Methods, systems, and devices for calibration and optimization of glucose sensors and sensor output

Patent metadata

Field	Value
Publication number	US-11957464-B2
Application number	US-202217574700-A
Country	US
Kind code	B2
Filing date	Jan 13, 2022
Priority date	Sep 13, 2017
Publication date	Apr 16, 2024
Grant date	Apr 16, 2024

Abstract

A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects. Correction actors, fusion algorithms, EIS, and advanced ASICs may be used to implement the foregoing, thereby achieving the goal of improved accuracy and reliability without the need for blood-glucose calibration, and providing a calibration-free, or near calibration-free, sensor.

First claim

What is claimed is:

1. A method for calibrating one or more sensor parameters of a glucose sensor used for measuring a level of glucose in a body of a user, the glucose sensor including physical sensor electronics, a microcontroller, and a working electrode, the method comprising:
periodically measuring, by the physical sensor electronics, electrode current signal (Isig) values for the working electrode;
generating, by the microcontroller, Electrochemical Impedance Spectroscopy (EIS) parameter values for the working electrode based on an EIS procedure;
measuring, by the physical sensor electronics, Vcntr values of counter voltage for the glucose sensor;
based on the Isig values, the EIS parameter values, the Vcntr values, and a plurality of sensor glucose (SG) predictive models, calculating, by the microcontroller, a respective SG value for each of the SG predictive models;
applying a factory calibration factor, by the microcontroller, to fuse the respective SG values to calculate a single, fused SG value;
performing, by the microcontroller, error detection diagnostics on the single, fused SG value to determine whether a correctable error exists in the single, fused SG value;
in a case where the error detection diagnostics determine that a correctable error exists, correcting, by the microcontroller, the correctable error in the single, fused SG value to generate a corrected, single, fused SG value; and
providing the corrected, single, fused SG value.

2. The method of claim 1 , further comprising: in a case where the error detection diagnostics determine that an error in the single, fused SG value is not correctable, blanking the single, fused SG value.

3. The method of claim 1 , wherein the plurality of SG predictive models includes at least two of a genetic programming model, an analytical model, a bag of trees model, or a decision tree model.

4. The method of claim 1 , wherein the plurality of SG predictive models includes a genetic programming model, an analytical model, a bag of trees model, and a decision tree model.

5. The method of claim 1 , wherein the factory calibration factor is a correction parameter that mitigates deviations in sensor performance characteristics between a prior batch and a subsequent batch.

6. The method of claim 5 , wherein the correction parameter is a weighting factor that is multiplied by the respective SG values of the SG predictive models.

7. The method of claim 1 , wherein the EIS parameter values include 1 kHz real impedance.

8. The method of claim 1 , wherein the EIS parameter values include 1 kHz imaginary impedance.

9. The method of claim 1 , further comprising applying, by the microcontroller, a filter to the single, fused SG value.

10. The method of claim 1 , wherein the glucose sensor is used in a hybrid closed-loop glucose monitoring system.

11. A glucose sensor for calibrating one or more sensor parameters used for measuring a level of glucose in a body of a user, the glucose sensor comprising:
a working electrode;
physical sensor electronics configured to periodically measure electrode current signal (Isig) values for the working electrode and Vcntr values of counter voltage for the glucose sensor; and
a microcontroller configured to
generate Electrochemical Impedance Spectroscopy (EIS) parameter values for the working electrode based on an EIS procedure;
based on the Isig values, the EIS parameter values, the Vcntr values, and a plurality of sensor glucose (SG) predictive models, calculate a respective SG value for each of the SG predictive models;
apply a factory calibration factor to fuse the respective SG values to calculate a single, fused SG value;
perform error detection diagnostics on the single, fused SG value to determine whether a correctable error exists in the single, fused SG value;
in a case where the error detection diagnostics determine that a correctable error exists, correct the correctable error to generate a corrected, single, fused SG value; and
provide the corrected, single, fused SG value.

12. The glucose sensor of claim 11 , wherein in a case where the error detection diagnostics determine that an error in the single, fused SG value is not correctable, the microcontroller blanks the single, fused SG value.

13. The glucose sensor of claim 12 , wherein the plurality of SG predictive models includes at least two of a genetic programming model, an analytical model, a bag of trees model, or a decision tree model.

14. The glucose sensor of claim 11 , wherein the plurality of SG predictive models includes a genetic programming model, an analytical model, a bag of trees model, and a decision tree model.

15. The glucose sensor of claim 11 , wherein the factory calibration factor is a correction parameter that mitigates deviations in sensor performance characteristics between a prior batch and a subsequent batch.

16. The glucose sensor of claim 15 , wherein the correction parameter is a weighting factor that is multiplied by the respective SG values of the SG predictive models.

17. The glucose sensor of claim 16 , wherein the EIS parameter values include 1 kHz real impedance.

18. The glucose sensor of claim 11 , wherein the EIS parameter values include 1 kHz imaginary impedance.

19. The glucose sensor of claim 11 , wherein the microcontroller is further configured to apply a filter to the single, fused SG value.

20. A non-transitory, computer-readable medium having instructions that, when executed by one or more processors, cause the one or more processors to perform a method for calibrating one or more sensor parameters of a glucose sensor used for measuring a level of glucose in a body of a user, the method comprising:
periodically measuring electrode current signal (Isig) values for a working electrode;
generating Electrochemical Impedance Spectroscopy (EIS) parameter values for the working electrode based on an EIS procedure;
measuring Vcntr values of counter voltage for the glucose sensor;
based on the Isig values, the EIS parameter values, the Vcntr values, and a plurality of sensor glucose (SG) predictive models, calculating a respective SG value for each of the SG predictive models;
applying a factory calibration factor to fuse the respective SG values to calculate a single, fused SG value;
performing error detection diagnostics on the single, fused SG value to determine whether a correctable error exists in the single, fused SG value;
in a case where the error detection diagnostics determine that a correctable error exists, correcting the correctable error to generate a corrected, single, fused SG value; and
providing the corrected, single, fused SG value.

Assignees

• Medtronic Minimed Inc

Inventors

• Ajemba Peter
• Nogueira Keith
• Kannard Brian T

Classifications

• A61B5/1495 Primary

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/14532 Primary

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

• A61B5/1468

  using chemical or electrochemical methods, e.g. by polarographic means · CPC title

• A61B5/14865

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

• A61B5/6849

  in combination with a needle set · CPC title