Signal Dropout Detection and/or Processing in Analyte Monitoring Device and Methods

• US 20110081726A1
• Filed: 09/30/2010
• Published: 04/07/2011
• Est. Priority Date: 09/30/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Berman, Glenn Howard
• Application Number:
  US12/895,790
• Publication Number:
  US 20110081726A1
• Time in Patent Office: Days
• US Class Current: 436/95
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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: Y10T 436/144444 Glucose

Abstract

Methods and devices for receiving a plurality of signals from a transcutaneously positioned analyte sensor, receiving a reference data, calibrating the analyte sensor based on the received reference data to generate calibrated sensor data, detecting a change in the level of the received plurality of signals from the analyte sensor exceeding a predetermined threshold level within a preset time period after calibrating the analyte sensor, and generating an output signal based on the detected change are provided. Systems and kits for performing the same are also provided.

Claims

1. A method, comprising:

receiving a plurality of signals from a transcutaneously positioned analyte sensor;

receiving a reference data;

calibrating the analyte sensor based on the received reference data to generate calibrated sensor data;

detecting a change in the level of the received plurality of signals from the analyte sensor exceeding a predetermined threshold level within a preset time period after calibrating the analyte sensor; and

generating an output signal based on the detected change.

2. The method of claim 1 wherein the received reference data is a blood glucose measurement.

3. The method of claim 2 including performing an in vitro test to obtain the blood glucose measurement.

4. The method of claim 1 wherein calibrating the analyte sensor includes determining a calibration factor based on the received reference data and a substantially time corresponding signal received from the analyte sensor.

5. The method of claim 4 wherein determining the calibration factor includes matching the received reference data to the substantially time corresponding sensor signal.

6. The method of claim 4 wherein the calibration factor includes a sensitivity ratio.

7. The method of claim 4 wherein calibrating the analyte sensor includes applying the calibration factor to the received plurality of signals from the sensor.

8. The method of claim 1 wherein the detected change in the level of the received plurality of signals from the sensor is associated with a signal dropout condition.

9. The method of claim 1 wherein the predetermined threshold level includes a variation in the level of at least two adjacent signals from the received plurality of signals exceeding approximately 5%.

10. The method of claim 1 wherein the preset time period includes approximately 60 minutes or less, 45 minutes or less, 30 minutes or less, 15 minutes or less, 10 minutes or less, or 5 minutes or less.

11. The method of claim 1 wherein the generated output includes a prompt to recalibrate the sensor.

12. The method of claim 1 including masking the calibrated sensor data.

13. The method of claim 12 wherein masking the calibrated sensor data includes disabling the output of the calibrated sensor data.

14. The method of claim 1 wherein the reference data is received from the transcutaneously positioned analyte sensor.

15. A method, comprising:

receiving a plurality of signals from a transcutaneously positioned analyte sensor;

outputting an indicator associated with the received plurality of signals from the sensor;

detecting a change in the level of the received plurality of signals from the analyte sensor exceeding a predetermined threshold level within a preset time period;

confirming an adverse condition based on the detected change in the level of the received plurality of signals from the sensor; and

modifying a portion of the outputted indicator based on the confirmed adverse signal condition.

16. The method of claim 15 wherein the adverse condition includes a signal dropout condition.

17. The method of claim 15 wherein the indicator includes a graphical representation associated with the received plurality of signals from the sensor.

18. The method of claim 15 wherein modifying the portion of the outputted indicator includes identifying a subset of the received plurality of signals from the sensor associated with the confirmed adverse condition, and modifying the portion of the outputted indicator corresponding to the subset of the received plurality of signals from the sensor.

19. An apparatus, comprising:

one or more processors; and

a memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to receive a plurality of signals from a transcutaneously positioned analyte sensor, receive a reference data, calibrate the analyte sensor based on the received reference data to generate calibrated sensor data, detect a change in the level of the received plurality of signals from the analyte sensor exceeding a predetermined threshold level within a preset time period after calibrating the analyte sensor, and generate an output signal based on the detected change.

20. The apparatus of claim 19 wherein the received reference data is a blood glucose measurement from an in vitro test strip.

21. The apparatus of claim 19 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a calibration factor based on the received reference data and a substantially time corresponding signal received from the analyte sensor.

22. The apparatus of claim 21 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to match the received reference data to the substantially time corresponding sensor signal.

23. The apparatus of claim 21 wherein the calibration factor includes a sensitivity ratio.

24. The apparatus of claim 21 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to apply the calibration factor to the received plurality of signals from the sensor.

25. The apparatus of claim 19 wherein the detected change in the level of the received plurality of signals from the sensor is associated with a signal dropout condition.

26. The apparatus of claim 19 wherein the predetermined threshold level includes a variation in the level of at least two adjacent signals from the received plurality of signals exceeding approximately 5%.

27. The apparatus of claim 19 wherein the preset time period includes approximately 60 minutes or less, 45 minutes or less, 30 minutes or less, 15 minutes or less, 10 minutes or less, or 5 minutes or less.

28. The apparatus of claim 19 wherein the generated output includes a prompt to recalibrate the sensor.

29. The apparatus of claim 19 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to mask the calibrated sensor data.

30. The apparatus of claim 29 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to disable the output of the calibrated sensor data.

31. The apparatus of claim 19 wherein the reference data is received from the transcutaneously positioned analyte sensor.

32. An apparatus, comprising:

one or more processors;

an output unit operatively coupled to the one or more processors; and

a memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to receive a plurality of signals from a transcutaneously positioned analyte sensor, output an indicator associated with the received plurality of signals from the sensor to the output unit, detect a change in the level of the received plurality of signals from the analyte sensor exceeding a predetermined threshold level within a preset time period, confirm an adverse condition based on the detected change in the level of the received plurality of signals from the sensor, and modify a portion of the outputted indicator based on the confirmed adverse signal condition.

33. The apparatus of claim 32 wherein the adverse condition includes a signal dropout condition.

34. The apparatus of claim 33 wherein the indicator includes a graphical representation associated with the received plurality of signals from the sensor.

35. The apparatus of claim 32 wherein the memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, causes the one or more processors to identify a subset of the received plurality of signals from the sensor associated with the confirmed adverse condition, and to modify the portion of the outputted indicator corresponding to the subset of the received plurality of signals from the sensor.