Granted Patent B2

US 12,390,135 · App. 17/392,209 · Granted Aug 19, 2025

Inventors: Gary Alan Hayter (Oakland, CA); Geoffrey V. McGarraugh (Bodega Bay, CA); Kenneth J. Doniger (Menlo Park, CA)

Assignee: ABBOTT DIABETES CARE INC.

A61B5/1486A61B5/0008A61B5/002A61B5/0022A61B5/1451A61B5/14532A61B5/14546A61B5/1473A61B5/4845A61B5/7275G16H40/63A61B2560/0223A61B2560/0242A61B2560/0276G16H15/00

Abstract

Claims (53)

1. A glucose monitoring device, comprising:

a data communication unit comprising a RF transmitter, the data communication unit configured to wirelessly receive sensor data generated by an in vivo glucose sensor when the sensor is positioned in contact with biofluid under a skin surface of a user, the sensor data being indicative of a monitored glucose level of the user and one or more uncertainty indicators corresponding to uncertain conditions detected during measurement;

one or more memories configured to store the received data;

a data processing unit comprising one or more processors, the data processing unit operatively coupled to the data communication unit and the one or more memories, the data processing unit configured to:

obtain the monitored glucose level from the sensor data;

determine one or more data points over a period of time based on the sensor data and the one or more uncertainty indicators;

determine an uncertainty parameter using a number of the uncertainty indicators received over the period of time; and

determine glucose trend information corresponding to the monitored glucose level when the uncertainty parameter indicates that the number of the one or more uncertainty indicators received over the period of time are less than a predetermined amount; and

one or more output units of the glucose monitoring device configured to output one or more notifications upon detection of one or more alarm conditions associated with the one or more uncertainty indicators exceeding a predetermined threshold level.

2. The device of claim 1 , wherein the biofluid is interstitial fluid.

3. The device of claim 1 , wherein the data communication unit is configured to wirelessly receive the sensor data corresponding to the monitored glucose level using a communication protocol, the communication protocol comprising at least one of an RF communication protocol, an infrared communication protocol, an 802.11x wireless communication protocol, or an IEEE 802.15.4-based protocol such as ZIGBEE transmission protocol.

4. The device of claim 1 , wherein the one or more uncertainty indicators comprise one or more missing or unavailable values in one or more data fields of the sensor data.

5. The device of claim 1 , wherein the data processing unit is configured to postpone determining the glucose trend information when the one or more uncertainty indicators are less than the predetermined amount.

6. The device of claim 1 , wherein the in vivo glucose sensor comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

7. The device of claim 6 , wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

8. The device of claim 6 , wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

9. The device of claim 8 , wherein the mediator is crosslinked with the polymer disposed on the working electrode.

10. The device of claim 1 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications concurrent to execution of a predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

11. The device of claim 1 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications concurrent to execution of a predetermined routine and output one or more notifications after a termination of the predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

12. The device of claim 1 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications indications after a termination of the predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

13. The device of claim 1 , wherein the one or more notifications, associated with the one or more corresponding alarm conditions, are assigned and viewed with different priorities in a predetermined notification hierarchy structure.

14. The device of claim 1 , wherein the determination of the one or more data points over the period of time is further based on at least one calibration factor from a calibration event.

15. The device of claim 1 , wherein the one or more uncertainty indicators comprises a rate variance of the one or more data points.

16. The device of claim 1 , wherein the one or more uncertainty indicators comprises a number of the one or more data points deviating beyond a predetermined tolerance range.

17. The device of claim 1 , wherein the one or more notifications are disabled.

18. A glucose monitoring system, comprising:

an in vivo glucose sensor configured to be positioned in contact with biofluid under a skin surface and to generate sensor data, the sensor data being indicative of a monitored glucose level and one or more uncertainty indicators corresponding to uncertain conditions detected during measurement;

a transmitter unit operatively coupled to the in vivo glucose sensor to receive the sensor data; and

a receiving device communicatively coupled to the transmitter unit, the receiving device comprising:

a data communication unit comprising a RF transmitter, the data communication unit configured to wirelessly receive the sensor data;

one or more memory memories configured to store the sensor data; and

a data processing unit comprising one or more processors, the data processing unit operatively coupled to the data communication unit and the one or more memories, the data processing unit configured to:

determine the monitored glucose level from the sensor data;

determine one or more data points over a period of time based on the sensor data and the one or more uncertainty indicators;

determine an uncertainty parameter using a number of the one or more uncertainty indicators received over the period of time;

determine glucose trend information corresponding to the monitored glucose level when the uncertainty parameter indicates that the number of the one or more uncertainty indicators received over the period of time are less than a predetermined amount; and

one or more output units of the receiving device configured to output one or more notifications upon detection of one or more alarm conditions associated with the one or more uncertainty indicators exceeding a predetermined threshold level.

19. The system of claim 18 , wherein the biofluid is interstitial fluid.

20. The system of claim 18 , wherein the data communication unit is configured to wirelessly receive the sensor data corresponding to the monitored glucose level using a communication protocol, the communication protocol being one of an RF communication protocol, an infrared communication protocol, or an 802.11x wireless communication protocol, or an IEEE 802.15.4-based protocol such as ZIGBEE transmission protocol.

21. The system of claim 18 , wherein the one or more uncertainty indicators comprise one or more missing or unavailable values in one or more data fields of the sensor data.

22. The system of claim 18 , wherein the data processing unit is configured to postpone determining the glucose trend information when the one or more uncertainty indicators are less than the predetermined amount.

23. The system of claim 18 , wherein the in vivo glucose sensor comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

24. The system of claim 23 , wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

25. The system of claim 23 , wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

26. The system of claim 25 , wherein the mediator is crosslinked with the polymer disposed on the working electrode.

27. The system of claim 18 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications concurrent to execution of a predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

28. The system of claim 18 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications concurrent to execution of a predetermined routine and output one or more notifications after a termination of the predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

29. The system of claim 18 , wherein the one or more output units are configured to, upon detection of the one or more alarm conditions, output the one or more notifications indications after a termination of the predetermined routine, wherein the predetermined routine is a process by the data processing unit that is ongoing at the time of detection of the one or more alarm conditions.

30. The system of claim 18 , wherein the one or more notifications, associated with the one or more corresponding alarm conditions, are assigned and viewed with different priorities in a predetermined notification hierarchy structure.

31. The system of claim 18 , wherein the determination of the one or more data points over the period of time is further based on at least one calibration factor from a calibration event.

32. The system of claim 18 , wherein the one or more uncertainty indicators comprises a rate variance of the one or more data points.

33. The system of claim 18 , wherein the one or more uncertainty indicators comprises a number of the one or more data points deviating beyond a predetermined tolerance range.

34. The system of claim 18 , wherein the one or more notifications are disabled.

Assignments (1)

Continuity (7)

References Cited (400)