Method and Apparatus for Providing Analyte Sensor Calibration

• US 20140372065A1
• Filed: 08/28/2014
• Published: 12/18/2014
• Est. Priority Date: 07/31/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Hayter, Gary Alan, McGarraugh, Geoffrey V., Naegeli, Andrew H., Mazza, John Charles, Feldman, Benjamin Jay, Harper, Wesley Scott
• Granted Patent: US 9,398,872 B2
• Time in Patent Office: Days
• US Class Current: 702/104
• 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, comprising:

determining, using one or more processors, a new sensor sensitivity when a difference between a current sensor sensitivity and a prior sensor sensitivity is not within a predetermined range;

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

determining, using the one or more processors, a composite sensitivity based on the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity when it is determined that the difference between the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range.

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 an analyte sensor in fluid contact with interstitial 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 an analyte sensor.

8. An apparatus, comprising:

a data storage unit; and

a processing unit operatively coupled to the data storage unit, and configured to, determine a new sensor sensitivity when a difference between a current sensor sensitivity and a prior sensor sensitivity is not within a predetermined range, determine if a difference between the new sensor sensitivity and one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range, and determine a composite sensitivity based on the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity when it is determined that the difference between the new sensor sensitivity and the one of the current sensor sensitivity or the prior sensor sensitivity is within the predetermined range.

9. The apparatus of claim 8, wherein the processing unit is configured to determine a calibration time period based on a predetermined calibration schedule.

10. The apparatus of claim 9, wherein the predetermined calibration schedule includes a plurality of calibration time periods after positioning of an analyte sensor in fluid contact with interstitial fluid.

11. The apparatus of claim 10, wherein the plurality of calibration time periods is determined based on a valid calibration procedure to calibrate the positioned analyte sensor.

12. The apparatus of claim 8, 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.

13. The apparatus of claim 12, 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.

14. The apparatus of claim 8, wherein the processing unit is configured to store the generated notification in the data storage unit.

15. The apparatus of claim 8, wherein the processing unit is further configured to compare the current sensor sensitivity to a nominal sensitivity for a first baseline calibration of an analyte sensor.