Methods for generating hybrid analyte level output, and devices and systems related thereto

• US 9,289,164 B2
• Filed: 06/29/2012
• Issued: 03/22/2016
• Est. Priority Date: 06/30/2011
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary A.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US13/538,406
• Publication Number:
  US 20130006081A1
• Time in Patent Office: 1,362 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

Generally, methods, devices, and systems for generating a hybrid analyte level output are provided. The uncompensated analyte levels lag in time with respect to the lag-compensated analyte levels, and the hybrid analyte level output tracks between the uncompensated analyte levels and the lag-compensated analyte levels according to predetermined criteria.

Claims

1. A method of generating a hybrid analyte level output, comprising:

receiving sensor data, wherein the sensor data comprises uncompensated analyte levels received from an in vivo sensor, wherein the uncompensated analyte level comprises interstitial fluid analyte levels;

deriving lag-compensated analyte levels from the uncompensated analyte levels using a processor, wherein the lag-compensated analyte levels comprises estimated blood analyte levels; and

generating a hybrid analyte level output comprised of uncompensated analyte levels and lag-compensated analyte levels using the processor, wherein the uncompensated analyte levels lag in time with respect to the lag-compensated analyte levels;

wherein the hybrid analyte level output tracks between the uncompensated analyte levels and the lag-compensated analyte levels according to predetermined criteria,

wherein the predetermined criteria comprises;

criteria for tracking the uncompensated analyte levels when selected analyte levels are below a predetermined threshold and have been rising for at least a predetermined duration of time; and

criteria for tracking the lag-compensated levels when the selected analyte levels are not below the predetermined threshold or have not been rising for at least the predetermined duration of time.

2. The method of claim 1, wherein the

uncompensated analyte levels comprise interstitial fluid (ISF) glucose levels;

and

the lag-compensated levels comprise estimated blood glucose levels derived from the ISF glucose levels.

3. The method of claim 2, wherein the selected analyte levels comprise at least one selected from the group consisting of most recently derived lag-compensated analyte levels and most recently received uncompensated analyte levels.

4. The method of claim 2, wherein the predetermined threshold comprises a glucose value that indicates hypoglycemia.

5. The method of claim 1, wherein the generating comprises:

transitioning from the uncompensated analyte levels to the lag-compensated analyte levels and wherein the hybrid analyte level output comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels when transitioning from the uncompensated analyte levels to the lag-compensated analyte levels and/or

transitioning from the lag-compensated analyte levels to the uncompensated analyte levels and wherein the hybrid analyte level output comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels when transitioning from the lag-compensated analyte levels to the uncompensated analyte levels.

6. The method of claim 1, wherein the predetermined criteria further comprises criteria for tracking the lag-compensated analyte level until the hybrid analyte output level falls below a second predetermined threshold, wherein the hybrid analyte output level tracks a lower of the lag-compensated analyte level and the uncompensated analyte level when the hybrid analyte output level falls below the second predetermined threshold.

7. The method of claim 1, wherein deriving the lag-compensated analyte levels comprise applying a lag compensation filter to the uncompensated analyte levels.

8. The method of claim 1, comprising audibly or visually outputting the hybrid analyte level output on a user interface in communication with the processor.

9. The method of claim 1, wherein the uncompensated analyte levels comprise interstitial fluid ketone bodies levels and wherein the lag-compensated the lag compensated analyte levels comprises estimated blood ketone bodies levels derived from applying a lag-compensation filter to the interstitial fluid ketone bodies levels.

10. The method of claim 1, comprising:

audibly or visually outputting the lag-compensated analyte levels on a user interface in communication with the processor; and

indicating a low analyte level with the user interface when the lag-compensated analyte levels fall below a predetermined low-entering threshold value.

11. The method of claim 10, comprising

removing the indication of the low analyte level when a predetermined low-exiting threshold is exceeded by at least one signal selected from a group consisting of the lag-compensated analyte levels, the uncompensated analyte levels, and the hybrid analyte level output.

12. An Analyte monitoring device, comprising:

a processor; and

non-transitory memory operably coupled to the processor, wherein the memory includes instructions stored therein that, when executed by the processor, cause the processor to;

receive sensor data, wherein the sensor data comprises uncompensated analyte levels received from an in vivo sensor, wherein the uncompensated analyte level comprises interstitial fluid analyte levels;

derive lag-compensated analyte levels from the uncompensated analyte levels, wherein the lag-compensated analyte levels comprises estimated blood analyte levels; and

generate a hybrid analyte level output comprised of uncompensated analyte levels and lag-compensated analyte levels, wherein the uncompensated analyte levels lag in time with respect to the lag-compensated analyte levels;

wherein the hybrid analyte level output tracks between the uncompensated analyte levels and the lag-compensated analyte levels according to predetermined criteria, wherein the predetermined criteria comprises;

criteria for tracking the uncompensated analyte levels when selected analyte levels are below a predetermined threshold and have been rising for at least a predetermined duration of time; and

criteria for tracking the lag-compensated levels when the selected analyte levels are not below the predetermined threshold or have not been rising for at least the predetermined duration of time.

13. The analyte monitoring device of claim 12, wherein

the uncompensated analyte levels comprise interstitial fluid (ISF) glucose levels;

and

the lag-compensated levels comprise estimated blood glucose levels derived from the ISF glucose levels.

14. The analyte monitoring device of claim 13, wherein the selected analyte levels comprise at least one selected from the group consisting of most recently derived lag-compensated analyte levels and most recently received uncompensated analyte levels.

15. The analyte monitoring device of claim 13, wherein the predetermined threshold comprises a glucose value that indicates hypoglycemia.

16. The analyte monitoring device of claim 12, wherein the hybrid analyte level output transitions from:

the uncompensated analyte levels to the lag-compensated analyte levels and comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels; and

/or

the lag-compensated analyte levels to the uncompensated analyte levels and comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels.

17. The analyte monitoring device of claim 12, wherein the predetermined criteria further comprises criteria for tracking the lag-compensated analyte level until the hybrid analyte output level falls below a second predetermined threshold, wherein the hybrid analyte output level tracks a lower of the lag-compensated analyte level and the uncompensated analyte level when the hybrid analyte output falls below the second predetermined threshold.

18. The analyte monitoring device of claim 12, wherein a lag compensation filter is applied to the uncompensated analyte levels to derive the lag-compensated analyte levels.

19. The analyte monitoring device of claim 12, further comprising a user interface, wherein the non-transitory memory includes instructions stored therein that, when executed by the processor, cause the processor to audibly or visually output the hybrid analyte level output on the user interface of the analyte monitoring device.

20. The analyte monitoring device of claim 12, wherein the uncompensated analyte levels comprise interstitial fluid ketone bodies levels and wherein the lag-compensated analyte levels comprises estimated blood ketone bodies levels derived from applying a lag-compensation filter to the interstitial fluid ketone bodies levels.

21. The analyte monitoring device of claim 12, further comprising a user interface, wherein the non-transitory memory includes instructions stored therein that, when executed by the processor, cause the processor to:

audibly or visually output the lag-compensated analyte levels on the user interface of the analyte monitoring device; and

indicate a low analyte level with the user interface when the lag-compensated analyte levels fall below a predetermined low-entering threshold value.

22. The analyte monitoring of claim 21, wherein the non-transitory memory includes instructions stored therein that, when executed by the processor, cause the processor to remove the indication of a low analyte level when a predetermined low-exiting threshold is exceeded by at least one signal selected from a group consisting of the lag-compensated analyte levels, the uncompensated analyte levels, and the hybrid analyte level output.

23. An Analyte monitoring system, comprising:

an on-body unit, comprising;

a first processor and first non-transitory memory operably coupled to the first processor;

an in vivo analyte sensor operably coupled to the first processor; and

a receiver configured to communicate with the on-body unit, the receiver comprising;

a second processor and second non-transitory memory operably coupled to the second processor;

wherein at least one of the first non-transitory memory and second non-transitory memory includes instructions stored therein that, when executed by at least one of the first and second processors, cause the at least one first and second processor to;

receive sensor data, wherein the sensor data comprises uncompensated analyte levels received from the in vivo analyte monitor, wherein the uncompensated analyte level comprises interstitial fluid analyte levels;

derive lag-compensated analyte levels from the uncompensated analyte levels, wherein the lag-compensated analyte levels comprises estimated blood analyte levels; and

generate a hybrid analyte level output comprised of uncompensated analyte levels and lag-compensated analyte levels, wherein the uncompensated analyte levels lag in time with respect to the lag-compensated analyte levels;

wherein the hybrid analyte level output tracks between the uncompensated analyte levels and the lag-compensated analyte levels according to predetermined criteria, wherein the predetermined criteria comprises;

criteria for tracking the uncompensated analyte levels when selected analyte levels are below a predetermined threshold and have been rising for at least a predetermined duration of time; and

criteria for tracking the lag-compensated levels when the selected analyte levels are not below the predetermined threshold or have not been rising for at least the predetermined duration of time.

24. The analyte monitoring system of claim 23, wherein

the uncompensated analyte levels comprise interstitial fluid (ISF) glucose levels;

and

the lag-compensated levels comprise estimated blood glucose levels derived from the ISF glucose levels.

25. The analyte monitoring system of claim 24, wherein the selected analyte levels comprise at least one selected from the group consisting of most recently derived lag-compensated analyte levels and most recently received uncompensated analyte levels.

26. The analyte monitoring system of claim 24, wherein the predetermined threshold comprises a glucose value that indicates hypoglycemia.

27. The analyte monitoring system of claim 23, wherein the hybrid analyte level output transitions from:

the uncompensated analyte levels to the lag-compensated analyte levels and comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels; and

/or

the lag-compensated analyte levels to the lag-compensated analyte levels and comprises weighted combinations of the uncompensated analyte levels and the lag-compensated analyte levels.

28. The analyte monitoring system of claim 23, wherein the predetermined criteria further comprises criteria for tracking the lag-compensated analyte level until the hybrid analyte output level falls below a second predetermined threshold, wherein the hybrid analyte output level tracks a lower of the lag-compensated analyte level and the uncompensated analyte level when the hybrid analyte output level falls below the second predetermined threshold.

29. The analyte monitoring system of claim 23, wherein a lag compensation filter is applied to the uncompensated analyte levels to derive the lag-compensated analyte levels.

30. The analyte monitoring system of claim 23, further comprising a user interface, wherein the at least one first and second non-transitory memories include instructions that, when executed by the at least one first and second processor, cause the at least one first and second processor to audibly or visually output the hybrid analyte level output on the user interface of the analyte monitoring system.

31. The analyte monitoring system of claim 23, wherein the uncompensated analyte levels comprise interstitial fluid ketone bodies levels and wherein the lag-compensated analyte levels comprises estimated blood ketone bodies levels derived from applying a lag-compensation a lag compensation filter to the interstitial fluid ketone bodies levels.

32. The analyte monitoring system of claim 23, further comprising a user interface, wherein the at least one of the first non-transitory memory and second non-transitory memory includes instructions stored therein that, when executed by at least one of the first and second processors, cause the at least one first and second processor to:

audibly or visually output the lag-compensated analyte levels on the user interface of the analyte monitoring system; and

indicate a low analyte level with the user interface when the lag-compensated analyte levels fall below a predetermined low-entering threshold.

33. The analyte monitoring system of claim 32, wherein at least one of the first non-transitory memory and second non-transitory memory includes instructions stored therein that, when executed by the at least one of the first and second processors, cause the at least one first and second processor to remove the indication of a low analyte level when a predetermined low-exiting threshold is exceeded by at least one signal selected from a group consisting of the lag-compensated analyte levels, the uncompensated analyte levels, and the hybrid analyte level output.