IP Library Granted Patent US 10,617,336
Granted Patent B2
US 10,617,336 · App. 16/457,692 · Granted Apr 14, 2020

System and methods for processing analyte sensor data for sensor calibration

Inventors: Apurv Ullas Kamath (San Diego, CA); James H. Brauker (Addison, MI); Paul V. Goode, Jr. (Round Rock, TX); Aarthi Mahalingam (San Diego, CA); Jack Pryor (Ladera Ranch, CA)
Assignee: DexCom, Inc.
A61B5/14546A61B5/0031A61B5/1451A61B5/1473A61B5/1495A61B5/14532A61B5/14865A61B5/1468A61B5/1486A61B5/14503A61B5/14735A61B2560/0223Y02A90/26
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Quick Facts
Patent No.
US 10,617,336
App. No.
16/457,692
Granted
Apr 14, 2020
Kind
B2
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 (27)

1. A method for calibrating a transcutaneous glucose sensor, 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;

receiving predetermined calibration information, wherein the predetermined calibration information comprises predetermined baseline information and predetermined sensitivity information associated with the transcutaneous glucose sensor; and

calibrating, using a processor module, the transcutaneous glucose sensor based on the predetermined calibration information, wherein the calibrating is performed without reference data from a reference glucose monitor.

2. The method of claim 1 , wherein the predetermined baseline information is derived from in vivo testing of at least one other transcutaneous glucose sensor.

3. The method of claim 1 , wherein the calibrating is based on a conversion function comprising a sensitivity value and a baseline value, and wherein the method further comprises validating the conversion function based on at least one of the predetermined baseline information or the predetermined sensitivity information.

4. The method of claim 3 , further comprising determining an error if the validation fails.

5. The method of claim 3 , further comprising requesting reference data if the validation fails.

6. The method of claim 3 , further comprising adjusting the conversion function if the validation fails.

7. The method of claim 6 , wherein adjusting the conversion function comprises adjusting the baseline value of the conversion function.

8. The method of claim 7 , wherein adjusting the baseline value is based on the predetermined baseline information.

9. The method of claim 1 , wherein the predetermined sensitivity information is derived from in vitro testing and provided as a calibration code.

10. A system for calibrating a transcutaneous glucose sensor, comprising:

the 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, wherein the predetermined calibration information comprises one or both of predetermined baseline information and predetermined sensitivity information associated with the transcutaneous glucose sensor, wherein the processor module is configured to calibrate the sensor data without reference data from a reference glucose monitor.

11. The system of claim 10 , wherein the predetermined baseline information is derived from in vivo testing of at least one other transcutaneous glucose sensor.

12. The system of claim 10 , wherein the calibration is based on a conversion function comprising a baseline value and a sensitivity value, and wherein the processor module is configured to validate the conversion function based on at least one of the predetermined sensitivity information or the predetermined baseline information.

13. The system of claim 12 , wherein the processor module is configured to detect an error if the validation fails.

14. The system of claim 12 , wherein the processor module is configured to request reference data if the validation fails.

15. The system of claim 12 , wherein the processor module is configured to adjust the conversion function if the validation fails.

16. The system of claim 15 , wherein the processor module is configured to adjust the conversion function by adjusting the baseline value of the conversion function.

17. The system of claim 10 , wherein the calibration is based on a conversion function comprising a baseline value and a sensitivity value, and wherein the processor module is configured to adjust the baseline value based on the predetermined baseline information.

18. The system of claim 10 , wherein the predetermined sensitivity information is derived from in vitro testing and provided as a calibration code.

19. 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.

20. The system of claim 19 , wherein the processor module is incorporated in the transmitter unit, wherein the processor module is configured to calibrate the sensor data prior to the sensor data being transmitted by the radio frequency transmitter.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2020
From: MAHALINGAM, AARTHI
To: DEXCOM, INC.
Reel/Frame 051905/0492 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 4, 2020
From: MAHALINGAM, AARTHI
To: DEXCOM, INC.
Reel/Frame 051712/0839 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2019
From: PRYOR, JACK
To: DEXCOM, INC.
Reel/Frame 049664/0410 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2019
From: GOODE, PAUL V., JR.; BRAUKER, JAMES H.; KAMATH, APURV U.
To: DEXCOM, INC.
Reel/Frame 049664/0461 →
Continuity (7)
Continuation 15787595 · Oct 18, 2017
Continuation 15065623 · Mar 9, 2016
Continuation 13607162 · Sep 7, 2012
Continuation 12683755 · Jan 7, 2010
Continuation 11373628 · Mar 9, 2006
Provisional Application 60660743 · Mar 10, 2005
Related Publication 20190320954A1 · Oct 24, 2019
Cited By (4)
US 12,453,494 US 12,458,257 US 12,458,258 US 12,690,787