memory 334, and a real-time clock 336 for displaying, storing, and tracking sensor data. Display devices 110, 120, 130, and 140 may further include a wireless unit or transceiver 338 for receiving sensor data and transmitting requests, commands, and data to the analyte sensor system 8. The transceiver 338 may further utilize a communication protocol. Memory 334 may also be used to store an operating system for a custom (e.g., dedicated) application designed for wireless data communication between the display devices and / or the transceiver and the display devices. 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 may be executed by the processor 330 to control and manage the transceiver 338.

[0127] In some embodiments, when a standard communication protocol is used, a commercially available transceiver circuit incorporating processing circuits that handle low-level data communication functions such as data coding, transmission frequency, and handshake protocol management may be used. In these embodiments, processors 314 and 330 do not need to manage these operations, but they do manage high-level functions such as providing the data values ​​desired for transmission, powering on and off, and setting the rate at which messages are transmitted. Instructions and data values ​​for performing these high-level functions may be provided to the transceiver circuit 316 via a data bus and transition protocol established by the manufacturer of the transceiver circuit 316.

[0128] Components of the analyte sensor system 8 may require periodic replacement. For example, the analyte sensor system 8 may include an embedded sensor 312 that can be mounted in a sensor electronics module including a sensor measurement circuit 310, a processor 314, a memory 318, and a transceiver 316, as well as a battery (not shown). 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 operated for a longer period than the sensor 312 (e.g., 3 months, 6 months, or longer) until the battery needs to be replaced. Replacing these components may be difficult and may require assistance from a trained person. Reducing the need to replace such components, especially the battery, would greatly improve the convenience of the analyte sensor system 8 for the user. In some embodiments, the sensor sessions defined above may correspond to the lifespan of the sensor 312 (e.g., in the range of 7 to 30 days). When the sensor electronic device module is used for the first time (or, in some cases, when it is restarted after the battery has been replaced), it may be connected to the sensor 312 and a sensor session may be established. As described in more detail below, when it is used for the first time or restarted (e.g., after the battery has been replaced), there may be a process to first establish communication between the display devices 110, 120, 130, 140 and the sensor electronic device module. Once the display devices 110, 120, 130, 140 and the sensor electronic device module have established communication, they may remain in a state of communication periodically and / or continuously for the lifespan of the multiple sensors 312, for example, until the battery needs to be replaced. Whenever a sensor 312 is replaced, a new sensor session may be established. A new sensor session may be initiated through a process completed using display devices 110, 120, 130, and 140, which may be triggered by notification of a new sensor via communication between the sensor electronic device module and the display devices 110, 120, 130, and 140, which may persist throughout all sensor sessions.

[0129] The analyte sensor system 8 collects analyte data from the sensor 312 and periodically transmits it to the display devices 110, 120, 130, and 140. Data points are collected and transmitted for the duration of the sensor's lifespan (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. Rather than having separate transmission and reception circuits for the sensor system 8 and the display devices 110, 120, 130, and 140 communicating continuously, the analyte sensor system 8 and the display devices 110, 120, 130, and 140 can establish communication channels between them periodically and periodically. Thus, the sensor system 8 can communicate with the display devices 110, 120, 130, and 140 (e.g., handheld computing devices) via wireless transmission at predetermined time intervals. The duration of the predetermined time interval can be selected such that it is long enough to prevent the sensor system 8 from consuming too much power by transmitting data more frequently than necessary, while still being frequent enough to provide substantially real-time sensor information (e.g., measured glucose values) to the display devices 110, 120, 130, and 140 for output to the user (e.g., display). The predetermined time interval is every 5 minutes in some embodiments, but it is understood that this time interval can vary to any desired length.

[0130] Figure 4 is a flowchart illustrating exemplary wireless data communication between an analyte sensor system 8 and display devices 110, 120, 130, and 140 capable of wirelessly receiving analyte values ​​from the analyte sensor system 8, according to a particular aspect of the present disclosure. Various tasks performed in connection with the procedure illustrated in Figure 4 may be performed by a processor executing instructions embodied in a non-transient computer-readable medium. For example, tasks performed in connection with this procedure may be performed by hardware, software, firmware, or any combination thereof, incorporated into one or more computing devices, such as the sensor system 8 in Figure 1 and / or Figure 3, and one or more of the display devices 110, 120, 130, and 140. This procedure may include any number of additional or alternative tasks. The tasks shown in Figure 4 do not need to be performed in the order shown, and this procedure may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein.

[0131] In the embodiments described below, the analyte value is a glucose value based on one or more measurements of glucose level by the analyte sensor 312 for illustrative purposes. However, the analyte value may be any other analyte value described herein. Wireless data communication between the analyte sensor system 8 and the display device may correspond to the period between two consecutive wireless communication sessions between the transceiver 316 of the analyte sensor system 8 and the transceiver 338 of the display devices 110, 120, 130, and 140, "T interval This can occur periodically at intervals defined by the update interval indicated as "T". Alternatively, the update interval can be considered the period during which the most recently measured glucose value is acquired and transmitted. The transmission of advertisement signals, the establishment of data connections (e.g., communication channels), and the request and transmission of data each occur within the update interval T. interval Active time within or "T ActiveThis can occur during a wireless communication session, lasting for the duration indicated by "T". Between two consecutive wireless communication sessions, the transceiver 316 may, for example, conserve battery life and / or reduce peak voltage requirements. Inactive During the stop period indicated as "[stopped]", the system will enter a stopped or sleep mode.

[0132] Figure 4 shows two such wireless communication sessions, namely the first wireless communication session 410 and the second wireless communication session 420. Each wireless communication session 410, 420 is initiated by the analyte sensor system 8 establishing a data connection with the display devices 110, 120, 130, and 140. To establish a data connection with the display devices 110, 120, 130, and 140, the transceiver 316 of the analyte sensor system 8 transmits a series of advertisement signals 412 during the first wireless communication session 420. Each advertisement signal can be considered an invitation for the display devices 110, 120, 130, and 140 to establish a data connection with the transceiver 316.

[0133] In the example illustrated in Figure 4, the analyte sensor system 8 is said to require initial system setup because it is now being started for the first time and / or is not currently paired with the display devices 110, 120, 130, and 140. Typically, a user of the display devices 110, 120, 130, and 140 identifies a new or previously unused analyte sensor system 8 that needs to be paired with the display device by entering identification information (e.g., serial number) associated with the new / unpaired analyte sensor system 8 via a custom application launched on the display device using a user interface (e.g., a touchscreen display). During the first wireless communication session 410, an authentication procedure must be performed as part of the data connection process 414. To establish a data connection with the analyte sensor system 8, the display devices 110, 120, 130, and 140 wait until they receive an advertisement signal transmitted by the transceiver 316 of the analyte sensor system 8. Once transceiver 316 begins transmitting advertisement signals 412, display devices 110, 120, 130, and 140 may require one, two, or more advertisement signals to receive and respond to the advertisement signals. In some embodiments, transceiver 316 stops transmitting additional advertisement signals once a display device has received an advertisement signal and responded to it, for example, via an acknowledgment. In other embodiments, transceiver 316 may continue transmitting additional advertisement signals even after receiving a response from a display device, so that another display device may receive and respond to one of the additional advertisement signals.

[0134] After the display devices 110, 120, 130, and 140 have successfully received the advertisement signals, the display devices and the analyte sensor system 8 perform a first data connection process 414. During the first data connection process 414, the display devices request a challenge value from the analyte sensor system 8, and the analyte sensor system 8 responds by sending the challenge value to the display devices. Upon receiving the challenge value, the display devices calculate a hash value based on the challenge value and the identification information associated with the analyte 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 from the hash value, and verifies that the received identification information matches the identification information associated with the sensor system 8 and / or transceiver 316 that has been previously stored in the memory 318 of the analyte sensor system 8, such as during the manufacturing of the sensor system 8. Once verification is complete, transceiver 316 transmits a signal to display devices 110, 120, 130, and 140 confirming the success of authentication. After authentication is complete, the analyte sensor system 8 and display devices 110, 120, 130, and 140 may exchange information to determine how to exchange data (e.g., specific frequency, data slot assignment, encryption, etc.).

[0135] After completion of the first data connection process 414, the analyte sensor system 8 and the connected display devices 110, 120, 130, 140 participate in a first data communication 416, during which the connected display devices request and receive the information desired from the analyte sensor system 8 (e.g., analyte data, control information, identification information, and / or instructions). When the first data communication 416 is completed, the data connection ends (e.g., by closing the established communication channel), and the transceiver 316 and / or processor 314 of the analyte sensor system 8 (and possibly also the transceiver 338 and / or processor 330 of the display devices 110, 120, 130, 140, depending on implementation preferences) can be deactivated by putting the transceiver 316 and / or processor 314 into a sleep or stop mode. In some embodiments, the transceiver 316 is completely powered down during sleep mode. In other embodiments, the transceiver 316 is in a low power mode that uses only a small fraction (e.g., 1 - 10%) of normal current / power.

[0136] The active period T corresponding to the duration of each wireless communication session Active is only a fraction of the update interval T corresponding to the period between two consecutive wireless communication sessions. For example, T interval can be. For example, T interval can be about 200 - 400 seconds, and T Active can be 20 - 40 seconds. Thus, the transceiver 316 of the analyte sensor system 8 can be fully powered only for 10 percent (e.g., 30 seconds) of a 5 - minute T interval . This can significantly reduce power consumption and the need for peak voltage. In some cases, the transceiver 316 does not completely power down but enters a low power mode except during transmission. As shown in FIG. 4, the downtime, i.e., the period T InactiveSubsequently, when the transceiver 316 (and transceiver 338) is powered on again, a second wireless communication session 420 begins, initiating the transmission of a second series of advertisement signals 422, and performing a second data connection process 424 and a second data communication process 426 with the transceiver 338 of the display devices 110, 120, 130, and 140. However, unlike the first data connection process 414, the second data connection process 424 does not involve authentication, because the analyte sensor system 8 and the display devices 110, 120, 130, and 140 have already paired or successfully coupled during the first wireless communication session 410, as described above. This process may continue, with new data connections and communications being completed at predetermined intervals. Each downtime T while the transceiver 316 is in sleep mode... Inactive During all or part of the process, the processor 314 may use the analyte sensor 312 and the sensor measurement circuit 310 to acquire one or more measured values ​​of an analyte. For example, the processor 314 may take multiple measured values ​​of an analyte and average them to generate a single averaged analyte value to be transmitted in the next wireless communication session.

[0137] Continuously re-establishing new communication channels at each interval T interval By allowing the power to be partially or completely cut off during operation of the transceiver 316, significant power savings are achieved, potentially enabling the sensor electronic device module 12 (Figure 1) to operate continuously for more than six months without requiring battery replacement. Furthermore, the update interval T intervalRather than indiscriminately transmitting glucose data points, unauthorized use and interception of glucose measurements can be prevented by establishing specific data connections (e.g., communication channels) only with the desired display devices 110, 120, 130, and 140. In some embodiments, only a subset of the multiple display devices 110, 120, 130, and 140 may be configured to receive different data, such as glucose measurements and / or alarm conditions. This has the advantage of preventing multiple display devices from issuing alarms, thereby preventing confusion and / or frustration of the user. In addition, by establishing a reliable two-way communication channel, requests for communication of specific glucose measurements or calibration or configuration information can be transmitted between the analyte sensor system 8 and the display devices 110, 120, 130, and 140 as needed / as requested.

[0138] Furthermore, in some embodiments, the transceiver 316 has a refresh interval T interval It may not be activated for data communication. Instead, the transceiver 316 is used for communication between, for example, the sensor system 8 and the display devices 110, 120, 130, and 140, with each update interval T interval Two, three, or four update intervals T are used to make it occur less frequently than interval It may be activated once per instance. Doing so can further reduce power consumption. Activation may also depend on sensor data. For example, the transceiver may be activated only when the data meets a certain threshold, such as the current rate of change, the current high value, the current low value, the absolute difference from a previously exchanged value, the percentage difference from a previously exchanged value, etc. In some embodiments, instead of skipping a certain fixed update interval, the length of each interval may vary based on sensor data. For example, if sensor data indicates that a low glucose value and / or hypoglycemic response has been detected, the update interval value may be shortened from the normal update interval value so that more frequent readouts are acquired and transmitted.

[0139] In some embodiments, the update interval T in which the transceiver is activated interval Active period T Active , and frequency F Activation (For example, once every two, three, or four update intervals) may be a variable. In a particular embodiment, the parameters identified above may be user-configurable (for example, by entering variable values ​​using the 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 include: (i) the monitored battery level of the sensor system 8; (ii) the currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold; (iii) the trend of the host glucose concentration based on the currently measured, previously measured, and / or predicted glucose concentration; (iv) the rate of change of the host glucose concentration based on the currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold; and (v) the current measured, previously measured, and / or predicted glucose concentration of the host. (vi) whether the host is determined to be in or near hyperglycemia based on the degree; (vii) whether the host is determined to be in or near hypoglycemia based on the currently measured, previously measured, and / or predicted glucose concentration; (vii) host activity entered by the user (e.g., exercise or sleep); (viii) time since the start of the sensor session (e.g., if a new sensor 10 is used); (ix) one or more errors detected by the sensor system 8 or display devices 110, 120, 130, 140; and (x) type of display device.

[0140] T as described herein interval , T Active F Activation, and / or other components may form part of a communication protocol profile that can be stored on any device that implements an underlying communication protocol to enable customized use of the protocol for communicating analyte measurements in the analyte sensor system 10 and the display devices 110, 120, 130, 140. Facilitating the initial data connection process

[0141] When a user attempts to pair a display device 110, 120, 130, or 140 with a new analyte sensor system 8, they input identification information (e.g., serial number or some other unique identifier) ​​associated with the analyte sensor system 8 (or the transceiver 316 of system 8) into the display device, for example, via the user interface of the display device (e.g., touchscreen). For example, a programmed update interval T interval Depending on the and / or any sensor system initialization time, it may take 5 to 10 minutes before the transceiver 316 begins transmitting the advertisement signal. Therefore, it may take up to 10 minutes to pair the analyte sensor system 8 with the display devices 110, 120, 130, and 140. In some embodiments, the display device may be a mobile device, such as a mobile phone 120, a tablet 130, or a smartwatch 140 based on a specific mobile operating system (e.g., Android or iOS). A custom application launched on the mobile device to address the authentication procedure of the analyte sensor system 8 may be in a stopped or background mode, and therefore the mobile device may not be able to complete the authentication procedure when the transceiver 316 begins transmitting the advertisement signal. This problem may further increase the pairing time.

[0142] One solution to the aforementioned problem is to have the analyte sensor system 8 display a message to the user via the user interface on the mobile device, informing the user that it is ready to establish a data connection with the mobile device and allowing the custom application to enter foreground mode. Optionally, once in foreground mode, the custom application may prompt the user for confirmation that a data connection with the transceiver is desired. Figure 5 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 a particular aspect of the present disclosure. Various tasks performed in connection with the process 500 illustrated in Figure 5 may be performed by a processor executing instructions embodied in a non-transient computer-readable medium. For example, tasks performed in connection with the process 500 may be performed by hardware, software, firmware, or any combination thereof, incorporated into one or more computing devices, such as the sensor system 8 and one or more of the display devices 110, 120, 130, and 140 in Figures 1 and / or 3. This procedure may include any number of additional or alternative tasks. The tasks shown in Figure 5 do not need to be performed in the order shown, and this procedure may be incorporated into a more comprehensive procedure or process with additional functionality not described in detail herein.

[0143] As shown 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 launch custom applications to handle the communication and management of analyte data from the analyte sensor system 8. In certain embodiments, wireless data communication may be based on short-range and / or low-power wireless communication, such as WiFi, Bluetooth®, and Bluetooth® Low Energy (BLE). In certain embodiments, the mobile device is an iPhone® based on iOS, and the wireless communication protocol is BLE.

[0144] Process 500 begins in a starting state 501 and proceeds to operation 510, where the mobile devices 120, 130, and 140 read identification information associated with the transceiver 316 of the analyte system 8 that the user intends to pair. The identification information may be, for example, a serial number associated with the sensor system. The user may input this information via a custom application using a user interface such as the touchscreen displays 122, 132, and 142 provided on the mobile devices 120, 130, and 140. Process 500 proceeds to operation 520, where the identification information entered by the user is stored in the memory 334 of the mobile devices 120, 130, and 140. Process 500 proceeds to operation 530, where the processor 330 of the mobile devices 120, 130, and 140 puts the custom application into background mode. The custom application may be designed to enter background mode for various reasons. For example, in a particular embodiment, it enters background mode after a predetermined pause period. Depending on the mobile operating system, the predetermined stop period may be 10 to 100 seconds. In some embodiments, the mobile operating system and / or the user decide to put one or more active applications into background mode after detecting conditions such as the mobile device's memory usage exceeding some predetermined threshold.

[0145] Process 500 then proceeds to operation 540, where mobile devices 120, 130, and 140 search for an advertisement signal from transceiver 316 until the mobile device receives an advertisement signal. Process 500 then proceeds to operation 550, where the mobile device authenticates transceiver 316 based on user-entered identification information and a challenge value. As described above with respect to Figure 4, the authentication operation 500 may include the mobile device requesting a challenge value from transceiver 316, receiving the challenge value, generating or calculating a hash value from the challenge value and identification information, transmitting the hash value to the transceiver, and receiving confirmation from transceiver 316 indicating successful authentication.

[0146] Process 500 then proceeds to operation 560, where mobile devices 120, 130, 140 prompt the user to bring the custom application into foreground mode, for example, by touching an icon associated with the custom application (e.g., via one or a combination of an audible alarm, a vibration alarm, and a pop-up message), and / or the mobile device displays a pop-up message on the display, prompting the user to touch a selectable field corresponding to the custom application. After the custom application is in foreground mode, process 500 proceeds to operation 570, where the custom application requests confirmation from the user that a data connection with the transceiver 316 is desired. Process 500 then proceeds to query state 575, where it is determined whether such confirmation has been received from the user within a predetermined time. If confirmation is received (yes), process 500 proceeds to operation 580, where the data connection with transceiver 316 is completed by data communication, for example, after the mobile device sends a signal indicating confirmation to the transceiver, and then requests and receives analyte values ​​from transceiver 316. After the data connection and data communication are completed, process 500 proceeds to operation 590, where the data connection is terminated and the process ends in termination state 503. On the other hand, if confirmation is not received from the user within a predetermined time (no), process 500 ends without completing the pairing between the analyte sensor system 8 and the mobile devices 120, 130, and 140.

[0147] As an example, the process 500 described above can be implemented on an Apple iPhone® with the iOS7 operating system. iOS7 has a “Restore / Restore function” that causes iOS7 to be reminded that a custom application in suspend or background mode is scheduled for another Bluetooth® event. Before this event, iOS7 may unsuspend the application, thereby allowing it to scan for Bluetooth® signals (e.g., advertisements) from the transceiver 316. Recover a custom application from a suspended state.

[0148] In some cases, the processor 300 of mobile devices 120, 130, and 140 may interrupt a custom application if certain conditions occur. For example, in some mobile operating systems, if it is determined that one or more applications are using an excessive amount of memory, the system may decide to deactivate or otherwise interrupt one or more applications, including a custom application for a mobile device that facilitates wireless communication with the analyte sensor system 8. If such deactivation or interruption of a custom application occurs, the transceiver 338 of the mobile device may not scan or retrieve advertisement signals as frequently or at all, which may interfere with the mobile device's ability to display updated analyte values ​​and / or provide warnings based on those values.

[0149] This problem can be solved by using a reminder feature available in some mobile operating systems, such as Apple, Inc.'s iOS 7 mobile operating system, which reminds the operating system that a custom application is suspended and that the application has a wireless communication event scheduled. In response to the reminder, the operating system understands to bring the custom application out of a stopped state (e.g., suspend, closed, background, etc.) or to start the BLE radio, thereby allowing the custom application to prepare for the upcoming wireless communication event. Figure 6 is a flowchart illustrating an exemplary process 600 for facilitating wireless data communication between an analyte sensor device 8 and mobile display devices 120, 130, 140 that can wirelessly receive analyte values ​​from the analyte sensor system 8, by bringing the custom application out of a stopped state before the next scheduled data communication event, according to a particular aspect of the present disclosure.

[0150] Process 600 begins in a starting state 601 and proceeds to operation 610, where excessive memory usage by the custom application is determined. Excessive memory usage can occur, for example, when the memory usage on the mobile display devices 110, 120, 130, and 140 exceeds a certain pre-configured memory threshold. For example, multiple applications running on the mobile display devices may be using more memory than desired, which can lead to an overall decrease in performance. Process 600 proceeds to operation 610, where the processor 300 of the display devices 110, 120, 130, and 140 puts the custom application into a stopped state, for example, to reduce overall memory usage. As described above, when the custom application is in a stopped state, the transceiver 338 of the mobile device may be configured not to scan or search for advertisement signals as frequently, or not at all. Process 600 then proceeds to operation 620, where processor 330 determines the next scheduled time when transceiver 316 is expected to begin transmitting the next set of advertisement signals. Process 600 then proceeds to operation 630, where processor 330 exits the suspended state before the next scheduled time. By bringing the custom application back from the suspended state before transceiver 316 exits the suspended mode and transmits the next set of advertisement signals, the mobile device is able to receive the advertisement signals and establish a data connection and communicate with transceiver 316. After exiting in termination state 603, process 600 proceeds to request connection and exchange data, as described above with respect to operation 420 in Figure 4. Minimize the number of advertisement signals required to establish a data connection.

[0151] As described above with respect to Figure 4, when transceiver 316 begins transmitting the advertisement signal sets 412 and 422, display devices 110, 120, 130, and 140 may require several advertisement signals to receive the advertisement signals and establish a data connection with transceiver 316. In some cases, this number can be as high as 10 or more. Transmitting such a large number of advertisement signals can consume a significant amount of power from the battery of the analyte sensor system 8. Therefore, minimizing the number of advertisement signals transmitted by transceiver 316 can extend the lifespan of the analyte sensor system 8. In certain embodiments of this disclosure, minimization can be achieved by causing the transceivers or wireless units 338 of display devices 110, 120, 130, and 140 to exit stop mode and actively scan for advertisement signals from the transceivers of the analyte sensor system 8 before the transmission of the advertisement signals. The specific time at which transceiver 338 exits stop mode can be calculated from the previous radio communication cycle based on the connection interval received from the analyte sensor system 8. The connection interval represents the amount of time elapsed in the previous communication cycle between the start of transmission of a series of advertisement signals by transceiver 318 of the analyte sensor system 8 and the reception of data connection requests from display devices 110, 120, 130, and 140 by transceiver 316. This scheme prevents the display devices 110, 120, 130, and 140 from missing one or more advertisement signals at the start of transmission due to the transceiver 338 exiting stop mode too late.

[0152] Figure 7 is a flowchart illustrating an exemplary process 700 for minimizing the number of advertisement 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 a particular aspect of the present disclosure. The flowchart shows two sets of operations. The sets indicated on the left, numbered in the range of 750–768, correspond to operations performed on the display devices 110, 120, 130, and 140, and the sets indicated on the right, numbered in the range of 710–722, correspond to operations performed on the analyte sensor system 8. The various tasks performed in connection with the process 700 illustrated in Figure 7 can be performed by a processor executing instructions embodied in a non-transient computer-readable medium. For example, tasks performed in connection with process 700 may be carried out by hardware, software, firmware, or any combination thereof, incorporated into one or more computing devices, such as the sensor system 8 and one or more of the display devices 110, 120, 130, and 140 in Figures 1 and / or 3. This procedure may include any number of additional or alternative tasks. The tasks shown in Figure 7 do not have to be performed in the order shown, and this procedure may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein.

[0153] Process 700 begins in the start state 701 and proceeds to operation 710, where the transceiver 316 exits the sleep or stop mode in the analyte sensor system 8, from which it does not communicate data with the display devices 110, 120, 130, and 140.

[0154] In display devices 110, 120, 130, and 140, process 700 proceeds to operation 750, where the display device processor 330 instructs the transceiver 338 to retrieve an advertisement signal from the analyte sensor system 8. In the analyte sensor system 8, process 700 proceeds to operation 712, where the processor 314 of the analyte sensor system 8 instructs the transceiver 316 to begin transmitting a first series of advertisement signals at a first time T1. The processor 314 of the analyte sensor system 8 measures the first time T1 using a real-time clock (RTC) 320 and stores T1 in memory 318.

[0155] In display devices 110, 120, 130, and 140, process 700 proceeds to operation 752, where the display device's processor 330 receives an advertisement signal from the analyte sensor system 8 via transceiver 338. Subsequently, in operation 754, the processor 330 causes transceiver 338 to transmit a data connection request to the analyte sensor system 8. In 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 measures the second time T2 using RTC 320 and stores T2 in memory 318. In operation 716, the processor 314 approves the data connection request by causing transceiver 316 to transmit a signal indicating approval of the data connection request to the display devices 110, 120, 130, and 140, thereby establishing a data connection with the display devices. In the display device, the display device's processor 330 receives a signal from the analyte sensor system 8, and in operation 758, causes the transceiver 338 to establish a data connection with the transceiver 316.

[0156] In the analyte sensor system 8, process 700 proceeds to operation 718, where processor 314 causes transceiver 316 to transmit the connection interval to display devices 110, 120, 130, and 140. The connection interval is for the display devices to use to calculate the exit time, which is when the display devices exit stop mode and begin searching for advertisement signals from the analyte sensor system 8. The connection interval is calculated based on first and second times, T1 and T2, and represents the difference between these two times. For example, in some embodiments, the connection interval is the difference, i.e., (T2-T1). In other embodiments, the connection interval is a function of the difference, such as current time + (T2-T1).

[0157] In display devices 110, 120, 130, and 140, process 700 proceeds to operation 760, where processor 330 receives the connection interval from the analyte sensor system 8. Processor 330 then transmits a request for analyte values ​​to the analyte sensor system 8 in operation 762. In the analyte sensor system 8, processor 314 receives the request, transmits the analyte values ​​to the display device in operation 718, terminates the data connection to the transceiver in operation 720, and enters sleep mode in operation 722. In some embodiments, the transceiver 316 is completely powered off. In other embodiments, the transceiver 316 enters low-power mode.

[0158] In display devices 110, 120, 130, and 140, the processor 330 receives the analyte value in operation 762 and terminates the data connection with the analyte sensor system 8. The processor 330 also puts the transceiver 338 into stop mode in operation 764. During stop mode, the display device's transceiver 338 does not engage in wireless data communication with the transceiver 316 of the analyte sensor system 8. In operation 766, the processor 330 also calculates the exit time for the transceiver 316 to exit stop mode based on the connection interval received from the analyte sensor system 8. In a particular embodiment, the calculated exit time is current time + update interval (T interval The connection interval, notification delay, and safeguard are obtained by the connection interval, notification delay, and safeguard. As used herein, notification delay is a measure of time elapsed between when the connection is first established and when the synchronous notification is actually sent. The actual duration can vary depending on the device used. Safeguard is a measure of time before the stop state of the transceiver 316 of the analyte sensor system is released, and before the stop state of the transceiver 338 of the display device is released, the transceiver 338 must be released and begin scanning. In some embodiments, the connection interval is approximately 90–300 milliseconds, the notification delay is approximately 100–300 milliseconds, and the safeguard is typically approximately 300–700 milliseconds. In operation 768, the processor 330 causes the transceiver 338 to exit stop mode at a calculated exit time so that the transceiver 338 can begin searching for the next series of advertisement signals from the transceiver 316 of the analyte sensor system 8.

[0159] As can be seen in Figure 7, process 700 is substantially repeated during a given wireless communication session so that the transceivers 338 of display devices 110, 120, 130, and 140 can exit stop mode at an exit time calculated based on the connection interval received from the analyte sensor system 8 during the previous wireless communication. When implemented in a mobile device using the Android operating system, this scheme has been shown to reduce the number of advertisement signals that the transceivers need to transmit from, on average, more than 50 to about 3-4. Furthermore, the use of this scheme has been shown to reduce the power consumption of advertisements by up to approximately 68% of the connection process. Switching between display devices

[0160] In some cases, it may be desirable or necessary for a user to switch between two or more display devices. For example, a user might typically want to check glucose readings on their mobile phone 120. However, if the mobile phone 120's battery level is low, they might switch to the custom monitoring device 110 to check the glucose readings there. After charging the mobile phone, the user might want to switch back to the mobile phone for better checking. Therefore, a convenient and efficient method for switching between display devices is desirable.

[0161] In addition, it is desirable to be able to efficiently reject data connection requests from one or more display devices other than the display device selected by the user. For example, even when the mobile phone 120 selected by the user is the only permitted display device, the transceiver 316 may receive data connection requests from other display devices. In such cases, it is desirable to immediately reject the data connection requests without consuming a lot of time and battery power.

[0162] One solution to facilitate switching between two display devices is to identify a single authorized display device (the mobile phone 120 in the example above) in a list, and if a data connection request is received from a display device that is not the single authorized display device identified in the list, the request is rejected at the radio hardware level rather than at a higher software level. Such a list may be implemented in memory with a processor that controls the functionality 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 the link layer (LL) controller in the 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 if not, rejects the request at the radio hardware level rather than at a higher software level. This can significantly reduce the time and battery power associated with rejecting data connection requests from unwanted devices. In some embodiments, there may be more than one authorized display device; that is, there may be multiple display devices connected to and communicating with the analyte sensor system 8 simultaneously.

[0163] In certain embodiments, the analyte sensor system 8 may also store information identifying one or more display devices that have previously been paired with the transceiver. In some embodiments, such information is stored in the same list or memory as information identifying a single authorized display device. In other embodiments, such information is stored in a different list or memory. By storing this information, the device can form authenticated communications more quickly and efficiently.

[0164] Figures 8A and 8B represent flowcharts illustrating exemplary systems and methods for rejecting data connection requests from display devices not specified in a list containing a single permitted display device, according to certain embodiments of the present disclosure. In some embodiments, however, multiple permitted display devices may be present in the list. Figure 8A shows an analyte sensor system 801, a first display device (DD1) 803, and a second display device (DD2) 805. The vertical arrow 805 on the left side of Figure 8, labeled “Devices Specified in the List,” identifies a display device currently stored in a list that is included in a single permitted list. In the illustrated example, DD2 805 is the display device specified in the list in Figure 8A. In Figure 8B, the contents of the list change from DD2 805 to none and then to DD1 803.

[0165] Without any intention to limit the scope of this disclosure, for the sake of ease of illustration, the analyte sensor system 801 in Figures 8A and 8B is described with reference to the analyte sensor system 8 illustrated in Figure 4. Similarly, the first and second display devices 8031 ​​and 805 are described with reference to the display devices 110, 120, 130, and 140 illustrated in Figure 4.

[0166] In relation to Figure 4, it is explained that DD1 and DD2 are already authenticated and paired. At the start of the first communication session 810, the analyte sensor system 801 begins transmitting a first set of advertisement signals 812. At this stage, both DD1 803 and DD2 805 are paired with the analyte sensor system 8 according to the pairing operations 414 and 416 described above in relation to Figure 4. However, only DD2 805 is currently in the list containing a single authorized display device. The advertisement signal 812 may be received by both DD1 803 and DD2 805, and DD2 805 is the display device specified in the list containing a single authorized display device. In the illustrated example, DD1 803 receives the advertisement signal from the analyte sensor system 8 and responds first by transmitting a data connection request 813. DD2 805 may also have received the advertisement signal, but cannot respond to the signal before DD1 803. Therefore, the response signal from DD2 805 is not received or recognized by the transceiver 316 of the analyte sensor system 8. By comparing the ID of DD1 803 included in the first data connection request 813 with identification information stored in a list containing a single authorized display device, the processor (e.g., the link layer (LL) controller) that controls the radio hardware-level functionality of the 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 a particular embodiment, the analyte sensor system 8 transmits a signal to cause DD1 803 to stop transmitting additional connection requests. In another embodiment, DD1 803 stops transmitting additional connection requests if it does not receive a response to the first advertisement signal within a predetermined time.

[0167] In the illustrated example, after rejecting the first data connection request 813 from DD1 802, the transceiver 316 of the analyte sensor system 801 continues to transmit additional advertisement signals during the first wireless communication session 810, as shown in Figure 8A. In response to one of the additional advertisement 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 authorized device and approves the request. Once the data connection is complete, 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 the completion of data communication processes 817 and 818, the data connection between the analyte sensor system 801 and DD2 805 is terminated / closed, and the transceiver 316 of the analyte sensor system 801 is deactivated by putting it into sleep mode.

[0168] Stop time T InactiveAfter the downtime shown in Figure 4 (during which time analyte measurement may be performed by the analyte sensor 312 as described above), the second communication session 820 begins with the transceiver 316 of the analyte sensor system 801 starting to transmit a second series of advertisement signals 822. This time, DD2 805 receives the advertisement signals and responds first by transmitting a second data connection request 815. By comparing the ID of DD2 805 included in the second data connection request 815 with identification information stored in a list containing a single authorized display device, the processor of the analyte sensor system 810 determines that DD2 805 is a currently authorized display device and approves the request, for example, by transmitting an approval signal 826. Once the data connection is complete, DD2 805 transmits a request for data 827, and the analyte sensor system 801 transmits the requested data 828. After the completion of data communication processes 827 and 828, the data connection between the analyte sensor system 801 and DD2 805 is terminated / closed, and the transceiver 316 of the analyte sensor system 801 is deactivated by putting it into sleep / powered-off mode.

[0169] Under certain predetermined conditions, a list containing a single permitted display device may be cleared so that another display device can connect to the analyte sensor system 8 without being rejected at the wireless hardware level. This feature solves the problem of attempting to connect to a new display device when the current display device on the list is gone or not functioning. Figure 8B shows a predetermined number (N) of wireless communication sessions 8301-830. N An exemplary process is illustrated in which the list may be cleared if no data connection request is received from a display device identified in the list within a certain time. As can be seen in Figure 8B, N sets of advertisement signals 8321-832 NThe data connection request is not received from DD2 805, which is a display device identified in a list containing a single authorized display device. When this occurs, the processor controlling the radio function of transceiver 316 clears the information identifying DD2 805 stored in the list.

[0170] In the subsequent communication session 840, transceiver 316 transmits an advertisement signal set 842, and this time a third data connection request 845 is received by DD1 803. Note that at this stage, the list containing a single authorized display device is empty. Upon receiving the third data connection request 845, the processor controlling the radio functions of transceiver 316 approves the request 845 and writes information identifying DD1 803 to the list. As long as DD1 803 is identified in the list, subsequent data connection requests received from DD1 803 will be approved without being rejected at the radio hardware level.

[0171] Another predetermined condition under which a list clearing may occur is when the listed display device receives a signal from the listed display device (i.e., the display device identified in the list) indicating that it is to be cleared from the list. This can occur, for example, when a user who wishes to switch to a different display device (e.g., from mobile phone 120 to custom display device 120, or vice versa) explicitly enters a command into the currently listed display device to clear the listed display device from the list. Another possibility is that the listed device automatically transmits a clear signal if it determines, for example, that it is about to run out of power due to a low battery level.

[0172] As described above, the analyte sensor system 8 is also configured to store information that identifies one or more display devices paired with the transceiver, either in the same list or a different list. If no such information is stored in the analyte sensor system 8, it means that there are no other display devices paired with the transceiver, and the transceiver continues to receive data connection requests from one or more display devices until at least one display device is paired with the transceiver, and information that identifies the paired display device is stored in one or more lists that store previously paired display devices.

[0173] Figures 9A and 9B represent flowcharts illustrating exemplary procedures for facilitating switching between two display devices utilizing two separate lists according to a particular aspect of the present disclosure. The first list is intended to contain information identifying one or more permitted display devices, and the second list is intended to contain information identifying a single currently active display device, i.e., a display device selected to receive and display analytic values ​​from an analytic sensor system. The first list is preferably implemented in memory with a processor that controls the transceiver's functionality at the wireless hardware level described above. The second list may be implemented in the same memory containing the first list, or in a different memory.

[0174] Without any intention to limit the scope of this disclosure, for the sake of ease of illustration, the analyte sensor system 901 in Figures 9A and 9B is described with reference to the analyte sensor system 8 illustrated in Figure 4. Similarly, the first and second display devices 903 and 905 are described with reference to the display devices 110, 120, 130, and 140 illustrated in Figure 4.

[0175] At this stage, both DD1 903 and DD2 905 are paired with the analyte sensor system 901 according to the pairing operations 414 and 416 described above in relation to Figure 4, and are present in the list of permitted display devices. However, only DD2 905 is currently present in the list of single active display devices. In the illustrated example, suppose the user decides to select DD1 903 as the new active display device for receiving and displaying analyte values ​​from the analyte sensor system 901. At the start of the first communication session 910 shown in Figure 9A, the transceiver 316 of the analyte sensor system 801 begins transmitting a first set of advertisement signals 912. The advertisement signals 812 may be received by both DD1 903 and DD2 905. As indicated by the two vertical arrows on the left side of the diagram, at this stage, both DD1 903 and DD2 905 are identified in a first list containing information identifying one or more authorized display devices, while only DD2 905 is identified in a second list containing information identifying a single active display device. The newly selected active display device, DD1 903, receives an advertisement signal 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 included in the first data connection request 913 with the data stored in the first list containing one or more authorized display devices, the processor controlling the functionality of the transceiver 316 at the wireless hardware level (e.g., a link layer (LL) controller) determines that DD1 903 is identified in the first list and approves the data connection request 914 by transmitting an approval signal 914 to DD1 903.

[0176] DD1 903 then transmits a request 915 for identification of a display device specified in a second list. The analyte sensor system 901 responds to the request 915 by transmitting a signal 916 indicating that DD2 905 is specified in the second list. Upon receiving signal 916, DD1 903 transmits a signal 917 indicating that it has been selected as the new active display device. In response, the analyte sensor system 901 modifies the second list to indicate that DD1 903 is now the active display device. In some embodiments, the analyte sensor system 901 also transmits a signal 918 indicating that DD1 903 is now specified in the second list. Signal 919 may inform DD2 905 that the display device 905 is no longer the active display device, causing the display device 905 to cease responding to advertisement signals and / or enter a stopped state during the next communication session. After the transmission of signal 917 (and possibly signal 918), the data connection is terminated, the transceiver 316 is deactivated, and the first radio communication session 910 is completed.

[0177] Stop time T InactiveAfter a predetermined downtime indicated by (during which one or more analyte measurements may be obtained from the analyte sensor 312), the second wireless communication session 920 begins with the transceiver 316 of the analyte sensor system 901 starting to transmit a second set of advertisement signals 922. DD1 903 receives the advertisement 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 acceptance of the second data connection request 923. DD1 903 then transmits a data request 925, and the analyte sensor system 901 responds to the request 925 by transmitting the requested data 926. After data communication 925 and 926, the data connection is terminated, the transceiver 316 is deactivated, and the second wireless communication session 920 is completed.

[0178] Figure 9B illustrates what happens when a display device that is not currently an active display device transmits a data connection request to the analyte sensor system 901, according to a particular aspect of the present disclosure. In the illustrated example, during a third wireless communication session 930, DD2 905 transmits a third data connection request 933 in response to a series of advertisement signals transmitted from the analyte sensor system 901. In response to the third data connection request 933, the analyte sensor system 901 approves the third data connection request 933 after determining that DD2 905 is identified in a first list, and transmits an approval signal 924 to DD2 905. DD2 905 then transmits a request 936 for identification of a display device identified in a second list. The analyte sensor system 901 responds to the request 936 by transmitting a signal 937 indicating that DD1 902 is identified in a second list. Upon receiving identification information 937, DD2 905 transmits a signal 938 indicating that the display device 905 is not the newly selected active display device. In response, the analyte 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 changing the second list. Since the second list is not changed 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, as well as the data communication processes 946, 947, typically occur during the fourth wireless communication session 940, as shown in Figure 9B.

[0179] In the systems and methods shown in Figures 9A and 9B, only one active display device is permitted 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 may be permitted to establish a data connection with the analyte sensor system 901. However, for ease of illustration, only one active display device is permitted to establish a data connection in the examples of Figures 9A and 9B. In some embodiments, a list containing one or more permitted display devices and / or a list containing one or more active display devices may be cleared if no connection request(s) are received from any display device on the list(s) during a predetermined number of wireless communication sessions. In some cases, it is desirable for a passive device to receive analyte data and / or other information from the analyte sensor system without being paired with and / or connected to the analyte sensor system. Figure 10 illustrates a wireless data communication system 1000, comprising an analyte sensor system 1010, an active display device 1020, and a passive device 1050, according to a particular aspect of the present disclosure. In the illustrated example, the analyte sensor system 1010 is a continuous glucose sensor system comprising 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 desirable for the insulin pump 1050 to receive and track glucose values ​​transmitted from the continuous glucose sensor system 1010. One reason is to provide the insulin pump 1050 with the ability to interrupt isolated administration when the glucose value falls below a threshold.One solution that enables a passive device (e.g., an insulin pump 1050) to receive desired data (e.g., glucose values) without requiring the establishment of an authenticated communication channel with an analyte sensor system (e.g., a glucose sensor system 1010) is to include the desired data in an advertisement signal transmitted from the analyte sensor system. The data included in the advertisement signal can be encoded so that only a device having identification information associated with the analyte sensor system 1010 can decode the data. In some embodiments, an active display device 1020 extracts and uses the data included in the advertisement signal. In other embodiments, the active display device 1020 does not extract the data included in the advertisement signal, but instead acquires the data after the display device 1020 has established a data connection with the analyte sensor system 1010 in the manner described above with respect to Figure 4.

[0180] Figure 11 is a flowchart illustrating an exemplary process 1100, according to a particular aspect of the present disclosure, for enabling a passive device to receive desired data from an analyte sensor system without being paired with or connected to the analyte sensor system. 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 advertisement signals containing analyte values ​​(or other information used by the passive device). Process 1100 proceeds to operation 1120, where the passive device 1050 receives a first advertisement signal containing the analyte values. In a particular embodiment, the analyte values ​​contained in the advertisement signal are encoded such that they can only be read or decoded by the analyte values ​​having identification information associated with the analyte sensor system 1010. As an example, the user has 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 value from the first advertisement signal. In embodiments where the analyte value contained in the advertisement signal is encoded, the extraction process involves decoding the encoded analyte value using a key or code that may be generated by using the analyte sensor system 1010 and associated identification information. The passive device 1050 can use the extracted analyte value for various purposes. For example, in embodiments where the passive device 1050 is an insulin pump, the extracted glucose value may be displayed on the interface of the device 1050 and used to calculate the optimal insulin administration rate and / or to interrupt insulin administration when the glucose value falls below a threshold.

[0181] Process 1100 proceeds to operation 1140, where the active display device 1020 receives an advertisement signal from the transceiver of the analyte sensor system 1010. This advertisement signal may be the same as or different from the one 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 processes, examples of which are described above in relation to Figures 4, 5, 6, 7, 8A, 8B, 9A, and 9B. Process 1100 proceeds to operation 1170, where the active display device 1020 requests and receives analyte values ​​from the analyte sensor system 1010 using one or more data communication processes, examples of which are described above in relation to Figures 4, 5, 6, 7, 8A, 8B, 9A, and 9B. Process 1100 proceeds to operation 1180, where the analyte sensor system 1010 terminates its data connection with the active display device 1020 and puts its transceiver into sleep mode. Process 1100 returns to operation 1110 and repeats.

[0182] Various implementations of the subject matter described herein may be realized in digital electronic circuits, integrated circuits, specially designed ASICs (application-specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. Circuits may be mounted on printed circuit boards (PCBs), etc., and may take various forms as described. These various implementations may include implementations in one or more non-transient computer programs executable and / or interpretable on a programmable system which may be special-purpose or general-purpose and includes at least one programmable processor connected to receive data and instructions from a memory system, at least one input device, and at least one output device, and to transmit data and instructions thereto.

[0183] These computer programs (also known as programs, software, software applications, or code) include machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages, as well as / or assembly / machine languages. As used herein, the term “machine-readable medium” refers to any non-transient computer program product, apparatus, and / or device (e.g., magnetic disks, optical disks, memory, programmable logical devices (PLDs)) that includes a machine-readable medium that receives machine instructions and is used to provide machine instructions and / or data to a programmable processor.

[0184] While this disclosure is illustrated and described in detail in the drawings and the foregoing description, such illustrations and descriptions are illustrative or illustrative and not limiting. This disclosure is not limited to the embodiments disclosed. Variations to embodiments of this disclosure may be understood and realized by those skilled in the art from the drawings, this disclosure, and the appended claims when carrying out the claimed disclosure.

[0185] All references cited herein are incorporated herein in their entirety by reference. To the extent that any publication or patent or patent application incorporated herein conflicts with the disclosure contained herein, this specification is intended to prevail and / or precede any such conflicting element.

[0186] Unless otherwise defined, all terms (including technical and scientific terms) are given the ordinary and customary meanings to those skilled in the art and are not limited to any special or customized meanings unless expressly defined herein. It should be noted that the use of any particular term in describing a particular feature or aspect of the Disclosure is not to be considered an implication that the term is redefined herein to be limited to any specific characteristic of the feature or aspect of the Disclosure to which the term relates. The terms and phrases used in this application, and their variations, should be considered unrestricted, in contrast to limitations, unless expressly stated otherwise, particularly in the appended claims.As an example of those mentioned above, the term "including" means "including without limitation," "including but not limited," etc., the term "comprising," when used herein, is synonymous with "including," "containing," or "characterized by," and is comprehensive or unrestrictive, not excluding additional undescribed elements or method steps, the term "having" should be interpreted as "having at least," the term "include" should be interpreted as "including but not limited," and the term "example" is used to provide an exemplary example of the item being discussed, not an complete example. The list is not to be limited, and adjectives and similar terms such as “known,” “common,” and “standard” should not be considered to limit the items listed to those available at a given time or point in time, but rather to be interpreted as encompassing known, common, or standard techniques that are available or may be known at any point in time or in the future. Similarly, terms and similar words such as “preferred,” “desired,” or “coveted” should not be understood to imply that a particular feature is critical, essential, or even important for the structure or function of the invention, but are simply intended to highlight alternative or additional features that may or may not be available in a particular embodiment of the invention. Likewise, groups of items associated with the conjunction “and” should not be interpreted as requiring that every single item in that group be present, but should be interpreted as “and / or” unless otherwise explicitly stated. Likewise, groups of items associated with the conjunction “or” should not be interpreted as requiring mutual exclusion among the groups, but should be interpreted as “and / or” unless otherwise explicitly stated.

[0187] If a range of values ​​is provided, the upper and lower limits, as well as each intermediate value between the upper and lower limits of that range, are included in the embodiment.

[0188] With regard to substantially all use of plural and / or singular terms herein, those skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the situation and / or application. Various singular / plural substitutions may be expressly described herein for clarity. The indefinite articles “a” or “an” do not preclude the plural. A single processor or other unit may fulfill the functions of several items described in the claims. The mere fact that certain measures are described in different dependent claims does not imply that it is not possible to benefit from using combinations of these measures. Any reference symbols within the claims are not to be deemed to limit their scope.

[0189] If the claims are intended to introduce a specific number, such intent is explicitly stated within the claims, and it will be further understood by those skilled in the art that such intent does not exist if it is not explicitly stated. For example, to aid understanding, the claims attached below may include the use of the prefixes “at least one” and “one or more” to introduce the claims. However, the use of such phrases does not imply that the introduction of a claim description with the indefinite article "a" or "an" is intended to limit any particular claim containing such an introduced claim description to only one embodiment containing such description, even if the same claim description includes the prepositional phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (for example, "a" and / or "an" should typically be interpreted as meaning "at least one" or "one or more"). This also applies to the use of definite articles used to introduce a claim description. Furthermore, even when a claim description explicitly introduces a specific number, it should be understood that such a description should typically be interpreted as meaning at least the number described (for example, the bare statement “two descriptions” typically means at least two references or two or more references without any modifiers). Moreover, in cases where a conventional analogue to “at least one of A, B, and C, etc.” is used, such limitations are generally intended to be understood by those skilled in the art (for example, “a system having at least one of A, B, and C” would include, but not be limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or systems having A, B, and C together).In cases where conventional analogues for “at least one of A, B, or C, etc.” are used, such limitations are generally intended in the sense that those skilled in the art will understand the convention (for example, “a system having at least one of A, B, or C” would include, but not be limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or systems having A, B, and C together). It will further be understood by those skilled in the art that virtually all disjunct words and / or phrases representing two or more alternative terms, whether in descriptions, claims, or drawings, are understood to contemplate the possibility of including one of those terms, either of those terms, or both of those terms. For example, the phrase “A or B” would be understood to include the possibilities of “A” or “B” or “A and B”.

[0190] All figures representing quantities of components, reaction conditions, etc., shall be understood in all cases to be modified by the term "approximately." Therefore, unless otherwise indicated, the numerical parameters described herein are approximate values ​​and may vary depending on the desired properties to be obtained. Finally, each numerical parameter should be interpreted with regard to significant figures and conventional rounding approaches, not as an attempt to limit the application of the doctrine of equivalents to any claim in any specification claiming priority to this specification.

[0191] Furthermore, although the foregoing has been described in some detail as illustrations and examples for the purpose of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be made. Therefore, the description and examples should not be considered as limiting the present invention to the specific embodiments and examples described herein, but rather as encompassing all modifications and alternatives in the true scope and spirit of the invention. [Explanation of symbols]

[0192] 8 Sensor Systems 10 sensors 12 Sensor Electronic Device Module 100 Continuous Analytical Substance Monitoring System 110 Display Devices 112 Touchscreen Display 120 Mobile phones 122 Touchscreen Display 130 mobile display devices 132 Touchscreen displays 140 Smartwatches 142 Touchscreen displays 208 Adhesive Pads 214 Mounting Unit 234 Base 236 Contact Subassembly 238 Contact area 310 Sensor Measurement Circuit 312 Analytical Sensor 314 processors 316 Transceiver 318 memory 320 RTC 320 Real-time Clock 330 processor 332 displays 334 memory 336 Real-time Clock 338 transceivers 1000 Wireless Data Communication Systems 1010 Analytical Sensor System 1012 Sensor Electronic Device Module 1014 Continuous glucose sensor 1020 Display Devices 1050 devices

Claims

1. A system for wireless data communication, An analyte sensor system configured to transmit a series of advertisement signals, It is a passive device, Receiving a first advertisement signal from the analyte sensor system, which is one of the series of advertisement signals transmitted by the analyte sensor system, includes data used by the passive device, and the data is encoded so that it can only be decoded by a device having identification information associated with the analyte sensor system; A passive device configured to extract data from the first advertisement signal without establishing a data connection with the aforementioned analyte sensor system, An active display device, The system receives a second advertisement signal, which is one of the series of advertisement signals transmitted by the aforementioned analyte sensor system, from the aforementioned analyte sensor system. In response to the second advertisement signal, a data connection is established with the analyte sensor system, Receiving analyte values ​​from the aforementioned analyte sensor system, Terminating the aforementioned data connection, A system comprising an active display device configured to display the aforementioned analyte values.

2. The system according to claim 1, wherein the data to be used by the passive device includes encoded analyte values.

3. The system according to claim 1 or 2, wherein the analyte sensor system is a continuous glucose sensor system, and the passive device is an insulin pump configured for insulin administration.

4. The system according to claim 3, wherein the data included in the first advertisement signal indicates a glucose level, and the insulin pump is configured to interrupt insulin administration when the glucose level falls below a threshold.

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