IP Library Granted Patent US 8,631,679
Granted Patent B2
US 8,631,679 · App. 12/554,830 · Granted Jan 21, 2014

Additional calibration for analyte monitor

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Quick Facts
Patent No.
US 8,631,679
App. No.
12/554,830
Granted
Jan 21, 2014
Kind
B2
Abstract

Embodiments provide a method and related systems that take into account the difference between a measured glucose value and the calibration level and the amount of elapsed time since the prior calibration. As one or both of these determined differences increases, the desirability of an additional calibration also increases. The methodology described herein thus analyzes the combination of change in glucose level as well as the time since the prior calibration. If the combination exceeds a predetermined value, the system recommends, but does not require, that the subject user perform an additional calibration.

Claims (43)

1. A method, comprising:

determining by an analyte monitoring system a change in analyte value since a prior calibration;

determining by an analyte monitoring system a time elapsed since a prior calibration;

providing a threshold for the change in analyte value, wherein the threshold is a function of the time elapsed;

determining by the analyte monitoring system whether the threshold has been exceeded based on the change in analyte value and the time elapsed; and

in response to determining that the change in analyte value exceeds the threshold, providing by the analyte monitoring system an indication of that determination, or in response to determining that the change in analyte value does not exceed the threshold, providing no indication by the analyte monitoring system that the change in analyte value exceeds the threshold.

2. The method of claim 1 , wherein providing an indication comprises providing by the analyte monitoring system a recommendation to perform an additional calibration of the analyte monitoring system.

3. The method of claim 1 , wherein the analyte monitoring system is a glucose monitoring system.

4. The method of claim 1 , wherein the threshold defines a maximum allowable change in analyte value since the prior calibration.

5. The method of claim 1 , wherein the threshold defines a maximum allowable elapsed time since the prior calibration.

6. The method of claim 1 , wherein the threshold defines a line between a maximum allowable change in analyte value since the prior calibration and a maximum allowable elapsed time since the prior calibration.

7. The method of claim 1 , wherein the threshold defines a parameterized curve or function between a maximum allowable change in analyte value since the prior calibration and a maximum allowable elapsed time since the prior calibration.

8. The method of claim 1 , wherein providing no indication by the analyte monitoring system that the change in analyte value exceeds the threshold further comprises waiting a period of time before re-determining a change in analyte value since the prior calibration and re-determining whether the change in analyte value exceeds the threshold.

9. The method of claim 1 , wherein the threshold defines a line with negative slope.

10. An electronic monitoring unit comprising,

a telemetry component configured to receive signals representative of analyte values transmitted from an on-skin unit of an analyte monitoring system; and

a processor configured to

determine a change in analyte value since a prior calibration;

determine a time elapsed since a prior calibration;

provide a threshold for the change in analyte value, wherein the threshold is a function of the time elapsed;

determine whether the threshold has been exceeded based on the change in analyte value and the time elapsed; and

in response to determining that the change in analyte value exceeds the threshold, provide an indication of that determination, or in response to determining that the change in analyte value does not exceed the threshold, providing no indication by the analyte monitoring system that the change in analyte value exceeds the threshold.

11. The electronic monitoring unit of claim 10 , further comprising a display operatively coupled to the processor.

12. The electronic monitoring unit of claim 11 , wherein the processor configured to provide an indication comprises a processor configured to provide a recommendation to perform an additional calibration of the analyte monitoring system.

13. The electronic monitoring unit of claim 12 , wherein the display includes one or more indicators configured to indicate the additional recommended calibration.

14. The electronic monitoring unit of claim 13 , wherein the one or more indicators are at least one of a textual, graphical, numerical, and pictorial indicator.

15. The electronic monitoring unit of claim 10 , wherein the threshold defines a line with negative slope.

16. An analyte monitoring system comprising:

an on-skin unit coupled to at least one analyte sensor;

an electronic monitoring unit comprising,

a telemetry component configured to receive signals measured by the analyte sensor and transmitted from the on-skin unit; and

a processor configured to

determine a change in analyte value since a prior calibration;

determine a time elapsed since a prior calibration;

provide a threshold for the change in analyte value, wherein the threshold is a function of the time elapsed;

determine whether the threshold has been exceeded based on the change in analyte value and the time elapsed; and

in response to determining that the change in analyte value exceeds the threshold, provide an indication of that determination, or in response to determining that the change in analyte value does not exceed the threshold, providing no indication by the analyte monitoring system that the change in analyte value exceeds the threshold.

17. The analyte monitoring system of claim 16 , wherein the analyte sensor is a glucose sensor.

18. The analyte monitoring system of claim 16 , further comprising a display operatively coupled to the processor.

19. The analyte monitoring system of claim 18 , wherein the processor configured to provide an indication comprises a processor configured to provide a recommendation to perform an additional calibration of the analyte monitoring system.

20. The analyte monitoring system of claim 19 , wherein the display includes one or more indicators configured to indicate the additional recommended calibration.

21. The analyte monitoring system of claim 20 , wherein the one or more indicators are at least one of a textual, graphical, numerical, and pictorial indicator.

22. The analyte monitoring system of claim 16 , wherein the threshold defines a line with negative slope.

Assignments (9)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2024
From: WAVEFORM TECHNOLOGIES, INC.; WAVEFORM HOLDINGS, LLC
To: KONAMITE LIMITED
Reel/Frame 067073/0813 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY'S NAME PREVIOUSLY RECORDED ON REEL 043745 FRAME 0347. ASSIGNOR(S) HEREBY CONFIRMS THE RELEASE OF SECURITY INTEREST. Recorded Oct 2, 2017
From: MIDCAP FINANCIAL TRUST
To: WAVEFORM TECHNOLOGIES, INC.
Reel/Frame 044100/0053 →
RELEASE OF SECURITY INTEREST Recorded Sep 29, 2017
From: MIDCAP FINANCIAL TRUST
To: WAVEFORM TECHNOLOGIES
Reel/Frame 043745/0347 →
SECURITY INTEREST Recorded Jan 27, 2017
From: WAVEFORM TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 041517/0950 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2017
From: AGAMATRIX, INC.
To: WAVEFORM TECHNOLOGIES, INC.
Reel/Frame 041394/0955 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2016
From: ISENSE ACQUISITION, LLC
To: AGAMATRIX, INC.
Reel/Frame 037996/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2014
From: ISENSE CORPORATION
To: BAYER HEALTHCARE, LLC
Reel/Frame 034515/0626 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2014
From: BAYER HEALTHCARE, LLC
To: ISENSE ACQUISITION, LLC
Reel/Frame 034517/0785 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2013
From: KAPLAN, DANIEL; WARD, W. KENNETH
To: ISENSE CORPORATION
Reel/Frame 031214/0036 →