Granted Patent B2

US 12,313,622 · App. 17/717,556 · Granted May 27, 2025

Inventors: Gary Alan Hayter (Oakland, CA); Geoffrey V. McGarraugh (San Rafael, CA); Andrew H. Naegeli (Walnut Creek, CA); John Charles Mazza (Long Beach, CA); Benjamin Jay Feldman (Berkeley, CA)

Assignee: ABBOTT DIABETES CARE INC.

G01N33/49A61B5/14532A61B5/1473A61B5/1495G16H10/40G16H20/10G16H40/67A61B2560/0223A61B2560/0252G16H15/00G16H40/40G16H50/50

Abstract

Claims (54)

1. A glucose monitoring system, comprising:

one or more processors; and

a memory operatively coupled to the one or more processors for storing instructions which, when executed by the one or more processors, cause the one or more processors to:

obtain a first sensitivity of a glucose sensor,

wherein the glucose sensor comprises a working electrode and a reference electrode, the glucose sensor has an in vivo portion and an ex vivo portion, and is configured to generate electrical signals associated with the glucose level in an interstitial fluid of a user, wherein a portion of the glucose sensor is configured to be transcutaneously positioned in the user such that when operably positioned, the ex vivo portion of the glucose sensor is configured to reside above a skin surface of the user, and the in vivo portion of the glucose sensor is configured to reside below the skin surface and in contact with interstitial fluid of the user;

obtain a second sensitivity of the glucose sensor;

compare a difference between the first sensitivity and the second sensitivity to a predetermined range of values; and

upon determining that the difference is within the predetermined range of values:

determine a composite sensitivity for a current calibration of the glucose sensor based on a weighted combination of the first sensitivity and the second sensitivity; and

calculate the glucose level based on the current calibration of the glucose sensor.

2. The glucose monitoring system of claim 1 , wherein the instructions further cause the one or more processors to cause a calibration routine for the glucose sensor to be performed upon determining that the difference is outside the predetermined range of the values, wherein the calibration routine comprises:

causing a user input interface to be provided for display; and

receiving a current glucose value for the user from the user input interface.

3. The glucose monitoring system of claim 2 , wherein the instructions further cause the one or more processors to determine a new sensitivity for the glucose sensor based on the current glucose value.

4. The glucose monitoring system of claim 3 , wherein the instructions further cause the one or more processors to:

compare a second difference between the new sensitivity and at least one of the first sensitivity or the second sensitivity to the predetermined range of values; and

upon determining that the second difference is within the predetermined range of values:

determine the compositive sensitivity for the current calibration of the glucose sensor based on a weighted combination of the new sensitivity and the at least one of the first sensitivity or the second sensitivity; and

calculate the glucose level based on the current calibration of the glucose sensor.

5. The glucose monitoring system of claim 4 , wherein the instructions further cause the one or more processors to, if the second difference is outside the predetermined range of values, determine that a predetermined time period has lapsed before performing a second calibration routine.

6. The glucose monitoring system of claim 1 , wherein at least the first sensitivity is determined during manufacture of the glucose sensor.

7. The glucose monitoring system of claim 1 , wherein at least one of the first sensitivity and the second sensitivity is based on a monitored glucose level associated with the user.

8. The glucose monitoring system of claim 1 , wherein the first sensitivity is associated with a first time and the second sensitivity of the glucose sensor is associated with a second time, and wherein the first time and the second time correspond to successive intervals within a defined period of time.

9. The glucose monitoring system of claim 1 , wherein comparing the difference between the first sensitivity and second sensitivity to the predetermined range of values comprises determining whether the first sensitivity or the second sensitivity is an outlier sensitivity value.

10. The glucose monitoring system of claim 1 , wherein the instructions further cause the one or more processors to determine a baseline for the current calibration of the glucose sensor by performing a baseline calibration event for the composite sensitivity based on the difference being within the predetermined range of values.

11. The glucose monitoring system of claim 1 , wherein the instructions further cause the one or more processors to cause the calculated glucose level to be provided for output on a display.

12. The glucose monitoring system of claim 1 , wherein the instructions further cause the one or more processors to:

compare the calculated glucose level to a threshold alarm value; and

in response to the calculated glucose level satisfying the threshold alarm value, cause an output associated with an alarm to be provided.

13. The glucose monitoring system of claim 1 , wherein the glucose level is further calculated based on the electrical signals originating from the glucose sensor and provided to the one or more processors via a transmitter unit that is electrically and physically coupled to the ex vivo portion of the glucose sensor.

14. A computer-implemented method comprising:

obtaining a first sensitivity of a glucose sensor,

wherein the glucose sensor comprises a working electrode and a reference electrode, the glucose sensor has an in vivo portion and an ex vivo portion, and is configured to generate electrical signals associated with the glucose level in an interstitial fluid of a user, wherein a portion of the glucose sensor is configured to be transcutaneously positioned in the user such that when operably positioned, the ex vivo portion of the glucose sensor is configured to reside above a skin surface of the user, and the in vivo portion of the glucose sensor is configured to reside below the skin surface and in contact with interstitial fluid of the user;

obtaining a second sensitivity of the glucose sensor;

comparing a difference between the first sensitivity and the second sensitivity to a predetermined range of values; and

upon determining that the difference is within the predetermined range of values:

determining a composite sensitivity for a current calibration of the glucose sensor based on a weighted combination of the first sensitivity and the second sensitivity; and

calculating the glucose level based on the current calibration of the glucose sensor.

15. The computer-implemented method of claim 14 , further comprising causing a calibration routine for the glucose sensor to be performed upon determining that the difference is outside the predetermined range of the values, wherein the calibration routine comprises:

causing a user input interface to be provided for display; and

receiving a current glucose value for the user from the user input interface.

16. The computer-implemented method of claim 15 , further comprising determining a new sensitivity for the glucose sensor based on the current glucose value.

17. The computer-implemented method of claim 16 , further comprising:

comparing a second difference between the new sensitivity and at least one of the first sensitivity or the second sensitivity to the predetermined range of values;

upon determining that the second difference is within the predetermined range of values:

determining the compositive sensitivity for the current calibration of the glucose sensor based on a weighted combination of the new sensitivity and the at least one of the first sensitivity or the second sensitivity; and

calculating the glucose level based on the current calibration of the glucose sensor.

18. The computer-implemented method of claim 17 , further comprising, if the second difference is outside the predetermined range of values, determine that a predetermined time period has lapsed before performing a second calibration routine.

19. The computer-implemented method of claim 14 , wherein at least the first sensitivity is determined during manufacture of the glucose sensor.

20. The computer-implemented method of claim 14 , wherein at least one of the first sensitivity and the second sensitivity is based on a monitored glucose level associated with the user.

21. The glucose monitoring system of claim 1 , wherein the weighted combination of the first sensitivity and the second sensitivity comprises a time-weighted average.

22. The glucose monitoring system of claim 1 , wherein determining the composite sensitivity for the current calibration of the glucose sensor based on the weighted combination of the first sensitivity and the second sensitivity comprises accessing a lookup table which provides a non-linear correction.

23. The computer-implemented method of claim 14 , wherein the weighted combination of the first sensitivity and the second sensitivity comprises a time-weighted average.

24. The computer-implemented method of claim 14 , wherein determining the composite sensitivity for the current calibration of the glucose sensor based on the weighted combination of the first sensitivity and the second sensitivity comprises accessing a lookup table which provides a non-linear correction.

Assignments (1)

Continuity (11)

References Cited (400)