Method and apparatus for providing analyte sensor calibration

• US 9,398,872 B2
• Filed: 08/28/2014
• Issued: 07/26/2016
• Est. Priority Date: 07/31/2007
• 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 Alan, McGarraugh, Geoffrey V., Naegeli, Andrew H., Mazza, John Charles, Feldman, Benjamin Jay, Harper, Wesley Scott
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US14/472,341
• Publication Number:
  US 20140372065A1
• Time in Patent Office: 698 Days
• Field of Search: 600/365
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/1451 for interstitial fluid
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods and apparatus for providing data processing and control for use in verifying the stability of sensor sensitivity of an analyte sensor.

Claims

1. A method of determining a composite sensitivity for an analyte sensor of an electronic analyte monitoring system to compensate for an outlier or erroneous sensitivity, the method comprising:

positioning an analyte sensor in fluid contact with bodily fluid in a human body;

generating, with the analyte sensor, first data corresponding to a monitored analyte level in the bodily fluid;

determining a new sensor sensitivity, using a processor, based on the generated first data when a first difference between a current sensor sensitivity and a prior sensor sensitivity is not within a predetermined range;

determining, using the processor, if a second difference between the new sensor sensitivity and one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range;

after it is determined that the second difference between the new sensor sensitivity and one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range, then determining, using the processor, a composite sensitivity based on the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity that was used in determining that the second difference is within the predetermined range; and

generating, using the processor, second data based on calibrating the first data using the composite sensitivity, the second data corresponding to a monitored analyte level.

2. The method of claim 1, including determining a calibration time period based on a predetermined calibration schedule.

3. The method of claim 2, wherein the predetermined calibration schedule includes a plurality of calibration time periods after positioning of the analyte sensor in fluid contact with the bodily fluid.

4. The method of claim 3, wherein the plurality of calibration time periods is determined based on a valid calibration procedure to calibrate the positioned analyte sensor.

5. The method of claim 1, further comprising generating a notification including a request for a reference measurement value.

6. The method of claim 5, wherein the request includes one or more of a text information, a graphical information, an audible information, or a combined one or more of the text, graphical or audible information to alert a user to enter the reference measurement value.

7. The method of claim 1, further including comparing the current sensor sensitivity to a nominal sensitivity for a first baseline calibration of the analyte sensor.

8. The method of claim 1, wherein the bodily fluid is interstitial fluid.

9. The method of claim 1, wherein the second difference determined to be within the predetermined range is between the new sensor sensitivity and the current sensor sensitivity, and wherein the composite sensitivity is based on the new sensor sensitivity and the current sensor sensitivity.

10. The method of claim 1, wherein the second difference determined to be within the predetermined range is between the new sensor sensitivity and the prior sensor sensitivity, and wherein the composite sensitivity is based on the new sensor sensitivity and the prior sensor sensitivity.

11. An electronic analyte monitoring system capable of determining a composite sensitivity for an analyte sensor to compensate for an outlier or erroneous sensitivity, the system comprising:

an analyte sensor adapted to contact bodily fluid in a human'"'"'s body and configured to generate first data corresponding to monitored analyte level in the bodily fluid;

a data storage unit; and

a processing unit operatively coupled to the data storage unit and the analyte sensor, and configured to;

determine a new sensor sensitivity based on the generated first data from the analyte sensor when a first difference between a current sensor sensitivity and a prior sensor sensitivity is not within a predetermined range,

determine if a second difference between the new sensor sensitivity and one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range,

after it is determined that the second difference between the new sensor sensitivity and one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range, then determine a composite sensitivity based on the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity that was used to determine that the second difference is within the predetermined range; and

generate second data based on a calibration of the first data using the composite sensitivity, the second data corresponding to a monitored analyte level.

12. The system of claim 11, wherein the processing unit is configured to determine a calibration time period based on a predetermined calibration schedule.

13. The system of claim 12, wherein the predetermined calibration schedule includes a plurality of calibration time periods after positioning of the analyte sensor in fluid contact with the bodily fluid.

14. The system of claim 13, wherein the plurality of calibration time periods is determined based on a valid calibration procedure to calibrate the positioned analyte sensor.

15. The system of claim 11, further including an output unit operatively coupled to the processing unit, the output unit configured to generate and to output a notification to request for a reference measurement value.

16. The system of claim 15, wherein the request includes one or more of a text information, a graphical information, an audible information, or a combined one or more of the text, graphical or audible information.

17. The system of claim 15, wherein the processing unit is configured to store the generated notification in the data storage unit.

18. The system of claim 11, wherein the processing unit is further configured to compare the current sensor sensitivity to a nominal sensitivity for a first baseline calibration of the analyte sensor.

19. The system apparatus of claim 11, wherein the bodily fluid is interstitial fluid.

20. The system of claim 11, wherein the second difference determined to be within the predetermined range is between the new sensor sensitivity and the current sensor sensitivity, and wherein the composite sensitivity is based on the new sensor sensitivity and the current sensor sensitivity.

21. The system of claim 11, wherein the second difference determined to be within the predetermined range is between the new sensor sensitivity and the prior sensor sensitivity, and wherein the composite sensitivity is based on the new sensor sensitivity and the prior sensor sensitivity.