System and method for factory calibration or reduced calibration of an indwelling sensor based on sensitivity profile and baseline model of sensors

Patent metadata

Field	Value
Publication number	US-11974845-B2
Application number	US-202117368541-A
Country	US
Kind code	B2
Filing date	Jul 6, 2021
Priority date	Dec 30, 2015
Publication date	May 7, 2024
Grant date	May 7, 2024

Abstract

Systems and methods are disclosed which provide for a “factory-calibrated” sensor. In doing so, the systems and methods include predictive prospective modeling of sensor behavior, and also include predictive modeling of physiology. With these two correction factors, a consistent determination of sensitivity can be achieved, thus achieving factory calibration.

First claim

What is claimed is:

1. A system for calibrating an analyte concentration sensor, the sensor being a member of a manufactured lot of sensors, in which one or more operating parameters of the sensors of the lot have been determined, the determining of the operating parameters based on retrospective data, the operating parameters corresponding to at least a sensitivity of the sensors, the operating parameters representing in vivo values, the system comprising a device configured to perform operations comprising:
measuring an in vitro sensitivity of a first sensor in the lot of sensors;
measuring at least one drift characteristic for at least one sensor in the lot of sensors, the at least one drift characteristic being representative of the sensors in the lot of sensors;
determining at least a first coefficient for relating the in vitro sensitivity of the first sensor with the at least one drift characteristic;
determining an in vitro sensitivity of a second sensor in the lot of sensors; and
determining, using at least the first coefficient and the in vitro sensitivity of the second sensor, a predicted in vivo sensitivity of the second sensor.

2. The system of claim 1 , wherein the measuring at least one drift characteristic for the at least one sensor in the lot includes measuring at least two long-term drift characteristics for sensors of the lot, the long-term drift characteristics including an initial long-term drift-test sensitivity and a final long-term drift-test sensitivity.

3. The system of claim 2 , the operations further comprising determining a long-term drift-test rate of change sensitivity based on the initial long-term drift-test sensitivity and the final long-term drift-test sensitivity.

4. The system of claim 2 , wherein the device comprises a solution containing an analyte at a known concentration and wherein measuring of the initial long-term drift-test sensitivity and the final long-term drift-test sensitivity is performed by disposing the at least one sensor in the solution.

5. The system of claim 2 , the operations further comprising storing the predicted in vivo sensitivity of the second sensor for subsequent transmission to sensor electronics associated with the second sensor, or transmitting the predicted in vivo sensitivity of the second sensor to sensor electronics associated with the second sensor.

6. The system of claim 1 , wherein the at least one drift characteristic is characterized by a sensitivity model defined by a set of sensitivity parameters, wherein the sensitivity model includes an exponential function.

7. The system of claim 6 , wherein the function is a single exponential function.

8. The system of claim 6 , wherein the function is a dual exponential function.

9. The system of claim 6 , wherein the set of sensitivity parameters includes m0 or mF or both.

10. The system of claim 9 , wherein the sensitivity model further comprises mR.

11. The system of claim 1 , wherein the determining the in vitro sensitivity of the second sensor in the lot of sensors comprises measuring a parameter of the second sensor.

12. The system of claim 11 , wherein the parameter is a membrane thickness.

13. The system of claim 1 , wherein the determining the in-vitro sensitivity of the second sensor further comprises:
measuring an output signal of the second sensor at a plurality of values of an analyte concentration, and
performing a linear regression procedure using the measured output signals and measured values of the analyte concentration.

Assignees

• Dexcom Inc

Inventors

• Ma Rui
• Bhavaraju Naresh C
• Hamilton Thomas Stuart
• Hughes Jonathan
• Jackson Jeff
• Lee David I-Chun
• Simpson Peter C
• Vanslyke Stephen J

Classifications

• A61B5/1495 Primary

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• G01N33/66

  involving blood sugars, e.g. galactose · CPC title

• A61B5/14865

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title