System and methods for processing analyte sensor data for sensor calibration

• US 10,610,137 B2
• Filed: 06/28/2019
• Issued: 04/07/2020
• Est. Priority Date: 03/10/2005
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Brauker, James H., Goode, Jr., Paul V., Mahalingam, Aarthi, Pryor, Jack
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US16/457,688
• Publication Number:
  US 20190320953A1
• Time in Patent Office: 284 Days
• Field of Search: 600309, 600345-366
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Claims

1. A method of processing sensor data from a transcutaneous glucose sensor, the method comprising:

receiving sensor data from the transcutaneous glucose sensor by an electronics module operably connected to the transcutaneous glucose sensor, wherein the sensor data is indicative of a glucose concentration in a host; and

calibrating, using an electronic device, the sensor data based on predetermined calibration information without reference data from a reference glucose monitor, wherein the predetermined calibration information comprises predetermined sensitivity information and predetermined baseline information associated with the transcutaneous glucose sensor, and wherein the predetermined calibration information is derived from in vivo testing of at least one other transcutaneous glucose sensor.

2. The method of claim 1, wherein the calibrating comprises determining a conversion function for the sensor data, wherein the conversion function is based on the predetermined calibration information.

3. The method of claim 2, further comprising converting the sensor data using the conversion function.

4. The method of claim 1 wherein the calibrating comprises determining a conversion function for the sensor data, and wherein the calibrating further comprises at least one of guiding or validating the conversion function based on the predetermined calibration information.

5. The method of claim 4, further comprising validating the conversion function based on the predetermined calibration information and determining an error if the validation fails.

6. The method of claim 4, further comprising validating the conversion function based on the predetermined calibration information and requesting reference data if the validation fails.

7. The method of claim 4, further comprising validating the conversion function based on the predetermined calibration information and converting the sensor data if the validation passes.

8. The method of claim 1, wherein the predetermined calibration information is provided in a calibration code.

9. The method of claim 8, wherein the calibration code is detected or received by the electronic device after sensor insertion.

10. A system for processing sensor data from a transcutaneous glucose sensor, the system comprising:

a transcutaneous glucose sensor configured to provide sensor data indicative of a glucose concentration in a host; and

a processor module configured to calibrate the sensor data based on predetermined calibration information without reference data from a reference glucose monitor, wherein the predetermined calibration information comprises predetermined sensitivity information and predetermined baseline information associated with the transcutaneous glucose sensor, and wherein the predetermined calibration information is derived from in vivo testing of at least one other transcutaneous glucose sensor.

11. The system of claim 10, wherein the processor module is configured to determine a conversion function for the sensor data, wherein the conversion function is based on the predetermined calibration information.

12. The system of claim 11, wherein the processor module is configured to convert the sensor data using the conversion function.

13. The system of claim 12, wherein the conversion function is determined without reference data from a reference glucose monitor.

14. The system of claim 12, wherein the conversion function is based on reference data from a reference glucose monitor and the predetermined calibration information.

15. The system of claim 12, wherein the reference data comprises a single reference data point from the reference glucose monitor, and wherein the conversion function is based on the single reference data point and the predetermined calibration information.

16. The system of claim 10, wherein the processor module is incorporated into a receiver.

17. The system of claim 10, wherein the processor module is configured to determine a conversion function for the sensor data, and wherein the processor module is configured to guide or validate the conversion function based on the predetermined calibration information.

18. The system of claim 17, wherein the processor module is configured to validate the conversion based on the predetermined calibration information and determine an error if the validation fails.

19. The system of claim 17, wherein the processor module is configured to validate the conversion based on the predetermined calibration information and request reference data if the validation fails.

20. The system of claim 17, wherein the processor module is configured to validate the conversion based on the predetermined calibration information and convert the sensor data if the validation passes.

21. The system of claim 10, further comprising:

a transmitter unit configured to operably connect to the transcutaneous glucose sensor, the transmitter unit having a radio frequency transmitter configured to wirelessly transmit sensor data; and

a receiver unit comprising a radio frequency receiver and a display, the radio frequency receiver configured to receive the transmitted sensor data and the display configured to display information based on the transmitted sensor data.

22. The system of claim 21, wherein the processor module is incorporated in the transmitter unit.

23. The system of claim 10, wherein the predetermined calibration information is provided in a calibration code.

24. The system of claim 23, wherein the calibration code is detected or received by the processor module after sensor insertion.

25. The system of claim 23, wherein the electronic device is a receiver.

26. The system of claim 23, wherein the electronic device is sensor electronics.

27. A method of processing sensor data from a transcutaneous glucose sensor, the method comprising:

receiving sensor data from the transcutaneous glucose sensor by an electronics module operably connected to the transcutaneous glucose sensor, wherein the sensor data is indicative of a glucose concentration in a host;

configuring an electronic device to perform improved calibration of the sensor data from the transcutaneous glucose sensor, based on predetermined calibration information; and

calibrating, using the electronic device, the sensor data based on the predetermined calibration information without reference data from a reference glucose monitor, wherein the predetermined calibration information comprises predetermined sensitivity information and predetermined baseline information associated with the transcutaneous glucose sensor, and wherein the predetermined calibration information is derived from in vivo testing of at least one other transcutaneous glucose sensor.

28. The method of claim 27, wherein the calibrating comprises determining a conversion function for the sensor data, wherein the conversion function is based on the predetermined calibration information.

29. The method of claim 28, further comprising converting the sensor data using the conversion function.

30. The method of claim 27 wherein the calibrating comprises determining a conversion function for the sensor data, and wherein the calibrating further comprises at least one of guiding or validating the conversion function based on the predetermined calibration information.

31. The method of claim 30, further comprising validating the conversion function based on the predetermined calibration information and determining an error if the validation fails.

32. The method of claim 30, further comprising validating the conversion function based on the predetermined calibration information and requesting reference data if the validation fails.

33. The method of claim 30, further comprising validating the conversion function based on the predetermined calibration information and converting the sensor data if the validation passes.

34. The method of claim 27, wherein the predetermined calibration information is provided in a calibration code.

35. The method of claim 34, wherein the calibration code is detected or received by the electronic device after sensor insertion.