METHOD, SYSTEM AND COMPUTER PROGRAM PRODUCT FOR REAL-TIME DETECTION OF SENSITIVITY DECLINE IN ANALYTE SENSORS

• US 20080172205A1
• Filed: 10/26/2007
• Published: 07/17/2008
• Est. Priority Date: 10/26/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated), University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kovatchev, Boris P., Doniger, Kenneth J., Breton, Marc D., Budiman, Erwin S.
• Granted Patent: US 8,135,548 B2
• Time in Patent Office: Days
• US Class Current: 702/181
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04B 17/00 Monitoring; Testing of line transmission systems H04B3/46; arrangements for monitoring or testing transmission systems employing electromagnetic waves other than radio waves H04B10/07

Abstract

Method, system and computer program product for providing real time detection of analyte sensor sensitivity decline is continuous glucose monitoring systems are provided.

Claims

1. A computer implemented method, comprising:

receiving a plurality of analyte sensor related signals;

determining a probability of signal attenuation associated with the received plurality of analyte sensor related signals;

verifying the presence of signal attenuation when the determined probability exceeds a predetermined threshold level; and

generating a first output signal associated with the verification of the presence of signal attenuation.

2. The method of claim 1 wherein determining the probability of signal attenuation includes:

determining one or more characteristics associated with the received plurality of analyte sensor related signals; and

applying a predetermined coefficient to the plurality of analyte sensor related signals.

3. The method of claim 2 wherein the determined one or more characteristics includes one or more mean value associated with the analyte sensor related signals, the least square slope associated with the analyte sensor related signals, a standard deviation associated with the analyte sensor related signals, an average elapsed time from positioning the analyte sensor, or a variance about a least squares slope associated with the analyte sensor related signals.

4. The method of claim 1 wherein the predetermined threshold level is user defined.

5. The method of claim 1 wherein when the determined probability does not exceed the predetermined threshold level, generating a second output signal associated with absence of signal attenuation condition.

6. The method of claim 1 wherein verifying the presence of signal attenuation includes:

selecting a signal attenuation threshold level;

determining a sensitivity level associated with the analyte related sensor signals; and

confirming the presence of signal attenuation based at least in part on a comparison of the determined sensitivity level and the selected signal attenuation threshold level.

7. The method of claim 6 wherein the signal attenuation threshold level is associated with a blood glucose measurement.

8. The method of claim 7 wherein the blood glucose measurement include a capillary blood glucose sampling.

9. The method of claim 6 wherein the sensitivity level associated with the analyte related sensor includes a ratio of nominal sensitivity associated with the analyte related sensor signals and the sensitivity value associated with the analyte related sensor signals.

10. The method of claim 9 wherein the sensitivity value is determined as a ratio of the average of the analyte related sensor signals and a blood glucose measurement.

11. The method of claim 6 wherein confirming the presence of signal attenuation includes determining that the sensitivity level is less than the selected signal attenuation threshold level.

12. An apparatus, comprising:

a data storage unit; and

a processing unit operatively coupled to the data storage unit configured to receive a plurality of analyte sensor related signals, determine a probability of signal attenuation associated with the received plurality of analyte sensor related signals, verify the presence of signal attenuation when the determined probability exceeds a predetermined threshold level, and generate a first output signal associated with the verification of the presence of signal attenuation.

13. The apparatus of claim 12 wherein the processing unit configured to determine the probability of signal attenuation is configured to determine one or more characteristics associated with the received plurality of analyte sensor related signals, and to apply a predetermined coefficient to the plurality of analyte sensor related signals.

14. The apparatus of claim 13 wherein the determined one or more characteristics includes one or more mean value associated with the analyte sensor related signals, the least square slope associated with the analyte sensor related signals, a standard deviation associated with the analyte sensor related signals, an average elapsed time from positioning the analyte sensor, or a variance about a least squares slope associated with the analyte sensor related signals.

15. The apparatus of claim 12 wherein the predetermined threshold level is user defined.

16. The apparatus of claim 12 wherein when the determined probability does not exceed the predetermined threshold level, the processing unit is further configured to generate a second output signal associated with absence of signal attenuation condition.

17. The apparatus of claim 12 wherein the processing unit is further configured to select a signal attenuation threshold level, determine a sensitivity level associated with the analyte related sensor signals, and confirm the presence of signal attenuation based at least in part on a comparison of the determined sensitivity level and the selected signal attenuation threshold level.

18. The apparatus of claim 17 wherein the signal attenuation threshold level is associated with a blood glucose measurement.

19. The apparatus of claim 18 wherein the blood glucose measurement include a capillary blood glucose sampling.

20. The apparatus of claim 17 wherein the sensitivity level associated with the analyte related sensor includes a ratio of nominal sensitivity associated with the analyte related sensor signals and the sensitivity value associated with the analyte related sensor signals.

21. The apparatus of claim 20 wherein the sensitivity value is determined as a ratio of the average of the analyte related sensor signals and a blood glucose measurement.

22. The apparatus of claim 17 wherein the processing unit is further configured to determine that the sensitivity level is less than the selected signal attenuation threshold level.

23. The apparatus of claim 12 including a user output unit operatively coupled to the processing unit to display the first output signal.

24. A system for detecting signal attenuation in an analyte sensor, comprising:

an analyte sensor for transcutaneous positioning through a skin layer of a subject; and

a data processing device operatively coupled to the analyte sensor to periodically receive a signal associated with the analyte sensor, the data processing device configured to determine a probability of the early signal attenuation (ESA), and to verify the presence of early signal attenuation based on one or more predetermined criteria.

25. The system of claim 24 wherein the data processing device includes a user interface to output one or more signals associated with the presence or absence of early signal attenuation associated with the analyte sensor.