Method and system for providing real time analyte sensor calibration with retrospective backfill

• US 9,310,230 B2
• Filed: 06/24/2013
• Issued: 04/12/2016
• Est. Priority Date: 04/29/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Harper, Wesley Scott
• Primary Examiner(s): Lin, Jerry
• Application Number:
  US13/925,694
• Publication Number:
  US 20130282302A1
• Time in Patent Office: 1,023 Days
• Field of Search: 702/19
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01D 18/00 Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Provided are methods and apparatus for receiving sensor data from an analyte sensor of a sensor monitoring system, processing the received sensor data with time corresponding calibration data, outputting the processed sensor data, detecting one or more adverse conditions associated with the sensor monitoring system, disabling the output of the sensor data during the adverse condition time period, determining that the one or more detected adverse conditions is no longer present in the sensor monitoring system, retrieving the sensor data during the adverse condition time period, processing the retrieved sensor data during the adverse condition time period, and outputting the processed retrieved sensor data.

Claims

1. A method of monitoring for and responding to the occurrence of an adverse condition associated with an analyte monitoring system that includes an analyte sensor and one or more processors, the method implemented using one or more processors, comprising:

processing sensor data from the analyte sensor of an analyte monitoring system with time corresponding calibration data;

detecting one or more adverse conditions associated with the analyte monitoring system;

disabling output of the sensor data collected during an adverse condition time period in which the adverse condition exists such that a gap in any output sensor data exists;

storing sensor data collected by the analyte sensor during the adverse condition time period;

determining that the one or more detected adverse conditions is no longer present in the analyte monitoring system;

retrieving the stored sensor data collected during the adverse condition time period after determining that the one or more detected adverse conditions is no longer present; and

processing the retrieved sensor data collected during the adverse condition time period such that the gap in the sensor data is at least partially filled.

2. The method of claim 1, further including outputting the processed retrieved sensor data.

3. The method of claim 1, wherein the one or more detected adverse conditions includes one or more of a sensor instability condition, a calibration failure condition, and a monitoring system failure condition.

4. The method of claim 3, wherein the sensor instability condition includes one or more of an early signal attenuation condition of the analyte sensor, an analyte sensor mis-position error, an analyte sensor communication error, a temperature measurement outside a predetermined range, or a combination thereof.

5. The method of claim 3, wherein the calibration failure condition includes one or more of an analyte level exceeding a predetermined threshold, a rate of change of analyte level exceeding a predetermined threshold, a signal error associated with the reference data, a data unavailability condition, or a combination thereof.

6. The method of claim 1, further including storing the processed sensor data with associated time information based on the analyte level detection time by the analyte sensor.

7. The method of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

8. A method of detecting and responding to the occurrence of a condition unsuitable for calibration of an analyte sensor within an analyte monitoring system including one or more processors, the method implemented using the one or more processors and comprising:

detecting a condition unsuitable for calibration of the analyte sensor;

disabling output of information associated with an analyte level monitored using the analyte sensor such that a gap in any output information exists;

storing sensor data collected by the analyte sensor during a time period of disabled output of information;

retrieving one or more parameters associated with a successful calibration of the analyte sensor; and

after the one or more parameters associated with successful calibration has been retrieved, processing the stored sensor data with the one or more parameters associated with the successful calibration such that the gap in the information is at least partially filled.

9. The method of claim 8, wherein the condition unsuitable for calibration includes one or more of a failure mode of the analyte sensor, sensor data outside a predetermined acceptable range, a rate of change of sensor data above a predetermined level, a requirement for calibration of the analyte sensor, a temperature measurement outside a predetermined range, or any combination thereof.

10. The method of claim 8, further comprising displaying the processed sensor data substantially immediately upon processing.

11. The method of claim 8, further comprising displaying the processed sensor data only after waiting a predetermined period of time.

12. The method of claim 8, wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

13. An analyte monitoring system that detects and responds to the occurrence of a condition unsuitable for calibration of an analyte sensor, comprising:

an interface configured to receive sensor data from an analyte sensor;

one or more processors; and

a memory device for storing instructions which, when executed by the one or more processors, causes the one or more processors to process stored sensor data, to detect a condition unsuitable for calibration of the analyte sensor for a predetermined time period, to disable displaying of processed sensor data such that a gap in any displayed sensor data exists, to store sensor data collected during a time period of disabled display, to retrieve one or more parameters associated with a successful calibration event, and after the one or more parameters associated with successful calibration have been retrieved, to process the stored sensor data with the one or more parameters associated with the successful calibration such that the gap in the sensor data is at least partially filled.

14. The analyte monitoring system of claim 13, further comprising the analyte sensor, wherein the analyte sensor is a glucose sensor.

15. The analyte monitoring system of claim 13, wherein the sensor data corresponds to analyte concentration data.

16. The analyte monitoring system of claim 13, wherein the memory device further includes instructions to process and display the sensor data substantially in real-time.

17. The analyte monitoring system of claim 13, wherein the condition unsuitable for calibration includes one or more of a failure mode of a sensor, sensor data outside a predetermined acceptable range, a rate of change of sensor data above a predetermined level, a requirement for calibration of a sensor, a temperature measurement outside a predetermined range, or any combination thereof.

18. The analyte monitoring system of claim 13, wherein the memory device further includes instructions to display the processed sensor data for the time period of disabled display substantially immediately upon processing the sensor data.

19. The analyte monitoring system of claim 13, wherein the memory device further includes instructions to display the processed sensor data for the time period of disabled display only after waiting a predetermined period of time.

20. The analyte monitoring system of claim 13, further comprising the analyte sensor, wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.