Optional sensor calibration in continuous glucose monitoring

Patent metadata

Field	Value
Publication number	US-11213230-B2
Application number	US-201715840515-A
Country	US
Kind code	B2
Filing date	Dec 13, 2017
Priority date	Dec 13, 2017
Publication date	Jan 4, 2022
Grant date	Jan 4, 2022

Abstract

A method for optional external calibration of a calibration-free glucose sensor uses values of measured working electrode current (Isig) and EIS data to calculate a final sensor glucose (SG) value. Counter electrode voltage (Vcntr) may also be used as an input. Raw Isig and Vcntr values may be preprocessed, and low-pass filtering, averaging, and/or feature generation may be applied. SG values may be generated using one or more models for predicting SG calculations. When an external blood glucose (BG) value is available, the BG value may also be used in calculating the SG values. A SG variance estimate may be calculated for each predicted SG value and modulated, with the modulated SG values then fused to generate a fused SG. A Kalman filter, as well as error detection logic, may be applied to the fused SG value to obtain a final SG, which is then displayed to the user.

First claim

What is claimed is:

1. A method for optional external calibration of a calibration-free glucose sensor for measuring a level of glucose in a body of a user, said glucose sensor including physical sensor electronics, a microcontroller, and a working electrode, the method comprising:
periodically measuring, by said physical sensor electronics, electrode current (Isig) signals for the working electrode;
performing, by said microcontroller, an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode;
based on said Isig signals and EIS-related data and a plurality of calibration-free SG-predictive models, calculating, by said microcontroller, a respective sensor glucose (SG) value for each of the SG-predictive models;
fusing, by said microcontroller, said respective SG values from the plurality of SG-predictive models to obtain a single, fused SG value;
determining, by said microcontroller, whether an external blood glucose (BG) value is available;
in response to determining that the BG value is available, comparing the BG value to the fused SG value to determine whether the fused SG value has a difference from the BG value that exceeds a threshold;
in response to determining that the fused SG value has the difference from the BG value that exceeds the threshold, modulating the fused SG value for a period of time by scaling the respective SG value by a modulation factor that is proportional to a ratio of the BG value to the respective SG value;
applying, by said microcontroller, an unscented Kalman filter to said fused SG value; and
calculating, by said microcontroller, a calibrated SG value to be displayed to the user.

2. The method of claim 1 , wherein the physical sensor electronics further measure voltage values of a counter electrode (Vcntr) of said glucose sensor.

3. The method of claim 2 , wherein the microcontroller further preprocesses said Isig signals and Vcntr values prior to calculation of said respective SG values.

4. The method of claim 3 , further including applying a low-pass filter to said Isig signals.

5. The method of claim 3 , wherein said preprocessing comprises down-sampling Isig signals that are close together in time.

6. The method of claim 2 , wherein the microcontroller further preprocesses said Isig signals and Vcntr values prior to calculation of said respective SG values.

7. The method of claim 1 , wherein said plurality of SG-predictive models are machine learning models.

8. The method of claim 7 , wherein said machine learning models include at least one of a genetic programming algorithm, a regression decision tree, and a bagged decision tree.

9. The method of claim 1 , wherein said plurality of SG-predictive models are analytical models.

10. The method of claim 1 , wherein each SG variance estimate for each respective SG value is calculated empirically from training data.

11. The method of claim 1 , wherein said Kalman filter contains one set of measurement functions for when a BG calibration based on comparing the BG value to each respective SG value is available, and one set of measurement functions for when the BG calibration based on comparing the BG value to each respective SG value is not available.

12. The method of claim 1 , wherein the sensor includes a plurality of working electrodes.

13. The method of claim 1 , wherein the physical sensor electronics further measure voltage values of a counter electrode (Vcntr) of said glucose sensor.

14. A glucose sensor comprising:
physical sensor electronics;
a working electrode; and
a microcontroller configured to:
periodically measure electrode current (Isig) signals for the working electrode;
perform an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode;
based on said Isig signals and EIS-related data and a plurality of calibration-free SG-predictive models, calculate a respective sensor glucose (SG) value for each of the SG-predictive models;
fuse said respective SG values from the plurality of SG-predictive models to obtain a single, fused SG value;
determine whether an external blood glucose (BG) value is available;
in response to determining that the BG value is available, compare the BG value to the fused SG value to determine whether the fused SG value has a difference from the BG value that exceeds a threshold;
in response to determining that the fused SG value has the difference from the BG value that exceeds the threshold, modulate the fused SG value for a period of time by scaling the respective SG value by a modulation factor that is proportional to a ratio of the BG value to the respective SG value;
apply an unscented Kalman filter to said fused SG value; and
calculate a calibrated SG value to be displayed to a user.

15. A non-transitory computer-readable medium for generating recommendations for optional external calibration of a calibration-free glucose sensor for measuring a level of glucose in a body of a user, comprising instructions that, when executed by one or more processors, cause operations comprising:
periodically measuring electrode current (Isig) signals for a working electrode;
performing an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode;
based on said Isig signals and EIS-related data and a plurality of calibration-free SG-predictive models, calculating a respective sensor glucose (SG) value for each of the SG-predictive models;
fusing said respective SG values from the plurality of SG-predictive models to obtain a single, fused SG value;
determining whether an external blood glucose (BG) value is available;
in response to determining that the BG value is available, comparing the BG value to the fused SG value to determine whether the fused SG value has a difference from the BG value that exceeds a threshold;
in response to determining that the fused SG value has the difference from the BG value that exceeds the threshold, modulating the fused SG value for a period of time by scaling the respective SG value by a modulation factor that is proportional to a ratio of the BG value to the respective SG value;
applying an unscented Kalman filter to said fused SG value; and
calculating a calibrated SG value to be displayed to the user.

16. The non-transitory computer-readable medium of claim 15 , wherein said plurality of SG-predictive models are machine learning models.

Assignees

• Medtronic Minimed Inc

Inventors

• Nishida Jeffrey
• Varsavsky Andrea
• Engel Taly G
• Nogueira Keith
• Tsai Andy Y
• Ajemba Peter

Classifications

• A61B5/0537

  Measuring body composition by impedance, e.g. tissue hydration or fat content · CPC title

• A61B5/1495 Primary

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/725

  using specific filters therefor, e.g. Kalman or adaptive filters (specific diagnostics methods using using bioelectric or biomagnetic signals A61B5/316) · CPC title

• G01N27/3271

  Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood (amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001) · CPC title

• A61B5/14865

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