Diabetes Management Partner Interface for Wireless Communication of Analyte Data
The diabetes management partner interface enables flexible and reliable wireless communication between analyte sensor systems and partner devices by configuring parameters based on system requirements, addressing interoperability issues and enhancing blood glucose management.
Patent Information
- Application Number
- JP2023094151
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2017-10-30
- Filing Date
- 2023-06-07
- Publication Date
- 2025-07-08
- Estimated Expiration
- 2038-10-24
Smart Images

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Abstract
Description
Technical Field
[0001] Incorporation by reference to related applications All priority claims identified in the application data sheet, or any amendments thereto, are hereby incorporated by reference into this specification under 37 C.F.R. § 1.57. This application claims the benefit of U.S. Provisional Patent Application No. 62 / 579,061, filed October 30, 2017. The foregoing application is hereby incorporated by reference in its entirety and made a part hereof as if fully set forth herein.
[0002] The present disclosure generally relates to an interface for wireless communication of analyte data collected using an analyte sensor system. More specifically, the present disclosure is directed to systems, methods, apparatuses, and devices for using a diabetes management partner interface to improve the flexibility of an analyte sensor system in wireless communication with a display device, a medical device, and / or other (e.g., electronic) devices.
Background Art
[0003] Diabetes mellitus is a disease in which the pancreas cannot produce enough insulin (type I or insulin-dependent) and / or insulin is ineffective (type II or non-insulin-dependent). In a diabetic condition, the victim suffers from hyperglycemia, which causes many physiological disorders associated with deterioration of small blood vessels, (renal failure, skin ulcers, or bleeding into the vitreous humor of the eye). Hypoglycemic reactions (low blood sugar) can be induced by inadvertent overdose of insulin or by normal administration of insulin or glucose-lowering drugs accompanied by abnormal exercise or inadequate food intake.
[0004] Conventionally, people with diabetes carry self - monitoring blood glucose (SMBG) monitors, which may require an uncomfortable finger - pricking method. Due to lack of comfort and convenience, diabetic patients usually measure their glucose levels only 2 - 4 times a day. Unfortunately, because these time intervals are very far apart, diabetic patients may be warned too late about hyperglycemic or hypoglycemic conditions, which can result in dangerous side effects. In fact, not only is it less likely for diabetic patients to obtain SMBG values in a timely manner, but due to the limitations of conventional methods, it is not known whether their blood glucose levels are rising (getting higher) or falling (getting lower).
[0005] As a result, various non - invasive, transdermal (e.g., transcutaneous) and / or implantable electrochemical sensors have been developed to continuously detect and / or quantify blood glucose levels. These devices generally transmit raw data or minimally processed data for subsequent analysis on a remote device that can include a display. Transmission to a wireless display device can be wireless. The remote device can then provide the user with information regarding the user's blood glucose level. Systems using such implantable sensors can reduce the risk that the user will fail to adjust the user's blood glucose level because they can provide the user with more up - to - date information. Nevertheless, such systems still typically rely on the user to take actions to adjust the user's blood glucose level, for example, by administering an injection.
[0006] A particular device has been introduced that automates the regulation of a user's blood glucose level. The introduction of such a device can give rise to interoperability issues with other devices (e.g., the aforementioned remote device) that can be used for blood glucose monitoring, especially when, for example, the aforementioned device is deployed by different manufacturers. For example, a device introduced for automatic blood glucose level regulation may be subject to certain requirements regarding interference, battery life, accuracy, and reliability. Such requirements may not be known in advance by the manufacturer of the monitoring device and / or, in some cases, may depend on the ecosystem configuration, such as the available network connection, the number of connected devices, etc., and it may be desirable to change the requirements from time to time. In addition, as more electronic devices become network - connectable, more devices can be used to manage health conditions such as diabetes. However, maintaining synchronized analyte data communication among multiple devices, while useful, is becoming increasingly difficult for the user.
[0007] Therefore, conventional systems are not suitable for the deployment and integration of a device for monitoring blood glucose levels and an additional device for regulating blood glucose levels, especially when such devices are provided by different manufacturers, when such devices communicate wirelessly via various types of communication networks and / or media, and when a certain level of flexibility and / or adaptability is desired. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM
[0008] A first aspect of the present disclosure includes a method of configuring an analyte sensor system for wireless communication with a plurality of partner devices using a diabetes management partner interface. The method includes the analyte sensor system receiving, via the diabetes management partner interface, permission to provide access to a set of configuration parameters to one of the partner devices. The set of configuration parameters is stored in the memory of the analyte sensor system. The method also includes the analyte sensor system setting or causing a modification of the set of configuration parameters in response to an input received from one partner device via the diabetes management partner interface, according to the system requirements of the one partner device.
[0009] In a particular implementation of the first aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the first aspect, one partner device is an automatic insulin delivery device or a manual insulin delivery device.
[0010] In a particular implementation of the first aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the first aspect, the set of configuration parameters includes one or more of a wireless connectivity parameter set, an access control parameter set, and an analyte data parameter set.
[0011] In a particular implementation of the first aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the first aspect, the system requirements are associated with one of a battery capacity of one partner device, an accuracy requirement of one partner device, a communication protocol used by one partner device, regulatory requirements applicable to one partner device, and an expected operating time of one partner device.
[0012] While generally applicable, in certain implementations of the first aspect that may be particularly applicable in relation to any other implementation of the first aspect, the wireless connectivity parameter set includes conditions under which one partner device will be removed from the white list managed for the analyte sensor system. In an embodiment, the analyte sensor system setting or causing a modification of the configuration parameter set according to the system requirements of one partner device includes the analyte sensor system setting conditions such that one partner device will be excluded from the white list when the battery level of one partner delivery device meets a threshold.
[0013] While generally applicable, in certain implementations of the first aspect that may be particularly applicable in relation to any other implementation of the first aspect, the wireless connectivity parameter set includes an advertisement structure. In an embodiment, the analyte sensor system setting or causing a modification of the configuration parameter set according to the system requirements of one partner device includes the analyte sensor system setting or modifying the advertisement structure using a diabetes management partner interface.
[0014] While generally applicable, in certain implementations of the first aspect that may be particularly applicable in relation to any other implementation of the first aspect, the access control parameter set includes one or more of the number of display devices to which the analyte sensor system may connect and the level of access or control that the analyte sensor system may provide to one or more of the display devices.
[0015] In certain implementations of the first aspect, which may be generally applicable but are particularly applicable in connection with any other implementation of the first aspect, the analyte data parameter set includes a calibration period of the analyte sensor system. In an embodiment, the analyte sensor system setting or causing a modification of the configuration parameter set according to the system requirements of one partner device includes the analyte sensor system setting or modifying the calibration period using a diabetes management partner interface.
[0016] In certain implementations of the first aspect, which may be generally applicable but are particularly applicable in connection with any other implementation of the first aspect, the analyte data parameter set includes a factory calibration code. In an embodiment, the analyte sensor system receives an indication to use the factory calibration code from one partner device according to the system requirements of the one partner device using a diabetes management partner interface. The analyte sensor system setting or causing a modification of the configuration parameter set according to the system requirements of one partner device may include the analyte sensor system setting or modifying the calibration period to zero or none using a diabetes management partner interface.
[0017] In a particular implementation of the first aspect that may be generally applicable but is particularly applicable in the context of any other implementation of the first aspect, the wireless connectivity parameter set includes settings of a remote server. The analyte sensor system may be configured to set or cause a modification of a configuration parameter set according to the system requirements of one partner device, including configuring the analyte sensor to perform several operations using a diabetes management partner interface. Such operations may include using services provided via a remote server. Such operations may include transmitting diabetes management feedback to one or more display devices connected to the analyte sensor system in response to services provided via the remote server. Such operations may include disabling the use of the service and transmitting a relevant notification to the display device connected to the analyte sensor system when the service provided via the remote server becomes unavailable.
[0018] In a particular implementation of the first aspect that may be generally applicable but is particularly applicable in the context of any other implementation of the first aspect, the analyte date parameter set includes bolus calculation parameters. In an embodiment, the analyte sensor system may be configured to set or cause a modification of a configuration parameter set according to the system requirements of one partner device, including providing the one partner device with access to bolus calculation parameters using a diabetes management partner interface. In an embodiment, the method also includes the analyte sensor system providing a bolus recommendation based on calculations performed using the bolus calculation parameters.
[0019] A second aspect of the disclosure includes an analyte sensor system for wireless communication with a plurality of partner devices. The analyte sensor system is configurable by use of a diabetes management partner interface. The analyte sensor system includes an analyte sensor used to generate analyte information. The analyte sensor system includes a transceiver adapted to transmit and receive wireless signals. Further, the analyte sensor system includes a memory storing a set of configuration parameters used by the transceiver to transmit and receive wireless signals. The analyte sensor system also includes circuitry operably coupled to the transceiver and the memory and adapted to cause the analyte sensor system to perform several operations. Such operations include receiving, via the diabetes management partner interface, permission to provide access to the set of configuration parameters to one of the partner devices. Such operations include setting or causing a modification of the set of configuration parameters in accordance with the system requirements of the partner device in response to an input received from one partner device via the diabetes management partner interface.
[0020] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, one of the partner devices is an automated insulin delivery device or a manual insulin delivery device.
[0021] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, the set of configuration parameters includes one or more of a wireless connectivity parameter set, an access control parameter set, and an analyte data parameter set.
[0022] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, the system requirements are associated with one of the battery capacity of a partner device, the accuracy requirements of a partner device, the communication protocol used by a partner device, the regulatory requirements applicable to a partner device, and the expected operating time of a partner device.
[0023] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, the wireless connectivity parameter set includes conditions under which a partner device will be removed from the whitelist that a partner device manages for the analyte sensor system. In an embodiment, the circuit is further adapted to cause the analyte sensor system to set conditions such that a partner device will be removed from the whitelist when the battery level of a partner delivery device meets a threshold, according to the system requirements of the partner device.
[0024] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, the wireless connectivity parameter set includes an advertisement structure. In an embodiment, the circuit is further adapted to cause the analyte sensor system to set or modify the advertisement structure using the diabetes management partner interface.
[0025] In a particular implementation of the second aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the second aspect, the access control parameter set includes one or more of the number of display devices to which the analyte sensor system can connect and the level of access or control that the analyte sensor system can provide to one or more of the display devices.
[0026] While it may be generally applicable, in a particular implementation of the second aspect that is also particularly applicable in relation to any other implementation of the second aspect, the analyte data parameter set includes the calibration period of the analyte sensor system. In an embodiment, the circuit is further adapted to cause the analyte sensor system to set or modify the calibration period using the diabetes management partner interface.
[0027] While it may be generally applicable, in a particular implementation of the second aspect that is also particularly applicable in relation to any other implementation of the second aspect, the analyte data parameter set includes the factory calibration code. In an embodiment, the circuit is further adapted to cause the analyte sensor system to receive a display using the factory calibration code from one partner device according to the system requirements of one partner device using the diabetes management partner interface. In an embodiment, the circuit is further adapted to cause the analyte sensor system to set or modify the calibration period to zero or none using the diabetes management partner interface.
[0028] While it may be generally applicable, in a particular implementation of the second aspect that is also particularly applicable in relation to any other implementation of the second aspect, the wireless connectivity parameter set includes the settings of the remote server. In an embodiment, the circuit is further adapted to cause the analyte sensor system to perform additional operations using the diabetes management partner interface. One such operation is to use the services provided via the remote server. One such operation is to transmit diabetes management feedback to one or more display devices connected to the analyte sensor system in response to the services provided via the remote server. One such operation is, when the services provided via the remote server become unavailable, to disable the use of the services and send a relevant notification to the display devices connected to the analyte sensor system.
[0029] While it may be generally applicable, in a particular implementation of the second aspect which may also be particularly applicable in relation to any other implementation of the second aspect, the analyte date parameter set includes bolus calculation parameters. In an embodiment, the circuitry further adapts the analyte sensor system to cause the analyte sensor system to provide access to the bolus calculation parameters to one partner device in accordance with the system requirements of the partner device using a diabetes management partner interface. In an embodiment, the method is further adapted to cause the analyte sensor system to provide a bolus recommendation based on a calculation performed using the bolus calculation parameters.
[0030] A third aspect of the present disclosure includes a system. The system includes one or more partner devices adapted to deliver insulin to a user. The system includes an analyte sensor system adapted to generate analyte information. The analyte sensor system includes a set of configuration parameters used to transmit and receive wireless signals. The configuration parameters are configurable by use of a diabetes management partner interface. The system also includes a display device connectable to the analyte sensor system and adapted to display the analyte information and to provide permission for the analyte sensor system to provide access to the set of configuration parameters to one of the partner devices via the diabetes management partner interface. One partner device is adapted to set or cause a modification of the set of configuration parameters in accordance with the system requirements of the partner device using the diabetes management partner interface.
[0031] While it may be generally applicable, in a particular implementation of the third aspect which may also be particularly applicable in relation to any other implementation of the third aspect, one partner device is an automated insulin delivery device or a manual insulin delivery device.
[0032] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the third aspect, the configuration parameter set includes one or more of a wireless connectivity parameter set, an access control parameter set, and an analyte data parameter set.
[0033] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the third aspect, the system requirements are associated with one of the battery capacity of one partner device, the accuracy requirements of one partner device, the communication protocol used by one partner device, the regulatory requirements applicable to one partner device, and the expected operating time of one partner device.
[0034] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the third aspect, the wireless connectivity parameter set includes conditions under which one partner device will be removed from the whitelist managed for the analyte sensor system. In an embodiment, one partner device is further adapted to set or modify the conditions such that one partner device will be removed from the whitelist when the battery level of one partner delivery device meets a threshold, depending on the system requirements of one partner device.
[0035] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the third aspect, the wireless connectivity parameter set includes an advertisement structure. In an embodiment, one partner device is further adapted to set or modify the advertisement structure using a diabetes management partner interface.
[0036] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the third aspect, the access control parameter set includes one or more of the number of display devices to which the analyte sensor system may be connected and the level of access or control that the analyte sensor system may provide to one or more of the display devices.
[0037] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the third aspect, the analyte data parameter set includes the calibration period of the analyte sensor system. In an embodiment, one partner device is further adapted to set or modify the calibration period using the diabetes management partner interface.
[0038] In a particular implementation of the third aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the third aspect, the analyte data parameter set includes the factory calibration code. In an embodiment, one partner device is further adapted to use the diabetes management partner interface to provide the analyte sensor system with a display using the factory calibration code according to the system requirements of one partner device and to set or modify the calibration period to zero or none.
[0039] While it may be generally applicable, in a particular implementation of the third aspect that is also particularly applicable in relation to any other implementation of the third aspect, the wireless connectivity parameter set includes the configuration of the remote server. In an embodiment, one partner device is further adapted to use the diabetes management partner interface to configure the analyte sensor to perform several operations. One partner device is further adapted to use the services provided via the remote server. One partner device is further adapted to transmit diabetes management feedback to a display device connectable to the analyte sensor system in response to the services provided via the remote server. One partner device is further adapted to disable the use of the service and send a related notification to a display device connectable to the analyte sensor system if the services provided via the remote server become unavailable.
[0040] While it may be generally applicable, in a particular implementation of the third aspect that is also particularly applicable in relation to any other implementation of the third aspect, the analyte date parameter set includes bolus calculation parameters. In an embodiment, one partner device is further adapted to use the diabetes management partner interface to configure the analyte sensor system to provide access to the bolus calculation parameters to one partner device according to the system requirements of the one partner device. In an embodiment, one partner device is further adapted to use the diabetes management partner interface to receive a bolus recommendation from the analyte sensor system based on calculations performed using the bolus calculation parameters.
[0041] A fourth aspect of the present disclosure includes a method of configuring wireless communication between an analyte sensor system and one or more of a display device and a partner device using a diabetes management partner interface. The method includes enabling, by the analyte sensor system, a first wireless signal communication path. The first wireless communication signal path is between the analyte sensor system and the display device. With respect to the first wireless communication path, the analyte sensor system provides to the display device a first degree of access or control with respect to the analyte sensor system. The method also includes enabling, by the analyte sensor system, a second wireless signal communication path. The second wireless signal communication path is between the analyte sensor system and the partner device. Enabling, by the analyte sensor system, the second wireless signal communication path includes causing a modification of the first degree of access or control to implement a second degree of access or control according to the system requirements of the partner device. The modification is caused in response to an input received from the partner device via the diabetes management partner interface.
[0042] In a particular implementation of the fourth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fourth aspect, causing a modification of the first degree of access or control includes setting or changing a set of configuration parameters implemented by the analyte sensor system according to the system requirements of the partner device using the diabetes management partner interface.
[0043] In a particular implementation of the fourth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fourth aspect, the set of configuration parameters includes one or more of access control parameters of the display device or the partner device, accuracy or calibration parameters of the analyte sensor system, and wireless communication parameters of communication exchanged between the analyte sensor system and one or more of the display device and the partner device.
[0044] In a particular implementation of the fourth aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the fourth aspect, setting or changing a set of configuration parameters using the diabetes management partner interface includes granting the partner device permission to configure the accuracy or calibration parameters of the analyte sensor system via the diabetes management partner interface.
[0045] In a particular implementation of the fourth aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the fourth aspect, setting or changing a set of configuration parameters using the diabetes management partner interface includes revoking from the display device permission to configure the accuracy or calibration parameters of the analyte sensor system via the diabetes management partner interface.
[0046] In a particular implementation of the fourth aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the fourth aspect, the access control parameters include a white list of devices connectable to the analyte sensor system. The method also includes setting or modifying the amount of time that a partner device will remain on the white list before being removed from the white list when setting or changing a set of configuration parameters using the interface of the diabetes management partner.
[0047] A fifth aspect of the present disclosure includes an analyte sensor system for wireless communication with one or more of a display device and a partner device. The analyte sensor system is configurable by use of a diabetes management partner interface. The analyte sensor system includes a memory that stores a set of configuration parameters used by a transceiver for transmitting and receiving wireless signals. The analyte sensor system also includes circuitry operably coupled to the transceiver and the memory and adapted to cause the analyte sensor system to perform several operations. One such operation is enabling a first wireless signal communication path. The first wireless communication signal path is between the analyte sensor system and the display device. For the first wireless communication path, the analyte sensor system provides a first degree of access or control to the analyte sensor system to the display device. Another such operation is enabling a second wireless signal communication path. The second wireless signal communication path is between the analyte sensor system and the partner device. The second wireless signal communication path is enabled by a modification of the first degree of access or control performed by the analyte sensor system. In response to an input received from the partner device via the diabetes management partner interface, the modification of the first degree of access or control is performed. The modification of the first degree of access or control is performed to implement a second degree of access or control according to the system requirements of the partner device.
[0048] In a particular implementation of the fifth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the fifth aspect, to perform the modification of the first degree of access or control, the circuitry is further adapted to cause the analyte sensor system to use the diabetes management partner interface to set or change a set of configuration parameters implemented by the analyte sensor system according to the system requirements of the partner device.
[0049] In a particular implementation of the fifth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fifth aspect, the configuration parameter set includes one or more of access control parameters of the display device or partner device, accuracy or calibration parameters of the analyte sensor system, and wireless communication parameters of communication exchanged between the analyte sensor system and one or more of the display device and partner device.
[0050] In a particular implementation of the fifth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fifth aspect, the circuit is further adapted to cause the analyte sensor system to grant the partner device permission to configure the accuracy or calibration parameters of the analyte sensor system via the diabetes management partner interface.
[0051] In a particular implementation of the fifth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fifth aspect, the circuit is further adapted to cause the analyte sensor system to revoke permission from the display device to configure the accuracy or calibration parameters of the analyte sensor.
[0052] In a particular implementation of the fifth aspect, which may be generally applicable but is particularly applicable in relation to any other implementation of the fifth aspect, the access control parameter includes a white list of devices connectable to the analyte sensor system. In an embodiment, the circuit is further adapted to set or change the time that the partner device will remain on the white list before being removed from the white list.
[0053] A sixth aspect of the present disclosure includes a method of controlling wireless communication between an analyte sensor system and one or more remote devices connectable to the analyte sensor system using a diabetes management partner interface of the analyte sensor system. The one or more remote devices include a display device and a partner device. The method includes the analyte sensor system determining whether a connection request received from one of the remote devices was originated from a partner class within the one or more remote devices. Remote devices within the partner class are adapted to provide a medicament. The partner class includes partner devices. The method includes, when the connection request was originated from the partner class, enabling the diabetes management partner interface to select an operating mode corresponding to the partner class. The operating mode uses a set of configuration parameters of the partner class to support system requirements of the partner device.
[0054] In a particular implementation of the sixth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the sixth aspect, the method includes exchanging wireless communication with at least one of the remote devices using an operating mode corresponding to the partner class.
[0055] In a particular implementation of the sixth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the sixth aspect, exchanging wireless communication using an operating mode corresponding to the partner class includes transmitting a mode indicator usable by at least one of the remote devices to determine the operating mode being used.
[0056] In a particular implementation of the sixth aspect, which may be generally applicable but is particularly applicable in connection with any other implementation of the sixth aspect, the configuration parameter set includes one or more of access control parameters of a display device or a partner device, accuracy or calibration parameters of an analyte sensor system, and wireless communication parameters of communication exchanged between one or more of the analyte sensor system and a remote device.
[0057] In a particular implementation of the sixth aspect, which is generally applicable but is particularly applicable in connection with any other implementation of the sixth aspect, the mode indicator is operable by the analyte sensor system to deactivate access by a set of remote devices not within the partner class to one or more of the access control parameters, accuracy or calibration parameters, and wireless communication parameters, using the diabetes management partner interface. In an embodiment, access by a set of remote devices to one of the access control parameters, accuracy or calibration parameters, and wireless communication parameters is activated when the analyte sensor system uses an operating mode corresponding to the set of remote devices.
[0058] In a particular implementation of the sixth aspect, which is generally applicable but is particularly applicable in connection with any other implementation of the sixth aspect, the method also includes the analyte sensor system determining that it has not received wireless communication from the partner device for at least a predetermined amount of time. The method also includes, in response to the determination and further in response to receiving a connection request from one of the remote devices within the set of remote devices not within the partner class, the analyte sensor system selecting an operating mode corresponding to the set of remote devices not within the partner class. The operating mode corresponding to the set of remote devices not within the partner class follows a set of configuration parameters specific to the set of remote devices not within the partner class. In an embodiment, the method also includes removing the partner device from a whitelist.
[0059] While generally applicable, in a particular implementation of the sixth aspect, which is also particularly applicable in relation to any other implementation of the sixth aspect, the method includes the analyte sensor system receiving, using the diabetes management partner interface, a value of one of the configuration parameters from a partner device. The method also includes the analyte sensor system modifying one of the configuration parameters using the value received from the partner device.
[0060] While generally applicable, in a particular implementation of the sixth aspect, which is also particularly applicable in relation to any other implementation of the sixth aspect, the method includes the analyte sensor system transmitting a value of a configuration parameter to a display device. The value includes one or more of a specified time after which a partner device is to be removed from a whitelist managed for the analyte sensor system and a specified time after which the display device is to be removed from the whitelist.
[0061] While generally applicable, in a particular implementation of the sixth aspect, which is also particularly applicable in relation to any other implementation of the sixth aspect, exchanging wireless communication using an operation mode corresponding to a partner device includes, for the analyte sensor system, modifying a whitelist managed therefor and transmitting an advertisement message directed only to the partner device, and one or more of switching off slots of devices other than the partner device.
[0062] While generally applicable, in a particular implementation of the sixth aspect, which is also particularly applicable in relation to any other implementation of the sixth aspect, the method includes the analyte sensor system selecting an operation mode corresponding to a set of remote devices not within a partner class if the connection request is not originated from within the partner class. The operation mode corresponding to the set of remote devices not within the partner class uses a set of configuration parameters specific to the set of remote devices not within the partner class.
[0063] In a particular implementation of the sixth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the sixth aspect, the display device is within a set of remote devices that are not within the partner class. In an embodiment, the method further includes using a diabetes management partner interface to provide the display device with access to a set of configuration parameters specific to the set of remote devices that are not within the partner class. The method may further include the analyte sensor system setting or modifying a value of one of the configuration parameters specific to the set of remote devices that are not within the partner class in response to an input received from the display device.
[0064] In a particular implementation of the sixth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the sixth aspect, modifying an advertisement slot to advertise using an operating mode corresponding to the partner class only to the partner device or partner device controller includes exchanging wireless communication.
[0065] In a particular implementation of the sixth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the sixth aspect, in response to a command received via the diabetes management partner interface, the analyte sensor system accepting only connection requests received from the partner device includes exchanging wireless communication using an operating mode corresponding to the partner class. The command may be received from the partner device.
[0066] A seventh aspect of the present disclosure includes an analyte sensor system that controls wireless communication between an analyte sensor system and one or more remote devices connectable to the analyte sensor system using a diabetes management partner interface. The one or more remote devices include a display device and a partner device. The analyte sensor system includes circuitry operably coupled to a memory storing instructions that, when executed, cause the analyte sensor system to perform several operations. One such operation is for the analyte sensor system to determine whether a connection request received from one of the remote devices was originated from a partner class within the one or more remote devices. Remote devices within the partner class are adapted to provide a medicament. The partner class includes partner devices. Another such operation is, when the connection request was originated from the partner class, to enable selection of an operation mode corresponding to the partner class using the diabetes management partner interface. The operation mode uses a set of configuration parameters of the partner class to support the system requirements of the partner device.
[0067] In a particular implementation of the seventh aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to exchange the wireless communication with at least one of the remote devices using the operation mode corresponding to the partner class.
[0068] In a particular implementation of the seventh aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the seventh aspect, the wireless communication exchanged using the operation mode corresponding to the partner class includes a mode indicator transmitted by the analyte sensor system to at least one remote device. The mode indicator can be used by at least one of the remote devices to determine the operation mode being used.
[0069] In a particular implementation of the seventh aspect, which may be generally applicable but is particularly applicable in the context of any other implementation of the seventh aspect, a set of configuration parameters used to support the system requirements of a partner device includes one or more of access control parameters of the display device or partner device, accuracy or calibration parameters of the analyte sensor system, and wireless communication parameters of the communication exchanged between the analyte sensor system and one or more of the remote devices.
[0070] In a particular implementation of the seventh aspect, which is generally applicable but is particularly applicable in the context of any other implementation of the seventh aspect, a mode indicator is operable by an analyte sensor system to deactivate access by a set of remote devices not within a partner class to one or more of access control parameters, accuracy or calibration parameters, and wireless communication parameters, using a diabetes management partner interface. In an embodiment, the memory further stores instructions that, when executed, cause the analyte sensor system to provide access by a set of remote devices to one or more of access control parameters, accuracy or calibration parameters, and wireless communication parameters when the analyte sensor system uses an operating mode corresponding to the set of remote devices.
[0071] While generally applicable, in a particular implementation of the seventh aspect, which is also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is for the analyte sensor system to determine that it has not received wireless communication from the partner device for at least a predetermined amount of time. Another such operation, in response to this determination and further in response to a connection request received from one of the remote devices within a set of remote devices that are not within the partner class, is to select an operating mode corresponding to the set of remote devices that are not within the partner class. The operating mode corresponding to the set of remote devices that are not within the partner class follows a set of configuration parameters that are specific to the set of remote devices that are not within the partner class.
[0072] While generally applicable, in a particular implementation of the seventh aspect, which is also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to remove partner devices from the whitelist.
[0073] While generally applicable, in a particular implementation of the seventh aspect, which is also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is to receive a value of one of the configuration parameters from the partner device using the diabetes management partner interface. Another such operation is to modify one of the configuration parameters using the value received from the partner device.
[0074] In a particular implementation of the seventh aspect, which is generally applicable but particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to send the values of the configuration parameters to the display device. The values include one or more of the specified time after which the partner device will be removed from the whitelist managed for the analyte sensor system, and the specified time after which the display device will be removed from the whitelist.
[0075] In a particular implementation of the seventh aspect, which is generally applicable but particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is to modify the whitelist managed for the analyte sensor system to turn off the slots of devices other than the partner device. Another such operation is to transmit an advertisement message directed only to the partner device.
[0076] In a particular implementation of the seventh aspect, which is generally applicable but particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to select an operating mode corresponding to a set of remote devices not within the partner class if the connection request is not originated from within the partner class, and the operating mode corresponding to the set of remote devices not within the partner class uses a set of configuration parameters specific to the set of remote devices not within the partner class.
[0077] While generally applicable, in a particular implementation of the seventh aspect that is also particularly applicable in relation to any other implementation of the seventh aspect, the display device is in a set of remote devices not in the partner class, and the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is to use the diabetes management partner interface to provide the display device with access to a set of configuration parameters specific to the set of remote devices not in the partner class. Another such operation is to set or modify the value of one of the configuration parameters specific to the set of remote devices not in the partner class in response to an input received from the display device.
[0078] While generally applicable, in a particular implementation of the seventh aspect that is also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to modify the advertisement slot to advertise only to the partner device or partner device controller.
[0079] While generally applicable, in a particular implementation of the seventh aspect that is also particularly applicable in relation to any other implementation of the seventh aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to accept only connection requests received from the partner device in response to a command received via the diabetes management partner interface. The command may be received from the partner device.
[0080] The eighth aspect of the present disclosure includes a method that enables the configurability of an analyte sensor system to wirelessly communicate with one or more of a partner device and a display device using a diabetes management interface. The method includes the analyte sensor system determining that a first connection request has been sent from a remote device in a first class of remote devices. The method includes the analyte sensor system determining that a second connection request has been sent from a remote device in a second class of remote devices. The remote devices among the second class of remote devices are adapted to deliver a drug. The remote devices among the first class of remote devices do not belong to the second class of remote devices. The method includes the analyte sensor system using any one of a plurality of operating modes. The first operating mode among the plurality is specific to a first configuration that utilizes remote devices in the second class of remote devices and does not utilize remote devices in the first class of remote devices. The second operating mode among the plurality is specific to a second configuration that does not utilize devices from the second class of remote devices. The third operating mode among the plurality is specific to a third configuration that utilizes remote devices in the first class of remote devices and remote devices from the second class of remote devices.
[0081] In a particular implementation of the eighth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the eighth aspect, using the first operating mode among the plurality includes providing the remote devices in the second class of remote devices with the authority to modify permissions provided to the remote devices in the first class of remote devices using a diabetes management partner interface.
[0082] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, using the first of a plurality of operating modes further includes the analyte sensor system receiving, from a remote device in a first class of remote devices, permission for a remote device in a second class of remote devices to communicate with the analyte sensor system.
[0083] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, using the first of a plurality of operating modes further includes the analyte sensor system blocking a connection with a device other than the remote device in the second class of remote devices in response to an input received from the remote device in the second class of remote devices via a diabetes management partner device.
[0084] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, blocking the connection includes advertising to a remote device in the second class of remote devices using a first advertising slot. Blocking the connection also includes advertising to either the remote device in the second class of remote devices or a controller of the remote device in the second class of remote devices using a second advertising slot.
[0085] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, blocking the connection includes the analyte sensor system setting or causing a modification of an advertising structure to include a dedicated single advertising period to a remote device in the second class of devices using a diabetes management partner interface.
[0086] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, blocking a connection includes the analyte sensor system accepting connection requests only from remote devices in a second class of remote devices.
[0087] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, using a first operating mode among a plurality includes the analyte sensor system further modifying a timeout rule associated with a remote device in a second class of remote devices using an input received from the remote device in the second class of remote devices via a diabetes management interface.
[0088] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, using a second operating mode among a plurality includes one or more of the actions of modifying a whitelist to exclude a remote device in a second class of remote devices, rejecting a connection request received from a remote device in a second class of remote devices, and exclusively advertising to a remote device in a first class of remote devices.
[0089] While generally applicable, in a particular implementation of the eighth aspect that is also particularly applicable in relation to any other implementation of the eighth aspect, using a third operating mode among a plurality includes the analyte sensor system receiving, from a remote device in a second class of remote devices, a display of an access level to the analyte sensor system that is to be provided to a remote device in a first class of remote devices via a diabetes management interface.
[0090] In a particular implementation of the eighth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the eighth aspect, the method includes the analyte sensor system implementing an access level using a diabetes management interface. The method also includes notifying the access level to a remote device in a first class of remote devices.
[0091] In a particular implementation of the eighth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the eighth aspect, depending on the access level, a remote device in a first class of remote devices can receive analyte data from the analyte sensor system, but cannot access the accuracy or calibration parameters used by the analyte sensor system for a third mode of operation.
[0092] A ninth aspect of the present disclosure includes an analyte sensor system that exchanges wireless communications with one or more of a partner device and a display device. The analyte sensor system is configurable by a diabetes management partner interface. The analyte sensor system includes circuitry operably coupled to a memory storing instructions that, when executed, cause the analyte sensor system to perform several operations. One such operation is to determine that a first connection request has been sent from a remote device in a first class of remote devices. Another such operation is to determine that a second connection request has been sent from a remote device in a second class of remote devices. The remote devices among the second class of remote devices are adapted to deliver a drug. The remote devices among the first class of remote devices do not belong to the second class of remote devices. Another such operation is to use any one of a plurality of operating modes. A first operating mode among the plurality is specific to a first configuration that utilizes remote devices in a second class of remote devices and does not utilize remote devices in a first class of remote devices. A second operating mode among the plurality is specific to a second configuration that does not utilize devices from a second class of remote devices. A third operating mode among the plurality is specific to a third configuration that utilizes remote devices in a first class of remote devices and remote devices from a second class of remote devices.
[0093] In a particular implementation of the ninth aspect, which is generally applicable but also particularly applicable in the context of any other implementation of the ninth aspect, the memory stores instructions that, when executed, cause the analyte sensor system, in a first operating mode among the plurality, to provide a remote device in a second class of remote devices with the authority to modify a permission provided to a remote device in a first class of remote devices using the diabetes management partner interface.
[0094] While generally applicable, in a particular implementation of the ninth aspect, which is also particularly applicable in relation to any other implementation of the ninth aspect, when the memory is executed, it causes the analyte sensor system to receive, in a first operating mode of a plurality, permission from a remote device in a first class of remote devices for a remote device in a second class of remote devices to communicate with the analyte sensor system. The memory further stores an instruction to cause this.
[0095] While generally applicable, in a particular implementation of the ninth aspect, which is also particularly applicable in relation to any other implementation of the ninth aspect, when the memory is executed, it causes the analyte sensor system to block a connection with a device other than a remote device in a second class of remote devices in response to an input received from a remote device in a second class of remote devices via a diabetes management partner device in a first operating mode of a plurality. The memory further stores an instruction to cause this.
[0096] While generally applicable, in a particular implementation of the ninth aspect, which is also particularly applicable in relation to any other implementation of the ninth aspect, when the memory is executed, it stores an instruction to cause the analyte sensor system to advertise to a remote device in a second class of remote devices using a first advertisement slot and to advertise to a remote device in a second class of remote devices or a controller for a remote device in a second class of remote devices using a second advertisement slot.
[0097] While generally applicable, in a particular implementation of the ninth aspect, which is also particularly applicable in relation to any other implementation of the ninth aspect, when the memory is executed, it further stores an instruction to cause the analyte sensor system to set or cause a modification of an advertisement structure to include a dedicated single advertisement period for a remote device in a second class of devices using a diabetes management partner interface.
[0098] In a particular implementation of the ninth aspect, which is generally applicable but also particularly applicable in connection with any other implementation of the ninth aspect, when the memory is executed, it further stores instructions that cause the analyte sensor system to accept connection requests only from remote devices in a second class of remote devices.
[0099] In a particular implementation of the ninth aspect, which is generally applicable but also particularly applicable in connection with any other implementation of the ninth aspect, when the memory is executed, it further stores instructions that cause the analyte sensor system to use inputs received from a remote device in a second class of remote devices via a diabetes management interface in a first of a plurality of operating modes to modify a timeout rule associated with the remote device in the second class of remote devices.
[0100] In a particular implementation of the ninth aspect, which is generally applicable but also particularly applicable in connection with any other implementation of the ninth aspect, when the memory is executed, it further stores instructions that cause the analyte sensor system to perform additional operations in a second of a plurality of operating modes. One such operation is to modify a whitelist to exclude a remote device in a second class of remote devices. Another such operation is to reject connection requests received from a remote device in a second class of remote devices. Another such operation is to exclusively advertise to a remote device in a first class of remote devices.
[0101] In a particular implementation of the ninth aspect, which is generally applicable but particularly applicable in relation to any other implementation of the ninth aspect, when executed, the memory causes the analyte sensor system to receive a display of an access level for the analyte sensor system that is to be provided from a remote device in a first class of remote devices to a remote device in a second class of remote devices via a diabetes management interface in a third of a plurality of operating modes.
[0102] In a particular implementation of the ninth aspect, which is generally applicable but particularly applicable in relation to any other implementation of the ninth aspect, when executed, the memory further stores instructions that cause the analyte sensor system to implement an access level using the diabetes management interface and notify a remote device in a first class of remote devices of the access level.
[0103] In a particular implementation of the ninth aspect, which is generally applicable but particularly applicable in relation to any other implementation of the ninth aspect, depending on the access level, a remote device in a first class of remote devices can receive analyte data from the analyte sensor system but cannot access the accuracy or calibration parameters used by the analyte sensor system for a third operating mode.
[0104] A tenth aspect of the present disclosure includes a method for facilitating wireless communication exchange with an analyte sensor system using a diabetes management interface. The method includes establishing a first connection between the analyte sensor system and a first partner device using a diabetes management partner interface. The method includes the analyte sensor system providing the first partner device with access to a configuration parameter set via the diabetes management interface. The method further includes setting or causing a first modification of the configuration parameter set in response to an input received from the first partner device via the diabetes management partner interface. Setting or causing the first modification is performed in accordance with the system requirements of the first partner device. Additionally, the method includes establishing a second connection between the analyte sensor system and a second partner device using the diabetes management partner interface. The method also includes the analyte sensor system providing the second partner device with access to the configuration parameter set via the diabetes management interface. The method further includes causing a second modification of the configuration parameter set in response to an input received from the second partner device via the diabetes management partner interface. The second modification is performed in accordance with the system requirements of the second partner device.
[0105] In a particular implementation of the tenth aspect, which is generally applicable but particularly applicable in relation to any other implementation of the tenth aspect, establishing the second connection using the diabetes management partner interface is performed after the first connection has ended.
[0106] In a particular implementation of the tenth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the tenth aspect, the method attempts to establish a third connection between the analyte sensor system and a third partner device using a diabetes management partner interface in response to the analyte sensor system receiving identification information for the third partner device. The method also includes causing a third modification of a set of configuration parameters in response to the establishment of the third connection between the analyte sensor system and the third partner device and in response to an input received via the diabetes management partner interface. The third modification is made in accordance with the system requirements of the third partner device.
[0107] In a particular implementation of the tenth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the tenth aspect, identification information for the third partner device is stored in a server system. In an embodiment, the identification information indicates whether the third partner device has permission to communicate with the analyte sensor system.
[0108] In a particular implementation of the tenth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the tenth aspect, the analyte sensor system receiving identification information for the third partner device includes the analyte sensor system receiving identification information for the third partner device from a display device that received the identification information for the third partner device from the server system.
[0109] While generally applicable, in a particular implementation of the tenth aspect that is also particularly applicable in relation to any other implementation of the tenth aspect, this method includes additional operations. One such operation involves using the identification information for a third partner device to determine whether the third partner device has the authority to communicate with the analyte sensor system in response to the analyte sensor system receiving the identification information for the third partner device. Another such operation involves canceling an attempt to establish a third connection between the analyte sensor system and the third partner device in response to determining that the third partner device does not have the authority to communicate with the analyte sensor system. Another such operation involves establishing a third connection between the analyte sensor system and the third partner device using the diabetes management partner interface in response to determining that the third partner device has the authority to communicate with the analyte sensor system.
[0110] While generally applicable, in a particular implementation of the tenth aspect that is also particularly applicable in relation to any other implementation of the tenth aspect, determining that the third partner device does not have the authority to communicate with the analyte sensor system is done at a first time. In an embodiment, determining that the third partner device has the authority to communicate with the analyte sensor system is done at a second time. The identification information for the third partner device can be updated in the server system between the first time and the second time.
[0111] While generally applicable, in a particular implementation of the tenth aspect that is also particularly applicable in relation to any other implementation of the tenth aspect, the system requirements of the third partner device are stored in the server system. This method further includes causing a fourth modification to the set of configuration parameters in response to an input received via the diabetes management partner interface. The fourth modification is made in response to an updated version of the system requirements of the third partner device.
[0112] A tenth aspect of the present disclosure includes an analyte sensor system that facilitates wireless communication exchange using a diabetes management interface. The analyte sensor system includes circuitry operatively coupled to a memory storing instructions that, when executed, cause the analyte sensor system to perform several operations. One such operation includes establishing a first connection between the analyte sensor system and a first partner device using a diabetes management partner interface. Another such operation is providing access to a configuration parameter set to the first partner device via the diabetes management interface. Another such operation is setting or causing a first modification of the configuration parameter set in response to an input received from the first partner device via the diabetes management partner interface. The first modification is made according to the system requirements of the first partner device. Another such operation is establishing a second connection between the analyte sensor system and a second partner device using the diabetes management partner interface. Another such operation is providing access to the configuration parameter set to the second partner device via the diabetes management interface. Yet another such operation is causing a second modification of the configuration parameter set in response to an input received from the second partner device via the diabetes management partner interface. The second modification is made according to the system requirements of the second partner device.
[0113] In a particular implementation of the eleventh aspect, which is generally applicable but also particularly applicable in connection with any other implementation of the eleventh aspect, the second connection is established after the first connection has ended.
[0114] While generally applicable, in a particular implementation of the 11th aspect, which is also particularly applicable in relation to any other implementation of the 11th aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is to receive identification information for a third partner device. Another such operation is to attempt to establish a third connection between the analyte sensor system and the third partner device using the diabetes management partner interface in response to the receipt of the identification information for the third partner device. Another such operation is to cause a third modification of the configuration parameter set in response to an input received via the diabetes management partner interface in response to the establishment of the third connection between the analyte sensor system and the third partner device. The third modification is made according to the system requirements of the third partner device.
[0115] While generally applicable, in a particular implementation of the 11th aspect, which is also particularly applicable in relation to any other implementation of the 11th aspect, the identification information for the third partner device is stored in the server system. The identification information indicates whether the third partner device has the right to communicate with the analyte sensor system.
[0116] While generally applicable, in a particular implementation of the 11th aspect, which is also particularly applicable in relation to any other implementation of the 11th aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to receive the identification information for the third partner device from a display device that has received the identification information for the third partner device.
[0117] While generally applicable, in a particular implementation of the 11th aspect that is also particularly applicable in relation to any other implementation of the 11th aspect, the memory further stores instructions that, when executed, cause the analyte sensor system to perform additional operations. One such operation is to use the identification information for the third partner device to determine whether the third partner device has the right to communicate with the analyte sensor system in response to the receipt of the identification information for the third partner device. Another such operation is to cancel the attempt to establish a third connection between the analyte sensor system and the third partner device in response to determining that the third partner device does not have the right to communicate with the analyte sensor system. Another such operation is to establish a third connection between the analyte sensor system and the third partner device using the diabetes management partner interface in response to determining that the third partner device has the right to communicate with the analyte sensor system.
[0118] While generally applicable, in a particular implementation of the 11th aspect that is also particularly applicable in relation to any other implementation of the 11th aspect, the determination that the third partner device does not have the right to communicate with the analyte sensor system is made at a first time. In an embodiment, the determination that the third partner device has the right to communicate with the analyte sensor system is made at a second time. In an embodiment, the identification information for the third partner device is updated in the server system between the first time and the second time.
[0119] While generally applicable, in a particular implementation of the 11th aspect that is also particularly applicable in relation to any other implementation of the 11th aspect, the system requirements of the third partner device are stored in the server system. The memory, when executed, causes the analyte sensor system to cause a fourth modification to the set of configuration parameters in response to an input received via the diabetes management partner interface. The fourth modification is made in response to an updated version of the system requirements of the third partner device.
[0120] A twelfth aspect of the present disclosure includes a method. The method includes the analyte sensor system receiving a display for entering an operating mode specific to the use of the partner device. The method further includes establishing a connection between the analyte sensor system and the partner device. The method also includes the analyte sensor system setting or modifying configuration parameters in response to input received from the partner device via a diabetes management partner interface. The input received from the partner device indicates corresponding operating parameters used by the partner device to communicate with the analyte sensor system using the operating mode. The configuration parameters are configured according to the system requirements of the partner device. The method also includes implementing an operating mode specific to the use of the partner device using the operating parameters of the analyte sensor system to conform to the system requirements of the partner device.
[0121] In a particular implementation of the twelfth aspect, which is generally applicable but particularly applicable in connection with any other implementation of the twelfth aspect, the configuration parameters include permission parameters for the display device to issue commands or control signals to start, stop, calibrate, or set the length of a sensor session for the analyte sensor system, battery or power management parameters, connection model parameters, and timeout parameters, where one or more of the timeout parameters are related to the length of time to keep the partner device on a whitelist, advertising timeout, connection establishment timeout, and permission timeout, warning parameters, configuration settings for managing the operating mode of the analyte sensor system, and remote server parameters.
[0122] Although generally applicable, in a particular implementation of the twelfth aspect that is also particularly applicable in relation to any other implementation of the twelfth aspect, the method further includes the analyte sensor system receiving an indication of a transition from an implementation in an operating mode specific to the use of the partner device. Further, the method includes an analyte sensor system restoring configuration parameters to a previous state that existed prior to setting or changing the configuration parameters in response to an input received from the partner device. Restoring a set of configuration parameters to a previous state may include removing the partner device from a whitelist.
[0123] A thirteenth aspect of the present disclosure includes a method. The method includes the analyte sensor system determining whether the wireless communication system includes one or more of a display device and a partner device. The method also includes, when the wireless communication system includes a display device, the analyte sensor system determining whether to connect to the display device using one of an intermittent connection model and a continuous connection model. The method includes, when the system includes a partner device, the analyte sensor system determining whether to connect to the partner device using one of an intermittent connection model and a continuous connection model. The analyte sensor system determining which of an intermittent connection model and a continuous connection model to use for connection to one or more of the display device and the partner device includes using configuration parameters set or modified using an input received from the partner device via a diabetes management partner interface.
[0124] Although generally applicable, in a particular implementation of the thirteenth aspect that is also particularly applicable in relation to any other implementation of the thirteenth aspect, determining that the analyte sensor system connects to the partner device in response to an intermittent connection model is performed using one of the configuration parameters set in response to the power requirements of the partner device.
[0125] In a particular implementation of the 13th aspect, which is generally applicable but particularly applicable in connection with any other implementation of the 13th aspect, determining that the analyte sensor system connects to the partner device according to the continuous connection model is done using the determination that the system includes a display device.
[0126] A 14th aspect of the present disclosure includes a method. The method includes the analyte sensor application of the display device receiving an interface to a partner device application associated with the partner device. The method includes the analyte sensor application using the interface to collect information collected by the partner device application. The information includes one or more of pairing data and analyte dosage data. The method also includes the analyte sensor application using the interface to provide analyte sensor system information. The analyte sensor information is used to indicate one or more of that the analyte sensor system is functioning, the connection model used by the analyte sensor system with respect to the partner device or the display device, and the configuration parameters used by the analyte sensor system to communicate with one or more of the partner device and the display device.
[0127] In a particular implementation of the 14th aspect, which is generally applicable but particularly applicable in connection with any other implementation of the 14th aspect, the method further includes the analyte sensor application receiving analyte data from the analyte sensor system. The method also includes the analyte sensor application providing a visual display including analyte data and information collected by the partner device application.
[0128] Although generally applicable, in a particular implementation of the 14th aspect, which is also particularly applicable in relation to any other implementation of the 14th aspect, this method also includes the analyte sensor application receiving information regarding analyte values from an analyte sensor system. This method also includes the analyte sensor application communicating analyte values to a partner device via an interface and through a partner device application.
[0129] Although generally applicable, in a particular implementation of the 14th aspect, which is also particularly applicable in relation to any other implementation of the 14th aspect, this method also includes the analyte sensor application receiving drug delivery information collected by a partner device via an interface.
[0130] Although generally applicable, in a particular implementation of the 14th aspect, which is also particularly applicable in relation to any other implementation of the 14th aspect, this method also includes the analyte sensor application receiving a warning from a partner device via an interface. The warning is related to an issue regarding the functionality of the partner device.
[0131] Although generally applicable, in a particular implementation of the 14th aspect, which is also particularly applicable in relation to any other implementation of the 14th aspect, this method also includes the analyte sensor application of a display device causing a warning to be provided via a user interface.
[0132] Although generally applicable, in a particular implementation of the 14th aspect, which is also particularly applicable in relation to any other implementation of the 14th aspect, this method also includes the analyte sensor application of a display device causing a warning to be provided via a remote server.
[0133] A fifteenth aspect of the present disclosure includes a method. The method includes establishing a connection between an analyte sensor system and a partner device. The method further includes the analyte sensor system receiving configuration parameter information from the partner device using a diabetes management partner interface. The configuration parameter information relates to the operation of the analyte sensor system according to the system requirements of the partner device. The configuration parameter information may include an access degree given to a remote device connectable to the analyte sensor system. The configuration parameter information may include one or more values of a set of configurable parameters used for the connection established between the analyte sensor system and the partner device. The one or more values of the set of configurable parameters are selected according to the system requirements of the partner device.
[0134] In a particular implementation of the fifteenth aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the fifteenth aspect, the set of configurable parameters includes one or more of the following. The set of configurable parameters may include connection information of a remote device. The set of configurable parameters may include a connection model used for a particular device connectable to the analyte sensor system. The set of configurable parameters may include connection command related data read by or transmitted to a remote device. The set of configurable parameters may include information related to the non-use of the partner device. The set of configurable parameters may include security or privacy related parameters. The set of configurable parameters may include information related to power control or battery usage. The set of configurable parameters may include several devices connectable to the analyte sensor system. The set of configurable parameters may include the device type of each device connectable to the analyte sensor system. The set of configurable parameters may include information of a type related to analyte data that can be read by and transmitted to a remote device connectable to the analyte sensor system.
[0135] While generally applicable, in a particular implementation of the 15th aspect that is also particularly applicable in relation to any other implementation of the 15th aspect, connection command-related data includes one or more of the following. The connection command-related data may indicate whether a partner device or a remote device is eligible to be included on the white list of the analyte sensor system. The connection command-related data may indicate whether a partner device or a remote device is compliant with the expiration of the white list. If a partner device or a remote device is compliant with the expiration of the white list, the connection command-related data may indicate the amount of time until the partner device or the remote device sets the white list to expire.
[0136] While generally applicable, in a particular implementation of the 15th aspect that is also particularly applicable in relation to any other implementation of the 15th aspect, information related to power control includes a proposal to extend the battery life of the analyte sensor system by expiring a particular device.
[0137] While generally applicable, in a particular implementation of the 15th aspect that is also particularly applicable in relation to any other implementation of the 15th aspect, information related to power control or battery usage is collected via a control mechanism that balances the battery life of the analyte sensor system against the connection reliability between the analyte sensor system and a partner device or a remote device.
[0138] While generally applicable, in a particular implementation of the 15th aspect that is also particularly applicable in relation to any other implementation of the 15th aspect, information related to power control triggers the low-power mode of the analyte sensor system.
[0139] While generally applicable, in a particular implementation of the 15th aspect that is also particularly applicable in relation to any other implementation of the 15th aspect, access is received only after the analyte sensor system has received permission for the access degree to be modified using parameter information received from a partner device.
[0140] The 16th aspect of the present disclosure includes a method. This method includes establishing a connection between a display device and an analyte sensor system. This method also includes the display device receiving an indication that the analyte sensor system is connected to a partner device. This method also includes, after receiving permission to provide access to a set of configuration parameters to the partner device via a diabetes management partner interface, receiving, via the diabetes management partner interface, configuration parameters of a warning transmitted from the partner device. This method also includes the display device providing a user interface that constitutes a warning transmitted from the analyte sensor system and a warning transmitted from the partner device. This method further includes causing a modification of the configuration parameters of a warning transmitted from the partner device using an input received via the user interface. The modification is performed in accordance with the system requirements of the partner device.
[0141] In a particular implementation of the 16th aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the 16th aspect, this method also includes receiving a selection of a partner device, which includes the display device, or a remote device among a plurality of remote devices, to be used as a primary device that provides, via the user interface, one or more of a warning transmitted from the analyte sensor system and a warning transmitted from the partner device.
[0142] In a particular implementation of the 16th aspect, which is generally applicable but also particularly applicable in relation to any other implementation of the 16th aspect, this method also includes providing a warning to a device other than the primary device when the battery capacity of the primary device falls below a threshold.
[0143] In a particular implementation of the sixteenth aspect, which is generally applicable but may also be particularly applicable in connection with any other implementation of the sixteenth aspect, the method also includes the display device receiving, via the user interface, a selection of each warning type provided for a warning transmitted from a partner device and a warning transmitted from an analyte sensor system.
[0144] In a particular implementation of the sixteenth aspect, which is generally applicable but may also be particularly applicable in connection with any other implementation of the sixteenth aspect, the method also includes providing a warning via a primary notification device. The method also includes providing a warning via a secondary notification device if an affirmative response is not received in response to providing the warning via the primary notification device. The primary notification device and the secondary notification device are at least one of a partner device, an analyte sensor system, and / or a plurality of remote devices.
[0145] The sixteenth aspect of the present disclosure includes a method of monitoring the operational status of a drug delivery device. The method includes receiving drug delivery device information from the drug delivery device related to one or more of the following. The drug delivery device information may be related to a reservoir change. The drug delivery device information may be related to a pump unwind. The drug delivery device information may be related to a pump prime. The drug delivery device information may be related to a cannula fill. The drug delivery device information may be related to a hydraulic pressure. The drug delivery device information may be related to determining a combination of analyte delivery device information and analyte data generated using an analyte sensor system. The drug delivery device information may be related to the analyte sensor system using this combination to determine the operational status of the drug delivery device.
[0146] A further aspect of the present disclosure will be more readily understood by considering the detailed description of the various disclosed embodiments, set forth below in conjunction with the accompanying drawings.
Brief Description of the Drawings
[0147]
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Embodiments for Carrying Out the Invention
[0148] The drawings are described in more detail in the following description and examples, provided for illustrative purposes only, and depict merely typical or exemplary embodiments of the present disclosure. The drawings are not intended to be comprehensive or to limit the disclosure to the exact form disclosed. It should also be understood that the present disclosure may be practiced with modifications or alterations, and the present disclosure may be limited only by the claims and their equivalents.
[0149] Embodiments of the present disclosure are directed to systems, methods, and devices for wireless communication of analyte data, and interfaces for wireless communication of analyte data collected using an analyte sensor system. In various developments described herein, the analyte data is glucose data generated by an analyte sensor system configured to connect to a display device, a partner device (e.g., a medical device such as an insulin pump), etc. More specifically, by implementing aspects of the present disclosure including the systems, methods, apparatuses, and devices described herein that use a diabetes management partner interface, the flexibility of the analyte sensor system in wireless communication with a display device, one or more partner devices, and / or other (e.g., electronic) devices can be improved.
[0150] Moreover, by implementing the aspects of the present disclosure, it may also be possible to improve the reliability, speed, and accuracy of wireless communication, as well as the associated connection protocols and configurations, including those for partner devices and display devices (e.g., the aforementioned devices can be manufactured by various third parties). Additionally, in some cases, system requirements such as those related to accuracy, power consumption, and reliability may not be as important, and in such cases, different configurations and connection modes can be utilized to optimize or adapt system performance. In particular, some aspects of the present disclosure relate to setting or modifying connection parameters of an analyte sensor system, for example, based on the system requirements of a partner device, among other factors.
[0151] Details of some exemplary embodiments of the systems, methods, and devices of the present disclosure are described in this description and, in some cases, in other parts of the present disclosure. Other features, objects, and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the present disclosure, the description, the drawings, the examples, and the claims. All such additional systems, methods, devices, functions, and advantages are included in this description (either explicitly or by reference) and are within the scope of the present disclosure and are intended to be protected by one or more of the appended claims.
[0152] A. Overview and Exemplary Configuration of the System FIG. 1 depicts a system 100 that can be used in connection with an embodiment of the present disclosure involving collecting, monitoring, and / or providing information regarding analyte values present in a user's body, including, for example, the user's blood glucose level. System 100 depicts aspects of an analyte sensor system 8 that can be communicatively coupled to display devices 110, 120, 130, and 140, partner device 136, and / or server system 134.
[0153] In the illustrated embodiment, 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 can wirelessly communicate (e.g., directly or indirectly) with one or more of display devices 110, 120, 130, and 140. In addition to or instead of display devices 110, 120, 130, and 140, the sensor electronics module 12 can wirelessly communicate (e.g., directly or indirectly) with a partner device 136 and / or a server system 134. Similarly, in some examples, display devices 110-140 can additionally or alternatively wirelessly communicate (e.g., directly or indirectly) with a partner device 136 and / or a server system 134. The various couplings illustrated in FIG. 1 can be facilitated using a wireless access point 138, as also mentioned below.
[0154] In certain embodiments, the sensor electronics module 12 includes electronic circuitry associated with the measurement and processing of continuous analyte sensor data and includes candidate algorithms associated with the processing and calibration of sensor data. The sensor electronics module 12 can be physically connected to the continuous analyte sensor 10 and can be integrated (non-removably attached) or removably attached to the continuous analyte sensor 10. The sensor device unit 12 can include hardware, firmware, and / or software that enables the measurement of the level of an analyte via a glucose sensor. For example, the sensor electronics module 12 can include a potentiostat, a power source for powering the sensor, other components useful for signal processing and data storage, and a remote measurement module for transmitting data from the sensor electronics module to one or more display devices. The electronics can be fixed to a printed circuit board (PCB) or the like and can take various forms. For example, the electronics can take the form of an integrated circuit (IC) such as an application specific integrated circuit (ASIC), a microcontroller, and / or a processor.
[0155] The sensor electronic module 12 may include a sensor electronic device configured to process sensor information such as sensor data and to generate the converted sensor data and displayable sensor information. Examples of systems and methods for processing sensor analyte data are described in more detail herein and in U.S. Patent Nos. 7,310,544 and 6,931,327 and U.S. Patent Publications 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 hereby incorporated by reference in their entirety.
[0156] Referring further to FIG. 1, display devices 110, 120, 130, and / or 140 can be configured to display (and / or warn of) displayable sensor information that can be transmitted by sensor electronics module 12 (e.g., a customized data package transmitted to the display device based on each of their respective preferences). Each of display devices 110, 120, 130, or 140 can include a display such as touch screen displays 112, 122, 132, / or 142 that display sensor information and / or analyte data to the user, and / or receive input from the user. For example, a graphical user interface may be presented to the user for such purposes. In embodiments, the display device can include other types of user interfaces, such as a voice user interface, instead of or in addition to a touch screen display for communicating sensor information to the user of the display device and / or receiving user input. In embodiments, one, some, or all of display devices 110, 120, 130, 140 can be configured to display or otherwise communicate sensor information without any additional future processing required for calibration and real-time display of the sensor data (e.g., in the data package transmitted to each respective display device) when the sensor information is transmitted from sensor electronics module 12.
[0157] The plurality of display devices 110, 120, 130, 140 depicted in FIG. 1 may include a custom display device, such as an analyte display device 110, that is specially designed to display certain types of displayable sensor information associated with analyte data received from a sensor electronics module 12 (e.g., in embodiments, numerical values and / or arrows). In embodiments, one of the plurality of display devices 110, 120, 130, 140 may be a smartphone, such as a mobile phone 120, configured to display a graphical representation of continuous sensor data (e.g., including current and / or historical data) based on Android, iOS, or other operating systems. The other display devices 110, 120, 130, 140 may include other handheld devices, such as tablets 130, smartwatches 140, partner devices 136 (e.g., insulin delivery devices, whether automatic or manual, or blood glucose meters), smart refrigerators, vehicles, smart mirrors, smart clocks, smart drinks, implantable insulin delivery devices, and / or desktop or laptop computers.
[0158] Different display devices 110, 120, 130, 140, etc. and partner device(s) 136 can customize different user interfaces, the content of data packages (e.g., the amount, format, and / or type of data displayed, alarms, etc.) for each specific display device 110, 120, 130, 140, etc. and / or partner device(s) 136 (e.g., programmed to be different by the manufacturer and / or end user). Thus, in embodiments, the plurality of different display devices 110, 120, 130, 140 can communicate directly wirelessly with a sensor electronics module 12 (e.g., a skin-mounted sensor electronics module physically connected to the continuous analyte sensor 10) to enable multiple different types and / or levels of displays and / or functions associated with displayable sensor information during a sensor session, which is described in more detail elsewhere in this specification.
[0159] Further shown in FIG. 1, as described above, system 100 may also include a wireless access point (WAP) 138 that can be used to couple one or more of an analyte sensor system 8, a plurality of display devices 110, 120, 130, 140, a server system 134, and a medical device 136 to each other. For example, WAP 138 may provide WiFi and / or cellular or other wireless connectivity within system 100. Near field communication (NFC) may also be used between the devices of system 100. The server system 134 can be used to collect analyte data from the analyte sensor system 8 and / or the plurality of display devices and provide services or feedback including, for example, performing an analysis, generating general or individualized models of glucose levels and profiles, and remotely monitoring an individual or system that can monitor the analyte data.
[0160] Referring now to FIG. 2A, system 200 is depicted. System 200 may be used in connection with implementations of the disclosed systems, methods, apparatuses, and / or devices, including, for example, the aspects described above in connection with FIG. 1. By way of example, the various components described below in FIG. 2A can be used to provide wireless communication of analyte (e.g., glucose) data between and / or among, for example, an analyte sensor system 308, a display device 310, a partner device 315, and / or one or more server systems 334.
[0161] As shown in FIG. 2A, system 200 may include analyte sensor systems 308, one or more display devices 310, and / or one or more partner devices 315. Additionally, in the illustrated embodiment, system 200 includes a server system 334, which includes a server 334a coupled to a processor 334c and a storage device 334b. Analyte sensor system 308 may be coupled to display device 310, partner device 315, and / or server system 334 via communication medium 305. Many details of the processing, collection, exchange, and / or execution of actions (e.g., execution of a drug or related instruction) by analyte sensor system 308, partner device 315, and / or display device 310, etc. are provided below.
[0162] As described in detail herein, analyte sensor system 308, display device 310, and / or partner device 315 can exchange messaging (e.g., control signaling) via communication medium 305, and can also use communication medium 305 to distribute analyte data to display device 310, partner device 315, and / or server system 334. As suggested above, display device 310 may include a variety of electronic computing devices such as, for example, smartphones, tablets, laptops, wearable devices, etc. Display device 310 may also include an analyte display device 110 customized for the display of analyte data and notifications related to the transmission thereof. Partner device 315 may include medical devices such as insulin pumps or pens, connectable devices such as smart refrigerators or mirrors, key fobs, and other devices.
[0163] In an embodiment, the communication medium 305 may be based on one or more wireless communication protocols such as, for example, Bluetooth, Bluetooth Low Energy (BLE), ZigBee, WiFi, IEEE 802.11 protocol, infrared (IR), radio frequency (RF), 2G, 3G, 4G, 5G, etc., and / or wired protocols and media. Also, considering the present disclosure, it will be understood that the communication medium can, in some cases, be implemented as one or more communication links including distinct links between components of the system 200, regardless of whether such links are explicitly shown or referred to in relation to FIG. 2A. By way of example, the analyte sensor system 308 may be coupled to the display device 310 via a first link of the communication medium 305 using BLE, whereas the display device 310 may be coupled to the server system 334 by a second link of the communication medium 305 using a cellular communication protocol (e.g., 4G LTE).
[0164] In an embodiment, the elements of the system 200 can be used to perform the operations of the various processes described herein and / or execute the various operations and / or features described herein with respect to one or more of the disclosed systems and / or methods. Considering the present disclosure, those skilled in the art will understand that the system 200 may include a single or multiple analyte sensor systems 308, communication medium 305, and / or server systems 334.
[0165] As described above, the communication medium 305 can be used to connect or communicatively couple the analyte sensor system 308, the display device 310, the partner device 315, and / or the server system 334 to each other or to a network. The communication medium 305 can be implemented in various forms. For example, the communication medium 305 can include one or more of a local area network (LAN), a personal area network (PAN), a wide area network (WAN), an optical fiber network, a power line internet, a hardwired connection (e.g., a bus), DSL, or any other type of network connection or communication coupling such as an internet connection. The communication medium 305 can be implemented using any combination of a router, a cable, a modem, a switch, an optical fiber, a wire, wireless (e.g., microwave / RF, AM, FM link, etc.). Further, the communication medium 305 can be implemented using various wireless standards such as Bluetooth®, BLE, Wi-Fi, IEEE 802.11, 3GPP® standards (e.g., 2G GSM / GPRS / EDGE, 3G UMTS / CDMA2000, or 4G LTE / LTE-A / LTE-U, 5G, or subsequent generations). Upon reading this disclosure, those skilled in the art will recognize other ways to implement the communication medium 305 for communication purposes and will also recognize that the features of this disclosure can be implemented using undeveloped communication standards that the communication medium 305 may be developed in the future.
[0166] Referring further to FIG. 2A, server 334a may receive, collect, and / or monitor information including analyte data, drug data, and related information from analyte sensor system 308, partner device 315, and / or display device 310, such as an input in response to analyte data or drug data, or an analyte monitoring application (e.g., analyte application sensor application 425a as shown in FIG. 4) executed on analyte sensor system 308 or display device 310, or an input received in relation to a drug delivery application executed on display device 310 or partner device 315 (e.g., drug delivery application 625 as shown in FIG. 5B). Thus, server 334a may receive, collect, and / or monitor information from partner device 315, such as information regarding the provision of drugs to a user and / or information regarding the operation of one or more partner devices 315. Server 334a may also receive, collect, and / or monitor information regarding the user of analyte sensor system 308, display device 310, and / or partner device 315.
[0167] In embodiments, server 334a may be adapted to receive such information via communication medium 305. This information may be stored in storage device 334b and / or processed by processor 334c. For example, processor 334c may include an analysis engine capable of performing analysis of information collected, received, etc. by server 334a via communication medium 305. In embodiments, server 334a, storage device 334b, and / or processor 334c may be implemented as a distributed computing network such as a Hadoop® network or as a relational database or the like. The aforementioned information may then be processed at server 334a such that services may be provided to analyte sensor system 308, display device 310, and / or partner device 315, and / or their user(s). For example, such services may include diabetes management feedback to the user.
[0168] Server 334a may include, for example, an Internet server, a router, a desktop or laptop computer, a smartphone, a tablet, a processor, a module, etc., and may be implemented in various forms including, for example, the following. It may be implemented in various formations including an integrated circuit or an aggregate of integrated circuits, a printed circuit board or an aggregate of printed circuit boards, or an individual housing / package / rack, or a plurality of them. In an embodiment, server 334a at least partially directs communications conducted via communication medium 305. Such communications may include the delivery of analyte data, drug data, and / or messaging related thereto (e.g., advertisements, authentication, commands, or other messaging). For example, server 334a may process and exchange messages between and / or among analyte sensor system 308, display device 310, and / or partner device 315 related to frequency band, transmission timing, security / encryption, alarms, warnings, notifications, etc. Server 334a may update the information stored in analyte sensor system 308, partner device 315, and / or display device 310, for example, by delivering an application to them or updating an application, and / or by reconfiguring system parameters or other settings of analyte sensor system 308, partner device 315, and / or display device 310. Server 334a may send and receive information to and from analyte sensor system 308, partner device 315, and / or display device 310 in real time, periodically, sporadically, or on an event-driven basis. Further, server 334a may implement cloud computing functions for analyte sensor system 308, partner device 315, and / or display device 310.
[0169] Referring now to FIG. 2B, system 202 is depicted in accordance with an embodiment of the present disclosure, some of which involve the configuration and / or setup of a kind of mesh network for connecting various devices described herein. As shown, an embodiment of system 202 includes an analyte sensor system 308 communicatively coupled to one or more of display devices 310a, 310b and / or partner devices 315 via a communication medium 305. Display device 310a may be communicatively coupled to display device 310b via communication medium 305a. By way of example, FIG. 2B shows that in an exemplary implementation of the present disclosure, display device 310a may connect to analyte sensor system 308 via communication medium 305 using a first connection scheme and a first wireless protocol (e.g., BLE). Next, display device 310a may also connect to display device 310b via communication medium 305a using a second connection scheme and a second wireless protocol (e.g., Wi-Fi, NFC, etc.). In an embodiment, the connection between display device 310a and analyte sensor system 308 may then be closed, and display device 310b may establish a connection to analyte sensor system 308 while maintaining a connection to display device 310a. Further, for example, if either or each of display devices 310a, 310b receives analyte data via communication medium 305, i.e., from analyte sensor system 308, display devices 310a and 310b may exchange analyte data with each other via communication medium 305a.
[0170] Partner device 315 can also be connected to display device 310b via communication medium 305 and / or communication medium 305b. Partner device 315 can also be connected to analyte sensor system 308 via communication medium 305. It will be understood that any number of different connection schemes / protocols can be used to communicatively couple the components of system 202. For example, some network connections may be intermittently available and / or in some cases may not be available or may be undesirable (due to system conditions such as device functionality, geography, time, battery life, interference requirements, etc.). Thus, in some cases, partner device 315 may not be directly connected to analyte sensor system 308, rather, it may be indirectly connected to analyte sensor system 308 via display device 310b that is connected to analyte sensor system 308 via communication medium 305. In some cases, display device 310b may not be directly connected to analyte sensor system 308, rather, it may be indirectly connected to analyte sensor system 308 via partner device 315 that is connected to analyte sensor system 308 via communication medium 305. Additional aspects and features represented by FIG. 2B will become apparent upon review of the present disclosure as a whole.
[0171] In an embodiment, the partner device 315 may not support the communication protocol utilized by the analyte sensor system 308 and / or, otherwise, it may be undesirable for the partner device 315 to connect directly to the analyte sensor system 308. Thus, the display device 310 (which, in the example, supports the communication protocol utilized by the analyte sensor system 308 and / or, otherwise, may be preferable for connection to the analyte sensor system 308) connects to the analyte sensor system 308 and may essentially function as a gateway device to the partner device 315. Thus, the partner device 315 can receive analyte data, etc. indirectly from the analyte sensor system 308 and / or can exchange information with the analyte sensor system 308. In some cases, this may be referred to as tethering. Also, in some cases, it will be understood that the partner device 315 can connect to display devices 310a, 310b and can function as a gateway device to the display devices 310a, 310b such that analyte data can be received from the analyte sensor system 308 via the partner device 315. Also, in an exemplary implementation of the system 304, it will be understood that one or more display devices 310a, 310b can be connected to the analyte sensor system 308 in parallel with each other and / or in parallel or series with one or more partner devices 315. Each display device 310a, 310b and / or partner device 315 can also connect a chain of display devices 310a, 310b and / or partner devices 315 to each display device 310a, 310b and / or partner device 315.
[0172] As suggested above, using a wireless communication protocol, analyte-related data, drug-related data, and other messaging or information (e.g., control signals, etc.) can be transmitted and received among the analyte sensor system 308, the display device 310, the partner device 315, and / or the server system 334 via the communication medium 305. In embodiments, such a wireless protocol can be designed for use in a wireless network optimized for periodic small data transmissions (which can be transmitted at a low rate if necessary) between multiple devices over a short distance (e.g., a personal area network). For example, one such protocol can be optimized for periodic data transfer where the transceiver can be configured to transmit data at short intervals and then enter a low-power mode at long intervals. The protocol can have low overhead requirements both in normal data transmission and in initializing the communication channel (e.g., reducing overhead) to reduce power consumption. In some embodiments, a burst broadcast scheme (e.g., one-way communication) can be used. This eliminates the overhead required for an acknowledgement signal and enables periodic transmissions that consume little power. In other embodiments, a passive or active proximity-based protocol, such as NFC as one specific example, can be used to reduce overhead (e.g., the overhead associated with a typical pairing operation) and / or enhance security.
[0173] The protocol may be further configured to establish communication channels with multiple devices while implementing an interference avoidance scheme. In some embodiments, the exemplary protocol described above may utilize an adaptive isochronous network topology that defines various time slots and frequency bands for communication with some devices. Thus, the protocol may change the transmission window and frequency to support communication with multiple devices in response to interference. Thus, the wireless protocol may use a time and frequency division multiplexing (TDMA / FDMA) based scheme. The wireless protocol may also use direct sequence spectrum spreading (DSSS) and frequency hopping spectrum spreading schemes. Various network topologies may be used to support short-range and / or low-power wireless communication such as peer-to-peer, star, tree, or mesh network topologies such as WiFi, Bluetooth, BLE, etc. The wireless protocol may operate in various frequency bands such as the open ISM band such as 2.4 GHz, for example. Further, to reduce power consumption, the wireless protocol may adaptively configure the data rate according to power consumption.
[0174] In an embodiment related to the configuration shown in FIG. 2B, a user interface, such as a GUI provided by the user interface 435 of FIG. 4, can present information regarding the mesh network to the user such that the user can maintain a certain level of control and / or input with respect to that configuration. For example, the topography / topology of the mesh network can be provided, and the user can access the connection links to change the connection model used, the connection parameters used, and / or the advertised characteristics associated with the various connections. Moreover, the user may be able to switch between the display device 310 and / or the partner device 315 with respect to which device can function as a gateway to other devices. Additionally, the user, the analyte sensor system 308, the display device 315, and / or the partner device 315 can send control signaling to other network elements to manage the permissions / functionality of other connected devices and / or to manage, for example, the number / type of devices that can connect to the analyte sensor system 308. In an embodiment, the display device 310 and / or the partner device 315 can manage the network topography / configuration in an automated manner, for example, based on the system requirements of the partner device 315. To facilitate such automatic or semi-automatic management, the partner device 315 can access mesh network configuration information via a diabetes management partner interface as described herein.
[0175] Based on the above description of aspects of the systems and methods of the present disclosure for wireless communication of analyte data, examples of some specific features of the present disclosure are provided here. Those skilled in the art, upon considering the present disclosure, will understand that these features can be implemented using the above-exemplified aspects of the configuration and / or combinations of aspects, whether or not explicit reference to these features is made.
[0176] B. Analyte Data Referring back to FIG. 1, as described above, in an embodiment, an analyte sensor system 8 is provided for continuous measurement of an analyte in a host or user. By way of overview and example, the analyte sensor system 8 engages in wireless communication (e.g., Bluetooth and / or other wireless protocols) that makes sensor measurements, generates analyte data (e.g., by calculating values of continuous glucose monitoring data), and transmits such data to remote devices (e.g., display devices 110, 120, 130, 140, partner device 136, and / or server system 134), and can be implemented as an encapsulated microcontroller.
[0177] The analyte sensor system 8 can include a continuous analyte sensor 10 configured to continuously measure the concentration of an analyte within a host, and a sensor electronics module 12 that is normally physically connected to the continuous analyte sensor 10 during sensor use. In an embodiment, the sensor electronics module 12 includes electronics configured to process a data stream associated with the analyte concentration measured by the continuous analyte sensor 10 to generate sensor information, including, for example, raw sensor data, converted sensor data, and / or other sensor data. The sensor electronics module 12 can be further configured to generate sensor information customized for each of the display devices 110, 120, 130, 140, partner device 136, and / or server system 134. The sensor electronics module 12 can be further configured such that different devices can receive different sensor information, and can be further configured to wirelessly transmit the sensor information to such display devices 110, 120, 130, 140, partner device 136, and / or server system 134.
[0178] As used herein, the term "analyte" is a broad term and is given its ordinary and customary meaning to one of ordinary skill in the art (not limited to a special or customized meaning), and further refers to, but is not limited to, substances or chemical components in a body fluid that can be analyzed (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine). Analytes can include naturally occurring substances, artificial substances, metabolites, and / or reaction products. In some embodiments, the analyte to be measured by the sensor head, device, system, and method is glucose. However, carboxyprothrombin, acylcarnitine, adenine phosphoribosyltransferase, adenosine deaminase, albumin, α-fetoprotein, amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), androstenedione, antipyrine, arabinitol enantiomers, arginase, benzoylecgonine (cocaine), biotinidase, biopterin, c-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β-hydroxychenodeoxycholic acid, cortisol, creatine kinase, creatine kinase MM isozyme, cyclosporin A, d-penicillamine, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylation polymorphism, alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, glucose-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 hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium malariae, sex differentiation, 21-deoxycortisol), desbutylhalofantrine, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte protoporphyrin, esterase D, fatty acid / acylglycine, free β-human chorionic gonadotropin, free erythrocyte protoporphyrin,Free thyroxine (FT4), free triiodothyronine (FT3), fumarylacetoacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, glucose-6-phosphate dehydrogenase, glutathione, glutathione peroxidase, glycolic acid, glycosylated hemoglobin, halofantrine, hemoglobin variants, hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-α-hydroxyprogesterone, hypoxanthine phosphoribosyltransferase, immunoreactive trypsin, lactate, lead, lipoproteins ((a), B / A-1, β), lysozyme, mefloquine, netilmicin, phenobarbital, phenytoin, phytanic acid / pristanic acid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase, kinins, reverse triiodothyronine (rT3), selenium, serum pancreatic lipase, sisomicin, somatomedin C, specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, OES virus, dengue virus, guinea worm, tapeworm, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic diseases), influenza virus, Leishmania donovani, Leptospira, measles / mumps / rubella, mycoplasma pneumoniae, myoglobin, Trichinella spiralis, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory rash virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponoma pallidium, Trypanosoma cruzi / Langerhans, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus), specific antigens (hepatitis B virus, HIV-1), succinylacetone, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, white blood cells,Other analytes including zinc protoporphyrin are contemplated, but not limited to these. Salts, sugars, proteins, fats, vitamins, and hormones that occur naturally in blood or interstitial fluid may also constitute analytes in certain embodiments. Analytes such as metabolites, hormones, antigens, antibodies, etc. may exist naturally in body fluids. Alternatively, analytes such as contrast agents for imaging diagnosis, radioisotopes, chemical agents, fluorocarbon-based artificial blood, or drugs or pharmaceutical compositions may be introduced into the body, including insulin, glucagon, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons), cocaine (crack cocaine), stimulants (amphetamine, methamphetamine, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine), depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene), hallucinogens (fenciclovir, lysergic acid, mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil), designer drugs (fentanyl, meperidine, amphetamine, methamphetamine, and analogs of fenciclovir such as Ecstasy), anabolic steroids, and nicotine, but not limited to these. Metabolites of drugs and pharmaceutical compositions are also considered analytes. For example, analytes such as 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), neurochemicals and other chemicals generated in the body, etc. may be analyzed.
[0179] C. Analyte Sensor System As suggested above with reference to FIG. 1, in an embodiment, the analyte sensor 10 includes, for example, a continuous glucose sensor such as a subcutaneous, transcutaneous (e.g., percutaneous), or intravascular device. In an embodiment, such a sensor or device can analyze multiple intermittent blood samples. The analyte sensor 10 can use any method of analyte measurement that includes glucose measurement, including, for example, enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, immunochemical, and the like.
[0180] In an embodiment where the analyte sensor 10 is a glucose sensor, the analyte sensor 10 can use any method, including invasive, minimally invasive, and non-invasive detection techniques (e.g., fluorescence monitoring), to provide a data stream indicative of the glucose concentration within the host. The data stream is typically an unprocessed data signal and can be converted into a calibrated and / or filtered data stream that can be used to provide useful glucose values to a user, such as a patient or caregiver (e.g., a parent, relative, guardian, teacher, physician, nurse, or any other individual interested in the health of the host).
[0181] The glucose sensor can be any device capable of measuring the concentration of glucose. According to an exemplary embodiment described below, an implantable glucose sensor can be used. However, it should be understood that the devices and methods described herein are applicable to any device capable of detecting the concentration of an analyte, such as glucose, and providing an output signal (e.g., in the form of analyte data) representative of the concentration of the analyte, also glucose.
[0182] In an embodiment, the analyte sensor 10 is an implantable glucose sensor as described with reference to U.S. Patent No. 6,001,067 and U.S. Patent Publication No. US2005 / 0027463-A1. In an embodiment, the analyte sensor 10 is a transcutaneous glucose sensor as described with reference to U.S. Patent Publication No. US2006 / 0020187-A1. In an embodiment, the analyte sensor 10 is configured to be implanted in a host blood vessel or extracorporeally as described in U.S. Patent Publication No. US2007 / 0027385-A1, co-pending U.S. Patent Publication No. US2008 / 0119703-A1 filed on Oct. 4, 2006, U.S. Patent Publication No. US2008 / 0108942-A1 filed on Mar. 26, 2007, and U.S. Patent Application No. US2007 / 0197890-A1 filed on Feb. 14, 2007. In an embodiment, the continuous glucose sensor includes, for example, a transcutaneous sensor as described in U.S. Patent No. 6,565,509 to Say et al. In an embodiment, the sensor 10 is a continuous glucose sensor including a subcutaneous sensor as described with 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 an embodiment, the continuous glucose sensor includes a refillable subcutaneous sensor as described with reference to U.S. Patent No. 6,512,939 to Colvin et al. The continuous glucose sensor may include, for example, an intravascular sensor as described with reference to U.S. Patent No. 6,477,395 to Schulman et al. The continuous glucose sensor may include, for example, an intravascular sensor as described with reference to U.S. Patent No. 6,424,847 to Mastrototaro et al.
[0183] Figures 3A and 3B depict a perspective view and a side view of an enclosure 200 that may be used in connection with an implementation of an embodiment of an analyte sensor system 8, according to certain aspects of the present disclosure. In certain embodiments, the housing 200 includes a mounting unit 214 and a sensor electronics module 12 attached to the mounting unit 214. The housing 200 is shown in a functional position including the mounting unit 214 and the sensor electronics module 12 in a mating engagement with the mounting unit 214. In an embodiment, the mounting unit 214, also referred to as a housing or sensor pod, includes a base 234 adapted to be secured to the skin of a host or user. The base 234 can be formed from a variety of rigid or flexible materials and can include a low profile to minimize protrusion of the device from the host during use. In an embodiment, the base 234 is at least partially formed from a flexible material, which can provide several advantages over other transcutaneous sensors that are unfortunately plagued by motion-related artifacts associated with the movement of the host while the host is using the device. The mounting unit 214 and / or the sensor electronics module 12 can be placed over the sensor insertion site to protect the site and / or provide a minimal footprint (utilization of the surface area of the host's skin).
[0184] In an embodiment, a removable connection is provided between the mounting unit 214 and the sensor electronics module 12, which can enable improved manufacturability, i.e., when modifying or servicing the analyte sensor system 8, potentially relatively inexpensive mounting units 214 can be discarded while the relatively expensive sensor electronics module 12 can be reused in multiple sensor systems. In an embodiment, the sensor electronics module 12 is configured, for example, with signal processing (programming) that filters, calibrates, and / or executes other algorithms useful for calibration and / or display of sensor information. However, an integrated (non-removable) sensor electronics module can be similarly configured.
[0185] In an embodiment, the contact 238 is mounted on or within an assembly, hereinafter referred to as the contact sub-assembly 236, configured to fit within the base 234 of the attachment unit 214 and a hinge 248 that allows the contact sub-assembly 236 to pivot between a first position (for insertion) and a second position (for use) relative to the attachment unit 214. As used herein, the term "hinge" is a broad term and is used in its original sense in an inclusive but not limiting manner to refer to any of a variety of pivoting, joint, and / or hinge mechanisms, such as an adhesive hinge, a sliding joint, etc., and the term "hinge" does not necessarily imply a pivot point or fixed point where the joint occurs. In an embodiment, the contact 238 is formed from a conductive elastomeric material such as carbon black elastomer through which the sensor 10 passes.
[0186] Referring further to FIGS. 3A and 3B, in an embodiment, the attachment unit 214 includes an adhesive pad 208 disposed on the back surface of the attachment unit and includes a peelable backing layer. Thus, removing the backing layer and finally pressing a portion of the base 234 of the attachment unit 214 against the host's skin causes the attachment unit 214 to adhere to the host's skin. In addition or alternatively, after insertion of the sensor is complete, an adhesive pad can be placed over a portion or all of the analyte sensor system 8 and / or the sensor 10 to ensure adhesion and, optionally, to create an airtight or waterproof seal around the wound exit site (or sensor insertion site) (not shown). An appropriate adhesive pad can be selected and designed to stretch, extend, conform to, and / or ventilate the area (e.g., the host's skin). The specific embodiments described with reference to FIGS. 2A and 2B are described in more detail with reference to U.S. Patent No. 7,310,544, which is hereby incorporated by reference in its entirety. The configuration and arrangement can provide the water resistance, waterproofness, and / or hermetic properties associated with the embodiments of the attachment unit / sensor electronic module described herein.
[0187] A variety of methods and apparatuses suitable for use in conjunction with the aspects of the embodiments described herein are disclosed in U.S. Patent Publication No. US2009 / 0240120 - A1, which is incorporated herein by reference in its entirety.
[0188] Referring now to FIG. 3C, a more detailed functional block diagram of the analyte sensor system 308 (e.g., as described above in connection with FIGS. 2A, 2B) is provided. As shown in FIG. 3C, the analyte sensor system 308 can include an analyte sensor 535 (e.g., which may also be designated by reference numeral 10 in FIG. 1) coupled to a sensor measurement circuit 525 for processing and managing sensor data. The sensor measurement circuit 525 can be coupled to a processor / microprocessor 530 (e.g., which may be part of item 12 in FIG. 1). In some embodiments, the processor 530 can perform some or all of the functions of the sensor measurement circuit 525 to acquire and process sensor measurements from the sensor 535.
[0189] The processor 530 can further be coupled to a wireless unit or transceiver 510 (e.g., which may be part of item 12 in FIG. 1) for transmitting sensor and other data and receiving requests, commands, and other signaling from external devices such as a display device 310. The external device can use the sensor data (or analyte data) or data derived therefrom to display or otherwise provide the sensor data or derived data to a user, a server system 334, and / or a partner device 315 that can utilize the sensor data or derived data for the administration of a pharmaceutical (e.g., insulin) and / or diabetes management guidance to the user. As used herein, the terms "wireless unit" and "transceiver" can be used interchangeably and generally refer to a device capable of wirelessly transmitting and receiving data.
[0190] The analyte sensor system 308 may further include a memory device 515 (which may be part of item 12 in FIG. 1, for example) and a real-time clock (RTC) 545 (which may be part of item 12 in FIG. 1, for example) for storing and tracking sensor data and other data. For example, the memory device 515 may store configuration parameters 520. Generally, the configuration parameters 520 are related to the operation of the analyte sensor system 308 and, in embodiments, are particularly related to the operation of the analyte sensor system 308 with respect to the partner device 315 and / or the display device 315. In an embodiment, the configuration parameters 520 may be accessed (directly or indirectly) by the partner device 315 using the diabetes management partner interface 550. In this way, the configuration parameters 520 may be set and / or modified according to the system requirements 650 of the partner device 315 (see FIG. 5B). For example, the configuration parameters 520 may be modified so that the analyte sensor system 308, the display device 310, and / or the partner device 315 operate such that one or more system requirements 650 of the partner device 315 are met.
[0191] As described above, further referring to FIG. 3C, an embodiment of the analyte sensor system 308 includes a diabetes management partner interface (DMPI) 550. The diabetes management partner interface 550 enables a partner device 315 connected to the analyte sensor system 308 to set and / or configure / modify configuration parameters 520 such that the system requirements 650 of the partner device 315 may be met in the operation of the analyte sensor system 308, the display device 310, and / or the partner device 315. The DMPI 550 may provide the partner device 315 with access to the configuration parameters 520 for the configuration of the partner device 315. When the partner device 315 and / or the display device 310 are provided by different manufacturers and have different design goals / constraints, the DMPI 550 enables a flexible system that may access, set, and / or modify the configuration parameters 520 of the analyte sensor system 308 according to the respective system requirements and / or design constraints of the partner device 315 and / or the display device 310. This flexibility improves the integration and interoperability of such devices and may enable a more user-friendly and versatile ecosystem. Additional aspects of the DMPI 550 are further described below.
[0192] Although not explicitly shown in FIG. 3C, embodiments of the analyte sensor system 308 also include an interface dedicated to the display device 310 (so as to be distinguished from the partner device 315). This interface may be a wireless interface that enables the display device 310 to connect to the analyte sensor system 308 and access, set, and / or modify / configure its configuration parameters 520 to facilitate communication with the analyte sensor system 308. As will be discussed further in connection with FIGS. 10A and 10B, this interface may be part of the DMPI 550 or implemented within the DMPI 550 (e.g., as the DMPI 750a), or may be implemented separately. In an embodiment, the DMPI 550 is reconfigurable for the adaptation of the characteristics of the display device 310 and / or the partner device 315 that may be connected to the analyte sensor system 308, as well as for the adaptation of the overall system requirements and dynamics of, for example, the system 200 (see FIG. 2A).
[0193] Some components of the analyte sensor system 308 may need to be replaced periodically. For example, the analyte sensor system 308 may include an implantable sensor 535 that can be attached to a sensor electronics module that includes a sensor measurement circuit 525. Additionally, the analyte sensor system 308 may include a processor 530, a memory device 515, and a transceiver 510, and a battery (not shown). The sensor 535 may need to be replaced periodically (such as every 7 - 30 days). The sensor electronics module may be configured to be powered and active for a much longer period (such as 3 - 6 months or more) than the sensor 535 until the battery needs to be replaced. Replacing these components can be difficult and may require the assistance of trained personnel. By reducing the need to replace such components, particularly the battery, the convenience and cost of using the analyte sensor system 308, including for the user, can be significantly improved. In an embodiment, when the sensor electronics module is first used (or, in some cases, restarted when the battery is replaced), the sensor electronics module can be connected to the sensor 535 and a sensor session can be established. As further described below, when the module is first used or restarted (such as after the battery is replaced), there may be a process to first establish communication between the display device 310 and the sensor electronics module. When the display device 310 and the sensor electronics module establish communication, they can communicate periodically and / or continuously over the lifetime of some sensors 535, for example, until the battery needs to be replaced. Each time the sensor 535 is replaced, a new sensor session can be established. The new sensor session may be initiated through a process using the display device 310 and the process may be triggered by a notification of the new sensor 535 via communication between the sensor electronics module and the display device 310 that can persist between sensor sessions.
[0194] The exemplary analyte sensor system 308 collects analyte data using sensor 535 and transmits the analyte data or a derivative of the analyte data to display device 310, partner device 315, and / or server system 334. Data points regarding analyte values can be collected and transmitted over the life of sensor 535. New measurements and / or related information can be transmitted at a frequency sufficient for a remote device / individual to appropriately monitor analyte (e.g., glucose) levels.
[0195] It should be understood that many details of the processing, collection, and exchange of data by analyte sensor system 308, partner device 315, and / or display device 310, etc. are provided elsewhere in this specification. Upon consideration of this disclosure, it will be understood that analyte sensor system 308 may include some similar components described with respect to FIGS. 4 and 5B for at least some embodiments of this specification. Thus, the details and use of such similar components may be understood with respect to analyte sensor system 308 even if not explicitly described herein with reference to FIG. 3C.
[0196] D. Display Device Referring again to FIG. 1 as an example, aspects of display devices 110, 120, 130, and 140 that can be used in system 100 are described herein. In embodiments of the present disclosure, sensor electronics module 12 is configured to search for and / or attempt wireless communication with a display device from a list of display devices. By way of overview and example, conventional display devices 110, 120, 130, 140 can communicate wirelessly with analyte sensor system 8, including in the case of authentication of display devices 110, 120, 130, 140 and / or analyte sensor system 8, and exchange of analyte data and control signaling.
[0197] In an embodiment, the sensor electronic module 12 is configured to search for and / or attempt wireless communication with a list of display devices 110, 120, 130, 140, for example, in a predetermined and / or programmable order (e.g., grading and / or escalation), and a failed attempt at communication and / or alert with a first display device among the display devices 110, 120, 130, 140 triggers an attempt at communication and / or alert with a second display device among the display devices 110, 120, 130, 140, etc. In an exemplary embodiment, the sensor electronic module 12 is configured to sequentially search for and alert a host or care provider using a list of display devices 110, 120, 130, 140 such as (1) a default display device (e.g., one of the display devices 110, 120, 130, 140) or a custom analyte monitoring device (e.g., display device 110), (2) a mobile phone (e.g., display device 120) via auditory, tactile, and / or visual means such as text messages to the host and / or care provider, voice messages to the host and / or care provider, and / or 911, and / or (3) a tablet (e.g., display device 130), (4) a smartwatch (e.g., display device 140). Of course, other types of display devices are included and / or described herein, and the alarm may be additionally or alternatively sent to the partner device 136 and / or the server system 334.
[0198] One or more display devices 110, 120, 130, 140 that receive data packages from the sensor electronic module 12 according to the embodiment can be adapted to be a "dummy display" and display the displayable sensor information received from the sensor electronic module 12 without additional processing (e.g., prediction algorithm processing that may be necessary for real-time display of sensor information). In an embodiment, the displayable sensor information includes converted sensor data that does not require processing by the display device before display of the displayable sensor information. Some display devices 110, 120, 130, 140 may include software (software programming including instructions configured to display the displayable sensor information and optionally query the sensor electronic module 12 to obtain the displayable sensor information) including display instructions configured to enable display of the displayable sensor information on the display device. In an embodiment, the display devices 110, 120, 130, 140 are programmed with display instructions at the manufacturer and can include security and / or authentication to avoid theft of the display devices 110, 120, 130, 140 and / or unauthorized access to the display devices. In an embodiment, the display devices 110, 120, 130, 140 are configured to display the displayable sensor information via a downloadable program (e.g., a Java script downloadable via the Internet), and thus any display device 110, 120, 130, 140 that supports downloading of the program (e.g., any display device 110, 120, 130, 140 such as a mobile phone, tablet, PDA, PC that supports Java applets) can be configured to display the displayable sensor information.
[0199] In embodiments, the particular display devices 110, 120, 130, 140 can communicate wirelessly directly with the sensor electronic module 12, but intermediate network hardware, firmware, and / or software can be included within the direct wireless communication path. In embodiments, a repeater (e.g., a Bluetooth repeater) can be used to retransmit the transmitted displayable sensor information to locations farther than within the immediate range of the remote measurement module of the sensor electronic module 12, and the repeater enables direct wireless communication when no substantial processing of the displayable sensor information takes place. In embodiments, a receiver / transmitter (e.g., a Bluetooth receiver / transmitter) can be used to retransmit the transmitted displayable sensor information in a different format, such as a text message to a TV screen in some cases, and the receiver / transmitter enables direct wireless communication when no substantial processing of the sensor information takes place. In embodiments, the sensor electronic module 12 wirelessly transmits the displayable sensor information directly to one or more of the display devices 110, 120, 130, 140, and the displayable sensor information transmitted from the sensor electronic module 12 is received by one or more of the display devices 110, 120, 130, 140 without intermediate processing of the displayable sensor information.
[0200] In an embodiment, one or more display devices 110, 120, 130, 140 include an embedded authentication mechanism, and authentication may be required for communication between the sensor electronic module 12 and the display devices 110, 120, 130, 140. In an embodiment, to authenticate data communication between the sensor electronic module 12 and the display devices 110, 120, 130, 140, a challenge-response protocol such as key authentication is provided, where the challenge is a request for a key or hash, or other value based on or derived from a key, and a valid response is the correct key or hash, or other value based on or derived from a key, whereby pairing between the sensor electronic module 12 and the display devices 110, 120, 130, 140 can be achieved via a key by the user and / or manufacturer. This may be referred to as two-way authentication in some cases. The key can be a software or hardware-level key. Additionally, the key may be a password (e.g., randomly generated or set by a user or other entity), and / or may be derived from uniquely identifying features (e.g., fingerprint, face, or retinal information) or information, etc.
[0201] In an embodiment, one or more display devices 110, 120, 130, 140 are configured to query the sensor electronic module 12 about displayable sensor information, and the display devices 110, 120, 130, 140 function as master devices that request sensor information from the sensor electronic module 12 (e.g., slave device) on demand, for example in response to a query. In some cases, the display devices 110, 120, 130, 140 function as masters and the sensor electronic module 12 functions as a slave, but in other cases, these roles may be reversed. For example, the roles may be reversed depending on the nature of the communication, etc.
[0202] In an embodiment, the sensor electronic module 12 is configured for periodic, systematic, and / or regular transmission of sensor information to one or more display devices 110, 120, 130, 140 (e.g., at 1, 2, 5, or 10 minute intervals, or longer or shorter intervals). In an embodiment, the sensor electronic module 12 is configured to transmit data packages associated with triggered warnings (e.g., triggered by one or more warning conditions). However, any combination of the above-described data transmission statuses can be implemented with any combination of the paired sensor electronic module 12 and display devices 110, 120, 130, 140. For example, one or more display devices 110, 120, 130, 140 can be configured to query (directly or indirectly) the sensor electronic module 12 and receive alarm information triggered by one or more satisfied alarm conditions. Additionally, the sensor electronic module 12 can be configured for periodic transmission of sensor information to one or more display devices 110, 120, 130, 140 (the same or different display devices as described in the previous example), whereby the system can include display devices 110, 120, 130, 140 that function differently with respect to how sensor information is obtained.
[0203] In an embodiment, the display devices 110, 120, 130, 140 are configured to query for a particular type of data content in a data storage memory (e.g., the storage device 515, referring to FIG. 3C) within the sensor electronic module 12, including a direct query to the memory of the sensor electronic module 12 or a database within the storage device and / or a request for a preconfigured or configurable package of data content from the database. That is, the data stored in the sensor electronic module 12 is configurable, queryable, predefined, and / or pre-packagable based on the characteristics and / or requirements of the display devices 110, 120, 130, 140 with which the sensor electronic module 12 communicates. In additional or alternative embodiments, the sensor electronic module 12 generates displayable sensor information based on information known to the sensor electronic module 12 regarding which of the display devices 110, 120, 130, 140 is to receive a particular transmission. Additionally, some of the display devices 110, 120, 130, 140 may be capable of obtaining calibration information by manual input of calibration information, automatic delivery of calibration information, and / or an integrated reference analyte monitor incorporated into the display devices 110, 120, 130, 140, and wirelessly transmitting the calibration information to the sensor electronic module 12. U.S. Patent Publications Nos. 2006 / 0222566, 2007 / 0203966, 2007 / 0208245, and 2005 / 0154271 are hereby incorporated by reference in their entirety and describe systems and methods for providing an integrated reference analyte monitor incorporated into a display device (e.g., the display devices 110, 120, 130, 140) and / or other calibration methods in which the embodiments disclosed herein may be implemented. In an embodiment, some of the display devices 110, 120, 130, 140 can transmit calibration information to the partner device(s) 136.
[0204] Generally, a plurality of display devices (e.g., a custom analyte monitoring device, which may also be referred to as analyte display device 110 in some cases, a mobile phone 120, a tablet 130, a smartwatch 140, a reference analyte monitor, a drug delivery or drug device, a medical device, and a personal computer, etc.) can be configured to communicate wirelessly with sensor electronic module 12. The plurality of display devices 110, 120, 130, 140 can be configured to display at least some of the displayable sensor information communicated wirelessly from sensor electronic module 12. Displayable sensor information can include, for example, sensor data such as raw data, and / or converted sensor data such as analyte concentration values, rate of change information, trend information, warning information, sensor diagnostic information, and / or calibration information. In an embodiment, the display devices 110, 120, 130, 140 can receive analyte data indirectly from the analyte sensor system 8 via another device (e.g., partner device 136 and / or server system 134). In an embodiment, the display devices 110, 120, 130, 140 can transmit commands or other control / configuration signaling indirectly to the analyte sensor system 8 via another device (e.g., partner device 136 and / or server system 134). Also, warnings, alarms, and / or notifications related to the analyte data can be provided (either visually, audibly, and / or tactilely) using the display devices 110, 120, 130, 140. Additional types of information that can be received by the display devices 110, 120, 130, 140 can include information related to battery life or power consumption, other diagnostics, timing, etc.
[0205] In some cases, display devices 110, 120, 130, 140 that communicate properly with the analyte sensor system 8 and successfully complete the authentication process can be regarded as approved display devices 110, 120, 130, 140. In some cases, display devices 110, 120, 130, 140 can be configured in a display-only state where the display devices 110, 120, 130, 140 can access analyte data in a read and display manner. In this state, display devices 110, 120, 130, 140 typically do not send commands related to continuous glucose monitoring (CGM) to the analyte sensor system 8. Nevertheless, other commands can be sent in this state. Exemplary CGM commands include commands to start, stop, or calibrate a CGM sensor session that uses the analyte sensor system 8 to generate analyte data. Examples of non-CGM commands include commands that do not affect the calculation of CGM data. Such non-CGM commands include, for example, commands to change advertisement parameters, modify whitelist criteria, and add additional display devices 110, 120, 130, 140 in read-only mode. Typically, examples of display devices 110, 120, 130, 140 that can operate in a display-only state include small devices such as key fobs, in which case the key fob displays analyte data and related warnings / alarms / notifications. However, depending on the situation, as described herein, display devices 110, 120, 130, 140 can operate in a display-only state.
[0206] In some cases, display devices 110, 120, 130, 140 may be configured in a display and control state, in which case, in addition to accessing analyte data in a read and display manner, display devices 110, 120, 130, 140 can send commands related to CGM and other commands. In this state, other types of data may be readable / displayable, and as described above, display devices 110, 120, 130, 140 can send various types of commands to the analyte sensor system 12 in addition to CGM commands.
[0207] FIG. 4 shows an exemplary aspect of the present disclosure that may be used in connection with an implementation of a display device 310 connectable to, for example, an analyte sensor system 308 and / or a partner device 315. It should be understood that many details of the processing, collection, and exchange of data by, for example, the analyte sensor system 308, the partner device 315, and / or the display device 310 are provided elsewhere in this specification. In considering the present disclosure, it will be understood that the display device 310 may include some similar components that may be described with respect to FIGS. 3C and / or 5B, at least for embodiments. Accordingly, the details and use of such similar components may be understood for the display device 310 even if not explicitly described herein with reference to FIG. 4.
[0208] As shown in FIG. 4, the display device 310 may include several components for communicatively coupling to the analyte sensor system 308 and / or the partner device 315 via the communication medium 305. The display device 310 may be used to alert the user and / or provide sensor information or analyte data, control signaling, and / or other information (e.g., related to the delivery of the partner device 315 and / or the drug) to the user and / or the analyte sensor system 308, another display device 310, and / or the partner device 315. The display device 310 includes a connectivity interface 405 (which includes a transceiver 320), a storage device 415 (which stores an analyte sensor application 425a, a partner device application 425b, and / or additional applications), a processor / microprocessor 430 that processes and manages sensor and / or other data, and a user interface 435 (e.g., a man-machine interface, an audio or visual interface (display, LED, speaker, microphone, etc.), tactile feedback, etc.) that can be used to provide information to / prompt the user and / or receive input from the user, and a real-time clock (RTC) 445. A bus (not shown here) may be used to interconnect the various elements of the display device 310 and transfer data between these elements.
[0209] The transceiver 410 can be used to receive sensors and / or other data and to send and receive requests, instructions, other signaling, and / or data between the analyte sensor system 308, the partner device 315, and / or the server system 334. The transceiver 410 can use a communication protocol to send and receive the aforementioned information. In embodiments, when a standardized communication protocol is used for communication with the display device 310, a commercially available transceiver circuit can be used in the transceiver 410 that incorporates a processing circuit for handling low-level data communication functions such as management of data encoding, transmission frequency, handshake protocol, etc. In these embodiments, the processor 430 may not necessarily need to manage these activities, and to that extent, it can provide the desired data values for transmission and manage high-level functions such as power-on or power-off and setting the rate at which messages are transmitted. Instructions and data values for performing these high-level functions can be stored in the storage device 415 and provided to the transceiver circuit via a data bus and transfer protocol established by the manufacturer of the transceiver 410.
[0210] Using the connectivity interface 405, the display device 310 can be interfaced to the communication medium 305 to communicatively couple the display device 310 to the analyte sensor system 308, another display device 310, and / or the partner device 315 (directly or indirectly) via the communication medium 305 (see, e.g., FIG. 2A). The transceiver 410 of the connectivity interface 405 can include multiple transceiver modules operable at different wireless standards and / or frequency bands. The transceiver 410 can be used to send and receive analyte or drug delivery data and / or related commands and messages between the analyte sensor system 308 and to wirelessly communicate with the partner device 315. Additionally, the connectivity interface 405 can include additional components for controlling wireless and / or wired connections, such as a baseband and / or Ethernet modem, an audio / video codec, etc., in some cases.
[0211] The memory device 415 can be used to store an operating system of a custom (e.g., proprietary) application designed for wireless data communication between the display device 310 and / or the remote transceiver and the display device 310. The memory device 415 can be a single memory device or multiple memory devices, and can be a volatile or non-volatile memory for storing data and / or instructions for software programs and applications. The instructions may be executed by the processor / microprocessor 430 to control and manage, for example, the transceiver 410, the user interface 435, the applications 425a, 425b, and / or other components of the display device 310. The memory device 415 can include a volatile memory (e.g., RAM) and / or a non-volatile memory (e.g., flash memory), can include any of EPROM, EEPROM, cache, and / or combinations / variations thereof. In various embodiments, the memory device 415 can store user input data collected by the display device 310 and / or other data (e.g., inputs from other users collected via the analyte sensor application 425a and / or the partner device application 425b, and / or information related to the partner device 315, including drug delivery data and related information). The memory device 415 can also be used to store, for later retrieval and use, for example, for trend determination and / or warning triggering, the volume of analyte-related data received from the analyte sensor system 308, and / or the volume of drug-related data received from the partner device 315.In addition, the memory device 415 can store, for example, the analyte sensor application 425a and / or the partner device application 425b when executed using, for example, the processor 430, and can receive input (e.g., by a conventional hard / soft key or touch screen, voice detection, or other input mechanism or user interface 435), enabling the user to interact, for example via the GUI, with analyte-related data and associated content, and / or drug-related data and associated content, and / or other information (e.g., related to the system configuration).
[0212] In an embodiment, the user can interact with the analyte sensor application 425a and / or the partner device application 425b via a GUI that can be provided by a display of the user interface 435 of the display device 310. The GUI of the display device 310 can perform functions such as, for example, accepting user input and displaying menus and information derived from analyte data or drug data. The GUI can be provided by various operating systems known in the art, such as, for example, iOS, Android, Windows Mobile, Windows, Mac OS, Chrome OS, Linux®, Unix, game platform OSs (e.g., Xbox, PlayStation, Wii). By way of example, the display can be a touch screen display that accepts various hand gestures as input.
[0213] In an embodiment, the application 425a processes and / or presents analyte-related data received by the display device 310 according to various operations described herein, and can present such data via the display of the user interface 435. In addition, as described in further detail herein, the application 425a can be used to obtain, access, display, control, and / or interface connect to analyte data, as well as associated messaging and processing related to the analyte sensor system 308.
[0214] The application 425a can be downloaded, installed, and initially configured / set up on the display device 310. For example, the display device 310 can obtain the application 425a from the server system 334 or from another source accessible via a communication medium 305 such as an application store. Following installation and setup, the application 425a can be used to access and / or interface with analyte data (e.g., whether stored on the server system 334, locally from the storage device 415, or from the analyte sensor system 308). By way of example, the application 425a can present a menu that includes various controls or commands that can be executed in relation to the operation of the analyte sensor system 308 and one or more display devices 310. The application 425a can also be used to interface or control other display devices 310 and / or partner devices 315 in order to distribute or make available analyte-related data, including, for example, by directly receiving / sending analyte data to / from other display devices 310 and / or partner devices 315, and / or by sending instructions to the analyte sensor system 308 and other connected display devices 310 and / or partner devices 315, etc. Additionally, the application 425a in some implementations may interact with one or more additional applications supported by the display device 310, for example, to search for or supply relevant data. Such applications can include, by way of example, fitness / lifestyle monitoring applications, social media applications, etc. Such applications can also include applications associated with partner devices 315, including the partner device application 425b, which will be described in detail below.
[0215] The analyte sensor application 425a may include various code / functional modules such as, for example, a display module, a menu module, a list module, etc., as will become apparent in light of the description of the various functionalities herein (e.g., related to the disclosed methods). These modules may be implemented individually or in combination. Each module can include a (non-transitory) computer-readable medium in which computer-executable code is stored, whereby the code is operably coupled to the processor 430 and / or executed by the processor 430 (which can include circuitry for such execution) to perform certain functions related to interfacing with analyte-related data and performing related tasks (e.g., as described herein with respect to various operations and flowcharts, etc.), and can interface with other applications / devices.
[0216] As further described below, the display module may present various screens to the user via a screen that includes a graphical representation of the information provided by the application 425a (e.g., via the display of the user interface 435). In further embodiments, the application 425a can be used to browse and display to the user an environment in which the analyte sensor system 308, and the analyte sensor system 308 itself, and / or various display devices 310 that can be connectable to the partner device 315 can be interacted with. The sensor application 425a may include a native application modified with a software design kit (e.g., depending on the operating system) to perform the functionalities / features described herein.
[0217] Referring further to FIG. 4, the partner device application 425b may also be included in the memory device 415 and, for example, when executed using the processor 430, the application 425b can accept inputs (e.g., via conventional hard / soft keys or touch screens, voice detection, or other input mechanisms or user interfaces 435) and enable the user to interact with pharmaceutical-related data and associated content, for example via the GUI of the user interface 435. The application 425b can process and / or present drug-related and other partner device or system data received by or transmitted from the display device 310 in accordance with the various operations described herein and can present such data via the display of the user interface 435. Additionally, as described in further detail herein, the application 425b can be used to obtain, access, display, control, and / or interface connect drug, analyte, and / or other data, and associated messaging and processing related to the partner device 315, the display device 310, and / or the server system 334.
[0218] In an embodiment, the application 425b can be downloaded, installed, and initially configured / set up on the display device 310. For example, the display device 310 may obtain the application 425b from the server system 334, in which case the application 425b may be provided by the manufacturer of the partner device 315 in some cases or from another source accessible via a communication medium 305 such as an application store. Following installation and setup, the application 425b can be used to access and / or interface with the partner device 315 containing drug-related data (e.g., on the server system 334, locally from the storage device 415, or regardless of whether stored on the partner device 315 and / or the analyte sensor system 308). By way of example, the application 425b may cause the user interface 435 to present a menu including various controls or commands that can be executed in relation to the operation of the partner device 315, the analyte sensor system 308, and / or one or more display devices 310.
[0219] As described herein, the application 425b may perform interface connection or control with respect to the partner device 315 for other display devices 310 and / or with respect to the operation of the partner device 315 in the system / ecosystem described herein, for example, by receiving drug-related data from, for example, the partner device 315 and / or the analyte sensor system 308, and / or by sending instructions to the analyte sensor system 308 and / or the partner device 315 that are connected or operated in a specific manner, etc., to receive / deliver or make available drug-related data. In addition, the application 425b in some implementations may interact with one or more additional applications supported by the display device 310, for example, to search for or supply relevant data. Such applications may include, by way of example, fitness / lifestyle monitoring applications, social media applications, etc. Such applications may also include applications related to the analyte sensor system 308 and / or the display device 310, including the analyte sensor application 425a. By way of example, communication between the analyte sensor application 425a and the partner device application 425b may facilitate the sharing and coordination of warning information transmitted from the analyte sensor system 308 and / or the partner device 315.
[0220] The analyte sensor application 425b can include various code / function modules such as, for example, a display module, a menu module, a list module, etc., as will become apparent in light of the description of the various functionalities herein (e.g., related to the disclosed methods). These modules can be implemented individually or in combination. Each module can include a (non-transitory) computer-readable medium in which computer-executable code is stored, whereby the code is operably coupled to the processor 430 and / or executed by the processor 430 to perform specific functions related to interfacing with the partner device 315, the display device 310, the server system 334, and / or drug-related or analyte-related data, and / or performing tasks related thereto, and can interface with other applications / devices.
[0221] As further described below, the display module can present various screens to the user (e.g., via the display of the user interface 435) by way of a screen that includes a graphical representation of the information provided by the application 425b. In further embodiments, the application 425b can be used to browse and present to the user an environment for interacting with various partner devices 315 that can be connectable to the analyte sensor system 308 and / or the display device 310. The sensor application 425b can include a native application modified with a software design kit (e.g., depending on the operating system) to perform the functionalities / features described herein. Such a software design kit can be provided by the manufacturer of the partner device 315 or other entity.
[0222] As shown in FIG. 4, the storage device 415 of the display device 310 may also include configuration parameters 420. In an embodiment, the configuration parameters 420 manage the manner of wireless communication between and / or among the display device 310, the analyte sensor system 308, and / or the partner device 315. The configuration parameters 420 are described in further detail below with reference to, for example, FIGS. 5B, 8, 9A-9S, 10A, and 10B. System requirements 450 may also be stored in the storage device 415. The system requirements 450 may relate to the partner device 315 and are described in further detail with reference to, by way of example, FIGS. 5B, 8, 9A-9S, 10A, and 10B.
[0223] Referring back to FIG. 4, as described above, the display device 310 also includes a processor / microcontroller 430. The processor 430 may include a processor sub-module that is, by way of example, an application processor that interfaces with and / or controls other elements of the display device 310 (e.g., connectivity interface 405, applications 425a, 425b, user interface 435, and their components, RTC 445, etc.). The processor 430 may, for example, provide various controls related to device management, such as a controller and / or microcontroller that provides various controls related to the timing, type, and / or structure of messaging exchanged between a list of available or previously paired devices, information related to measurements including analytes and drugs, information related to network conditions (e.g., link quality, etc.), the analyte sensor system 308, the display device 310, and / or the partner device 315, information related to the diagnosis of various systems, information related to the power management of the analyte sensor system 308, the display device 310, and / or the partner device 315, etc. (e.g., interface connections with virtual buttons / inputs and switches, etc.). Additionally, the controller may include various controls related to user input, such as a user's fingerprint (e.g., used to permit access to the user's data or for the approval / encryption of data including analyte data) or other identification information, as well as the collection of analyte data and / or drug delivery data and / or related information.
[0224] The processor 430 may include circuits such as logic circuits, memory, battery and power related management circuits, as well as peripheral components and other circuit drivers for the audio / video and other components of the display device 310. The display device 310 may include other peripheral components not shown in detail in FIG. 4, and the processor 430 may be adapted to drive such peripheral components. The processor 430 and any of its sub-processors may include logic circuits for receiving, processing, and / or storing data received and / or input to the display device 310 and data transmitted or distributed by the display device 310. The processor 430 may be coupled (e.g., by a bus) to the user interface 435, as well as to the connectivity interface 405 and the storage device 415 (including applications 425a, 425b). Thus, the processor 430 may receive and process electrical signals generated by each of these elements and thus perform various functions. By way of example, the processor 430 may access the stored content in the storage device 415 in accordance with the instructions of application 425a and / or 425b and process the stored content for display and / or output by a display or other mechanism of the user interface 435. Additionally, the processor 430 may process the stored content for transmission to other display devices 310, analyte sensor systems 308, server systems 334, and / or partner devices 315 via the connectivity interface 405 and the communication medium 305.
[0225] In an embodiment, the processor 430 may further acquire, detect, calculate, and / or store data input by a user via the user interface 435 over a certain period of time, or data received from the analyte sensor system 308 (e.g., analyte sensor data and related messaging) and / or data received from the partner device 315 (e.g., drug delivery data and related data / messaging). The processor 430 may use this input to measure the user's physical and / or mental reactions to analytes, drugs, or data, and other factors (e.g., time, location, etc.). In various embodiments, the user's response or other factors may indicate recommendations regarding the use of a particular display device 310 and / or partner device 315 under particular conditions, a preferred dosage under particular conditions, and / or the use of a particular connection / transmission scheme under various conditions, as described in more detail herein.
[0226] E. Partner Device Referring again to FIG. 1, in an embodiment of the present disclosure, the sensor electronic module 12 described above is configured to search for and / or attempt wireless communication with a partner device 136. By way of overview and example, a typical partner device 136 can communicate wirelessly with the analyte sensor system 8, including in the case of authentication of the partner device 136 and / or the analyte sensor system 8, and the exchange of analyte data, drug data, other data, and / or control signaling. The partner device 136 may include a passive device in an exemplary embodiment of the present disclosure.
[0227] FIG. 5A shows an example of a partner device 136 that can be an insulin pump for administering insulin to a user. For various reasons, such an insulin pump may desirably receive and track glucose values transmitted from the analyte sensor system 8 (see, e.g., FIG. 1). One reason for this is to provide the insulin pump with the ability to suspend / activate insulin administration based on the glucose value falling below / above a threshold. An exemplary solution to enable a passive device (e.g., partner device 136) to receive analyte data (e.g., glucose values) without being coupled to the analyte sensor system 8 is to include the analyte data in an advertisement message transmitted from the analyte sensor system 8 (as explained by way of example with reference to FIG. 7C). The data included in the advertisement message can be encoded such that only devices having identification information associated with the analyte sensor system 8 can decode the analyte data.
[0228] The partner device 136 can include an input / output unit 136a that can display, for example, glucose and other values and can receive inputs via buttons, a wireless connection, or other mechanisms including various user interface mechanisms. The partner device 136 can also include a connection unit 136b that interfaces with the user to administer insulin, for example, in response to an input received at the input / output unit 136a. In some cases, the connection unit 136b can provide a sensory warning or other notification to the user based on, for example, an input received and / or a value calculated at the input / output unit 136a. It should be understood that the insulin pump can be implemented in many additional or alternative configurations of the partner device 136.
[0229] More generally, partner device 136 may include medical and other devices configured to use analyte data received from analyte sensor system 8 for patient treatment and / or guidance. Partner device 136 may generally include a drug delivery device, in which case delivery of the drug to the patient is conditioned, among other factors, on characteristics of the analyte data received from analyte sensor system 8. An example of partner device 136 is an insulin pump. Another example of partner device 136 is an insulin pen. Partner device 136 may be adapted to execute a drug delivery application using code or instructions stored in a memory or storage device of partner device 136, as described in more detail herein (e.g., see FIG. 5B).
[0230] For example, a partner device 136, such as an insulin pump that automatically delivers a drug to a patient, may impose requirements on the quality and / or nature of the wireless connection / link through which the partner device 136 receives analyte data used to make drug delivery-related decisions, and on the configuration of the ecosystem in which the partner device 136 is used. Additional types of partner device 136 may similarly, or alternatively, impose requirements. For example, some partner device 136 may require a more dedicated and robust connection, for example, so that a user or patient who relies on a pump for insulin delivery does not miss an insulin dose. In such an example, the connection through which the insulin pump receives analyte data should be relatively secure and reliable and should reduce interference from other devices (e.g., display devices 110, 120, 130, 140). As another example, partner device 136 may have specific constraints with respect to battery life, accuracy in calculating CGM data, and the like. Partner device 136 may be able to transmit CGM commands and other types of commands to analyte sensor system 8, and control the operating mode of analyte sensor system 8 in accordance with system requirements 650 of partner device 136, as described herein (e.g., see FIG. 5B).
[0231] In an exemplary implementation where the partner device 136 is an insulin pump, the insulin pump, while receiving analyte data from the analyte sensor system 8 and being engaged in automatic insulin delivery, may require, for example, that the other display devices 110, 120, 130, 140 do not transmit CGM control commands to the analyte sensor system 8. Such CGM control commands can affect the algorithms used to calculate CGM data and, as a result, may affect the amount of insulin delivered by the insulin pump, which may be undesirable / unexpected. To maintain control over the amount of insulin delivered, it may be desirable for the insulin pump to prevent the display devices 110, 120, 130, 140 from transmitting such CGM control commands. This can be done using the various techniques described herein.
[0232] Other types of partner devices 136, such as insulin pens, smart refrigerators, smart mirrors, vehicles, and any other connected devices, may impose different or similar requirements and / or may have more relaxed requirements for wireless communication and other performance aspects. An injection device such as an insulin pen may receive analyte data from the analyte sensor system 8 and use the analyte data to provide the user with an indication or guidance (e.g., graphical, audible, tactile, etc.) as to whether the user should (or should not) administer a drug (e.g., inject insulin), and may also include a proposal for the dosage or timing of the administration. That is, unlike the insulin pump implementation of the partner device 136, the insulin pen may depend on the user's actions / interventions. The smart refrigerator implementation of the partner device 136 may connect to the analyte sensor system 8 and monitor the user's food / drink consumption and analyte data and provide the user with feedback regarding the expected or resulting blood glucose levels related to the food / drink consumption. The smart mirror implementation of the partner device 136 may connect to the analyte sensor system 8 and / or the display devices 110, 120, 130, 140 and provide the user with analyte information and / or other guidance cues in a heads-up display for diabetes management and other types of healthcare proposals.
[0233] As will be appreciated, there are also a very large number of manufacturers that may provide the partner device 136 for operation with the analyte sensor system 8 and / or the display devices 110, 120, 130, 140 such that many different types of partner devices 136 are contemplated. There is a need for flexibility and adaptability in the system such that the interactions and performance of the various devices can be controlled and / or optimized to maintain and facilitate interoperability, predictability, and extended use across a wide range of device types and manufacturers, etc.
[0234] Turning now to FIG. 5B, a more detailed exemplary functional block diagram of the partner device 315 is provided. In considering the present disclosure, at least for some embodiments, with respect to the partner device 315, some similar components are described with respect to FIGS. 4 and 5 and the display device 310 and the analyte sensor system 308, and the details and uses of such similar components will be understood with respect to the partner device 315 even if not explicitly described with reference to FIG. 5B.
[0235] As shown in FIG. 5B, embodiments of the partner device 315 may include a drug delivery mechanism 640 that can be used to deliver a drug (e.g., insulin) to a user, such as based on analyte data generated using the analyte sensor system 308 and received at the partner device 315 via the communication medium 305. For example, if the partner device 315 is an insulin pump, the drug delivery mechanism 640 may include, in an embodiment, an infusion set that can deliver insulin from an internal or external cannula or other type of reservoir of the partner device 315. Or, for example, if the partner device 315 is an insulin pen, the drug delivery mechanism 640 may include a needle that can be used to inject insulin into the user.
[0236] The partner device 315 may also include a processor / microcontroller 630 that can be coupled to a wireless unit or transceiver 610 for transmitting and receiving sensor data and requests and commands and other signals between the partner device 315 and external devices such as the display device 310 and / or the analyte sensor system 308 and / or another partner device 315. The transceiver 610 may be part of a connectivity interface 605 within the partner device 315 and may be used to transmit drug-related information including dosage, bolus information, warnings / alarms / notifications, etc. to the analyte sensor system 308, the display device 310, another partner device 315, and / or the server system 334 (see FIG. 2A).
[0237] Partner device 315 may further include a memory device 615 and a real-time clock (RTC) 645 for storing and tracking drug delivery data, sensor data, and / or other information (e.g., command / control signaling, link characteristics, user input, etc.). The memory device 615 may store, among other information / items, drug delivery application 625 and / or other applications, and / or system requirements 650. The system requirements 650 of partner device 315 may be imposed to address safety, regulatory, user experience, power consumption, reliability, and / or accuracy requirements regarding the operation and / or performance of partner device 315, and, in some cases, other requirements applicable to the ecosystem in which partner device 315 is used.
[0238] The drug delivery application 625 can process and / or present an analyte, a drug, and / or other data received or transmitted by the partner device 315 (e.g., received from the analyte sensor system 308, the display device 310, another partner device 315, and / or the server system 334) according to the various operations described herein, and can present some such data aspects via the user interface 635. Additionally, the application 625 can be used in conjunction with the user interface 635 to obtain, access, display, control, and / or interface connect to the processing associated with the drug, the analyte, and / or other data and related messaging and the partner device 315, the display device 310, the analyte sensor system 308, and / or the server system 334. For example, the user interface 635 can enable a user to input user or other information into the partner device 315 to assist in the administration of a drug to the user and authenticate the user (e.g., by fingerprint, face, voice, or security code, etc.), and / or input user preferences or plans regarding the operation of the partner device 315 (e.g., scheduled use or non-use, mode control, etc.), and / or the analyte sensor system 308 (e.g., sensor replacement, expected operation time, etc.), and / or the display device 310 (e.g., permission for access to data from the partner device 315). Also, it will be understood that the application 625 may be executed on the partner device 315 but may not be visible to the user on the partner device 315. For example, the application 625 may be used to execute instructions for controlling the operation of the partner device 315, but the user interface connection with the application 625 may be made via the display device 310 (or, not all, in some cases).
[0239] The application 625 can be downloaded, installed, and initially configured / set up on the display device 315. For example, the partner device 315 may obtain the application 625 from the server system 334, in which case the application 625 may be provided by the manufacturer of the partner device 315 in some cases or from another source accessible via a communication medium 305 such as an application store. Following installation and setup, the application 625 can be used to access and / or interface with the partner device 315 that includes drug-related data (e.g., on the server system 334, locally from the storage device 615, or regardless of whether it is stored on the display device 310 and / or the analyte sensor system 308). By way of example, a menu (regardless of whether on the display device 310, the analyte sensor system 308, and / or the partner device 315) including various controls or commands that can be executed in relation to the operation of the partner device 315, the analyte sensor system 308, and / or one or more display devices 310 may be presented using the application 625.
[0240] Application 625 may also perform interface connections or controls to other partner devices 315 with respect to the display device 310 and / or the operation of partner devices 315 in the system / ecosystem described herein (e.g., see FIGS. 8 and 9A-9S), to receive drug-related or analyte-related data, for example, from partner devices 315, display device 310, and / or analyte sensor system 308, and / or to send instructions to analyte sensor system 308, display device 310, and / or partner devices 315 connected in a particular manner, mode, etc., including, for example, by receiving drug-related data and / or making it available. Additionally, in some implementations, application 625 may interact with one or more additional applications supported by display device 310, for example, to search for or supply relevant data. Such applications may include, by way of example, fitness / lifestyle monitoring applications, social media applications, etc. Such uses may also include applications associated with analyte sensor system 308 and / or display device 310, including analyte sensor application 425a and partner device application 425b.
[0241] The drug delivery application 625 may include various code / functional modules, such as, for example, a drug delivery module, an authentication module, a system configuration module, etc., as will become apparent in light of the description of the various functionalities herein (e.g., related to the disclosed methods). These modules may be implemented individually and / or in combination. Each module can include a (non-transitory) computer-readable medium in which computer-executable code is stored, whereby the code is operably coupled to and / or executed by the processor 630 to perform specific functions related to interfacing with the partner device 315 and / or drug-related data, and / or performing tasks related thereto, and can interface with other applications / devices (e.g., the display device 310, the analyte sensor system 308, etc.).
[0242] As further described below, the display module of the display device 310 or the partner device 615 can present various screens to the user on a screen that includes a graphical representation of information (e.g., insulin dosage information) provided by the application 625 (e.g., via the display of the user interface 435 in reference to FIG. 4 and / or the display of the user interface 635 in reference to FIG. 5B). In further embodiments, the application 625 can be used to display an environment for the user of the display device 310 to browse and interact with the partner device 315. In an embodiment, the partner device 315 can include a display as part of the user interface 635, in which case the application 625 can provide information to be displayed directly on the partner device 315 (instead of using the display device 310). The drug delivery application 625 can include a native application modified with a software design kit (e.g., operating system-dependent) to perform the functionalities / features described herein. Such a software design kit can be provided by the manufacturer of the partner device 315 or other entity.
[0243] As shown in FIG. 5B, the partner device 315 optionally includes a partner device controller 645. The partner device controller 645 can be used with the partner device 315 to add functionality to the partner device controller 645. For example, in an embodiment, the partner device 315 may not be equipped with wireless connectivity hardware / software. In such an embodiment, the partner device controller 645 is coupled to the partner device 315 via the connectivity interface 605 and can be a “bolt-on” component of hardware that can enhance the operating capabilities, and / or processing capabilities (e.g., including software code / instructions that support its processing capabilities) of the partner device 315 by providing or adding, for example, a transceiver, memory. Therefore, in an exemplary implementation, the partner device controller 645 can include BLE or other wireless for communicably coupling the partner device 315 to the analyte sensor system 308 and / or the display device 310. In an embodiment, the drug delivery application 625 can exist at least partially on the partner device controller 645. In an embodiment, the user interface 635 can exist at least partially on the partner device controller 645. For example, if the partner device does not have a user interface such as a display, the partner device controller can be used to add a display function to the partner device 315.
[0244] At this point, it should be noted that elements with similar names, such as between the display device 310, the analyte sensor system 308, and / or the partner device 315 described in FIGS. 3C, 4, 5A, and 5B, may in some cases include similar features and / or functions. Thus, for such elements, the description of such elements for any one of the display device 310, the analyte sensor system 308, and the partner device 315 may apply to corresponding or similar elements within any one of the display device 310, the analyte sensor system 308, and the partner device 315.
[0245] F. Timing and Structure of Advertisements Additional aspects of the present disclosure include the order and manner in which various devices (e.g., the display device 310 and the partner device 315) connect to the analyte sensor system 308, which may depend on the order, timing, structure, and manner of the advertisement messages transmitted to such display device 310 and / or partner device 315. One potential scheme for the connection order of the various devices may be described as follows.
[0246] In an embodiment, the analyte sensor system 308 advertises to and establishes a connection with a display device 310 and / or a partner device 315 that is available for connection (e.g., within range and / or available in other ways). This can be done, for example, by transmitting an advertisement message. By way of example, operation 1005a shown in FIG. 7A is referenced. On the display device 310 / partner device 315 side, a display device 310 and / or a partner device 315 that requests a connection to the analyte sensor system 308 can scan for the analyte sensor system 308 or another similar sensor system and transition to a connection therewith in an exemplary embodiment. This generally involves receiving and processing an advertisement message broadcast by the analyte sensor system 308 or the like to determine whether such a message is being transmitted by a compatible / desirable analyte sensor system 308.
[0247] The display device 310 and / or the partner device 315 can then respond to the advertisement message by replying to the connection request to the analyte sensor system 308. As an example, operation 1005b shown in FIG. 7A is referenced. Upon receiving the connection request, the analyte sensor system 308 can accept the request, reject it, or simply ignore it. In an exemplary implementation, the analyte sensor system 308 services only one connection to a display device 310 or partner device 315 at a time. Thus, one reason to reject or ignore a connection request is that the analyte sensor system 308 is already connected to a display device 310 or partner device 315. If there is no basis to reject or ignore the connection request, the analyte sensor system 308 can accept the request and connect to the display device 310 or partner device 310 that sent the request. For example, operation 1005b shows the analyte sensor system 308 accepting the request by signaling to the display device 310 or partner device 315 that the connection request is permitted. Aspects of the advertisement and related context are also shown as examples with reference to FIGS. 6, 7A-7C. (See, e.g., operations 1065a, 1095a.) A more detailed discussion of these figures is further included below.
[0248] Referring further to FIG. 7A, when the display device 310 (or partner device 315) is connected to the analyte sensor system 308, messaging can be exchanged, including, for example, the analyte sensor system 308 transmitting analyte data to the display device 310 or partner device 315. By way of example, operation 1005d shown in FIG. 7A is referenced. In an embodiment, to prevent the display device 310 or partner device 315 from remaining connected to the analyte sensor system 308 longer than expected or desired, the analyte sensor system 308 can enforce a timeout and / or can cause a timeout to be enforced. That is, for example, there can be a predetermined limit set with respect to the duration of the connection, and when its expiration occurs, the connection to the analyte sensor system 308 can be terminated. By way of example, operation 1015 shown in FIG. 7A is referenced, where the data connection is closed and optionally the transceiver 410 is deactivated. By terminating the connection, the analyte sensor system 308 and other display devices 310 and / or partner devices 315 can be enabled to connect or at least attempt to connect. The analyte sensor system 308 can maintain a list of the display devices 310 and / or partner devices 315 that were most recently connected to the analyte sensor system 308. In some cases, this can be known as a whitelist. The analyte sensor system 308 can use this list to permit only the listed display devices 310 and / or partner devices 315 (i.e., those that were most recently connected or otherwise listed) to connect to the analyte sensor system 308.
[0249] FIG. 6 is a timing diagram showing an example of the transmission of an advertisement message according to an embodiment of the present disclosure. More specifically, FIG. 6 provides an example of an advertisement duration structure 622 that can be used in connection with the establishment of pairing or connection between / among the analyte sensor system 308, the display device 310, and / or the partner device 315. In connection with the above, according to an embodiment of the advertisement duration structure 622, the advertisement message 618 can be transmitted according to time intervals that occur periodically based on a schedule. This may be referred to herein as the advertisement window interval 612 in some cases. The period of repetition of the occurrence of the advertisement window interval 612 can be of any length.
[0250] In an embodiment, the advertisement window interval 612 can be configured or set to vary according to the nature of the operation of the analyte sensor system 308 regarding the collection and processing of analyte data and / or according to the nature of the operation of the partner device 315 regarding the administration of the pharmaceutical and / or based on other considerations. In an exemplary implementation, the advertisement window interval 612 can be configured or set to vary based on whether the partner device 315 can be connected to the analyte display device 308. In an exemplary implementation, the advertisement window interval 612 can be configured or set to vary based on the system requirements 650 of the partner device 315. In an exemplary implementation, the advertisement window interval 612 can be configured or set to vary based on the network topology of the system in which the analyte sensor system 308 communicates with one or more of the partner device 315, the display device 310, and the server system 334 (e.g., system 200 with reference to FIG. 2A, system 800 with reference to FIG. 8, and / or system 900 with reference to FIG. 9A). For example, the advertisement window interval 1012 can be configured or set to vary based on the number of display devices 310 connectable to the analyte sensor system 308, based on whether the partner device 315 is an automatic insulin delivery device, and / or based on the system requirements 650 of the partner device 315 that is an automatic insulin delivery device. In one particular example, the advertisement window interval 612 is about 5 minutes. Therefore, in this particular example, there is a time window every 5 minutes during which the advertisement message 618 is transmitted.
[0251] The time window of the advertisement message 618 can be regarded as the period during which the advertisement message 618 can actually be transmitted. This can also be referred to as the advertisement period 614 in some cases. As an example, in some exemplary implementations, the advertisement period 614 can range in length from 7 to 22 seconds. However, considering the present disclosure, those skilled in the art will understand that the length (in time) of the advertisement period 614 can range from 0 to any reasonable amount of time. In some cases, the advertisement period 1014 is shorter than the advertisement window interval 612. However, this can be changed based on the system configuration / requirements detailed elsewhere in this specification.
[0252] During the advertisement period 614, the advertisement message 618 can, in some cases, but not necessarily, be transmitted periodically according to the advertisement message interval 616. The advertisement message interval 616 can be considered as the time interval between successive or consecutive transmissions of the advertisement message 618. A specific exemplary range of the advertisement message interval 616 is 20 to 90 milliseconds. However, considering the present disclosure, the advertisement message interval 616 can be shorter or longer, and / or can be adaptively variable, programmable, and / or configurable in length according to the relevant situation, including adapting or (re)configuring the advertisement message interval 616 during the advertisement period 614.
[0253] In an embodiment, the advertisement message interval 616 can be configured or set to vary according to the nature of the operation of the analyte sensor system 308 regarding the collection and processing of analyte data and / or according to the nature of the operation of the partner device 315 regarding the administration of a pharmaceutical product and / or based on other considerations. In an exemplary implementation, the advertisement message interval 616 can be configured or set to vary based on whether the partner device 315 is connectable to the analyte display device 308. In an exemplary implementation, the advertisement message interval 616 can be configured or set to vary based on the system requirements 650 of the partner device 315. In an exemplary implementation, the advertisement message interval 616 can be configured or set to vary based on the network topology of the system in which the analyte sensor system 308 communicates with one or more of the partner device 315, the display device 310, and the server system 334 (e.g., the system 200 with reference to FIG. 2A, the system 800 with reference to FIG. 8, and / or the system 900 with reference to FIG. 9A). For example, the advertisement window interval 612 can be configured or set to vary based on the number of display devices 310 connectable to the analyte sensor system 308, based on whether the partner device 315 is an automatic insulin delivery device, and / or based on the system requirements 650 of the partner device 315 that is an automatic insulin delivery device.
[0254] After the advertisement window interval 612 has elapsed, the advertisement message 1018 can resume transmission and can repeat the advertisement duration structure 622 (e.g., as the advertisement duration structure 622’). Note also that one or more of the advertisement message interval 616, the advertisement period 1014, and the advertisement window interval 612 can be reconfigured between the advertisement period structures 622 and 622’ and / or within each advertisement period of the advertisement period structures 622, 622’ (e.g., 614, etc.).
[0255] The above-described features of the advertisement period structure 622, including the advertisement window interval 612, the advertisement period 614, and the advertisement message interval 616, can each vary based on a variety of factors. For example, the values of these parameters can be based on the type and / or number of display devices 310 present, as well as on the system requirements of such display devices 310 and / or the time since such display devices 310 were connected to the analyte sensor system 308. As another example, the values of these parameters can be based on the type and / or number of partner devices 315 present, as well as on the system requirements 650 and / or other characteristics of such partner devices 315 (e.g., whether automatic insulin delivery is provided). The values of these parameters can also vary to optimize the connection reliability, accuracy, battery life, and speed up connection time of the display device 310 and / or the partner device 315. Any one of a decrease in the advertisement window interval 612, an increase in the advertisement period 614, and a decrease in the advertisement message interval 616 can increase the likelihood of successfully establishing a connection between a particular display device 310 and / or partner device 315 and the analyte sensor system 308 or other devices. However, in the example, changing the parameters in this way may simultaneously increase power consumption.
[0256] It should also be understood that one or more advertisement periods 614 can be individually assigned to a particular display device 310 or partner device 315 for connection. Thus, it is possible to prevent a connection from being established between such a device and the analyte sensor system 308 by canceling the assignment of the advertisement period 614 from the particular device or by not assigning the advertisement period 614 to such a device in the first place. This can be done, for example, when a dedicated connection between the partner device 315 and the analyte sensor system 308 is desired, and such a dedicated connection can substantially avoid potential interference caused by devices other than the partner 315 that respond to the advertisement transmitted by the analyte sensor system 308.
[0257] Accordingly, aspects of the present disclosure include configuring an advertisement period structure 622 that includes configuring the advertisement window interval 612, the advertisement period 1014, and / or the advertisement message interval 616, as well as other functions associated with and / or related to advertisement messaging. Aspects of the present disclosure also include controlling the assignment of the advertisement period 614 to a particular device (e.g., the display device 310 and / or the partner device 315) to create an advertisement slot dedicated to such a particular device.
[0258] Using the foregoing aspects of the present disclosure, the likelihood of successfully establishing a connection with the analyte sensor system 308 can be increased. Additionally, configuring the advertisement period 612 and / or controlling the allocation of the advertisement period 614 can also reduce the power consumption associated with connection establishment due to improved efficiency of the connection protocol. In this way, the overall reliability of communications related to analyte data and / or drug delivery can be enhanced while reducing power consumption. In an embodiment, the foregoing aspects of advertisement messaging can be configured to provide intelligent trade-offs among reliability, speed, power consumption / efficiency, etc., such trade-offs being implemented dynamically based, for example, on the system requirements 650 of the partner device 315, which may be unknown prior to the partner device 315 attempting to establish a connection with the analyte sensor system 308.
[0259] Here, with regard to the above-described features of connection establishment and / or advertisement messaging, in addition to the analyte sensor system 308 transmitting an advertisement message to the display device 310 and / or the partner device 315 for connection establishment purposes, the display device 310 and / or the partner device 315 may similarly transmit an advertisement message for connection establishment purposes. In such cases, it will be understood that the above-described features may be used similarly in view of the present disclosure.
[0260] G. Connection Model As suggested above, aspects of the present disclosure also include various connection models for communication between and / or among analyte sensor system 308, display device 310, server system 334, and / or partner device 315. One connection model for communication can be referred to as an intermittent connection model (or, in some cases, a connect / disconnect model). According to the intermittent connection model, communication between and / or among analyte sensor system 308, display device 310, server system 334, and / or partner device 315 can be inherently periodic or intermittent according to a defined, or event-based / asynchronous schedule. For example, display device 310 and / or partner device 315 can establish a connection with analyte sensor system 308 periodically (e.g., once every five minutes) to exchange analyte and / or other data with analyte sensor system 308.
[0261] In an exemplary implementation, rather than the transmission and reception circuits of analyte sensor system 308, display device 310, and / or partner device 315 communicating continuously, analyte sensor system 308, display device 310, and / or partner device 315 can establish their communication channels among and / or between them intermittently, regularly, and / or periodically. Thus, for example, analyte sensor system 308 can communicate with display device 310 and / or partner device 315 via wireless transmission at a predetermined time interval in some cases. The duration of the predetermined time interval can be selected to be long enough so that analyte sensor system 308 does not consume too much power by transmitting data more frequently than necessary, but is frequent enough to provide substantially real-time sensor information (e.g., measured glucose value or analyte data) to display device 310 for output to the user and / or partner device 315 (e.g., via a display as part of user interface 435) for use in administering a drug. The predetermined time interval can be, for example, once every five minutes in some embodiments, but it should be understood that this time interval can be changed to any desired length of time (e.g., as described above in connection with FIG. 6).
[0262] In an embodiment, the intermittent connection model can result in power savings compared to other connection models. Thus, where battery power is a major concern related to packet loss and / or latency, etc., the intermittent connection model may be preferred over the continuous connection model. Additionally, according to the intermittent connection model, it will be understood that the display device 310 and / or the partner device 315 in an exemplary implementation are not simultaneously connected to the analyte sensor system 308. Rather, different display devices 310 and / or partner devices 315 connect for some limited amount of different time periods. Which display devices 310 and / or partner devices 315 can connect and when such devices can connect to the analyte sensor system 308 can be controlled, for example, using a list such as a whitelist and / or by changing the advertisement structure as described above with reference to FIG. 6. Thus, depending on the situation, an intermittent model may be appropriate and / or preferred. One such situation may be where the user prefers to monitor analyte values using multiple display devices 310. For example, if the user has type 1 diabetes, monitoring of analyte (e.g., glucose) data may be relatively important, and thus multiple display devices 310 may be used for a wider range / redundancy.
[0263] FIG. 7A is an operation flow diagram showing various operations that can be performed in connection with an embodiment of a method 700 for wireless communication of analyte data between / among the analyte sensor system 308, the display device 310, the server system 334, and / or the partner device 315 according to the intermittent connection model described above. The features of method 700 can also be applied in connection with embodiments of related systems, devices, and devices. More specifically, as shown in FIG. 7A, communication session 720 can include operations 1005a - 1015, although in an embodiment, not all of these operations are necessarily performed.
[0264] The various tasks executed in connection with the procedure shown in FIG. 7A can be executed, for example, by processors 430, 530, and / or 630 each executing instructions embodied in a memory device 415, 515, and / or 615 (which may include a non-transitory computer-readable medium). The tasks or operations executed in connection with the procedure can be executed by hardware, software, firmware, and / or combinations thereof incorporated in one or more computing devices such as one or more of the analyte sensor system 308, display device 310, server system 334, and / or partner device 315.
[0265] Upon consideration of this disclosure, it will be understood that the procedure can include any number of additional or alternative tasks or actions. This will not generally always apply to all procedures and / or methods described herein. The actions shown as an example in FIG. 7A need not be executed in the order shown, and the procedure may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein with particular reference to FIG. 7A. Again, this will not generally always apply to all procedures and / or methods described herein.
[0266] In some examples described below, the analyte value is a glucose value based on one or more measurements made by the analyte sensor system 308 and / or sensor 535 (see FIG. 3C). Nevertheless, upon consideration of this disclosure, it should be understood that in embodiments, the analyte value can be any other analyte value described herein or known in the art. Wireless data communication between the analyte sensor system 308, display device 310, server system 334, and / or partner device 315 can be a "T" corresponding to the duration between successive wireless communication sessions between a transceiver 510 of the analyte sensor system 308 (see FIG. 3C), a transceiver 410 of the display device 310 (see FIG. 4), and / or a transceiver 610 of the partner device (see FIG. 5B). intervalIt may occur periodically at times separated by the update interval appended with "」. Alternatively or in addition, the update interval may be considered as the period for acquiring and transmitting the most recently measured or generated glucose value, drug-related data, or other data. Transmission of an advertisement signal or message, establishment of a data connection (e.g., a communication channel, etc.), and request and transmission of data may each occur during a wireless communication session that persists for the active time or period appended with "T interval " within "T Active ". One consideration here is that T interval and / or T Active may vary between sessions. Between consecutive wireless communication sessions, components of the analyte sensor system 308 (e.g., transceiver 510), components of the display device 310 (e.g., transceiver 410), and / or components of the partner device 315 (e.g., transceiver 610) may transition to a low-power mode or a similar mode, such as an inactive or sleep mode, during the inactive period appended with "T Inactive ". This can, for example, enable protection of battery life and relax peak voltage requirements.
[0267] Thus, in some connection schemes used for communication of analyte data, drug data, and / or other data, and control signaling, connections may be periodically established between and / or among the analyte sensor system 308, the display device 310, the server system 334, and / or the partner device 315. For example, referring further to FIG. 7A, the communication session 720 may implement one such connection scheme (optionally including authentication). More specifically, the communication session 720 may be implemented during a time interval T interval . As suggested above, T interval may include an active portion corresponding to T Active and an inactive portion corresponding to T Inactive . Generally speaking, T ActiveDuring this time, the analyte sensor system 308 is connected to the display device 310 and / or the partner device 315 and actively exchanges messaging (e.g., according to operation 1005 and / or a sub-operation thereof), but as described above, the analyte sensor system 308, the display device 310, and / or the partner device 315 may transition to a low power mode, etc. T Active There may be a period in the middle.
[0268] Regarding the connection, in an exemplary implementation, the analyte sensor system 308 may transmit one or more advertisement messages during operation 1005 in the communication session 720. The advertisement message may be regarded as an invitation for the display device 310 and / or the partner device 315 to establish a data connection with the analyte sensor system 308 (e.g., via the transceiver 510). Exemplary structures of advertisement messages that may be transmitted for the purpose of establishing a connection between two devices in some cases according to various aspects of the present disclosure are described in relation to FIG. 6 and are in U.S. Provisional Patent Application Nos. 62 / 364,771 and 62 / 409,677, which are hereby incorporated by reference in their entirety. The transmitted advertisement message may then be received by the display device 310 (e.g., via the transceiver 410) and / or the partner device 315 (e.g., via the transceiver 610).
[0269] As suggested above, during communication session 720, authentication procedures may optionally be performed in connection with the data connection process corresponding to operation 1005b and / or the data transmission process corresponding to operation 1005d. To establish a data connection with the analyte sensor system 308, the display device 310 and / or the partner device 315 may wait or scan until an advertisement message transmitted by the analyte sensor system 308 is received. Thus, operation 1005b may involve the analyte sensor system 308 receiving a connection request from the display device 310 and / or the partner device 315 and responding thereto by granting or denying the request. If the analyte sensor system 308 grants the connection request, as part of operation 1005b, an affirmative response or other message may be transmitted to the display device 310 and / or the partner device 315. A data connection may then be established between the analyte sensor system 308 and the display device 310 and / or the partner device 315.
[0270] According to operation 1005c, an authentication procedure can be used before data is actually exchanged in operation 1005d. Authentication can involve the exchange of various messages, including challenge values, hash values, and associated signaling, between the analyte sensor system 308 and the display device 310 and / or partner device 315, according to a one-way or two-way handshake process for each operation 1005c. Once authenticated, the analyte sensor system 308 and the display device 310 and / or partner device 315 can exchange information to determine how to exchange data (e.g., specific frequencies, time slot assignments, encryption, etc.). Additionally, communication session 720 can also include the exchange of an application key between the analyte sensor system 308 and the display device 310 and / or partner device 315. Through the exchange of the challenge values and hash values described in relation to operation 1005c, such an application key can be effectively shared between the analyte sensor system 308 and the display device 310 and / or partner device 315. Thus, in embodiments, the application key can be used for both authentication and encryption purposes.
[0271] Referring further to FIG. 7A, after completion of the optional authentication process by operation 1005c, the analyte sensor system 308 and the connected display device 310 and / or partner device 315 may engage in data communication in operation 1005d, during which the connected display device 310 and / or partner device 315 can request and receive desired information (e.g., analyte data, control information, identification information, and / or instructions) from the analyte sensor system 308 and / or can transmit information including commands and control signaling or other information such as, for example, drug-related information. When the data communication in operation 1005d is complete, the data connection can end in operation 1015 (e.g., by closing the established communication channel).
[0272] However, in other situations, the continuous connection model may be appropriate and / or preferred as compared to the intermittent connection model described above. At a high level, the continuous connection model can include an initial pairing between the analyte sensor system 308 and the display device 310 and / or the partner device 315, after which the analyte sensor system 308 and the display device 310 and / or the partner device 315 remain connected and do not essentially close or disconnect the connection. That is, the connection and data exchange in the exemplary implementation are not performed periodically or intermittently as in the intermittent connection model (e.g., as described with reference to FIG. 7A), and instead, the connected devices exchange messages periodically to maintain the connection. When data becomes available in the analyte sensor system 308, the data can be transmitted to the display device 310 and / or the partner device 315 in substantially real time or at least substantially real time. In this way, the overall accuracy and responsiveness of the communication related to the analyte data can be improved. An additional advantage associated with the continuous connection model is that the analyte sensor system 308 may be able to better mitigate interference caused by unwanted devices (e.g., in some cases, an unwanted display device 310) that seek to connect to the analyte sensor system 308. Thus, the reliability of the data exchange and the robustness of the connection can be enhanced, which can be particularly important when the user depends on the partner device 315 for the administration of a drug such as insulin.
[0273] As an example, a potential increase in the reliability of data exchange can be beneficial, for example, when the partner device 315 is an insulin pump used to automatically deliver insulin to a user based on analyte data generated using the analyte sensor system 308 and transmitted to the partner device 315. In some such cases, the connection reliability / robustness between the analyte sensor system 308 and the partner device 315 is more important compared to the ability to establish a connection with a plurality of display devices 310, and as described above, connection requests from the display device 310 can cause interference with the connection or establishment of a connection between the partner device 315 and the analyte sensor system 308. For example, the continuous connection model used between the analyte sensor system 308 and the partner device 315 can function as a means to enhance the reliability / robustness of the connection, and thus may be preferred in certain embodiments involving the partner device 315, as well as in other situations described and / or suggested herein.
[0274] Accordingly, embodiments of the present disclosure include using a continuous connection model between specific devices. Such a connection model can, in some cases, shorten the delay between the collection and / or generation of analyte data at the analyte sensor system 308 and the transmission of such data, related data, and control signaling to the connected display device 310 and / or partner device 315, as well as the exchange of drug-related data and control signaling, while maintaining a sufficiently low power consumption of the analyte sensor system 308. Further, as described above, the continuous connection model can enhance the reliability / robustness and predictability of the connection between the analyte sensor system 308 and the display device 310 and / or partner device 315.
[0275] In this regard, FIG. 7B shows an exemplary implementation of a method 702 for wireless communication of analyte data between and / or among an analyte sensor system 308, a display device 310, and / or a partner device 315 according to an exemplary implementation of the continuous connection model suggested above. A communication session 740 can be initiated in connection with method 702. More specifically, as shown in FIG. 7B, communication session 740 can be accompanied by operations 1095a - 1095g and / or 1095a', although in embodiments not all of these operations are necessarily performed.
[0276] Similar to FIG. 7A, the various tasks performed in connection with the procedures shown in FIG. 7B can be performed, for example, by processors 430, 530, and / or 630 executing instructions embodied in respective storage devices 415, 515, and / or 615 (which may include, for example, non-transitory computer-readable media). The tasks or operations performed in connection with the procedures are generally not necessarily related to all of the procedures, operations, and methods described herein, and can be performed by hardware, software, firmware, and / or any combination thereof incorporated in one or more computing devices such as analyte sensor system 308, display device 310, server system 334, and / or partner device 315. It will be understood that upon review of this disclosure, the procedures can include any number of additional or alternative tasks or operations. The operations shown as examples in FIG. 7B are not necessarily performed in the order shown, and the procedures can be incorporated into more comprehensive procedures or processes having additional functionality not described in detail herein with particular reference to FIG. 7B.
[0277] With respect to the continuous connection model, if the connection between the analyte sensor system 308 and the display device 310 and / or the partner device 315 is not maintained, analyte data may be dropped or lost. This can lead to an inappropriate or inaccurate representation of analyte information such as estimated glucose values, and in some cases, can lead to the administration of drugs that are not as accurate or precise as desired. Therefore, embodiments of the present specification related to the continuous connection model involve sustaining and / or maintaining the connection established between the analyte sensor system 308 and the display device 310 and / or the partner device 315. Further, with respect to maintaining the connection, it may be useful to monitor the connection status and derive and / or provide an indication thereof. One way to do this is to use connection parameters.
[0278] In operation 1095a, method 702 may involve activating the transmitter of the analyte sensor system 308 and / or transmitting an advertisement message. This transmission of the advertisement message may be substantially similar to operation 1005a described above. The advertisement message transmitted in operation 1095a may be received, for example, by one or more display devices 310 and / or partner devices 315.
[0279] In operation 1095b, a connection may be established between the analyte sensor system 308 and the display device 310 and / or the partner device 315 that responds to the advertisement message. As part of operation 1095b, connection parameters may be exchanged between the analyte sensor system 308 and the display device 310 and / or the partner device 315. In this regard, the analyte sensor system 308, the display device 310, and / or the partner device 315 may propose and set up a set of connection parameters based on the manner of connection to the analyte sensor system 308.
[0280] Examples of connection parameters include connection interval (which in some cases may be referred to herein as ping interval), slave delay, and monitoring timeout. The analyte sensor system 308 and / or the display device 310 and / or the partner device 315 can use one or more of such connection parameters to maintain a connection for continuously exchanging data related to, for example, analyte levels, drug delivery, associated control signaling, system configuration signaling, etc. Additional connection parameters may relate to control signaling such as mode control of the display device 310 and / or the partner device 315, and / or control signaling related to network topologies that can be implemented in accordance with the embodiments described herein.
[0281] Following the connection determination that results in the establishment of a connection, in operation 1095c, method 702 may optionally involve authentication. In operation 1095d, an embodiment of method 702 includes exchanging data among / between the analyte sensor system 308, the display device 310, and / or the partner device 315. With respect to the continuous connection model, operation 1095d is periodically repeated when data transmission becomes available (e.g., in some cases non-periodically) and / or whenever required to exchange data (e.g., on demand). The exchange of data by operation 1095d may be interspersed with the exchange of other messaging, such as ping messaging or other control-related messaging exchanged with the analyte sensor system 308. In FIG. 7B, this may be represented, by way of example, using operations intervening between operations 1095d and 1095d' (i.e., operations 1095e and 1095f), although specific types of control signaling may not be explicitly shown.
[0282] In an embodiment, connection parameters agreed upon in connection with connection establishment (e.g., as part of operation 1095b), as well as other configuration aspects, may be updated / modified, for example, after a connection decision has been made. Thus, in operation 1095f, method 702 may involve updating one or more of the connection parameters. As shown in operation 1095g, in some cases, the connection with the analyte sensor system 308 may be terminated or lost. This can have various causes. In response to the connection being lost in operation 1095g, the analyte sensor system 308 may transmit an advertisement message by operation 1095a'. According to an exemplary embodiment of the continuous connection model, when the analyte sensor system 308 is disconnected from the display device 310 and / or the partner device 315, the analyte sensor system 308 may resume transmitting the advertisement message at least substantially immediately in some cases.
[0283] The user of the display device 310 and / or the partner device 315 may not notice the disconnection in operation 1095g. This can result in packet drops or data loss in some cases. Therefore, in some cases, the analyte sensor system 308 may automatically resume the advertisement without user intervention. Alternatively or in addition to this, the user may receive a notification that the connection has been lost via the analyte sensor system 308, the display device 310, and / or the partner device 315.
[0284] FIG. 7C shows that, in addition to the intermittent connection model and the continuous connection model, embodiments of the present disclosure also involve communication of data via broadcast of packets when establishment of such a connection is not necessary. As described in more detail herein, broadcast of data packets occurs when a particular device connectable to the analyte sensor system 308, such as the display device 310, is set to a display-only state, and another connectable device(s), such as the partner device(s) 315, has established a connection with the analyte sensor system 308 and is exchanging data and command / control messaging with the analyte sensor system 308.
[0285] In FIG. 7C, a method 706 for wireless communication of analyte-related data, drug-related data, and / or other information between and / or among the analyte sensor system 308, the display device 310, and / or the partner device(s) 315 is shown in connection with an implementation of the present disclosure. An exemplary embodiment of the method 706 involves, for example, establishing a first connection between the analyte sensor system 308 and the display device 310 and / or the partner device(s) 315. This is optional and may occur in connection with a communication session 720 corresponding to T interval Thus, establishing the first connection can optionally include authentication between the analyte sensor system 308 and the display device 310 and / or the partner device(s) 315.
[0286] The method 706 also involves interval which may be the same as or different from T, and establishing a communication session 760 that can be implemented during a time interval T interval ’. T interval ’ may include an active portion corresponding to T Active ’ and a non-active portion corresponding to T Inactive ’. During T Active ’, the communication session 760 may involve operation 1065 and sub-operations thereof.
[0287] Here, as noted above, it should be noted that communication session 760 may not include the establishment of a connection between and / or among the analyte sensor system 308, the display device 310, and / or the partner device. For example, the illustrated communication session 760 does not include the data connection mode of operation 1005b shown in FIG. 7A in relation to communication session 720. The illustrated communication session 760 also does not include the authentication process that may be included in communication session 720 (e.g., at operation 1005c). Rather, at operation 1065a, method 706 involves transmitting one or more advertisement messages to the display device 310 and / or the partner device 315.
[0288] Accordingly, as part of communication session 760, the analyte sensor system 308 may transmit a first advertisement message (e.g., at operation 1065a). The first advertisement message may include at least a first portion of the analyte value. The analyte value may not need to be encrypted (e.g., using an application key) prior to transmission. In other words, with respect to communication session 760, the analyte sensor system 308 may use one or more advertisement messages to transmit encrypted or unencrypted analyte values or analyte data and / or other signaling (e.g., timing and control information, etc.) in addition to other information that may be included in the advertisement message.
[0289] In some cases, the advertisement message may take the form of a packet. By way of example, analyte values (whether encrypted or not) may be included in reserved fields or other fields of the advertisement message packet and / or may be encoded in the packet. The advertisement message may also or additionally include other information such as, for example, a timestamp associated with the analyte value. In an exemplary implementation, method 706 may involve splitting a payload that may include an (encrypted) analyte value and associated data into a plurality of parts. In that case, a first advertisement message may indicate that a second advertisement message includes a second part of the analyte value and / or associated data. The first advertisement may be able to indicate so by tagging a first part of the payload, in which case the tag represents that a subsequent advertisement message may include a second part of the payload.
[0290] In other words, according to communication session 760, an advertisement message may be transmitted in connection with operation 1065a for the purpose of communicating analyte and / or other data to display device 310 and / or partner device 315. Encrypting the payload using the application key may maintain privacy / security even in the absence of authentication procedures executed during communication session 760. Similarly, since the payload is included in the advertisement message, data connection requests and data transmission processes (e.g., operations 1005b and 1005d, respectively, with reference to FIG. 7A) may also be bypassed or avoided. In this way, the number of messages (and thus power consumption) exchanged according to communication session 760 may be reduced compared to other communication sessions. Additionally, for example, even if partner device 315 maintains a dedicated connection to analyte sensor system 308 and functions as the only device having permission to transmit commands and control signals (e.g., calibration commands associated with the sensor session) to analyte sensor system 308, analyte and other data may be provided to display device 310.
[0291] Referring further to FIG. 7C, communication session 760 may also include, at operation 1065b, acknowledging receipt of the advertisement message(s) transmitted by display device 310 and / or partner device 315 during operation 1065a by sending an acknowledgement (ACK) message. In some cases, this acknowledgement may trigger data connection processing between the analyte sensor system 308 and the display device 310 and / or partner device 315 that acknowledges. For example, the analyte sensor system 308 may then send an ACK to the display device 310 and / or partner device 315, thereby establishing a connection with them. This data connection processing may be used, in an exemplary deployment, for updating applications and / or encryption key(s), and / or for exchanging other data, such as calibration data, timing information, permissions, and mode control signaling. When the communication at operation 1065 is complete, data transmission may end at operation 1075. At this point, the transceiver 510 and / or processor 530 of the analyte sensor system 308 may be deactivated. In FIG. 7C, this generally corresponds to operation 1075, T Inactive is appended with ’.
[0292] As described above, various trade-offs can exist between the intermittent connection model and the continuous connection model. For example, using the continuous connection model, in some cases, the battery power may be consumed more quickly, but the reliability / robustness can be improved. Therefore, in some cases, it may be desirable to switch to the intermittent connection model. In another example, due to multiple connection requests / acknowledgments, when operating in the intermittent connection model, there may be a higher possibility that data is dropped / lost. Therefore, in some cases, it may be desirable to switch to the continuous connection model. In an additional example, the control / command signaling permission of a specific device may be changed, for example, due to a change in the network topology and / or the operating mode. In such a case, the connection model may also be changed (for example, including the broadcast method for advertisements described with reference to FIG. 7C).
[0293] Accordingly, embodiments of the present disclosure involve switching between these connection models to provide a flexible and adaptable system that can be optimized for various applications, operating conditions, and user / system preferences. By adaptively switching (whether in an automated manner or based on user input, both are considered here), it becomes possible to optimize the battery power usage, as well as the transmission efficiency, data accuracy, and connection reliability / robustness. Additionally, in accordance with an exemplary embodiment, it can be used to track the performance and behavior of a device over time and develop an optimization profile for situations where various connection models may be preferred.
[0294] In some cases, the connection model can be automatically switched according to various criteria. For example, the connection model may be set according to the type of the display device 310 and / or the partner device 315 connected to the analyte sensor system 308. For example, the connection model may be set based on the number of display devices 310 being used. For example, when a single dedicated device is being used (e.g., for a predetermined amount of time), the system may switch to a continuous connection model. Or, when many display devices 310 are being used, the many display devices 310 may utilize the communication session 740. In another example, the connection model may be switched based on the current or predicted battery life of the analyte sensor system 308, the display device 310, and / or the partner device 315. Also, the quality of the exchanged signals can be used to determine whether switching between connection models is appropriate. Further, the switching of the connection model may be based on the time and / or location of the analyte sensor system 308, the partner device 315, and / or the display device 310. The switching may be initiated by the display device 310, the partner device 315, and / or the analyte sensor system 308 (e.g., using mode control signaling).
[0295] In an embodiment, the switch may be based on user input or may be semi-automatic. For example, a user may operate a GUI provided by the user interface 435 of the display device 310 to implement the switch. In another example, the switch may be triggered automatically or without user intervention (e.g., by or in response to a partner device 315), and then a prompt may be triggered to be presented to the user on the display device 310 via the GUI of the user interface 435. The user may then approve or reject the switch (and thus the switch can be semi-automatic). The prompt may provide information regarding the currently used connection model, the reason for the proposed switch, and in some cases, the consequences of rejecting and / or accepting the proposed switch. In other examples, the prompt may not be provided to the user.
[0296] Turning now to FIG. 7D, embodiments of the present disclosure involve configuring and / or setting up a kind of mesh network using various connection models described herein (e.g., referring to FIGS. 7A-7C). For example, the display device 310 and / or the partner device 315 (and / or multiple, any of the devices) can be connected to the analyte sensor system 308 using different connection models. Referring to FIG. 7D and the example of the system 304 shown, the analyte sensor system 308 may be connectable to the display device 310 and / or the partner device 315 via the communication medium 305 (see FIG. 2B). Further, the display device 310 and the partner device 315 may be connectable to each other via the communication medium 305 (again referring to FIG. 2B). Although the communication medium 305 is referred to here, it will be understood that additional communication media and / or links can be included in the mesh network described herein and / or the use of various connection models (e.g., communication media 305a, 305b, etc., see FIG. 2B).
[0297] Referring back to FIG. 7D, for example, a communication session 740 can be used between the analyte sensor system 308 and the partner device 315, while at the same time, different communication sessions (e.g., 720, 760, etc.) can be used between the display device 310 on one side and the analyte sensor system 308 on the other side. Additionally, yet another communication session can be used between the display device 310 and the partner device 315. FIG. 7D shows, in relation to the system 304, that the analyte sensor system 308 can be connectable to the display device 310 and / or the partner device 315 using various communication media (e.g., communication medium 305) and / or connection models (e.g., intermittent connection model, continuous connection model, etc.) illustrated as connections A and B for example. Additionally, the display device 310 and the partner device 315 may be connectable to each other using various communication media 305 and / or connection models illustrated here as connection C for example. Specific details of the continuous connection model and the intermittent connection model are described in more detail in U.S. Provisional Patent Applications Nos. 62 / 364,771 and 62 / 409,677, which are hereby incorporated by reference in their entirety.
[0298] For example, if the display device 310 and the partner device 315 are within range and connectable to the analyte sensor system 308, the analyte sensor system 308 and the display device 310 may connect to the analyte sensor system 308 using an intermittent connection model (e.g., connection A), and the partner device 315 may connect to the analyte sensor system 308 using a continuous connection model (e.g., connection B). Under the intermittent connection model, as an example, the display device 310 periodically connects to the analyte sensor system 308, exchanges data with the analyte sensor system 308, and then disconnects. As an example, under the continuous connection model, the partner device 315 and the analyte sensor system 308 establish a connection and then continuously exchange signaling to maintain that connection during data exchange. As a further example, in the intermittent connection model, during subsequent periodic connections, other devices may attempt to connect to the analyte sensor system 308 or connect simultaneously with the display device 310, and the display device 310 may fail when reconnecting to the analyte sensor system 308 (various other situations may also lead to this). In contrast, under the continuous connection model, typically unless there are significant events, the connection between the partner device 315 and the analyte sensor system 308 is likely to be maintained and not interrupted. In this way, the partner device 315 can maintain a more reliable and prioritized connection with the analyte sensor system 308 and as a result can have a better quality of service. Thus, for example, in patient-critical applications such as the automatic delivery of insulin by the partner device 315, a continuous connection model such as between the partner device 315 and the analyte sensor system 308 may be preferred.
[0299] Referring further to FIG. 7D, the partner device 315 and the display device 310 can maintain communication via connection C using any connection model described herein. Therefore, the partner device 315 can directly share drug delivery data and other information with the display device 310. It will be further understood here that the respective connection models used by the display device 310 and the partner device 315 to connect to the analyte sensor system 308 can be switched. Also, it will be understood that both the display device 310 and the partner device 315 can connect to the analyte sensor system 308 using an intermittent connection model or a continuous connection model. Also, in embodiments, one or more of the analyte sensor system 308, the display device 310, and the partner device 315 can use an advertisement broadcast connection scheme of the communication session 760 for any of the connections A, B, and / or C of the system 304, as described herein.
[0300] Regardless of the connection model used between the analyte sensor system 308 on one side and the display device 310 and / or the partner device 315 on the other side, the display device 310 and the partner device 315 can be connected to each other using any of an intermittent connection model, a continuous connection model, and / or an advertisement broadcast connection scheme of the communication session 760 (see FIG. 7C). Further, either the communication medium and / or any of the connection models used (e.g., connection A, connection B, and connection C) can be switched to a different connection model after connection establishment, including during subsequent communication sessions.
[0301] H. Summary of Warnings In certain embodiments, one or more warnings, alarms, and / or notifications (in some cases, simply "warnings") are associated with the analyte sensor system 308, the display device 310, and / or the partner device 315. For example, a warning may be accompanied by one or more warning conditions indicating when each warning was triggered. A warning may be triggered based on characteristics of analyte data generated using the analyte sensor system 308. For example, a hypoglycemic warning may include a warning condition indicating a minimum glucose level. Warning conditions may also be based on transformed sensor data, such as trend data, and / or sensor data from multiple different sensors (e.g., a warning may be based on sensor data from both a glucose sensor and a temperature sensor). For example, a hypoglycemic warning may include a warning condition indicating a minimum required trend of the host's glucose level that must have been present before triggering the warning. As used herein, the term "trend" generally refers to data indicating some attribute of data acquired over time, such as calibrated or filtered data from a continuous glucose sensor. A trend may indicate an amplitude, rate of change, acceleration, direction, etc. of data such as sensor data, including transformed or raw sensor data.
[0302] In embodiments, a warning may be triggered based on an event or condition monitored or detected by the partner device 315. For example, a warning is triggered when it is determined that there is a mechanical or other malfunction in the partner device (e.g., based on self-diagnosis). In an exemplary implementation where the partner device 315 is an insulin pump, a warning may be triggered based on a pump malfunction such as an occlusion. In embodiments, a warning may be triggered when the partner device 315 is not delivering insulin to the user or is not delivering insulin according to a calculated dosage (e.g., based on analyte data).
[0303] In certain embodiments, each warning is associated with one or more actions that are to be performed in response to a warning trigger. Warning actions can include, for example, activating an alarm via the user interface of the analyte sensor system 308, such as displaying information on a display of the analyte sensor system 308, activating an audible or vibrating alarm of the analyte sensor system 308. In an embodiment, the warning operation includes transmitting data to one or more display devices 310 and / or partner devices 315 such that a warning can be provided via the user interfaces 435 and / or 635 (see FIGS. 4 and 5B). For the warning actions associated with a triggered warning, one or more delivery options can define the content and / or format of the data to be transmitted, the destination devices to which the data can be transmitted, the timing at which the data can be transmitted, and / or the communication protocol that can be used for the delivery of the data. For example, the propagation of the warning may be prioritized to partner devices 315. However, in embodiments, due to the number of connected devices that may be used in connection with the collection and use of analyte data, there may be a flood of warnings to the user. In such cases, it may be beneficial to coordinate warnings and notifications across the user's devices according to an escalation scheme that can be predefined, adaptable based on the network topology, and / or based on user preferences.
[0304] In certain embodiments, a plurality of warning actions (each having its own delivery option) can be associated with a single warning, such that in response to a trigger of the single warning, viewable sensor information or other warning information having different content and formats, for example, can be transmitted to respective display devices 310 and / or partner devices 315 or other devices. For example, a mobile phone may receive a data package containing minimal viewable sensor information (which may be specially formatted for display on the mobile phone), whereas a desktop computer may receive a data package containing most (or all) of the viewable sensor information generated by the sensor electronic module of the analyte sensor system 308 in response to a trigger of a general warning. Advantageously, the sensor electronic module need not be tied to a single display device 310, but rather can be configured to communicate directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to a query, based on a warning or alarm, etc., with a plurality of different display devices 310.
[0305] In embodiments, the analyte sensor system 308 is configured to provide one or more different alarms directly and / or via transmission of a data package indicating that an alarm should be initiated by one or more display devices 310 (e.g., sequentially and / or simultaneously). In certain embodiments, the analyte sensor system 308 simply provides a data field indicating the presence of a warning condition, and the display device 310 may determine to trigger an alarm when it reads the data field indicating the presence of an alarm condition. In some embodiments, the sensor electronics module determines which of one or more alarms to trigger based on one or more warnings that are triggered. For example, if a warning trigger indicates severe hypoglycemia, the analyte sensor system 308 can perform multiple actions such as activating a warning to the sensor electronics module, transmitting a data package indicating activation of the alarm to the display, and transmitting a data package as a text message to a care provider.
[0306] In embodiments, the analyte sensor system 308 is configured to wait for a host to respond to a triggered warning (e.g., by pressing or selecting a snooze and / or off function and / or button on the analyte sensor system 308 and / or display device 310), and then be able to trigger additional warnings (e.g., progressively) until it responds to one or more warnings. In embodiments, the analyte sensor system can be configured to transmit a control signal (e.g., a stop signal) to a partner device 315 associated with an alarm condition (e.g., hypoglycemia) such as an insulin pump, and the stop warning triggers the cessation of insulin delivery by the pump. Although the above has referred to configuring the analyte sensor system to provide and / or trigger warnings, it should be understood that the display device 310 and / or partner device 315 may additionally or alternatively provide and / or trigger warnings.
[0307] I. Integration of Connectivity of Partner Devices FIG. 8 depicts a system 800 that can be used, for example, in connection with wireless analyte (e.g., glucose) monitoring and, in some cases, for diabetes management including, for example, the delivery of medications. System 800 can involve various components interconnected via one or more wired and / or wireless connections for the communication and exchange of information such as analyte data, drug delivery data, diabetes management feedback and related guidance and services, alerts / notifications, control signaling, and other information.
[0308] As shown by way of example in FIG. 8, an embodiment of system 800 includes one or more analyte sensor systems 308, display devices 310a, 310b, and / or 310c, partner device 315, server systems 334a and / or 334b, and services 805 that may be provided via server systems 334a and / or 334b. Here, in the embodiment, server system 334b may be associated with partner device 315 and / or may be maintained by the manufacturer or provider of partner device 315, and server system 334a may be associated with analyte sensor system 308 and / or may be maintained by the manufacturer or provider of analyte sensor system 308. It should be noted that in addition, embodiment services 805 may be divided into separate services supported, maintained, facilitated, and / or provided by the manufacturer / provider of analyte sensor system 308 on one side and partner device 315 on the other side, respectively. Therefore, either or both of server systems 334a and 334b may provide a gateway for receiving services 805 (e.g., backend cloud services). For services 805 supported only for the manufacturer of partner device 315 (e.g., in some cases, insulin pump related information, warnings, malfunction support, etc.), such services 805 may be provided via server system 334b. For services 805 supported only for the manufacturer of analyte sensor system 308 (e.g., in some cases, another individual / entity provides the function of monitoring analyte data to the user of display device 310), such services 805 may be provided via server system 334a in this example. In an embodiment, services 805 may utilize both server systems 334a and 334b (e.g., in some cases, another individual / entity provides the ability to monitor analyte data and insulin administration data to the users of display device 310 and partner device 315). Additional aspects of remote services that may be provided via a cloud server, such as server systems 334a / 334b, are described below.
[0309] For the specific aforementioned components and features shown in FIG. 8, for example, most of them have been described above with reference to FIGS. 1, 2A, 2B, 3A - C, 4, 5A, 5B, 6, and 7A - D. As shown in FIG. 8, the component system 800 can be interconnected by various links 802a - d, 804a - b, 806a - b, 808a - b, and 810, and each of these links can be implemented using the communication medium 305 for communication purposes. It should be understood that the links 802a - d, 804a - b, 806a - b, 808a - b, and 810 can be any type of communication link, including, for example, point - to - point, broadcast, multicast, etc. Regarding the embodiments, it should be understood that the same numbers shown in the system 800 can be implemented in the manner described above.
[0310] FIG. 9A depicts a system 900 that can be used, for example, in connection with wireless analyte (e.g., glucose) monitoring and, in some cases, for diabetes management, including, for example, the delivery of medications. System 900 can involve various components interconnected via one or more wired and / or wireless connections for the communication and exchange of information such as analyte data, drug delivery data, diabetes management feedback and associated guidance and services, alerts / notifications, control signaling, and other information. Embodiments of system 900 can include a display device 910 that includes an analyte sensor 308, a mobile phone 910a, an analyte display device 910b, and / or a wearable device 910c, a partner device 915 that can include a drug delivery device 915a, a first insulin pump 915b, a second insulin pump 915c, and an insulin pen 915d, and / or a display device 910' that can include a mirror 910d, a vehicle 910e, and / or a key fob 910f. In the exemplary implementation shown in FIG. 9A, these components are configured to be part of a personal area network (PAN) 902 and are interconnected by links 906a-j, 908, 916, and 918 as shown in FIG. 9A, where in this case these links can each be implemented using a communication medium 305 for communication purposes. PAN 902 can use at least one of BLE, Wi-Fi, etc.
[0311] System 900 may also include a router 920a coupled to one or more devices within PAN 920 (e.g., to mirror 910d via link 914), although not all possible links are explicitly shown. Next, router 920a may be coupled via link 922 to server(s) 920(b) (e.g., server system 334 with reference to FIG. 2A), and the server 920(b) may be coupled via link 924 to a cellular network 920c (e.g., a 4G LTE network, etc.). Cellular network 920c may also be coupled via link 926 to a cellular-enabled device within PAN 902, such as a mobile phone 910a. In an embodiment, any of the devices shown in FIG. 9A may be cellular-enabled and, therefore, may be directly coupled to cellular network 920c and / or WAN 904 or elements thereof. For example, the analyte sensor system 308 may be equipped with cellular or other longer-range wireless components and, therefore, may be directly coupled to cellular network 920c and / or WAN 904 or elements thereof. As shown in FIG. 9A, router 920a, server(s) 920b, and cellular network 920c may be configured to be part of a wide area network (WAN) 904. Links 914, 922, 924, and 926 may be implemented using a communication medium 305 (e.g., may be wired or wireless, etc.). WAN 904 may generally provide cloud services to one or more devices within PAN 902. Again, not all possible links between devices within WAN 904 and devices within PAN 902 are explicitly shown, but they will be understood by those skilled in the art upon considering the present disclosure. It should also be understood that in some cases, elements of WAN 904 may be incorporated into PAN 902, or vice versa.
[0312] Some of the foregoing components and features of system 900 have been described above with reference to, at least, for example, FIGS. 1, 2A, 2B, 3A - 3C, 4, 5A, 5B, 6, and 7A - 7C. Those skilled in the art, upon considering this disclosure, will recognize where and how the above description of these components may be applicable and whether it is explicitly conveyed herein.
[0313] With respect to system 900, when system 900 includes partner device 915, two examples may drive particular arrangements and / or implementations of the foregoing components of system 900 for wireless analyte monitoring and / or diabetes management. The first example does not involve drug (e.g., insulin) delivery by partner device 915 (e.g., by drug delivery device 915a). Under this example, in an embodiment, system 900 includes analyte sensor system 308, one or more display devices 910, 910' (e.g., mobile phone 910a and / or analyte display 910b) having the authority to transmit command / control signals to analyte sensor system 308, and one or more display devices 910, 910' (e.g., wearable device 910c and / or key fob 910f) configured to be in a display - only state. In an embodiment, this example involves display devices 910a and 910b (e.g., smartphone 120 and analyte display device 110, referring to FIG. 1) operating in a command / control state, and one or more display devices 910, 910' operating in a display - only state (e.g., key fob 910f and smart mirror 910d or wearable device 910c, etc.).
[0314] Unlike the first example, the second example involves the delivery of a drug (e.g., insulin) by at least one of the partner devices 915 (e.g., the drug delivery device 915a). The drug delivery by the drug delivery device 915 in this example may or may not be automated (e.g., an automatic insulin pump or a non-automatic insulin pen). In this second example where the drug delivery device 915a that delivers the drug is part of the system 900, interoperability issues may be introduced regarding which device (e.g., the drug delivery device 915, the analyte sensor system 308, and / or the display devices 910, 910') can control / manage the generation of analyte data, including calculations such as CGM values.
[0315] Regarding this second example, to flexibly and adaptively support the potentially varying and empirically unknown system requirements 650 (e.g., see Figure 5B) of the various partner devices 915 from an interoperability perspective, such partner devices 915 may be provided by various manufacturers / developers different from those of the other components of the system 900 (e.g., the display devices 910, 910' and / or the analyte sensor system 308, etc.). In some cases, the drug delivery device 915a (or a similar partner device 915) must be able to control the data exchange between the analyte sensor system 308 and the display devices 910, 910' via the links 906a - g. Such control may be provided, for example, by the user of the display devices 910, 910 (e.g., the user of the phone 910a who is given control authority over the drug delivery device 915 via the link 916 using the mobile phone 910a).
[0316] In embodiments, aspects of communication sessions and / or sensor sessions should also be controlled (e.g., partner device 915, analyte sensor system 308, and / or display devices 910, 910' may have to limit command / control signaling in some cases, including when such signaling is related to analyte data). For example, when drug delivery device 915a is used for insulin delivery, transmission of command signaling to analyte sensor system 308 may be restricted to only certain devices within system 900. Certain partner devices 915 may be generally less robust in some cases, e.g., in terms of maintaining accuracy in a relatively high interference environment. In such cases, for example, due to system requirements 650 of drug delivery device 915a, if display devices 910, 910' are restricted from transmitting control / command signaling related to, e.g., start, stop, calibration of a sensor session, the probability that drug delivery device 915a receives inaccurate analyte data from analyte sensor system 308 can be reduced. For example, such signaling can result in analyte sensor system 308 operating in a manner that is not compliant, optimal, or preferred with respect to drug delivery 915a, as may be reflected, e.g., by its system requirements 650. In embodiments, it may be beneficial to delegate the authority to send control / command signals to only certain devices within system 900, based on device type and / or based on the mode of operation of system 900. In embodiments, it can be beneficial to manage the flexible addition or removal of devices (e.g., partner device 915 and / or display devices 910, 910') to and from system 900, whether in PAN 902 or WAN 904, to manage access of such devices to analyte sensor system 308, and / or to manage how alerts propagate across various such devices and other devices within system 900.
[0317] In embodiments, it may also be beneficial for system 900 (e.g., including drug delivery device 915a) to provide means for controlling warning settings for safety and / or robustness purposes. In embodiments, either literally, or due to system constraints such as power, and / or depending on other network conditions / configurations of PAN 902 and / or WAN 904 described herein, if a particular link becomes unavailable (e.g., link 906d between analyte sensor system 308 and drug delivery device 915a, link 922 between mobile phone 910a and cell network 920c, etc.), it may be beneficial to adaptively change aspects of system 900. Additionally, in some cases, it is beneficial to authenticate partner device 915 that attempts to establish a connection with analyte sensor system 308 and / or prevent unauthorized partner device 915 from accessing analyte sensor system 308.
[0318] Accordingly, embodiments of the present disclosure provide a more flexible / adaptable system of an analyte sensor system 308, display devices 910, 910' and / or partner devices 915, and methods of using the same, such flexibility / adaptability including setting or modifying configuration parameters 520 of the analyte sensor system 308, alerts / alarms that may propagate through the system 900, control / command functions of the display devices 910, 910' and / or partner devices 915, connection models used between devices within the system 900, etc. In embodiments, a diabetes management partner interface (DMPI) 750, which may be implemented using the analyte sensor system 308, is at least partially used to facilitate flexibility / conformance. As will be described in further detail, in embodiments, various devices within the system 900, such as for example partner device 915, utilize the DMPI 750 to access / modify configuration parameters 520 of the analyte sensor system 308 and / or aspects thereof, and / or to (re)configure aspects of the display devices 910, 910' for operation in accordance with system requirements 650 of, for example, partner device 915 (e.g., drug delivery device 915a). For example, system requirements 650 may be driven based on safety and / or regulatory requirements applicable to the drug delivery device 915a, configuration / settings / constraints of the user experience, power consumption specifications / constraints, etc. System requirements 650 are used to determine the format of data packages transmitted to the partner device 915 and / or display devices 910, 910', and the protocol used to transmit such data packages based on respective preferences / specifications / etc. of the partner device 915 and / or display devices 910, 910'.
[0319] Referring further to FIG. 9A, an exemplary embodiment with various partner devices 915 within system 900 is described herein. In the exemplary implementation described below, system 900 may include three partner devices 915, namely, a first insulin pump 915b, a second insulin pump 915c, and an insulin pen 915d. Generally, each of these three partner devices 915 may have different functions and performance characteristics that may be reflected in the specific respective system requirements 650 (see FIG. 5B) of the three partner devices 915. Each of the three partner devices 915 may use the DMPI 750 of the analyte sensor system 308 (see FIG. 10A by way of example) to modify the configuration parameters 520 of the analyte sensor system 308 in accordance with its respective system requirements 650. In this way, the analyte sensor 308 can be adapted to better interoperability between either the first and second insulin pumps and the insulin pen, and always either partner device 915 is connected within the analyte sensor system 308 and / or system 900. Considering the present disclosure, it will be understood that this description of the first insulin pump 915b, the second insulin pump 915c, and the insulin pen 915d is equally applicable to any example of partner devices 915 including the drug delivery device 915a and similar devices.
[0320] For illustrative purposes, further details are provided regarding the respective characteristics of the first and second insulin pumps 915b, 915c and insulin pen 915d in these illustrative implementations. As an example, the first insulin pump 915b may have a relatively robust algorithm for drug administration, may have a larger (or higher capacity) battery or power source, and may require that blood glucose calibration be performed every 12 hours. The relatively robust algorithm of the first insulin pump 915b may essentially mean that such interference is relatively immune to interference from other devices that may attempt to connect to the analyte sensor system 308, such as display devices 910, 910', including cases where such interference may be associated with interference during connection establishment or transmission of command signaling to the analyte sensor system 308. For example, the algorithm of the first insulin pump 915b may be able to operate better over a wider range of configuration parameters 520 and may be able to better handle calibrations and start / stop events initiated by other devices. The 12-hour blood glucose calibration requirement may reflect the accuracy constraints of the first insulin pump (and can be reflected, for example, in the system requirements 650 of the first insulin pump 915b).
[0321] As a further example, the second insulin pump 915c may have a relatively less robust algorithm for drug administration and may have fewer constraints with respect to blood glucose accuracy calibration (e.g., it may be possible to use factory calibration accuracy levels), and may support remote services provided by the server 920b (e.g., via a connection / link to the server 920b via the cellular network 920c (not shown in FIG. 9A), indirectly via the router 920a (links not shown either), or indirectly, for example, via the mobile phone 910a). The relatively less robust algorithm of the second insulin pump 915c may essentially mean that the second insulin pump 915c is designed to operate well in a high interference environment when other devices within the system 900 may be competing to establish a connection with the analyte sensor system 308 and / or may be transmitting command / control signals to other devices.
[0322] Continuing with the exemplary examples, the insulin pen 915d may have hard / soft keys for receiving user input and may include a simple user interface, both of which can be represented, for example, by the user interface 635 (see FIG. 5B). The insulin pen 915d may be further adapted to query and share data with the analyte sensor system 308, for example, to read analyte data from the analyte sensor system 308 and to share insulin-related information (e.g., related to dosage) with the analyte sensor system 308.
[0323] Given the above exemplary information regarding the first insulin pump 915b, the second insulin pump 915c, and the insulin pen 915d, an exemplary scenario of how the DMPI 750 can be used to flexibly adapt the system 900 is provided herein. A first exemplary scenario may involve using the first insulin pump 915b together with the analyte sensor 308. When the first insulin pump 915b and the analyte sensor system 308 are configured for use (e.g., applied to a user, powered on, etc.), the first insulin pump 915b may control the analyte sensor system 308 and may require user permission to initiate drug administration to the user. For example, such a request may be provided to the user via the user interface 435 of the mobile phone 910a (see FIG. 4) that may be connected to the analyte sensor system 308 and / or the first insulin pump, via the user interface 635 of the first insulin pump 915b (see FIG. 5B), and / or via the user interface of the analyte sensor system 308. If the user permits the request, in accordance with the system requirements 650 of the first insulin pump 915b, the first insulin pump 915b may use the DMPI 750 to access and set and / or change the configuration parameters 520 of the analyte sensor system 308 (e.g., see FIG. 10A).
[0324] In this example, from the perspective of the first insulin pump 915b accessing the configuration parameters 520 via the DMPI 750, the developer of the first insulin pump 915b may already have integrated and tested the pump 915b with the analyte sensor system 308 before the product is sold or provided to the user. In this way, the first insulin pump 915b can include in the storage device 615 instructions, code, or other files that enable the first insulin pump 915b to appropriately operate the DMPI 750 and the configuration parameters 520. In an embodiment, such instructions can be obtained by the first insulin pump 915b by downloading and / or installing a software design kit associated with the analyte sensor system 308. For example, the insulin pump 915b may obtain such instructions or other information from the server 920b and / or the WAN 904 or elements thereof.
[0325] As an example, the first insulin pump 915b can use the DMPI 750 to change one or more wireless connectivity parameters of the configuration parameters 520. The wireless connectivity parameters can include settings related to a database that includes / stores information (e.g., a whitelist) related to the accessibility of the device maintained by the analyte sensor system 308, and the first insulin pump 915b can change such a whitelist setting, for example, so that the first insulin pump 915b does not have to age off the whitelist until the battery level of the first insulin pump 915b drops below a certain threshold (e.g., 5%). As described above, since the first insulin pen 915b has a larger battery (e.g., a higher battery capacity), the first insulin pump 915b may set the wireless connectivity parameters in this manner, and for example, if the first insulin pump 915b is disconnected from the analyte sensor system 308 for some reason (e.g., by going out of range), it may be beneficial for the first insulin pump 915b to attempt to re - establish a connection with the analyte sensor system 308 whenever an opportunity arises.
[0326] The first insulin pump 915b can set or change additional wireless connectivity parameters, such as the timeout setting of the transmission of the advertisement message, using the DMPI 750 so that, for example, the analyte sensor system 308 advertises for a total of 1 second before stopping the transmission of the advertisement message. That is, in this example, the advertisement period 614 (see FIG. 6) may be set to 1 second. If it is appropriate for the first insulin pump 915b to not advertise for a longer time (for example, once every advertisement window interval 612 which may be 5 minutes in some cases), the first insulin pump 915b can have a relatively accurate scan algorithm (as may be determined by, for example, the developer of the first insulin pump 915b or by other means) so that the first insulin pump 915b can reliably establish a connection with the analyte sensor system 308, and thus the wireless connection parameters can be set in this manner. By shortening the advertisement window interval 612, battery power can be conserved.
[0327] Furthermore, the first insulin pump 915b can use the DMPI 750 to change one or more access control parameters of the configuration parameters 520. The access control parameters can include, for example, the number of display devices 910, 910' to which the analyte sensor system 308 can maintain a connection, and / or, for example, the level of access or control that such display devices 910, 910' can have with respect to the analyte sensor system 308. By way of example, the first insulin pump 915b may set either or both of these access control parameters such that there are no restrictions. As described above, since the first insulin pump 915b has a relatively robust algorithm for insulin administration, the first insulin pump 915b may set the access control parameters in this manner, and thus there is no need to prevent other devices from sending calibrations (e.g., because the algorithm of the first insulin pump 915b may be able to process such external events and adjust to them accordingly).
[0328] In addition, the first insulin pump 915b of this example may use the DMPI 750 to change one or more analyte data parameters of the configuration parameters 520. The analyte data parameters may include the calibration period of the analyte sensor system 308. For example, the first insulin pump 915b may set the calibration period to 12 hours in accordance with the above-described system requirements 650 of the first insulin pump 915b.
[0329] A second exemplary scenario may involve using a second insulin pump 915c with an analyte sensor 308. Similar to the above example with the first insulin pump 915b, after setup and authorization, the second insulin pump 915c may use the DMPI 750 to access and set and / or modify the configuration parameters 520 of the analyte sensor system 308 according to the system requirements 650 of the second insulin pump 915c (see, e.g., FIG. 10A). Similar to the previous example, from the perspective of the second insulin pump 915c accessing the configuration parameters 520 via the DMPI 750, the developer of the second insulin pump 915c may already have integrated and tested the pump with the analyte sensor system 308 before the product is sold or provided to the user. In this way, the second insulin pump 915c may be adapted to operate the DMPI 750 and the configuration parameters 520 appropriately. In an embodiment, the second insulin pump may also reconfigure the DMPI 750 before accessing the configuration parameters 520.
[0330] Regarding the second exemplary scenario, several situations are envisioned here. In a first situation, as a first matter in deciding to use an insulin delivery device, the user selects the second insulin pump 915c instead of the first insulin pump 915b or insulin pen 915d. In a second situation, the user may have been using the first insulin pump 915b or insulin pen 915d for some time, but may then be able to switch to the second insulin pump 915c. That is, the first insulin pump 915b and the second insulin pump 915c and / or insulin pen 915d are not necessarily used simultaneously, but this example contemplates that the first insulin pump 915b and the second insulin pump 915c and / or insulin pen 915d are used sequentially (e.g., the user decides to use a different pump product or the first pump product breaks, etc.). It should also be understood that the partner device 915 may be used sequentially.
[0331] As an example, the second insulin pump 915c can set or change the wireless connectivity parameters of the analyte sensor system 308, including the timeout setting for the transmission of an advertisement message, using the DMPI 750 such that, for example, the analyte sensor system 308 can advertise for a total of 5 seconds before ceasing transmission of the advertisement message. The second insulin pump 915c may have a relatively inaccurate scan algorithm (as may be determined, for example, by the developer of the second insulin pump 915c or by other means) such that there may be cases where the second insulin pump 915c may not be able to reliably establish a connection with the analyte sensor system 308 if it is appropriate to not advertise for a relatively longer period of time (for example, once every advertisement window interval 612 which may be 5 minutes in some cases), and thus the wireless connection parameters can be set in this manner.
[0332] In addition, the second insulin pump 915c of this example may change additional wireless connectivity parameters using the DMPI 750. Such wireless connectivity parameters may be related to the use of a remote (e.g., cloud-based) service (e.g., service 805 with reference to FIG. 8) that may be provided by server 920b. By way of example, the second insulin pump 915c may configure wireless connectivity parameters to enable the use of such a remote service (e.g., a cloud-based support module) and transmit diabetes management feedback received in relation to such a remote service to display devices 910, 910' (e.g., in some cases the display devices 910, 910' may be in a display-only state / mode) that may be within the range of the analyte sensor system 308 and / or connectable to the analyte sensor system 308. The second insulin pump 915c may configure these wireless connectivity parameters in this way because it may be approved to propagate such diabetes management feedback to other display devices 910, 910', etc. Further, the second insulin pump 915c may configure these wireless connectivities and set related notifications to display devices 910, 910', etc. that can be within the range of the analyte sensor system 308 and / or connected to the analyte sensor system 308 so that the diabetes management feedback function can be disabled if the remote service becomes unavailable (e.g., due to the loss of links 914, 922, 924 or 926 to server 920b, etc.).
[0333] Furthermore, the second insulin pump 915c may change one or more access control parameters of the configuration parameters 520, such as by using the DMPI 750 to set the number of display devices 910, 910' to which the analyte sensor system 308 can be connected so that up to three display devices 910, 910' operate in a display-only state or mode, and by setting the level of access or control of such display devices 910, 910' to the analyte sensor system 308. Such display devices 910, 910' may be capable of displaying analyte and / or insulin delivery data, related notifications / alarms, and other information, but do not have the function of transmitting control / command signaling to the analyte sensor 308. As described above, since the second insulin pump 915c may have a relatively less robust algorithm for insulin administration, the second insulin pump 915c may set the access control parameters in this manner, and thus there is no need to prevent other devices from transmitting calibrations (e.g., because the algorithm of the second insulin pump 915c may not be able to process such external events and adjust to them accordingly).
[0334] Moreover, with respect to the analyte data parameters that may be included in the configuration parameters 520, the second insulin pump 915c may not make any changes to the factory calibration parameters (e.g., including the factory calibration period) that may be the default for the analyte sensor system 308 when commercially available or provided by its manufacturer. This may be because, as described above, the second insulin pump 915c can use the factory calibration accuracy level. In this situation, the analyte sensor system 308 may not generate a calibration prompt and can simply follow the default calibration schedule.
[0335] A third exemplary scenario may involve using an insulin pen 915d with an analyte sensor system 308. Similar to the above example with the first insulin pump 915b and the second insulin pump 915c, after setup and authorization of the insulin pen 915d for use, including multiple daily manual injections of insulin, the insulin pen 915d can use the DMPI 750 to access and set and / or modify the configuration parameters 520 of the analyte sensor system 308 according to the system requirements 650 of the insulin pen 915d (see, e.g., FIG. 10A). Similar to the previous example, from the perspective of the insulin pen 915d accessing the configuration parameters 520 via the DMPI 750, the developer of the insulin pen 915d may already have integrated and tested the pump with the analyte sensor system 308 before the product is sold or provided to the user. In this way, the insulin pen 915d can be adapted to operate the DMPI 750 and the configuration parameters 520 appropriately.
[0336] As an example, the insulin pen 915d can use the DMPI 750 to change one or more access control parameters of the configuration parameters 520, including making a choice to establish a direct connection with the analyte sensor system 308 as opposed to establishing a connection to the analyte sensor system 308 indirectly, e.g., via a mobile phone 910a. Despite this choice, the mobile phone 910a can still establish a connection with and exchange information with the analyte sensor system 308 and / or the insulin pen 915d according to how else the configuration parameters 520 can be set.
[0337] Insulin Pen 915d may also use the DMPI 750 to change the wireless connectivity parameters of the analyte sensor system 308, including, for example, those related to the transmission of an advertisement message so that the analyte sensor system 308 can advertise according to the default settings for the display devices 910, 910'. However, with respect to the Insulin Pen 915d, the analyte sensor system 308 can advertise using an extended advertisement period 614 and / or a shortened advertisement window interval 612 (see FIG. 6). In the case of a device such as the Insulin Pen 615d, the user may require a more responsive system that, for example, provides access to the latest glucose data readily available to the user. Thus, the Insulin Pen 615d can set its wireless connection parameters in this manner.
[0338] In addition, the Insulin Pen 615d may use the DMPI 750 to access the analyte data parameters of the configuration parameters 520 and enable, for example, the use of a bolus calculator that may be implemented by the analyte sensor system 308. For example, the DMPI 750 may provide the Insulin Pen 915d with access to bolus calculation parameters that may be maintained by the analyte sensor system 308 so that the analyte sensor system 308 can modify the bolus calculation parameters. In embodiments of the present disclosure, the analyte sensor system 308 can use the bolus calculation parameters to provide the user with bolus-related recommendations, which are based on calculations performed by the analyte sensor system 308 using the bolus calculation parameters (e.g., and the bolus calculator of the analyte sensor system 308).
[0339] The Insulin Pen 915d of this example may also use the DMPI 750 to change one or more additional analyte data parameters of the configuration parameters 520. For example, in some cases, the Insulin Pen 915d may set the calibration period to 12 hours for the same reasons described above with respect to the system requirements 650 of the first insulin pump 915b.
[0340] With respect to further exemplary scenarios involving the Insulin Pen 915d, in some cases, the user may desire and / or need to administer insulin and, accordingly, be able to select a bolus value for the Insulin Pen 915d (e.g., referring to FIG. 6, using the user interface 635). A connection can then be established between the Insulin Pen 915d and the analyte sensor system 308 such that the Insulin Pen 915d can send the bolus value selected by the user to the analyte sensor system 308. If the user's blood glucose level is lower than desirable / normal and / or the user is already carrying a significant amount of insulin, the analyte sensor system 308 can use the bolus calculator described above to create bolus-related recommendations for the user and / or determine safety. In this situation, the analyte sensor system 308 may also send a notification or warning to the user regarding the amount of insulin selected by the user (e.g., that the selected bolus value is too high). In such a case, the analyte sensor system 308 can attempt to prevent the injection of the bolus value selected by the user. For example, there may be a mechanical prevention function on the Insulin Pen 915d that prevents the user from injecting a bolus that exceeds the bolus value calculated by the analyte sensor system 308. Such a mechanical prevention function can be implemented, for example, by disabling (retracting) the drug delivery mechanism 640 (e.g., the needle) and / or preventing an overly large bolus from moving into the injection reservoir of the insulin pen. Signaling from the analyte sensor system 308 can, for example, trigger the mechanical prevention function.
[0341] As described below, there may be additional configuration parameters 520 and / or system requirements 650 in embodiments of system 900, and those skilled in the art, upon considering the present disclosure, will understand additional ways of using configuration parameters 520 and / or system requirements 650 in the context of the above exemplary scenarios, as well as in other contexts explicitly or implicitly described or suggested herein. It should be understood that the above exemplary scenarios and their features are not necessarily required in all embodiments of the present disclosure, and features may be disclosed for illustrative purposes only with respect to embodiments.
[0342] Assuming the general context of the above exemplary scenarios, additional details regarding configuration parameters 520 and system requirements 650 will be described with reference to FIG. 10A. For example, as shown in FIG. 10A, within system 1000, partner device 315 may include system requirements 650 associated with partner device 315 that are to be met in order to support functionality according to certain expectations, design constraints, system specifications, and / or the like. To support system requirements 650, partner device 315 may access configuration parameters 520 (e.g., of analyte sensor system 308) using the DMPI 750 of analyte sensor system 308. ...
Claims
Claim 1 An analyte sensor system for wireless communication with one or more of a display device and a partner device, the analyte sensor system being configurable by use of a diabetes management partner interface for the analyte sensor system to control wireless communication between the analyte sensor system and one or more remote devices connectable to the analyte sensor system, the one or more remote devices including the display device and the partner device, the analyte sensor system comprising a memory storing a set of configuration parameters used by a transceiver for transmitting and receiving wireless signals, a circuit operably coupled to the transceiver and the memory, the circuit being adapted to cause the analyte sensor system to activate a first wireless signal communication path between the analyte sensor system and the display device, and provide, to the first wireless signal communication path, a first degree of access or control by the analyte sensor system to the display device, activate a second wireless signal communication path between the analyte sensor system and the partner device, activation of the second wireless signal communication path by the analyte sensor system causing a change in the first degree of access or control, the change in the first degree of access or control being made in response to input received from the partner device via the diabetes management partner interface and being made to implement a second degree of access or control according to system requirements of the partner device, be adapted to cause, wherein the degree of access and the degree of control are each one of one or more values used to determine whether the display device is able to access the analyte sensor system, an analyte sensor system. Claim 2 To change the first access degree or control degree, the circuit causes the analyte sensor system to set or change a set of configuration parameters implemented by the analyte sensor system using the diabetes management partner interface according to the system requirements of the partner device. The analyte sensor system according to claim 1 is further adapted to perform this.
3. The analyte sensor system according to claim 2, wherein the set of configuration parameters includes one or more of access control parameters of the display device or the partner device, accuracy or calibration parameters of the analyte sensor system, and wireless communication parameters of communication exchanged between the analyte sensor system and one or more of the display device and the partner device.
4. The analyte sensor system according to claim 3, wherein the circuit further causes the analyte sensor system to grant the partner device permission to configure the accuracy or calibration parameters of the analyte sensor system via the diabetes management partner interface.
5. The analyte sensor system according to claim 3, wherein the circuit further causes the analyte sensor system to revoke permission from the display device to configure the accuracy or calibration parameters of the analyte sensor.
6. The access control parameter includes a white list of devices connectable to the analyte sensor system. The analyte sensor system according to claim 3, wherein the circuit is further adapted to set or modify the amount of time that the partner device will remain on the white list before being removed from the white list.
7. A method of controlling wireless communication between an analyte sensor system and one or more remote devices connectable to the analyte sensor system using a diabetes management partner interface of the analyte sensor system, wherein the one or more remote devices include a display device and a partner device, and the method includes: Determining whether a connection request received from one of the remote devices was originated from a partner class having the one or more remote devices, wherein the remote devices within the partner class are adapted to provide a medicament, and the partner class includes the partner device; When the connection request is originated from the partner class, enabling selection of an operation mode corresponding to the partner class, wherein the operation mode uses a set of configuration parameters of the partner class to support system requirements of the partner device; The method, wherein the set of configuration parameters used to support the system requirements of the partner device includes one or more of access control parameters of the display device or the partner device, accuracy or calibration parameters of the analyte sensor system, and wireless communication parameters of communication exchanged between the analyte sensor system and one or more of the remote devices.
8. The method of claim 7, comprising transmitting, by at least one of the remote devices, a mode indicator capable of determining the operation mode being used, to exchange the wireless communication with at least one of the remote devices using the operation mode corresponding to the partner class.
9. The mode indicator is operable by the analyte sensor system, using the diabetes management partner interface, to deactivate access by a set of remote devices not within the partner class to one or more of the access control parameters, the accuracy or calibration parameters, and the wireless communication parameters; The method of claim 8, wherein access by the set of remote devices to one or more of the access control parameters, the accuracy or calibration parameters, and the wireless communication parameters is activated when the analyte sensor system uses an operation mode corresponding to the set of remote devices.
10. determining that the analyte sensor system has not received wireless communication from the partner device for at least a predetermined amount of time; further comprising, in response to the determination and further in response to receiving a connection request from one of the remote devices in the set of remote devices not in the partner class, the analyte sensor system selecting an operating mode corresponding to the set of remote devices not in the partner class, wherein the operating mode corresponding to the set of remote devices not in the partner class follows a set of configuration parameters specific to the set of remote devices not in the partner class, the method of claim 7.
11. The method of claim 10, further comprising removing the partner device from a whitelist.
12. the analyte sensor system receiving, from the partner device, a value of one of the sets of configuration parameters using the diabetes management partner interface; the analyte sensor system further comprising modifying one of the sets of configuration parameters using the value received from the partner device, the method of claim 7.
13. further comprising the analyte sensor system transmitting a value of the set of configuration parameters to the display device, the value being a specified time until the partner device is removed from a whitelist managed for the analyte sensor system, and a specified time until the display device is removed from the whitelist, one or more of which are included in the method of claim 12.
14. exchanging the wireless communication using the operating mode corresponding to the partner device is modifying a whitelist managed for the analyte sensor system to turn off a slot of a device other than the partner device, and transmitting an advertisement message directed only to the partner device, one or more of which are included in the method of claim 8.
15. If the connection request was not sent from the partner class, the analyte sensor system further includes selecting an operating mode corresponding to a set of remote devices not within the partner class, and the operating mode corresponding to the set of remote devices not within the partner class uses a set of configuration parameters specific to the set of remote devices not within the partner class. The method according to claim 7.
16. The display device is within the set of remote devices not within the partner class, using the diabetes management partner interface to provide the display device with access to the set of configuration parameters specific to the set of remote devices not within the partner class; and the analyte sensor system further includes setting or modifying one value of the set of configuration parameters specific to the set of remote devices not within the partner class in response to an input received from the display device. The method according to claim 15.
17. Modifying an advertisement slot to advertise that exchanging the wireless communication using the operating mode corresponding to the partner class is only for the partner device or partner device controller. The method according to claim 8.
18. Exchanging the wireless communication using the operating mode corresponding to the partner class includes the analyte sensor system accepting only connection requests received from the partner device in response to a command received via the diabetes management partner interface. The method according to claim 8.
19. The method according to claim 18, wherein the command is received from the partner device.
Citation Information
Patent Citations
Continuous glucose monitoring injection device
CN107073207A
Monitoring and data conversion devices and methods for monitoring and data conversion for networked liquid injection systems
JP2009535715A
System and method for transmission and continuous monitoring of analyte values
JP2017503619A
Coordination of control commands in a medical device system having at least one therapy delivery device and at least one wireless controller device
US20110006876A1
Systems and methods for display device and sensor electronics unit communication
US20170281000A1