Additional calibration for analyte monitor

• US 8,631,679 B2
• Filed: 09/04/2009
• Issued: 01/21/2014
• Est. Priority Date: 09/04/2009
• Status: Active Grant

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation
• Inventors: Kaplan, Daniel, Ward, W. Kenneth
• Primary Examiner(s): Raevis, Robert R
• Application Number:
  US12/554,830
• Publication Number:
  US 20110056264A1
• Time in Patent Office: 1,600 Days
• Field of Search: None
• US Class Current: 73/1.02
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set

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

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.