Granted Patent B2

US 11,259,726 · App. 16/142,711 · Granted Mar 1, 2022

Inventors: Xiaoxiao Chen (Washington, DC); Ravi Rastogi (Columbia, MD); Andrew DeHennis (Germantown, MD); Patricia Sanchez (Germantown, MD)

Assignee: Senseonics, Incorporated

A61B5/1495A61B5/1451A61B5/1459A61B5/14532A61B5/742G01N33/66A61B5/14503A61B5/4866A61B2560/0223

Abstract

Claims (154)

1. A method of calculating an analyte level in a first medium using one or more measurements of an analyte level in a second medium, the method comprising:

receiving first sensor data from an analyte sensor;

calculating a first analyte level in the second medium using at least the first sensor data;

calculating a first analyte level rate of change using at least the first analyte level in the second medium;

calculating a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determining that the one or more lag parameters should be updated;

updating the one or more lag parameters;

receiving second sensor data from the analyte sensor;

calculating a second analyte level in the second medium using at least the second sensor data;

calculating a second analyte level rate of change using at least the second analyte level in the second medium; and

calculating a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters;

wherein the one or more lag parameters include one or more of an analyte diffusion rate and an analyte consumption rate.

2. The method of claim 1 , wherein the first medium is blood, and the second medium is interstitial fluid.

3. The method of claim 1 , further comprising determining whether to dynamically update one or more of the lag parameters.

4. The method of claim 3 , further comprising dynamically updating one or more of the lag parameters.

5. The method of claim 4 , wherein dynamically updating one or more of the lag parameters comprises using a minimum deviation divergence method.

6. The method of claim 1 , further comprising dynamically updating one or more of the lag parameters.

7. A method of calculating an analyte level in a first medium using one or more measurements of an analyte level in a second medium, the method comprising:

receiving first sensor data from an analyte sensor;

calculating a first analyte level in the second medium using at least the first sensor data;

calculating a first analyte level rate of change using at least the first analyte level in the second medium;

calculating a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determining that the one or more lag parameters should be updated, wherein determining that the one or more lag parameters should be updated comprises determining that a period of time has passed since the one or more of the lag parameters have been updated;

updating the one or more lag parameters;

receiving second sensor data from the analyte sensor;

calculating a second analyte level in the second medium using at least the second sensor data;

calculating a second analyte level rate of change using at least the second analyte level in the second medium; and

calculating a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

8. The method of claim 7 , wherein the one or more lag parameters include one or more of an analyte diffusion rate and an analyte consumption rate.

9. A method of calculating an analyte level in a first medium using one or more measurements of an analyte level in a second medium, the method comprising:

receiving first sensor data from an analyte sensor;

calculating a first analyte level in the second medium using at least the first sensor data;

calculating a first analyte level rate of change using at least the first analyte level in the second medium;

calculating a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters, wherein calculating the first analyte level in the first medium comprises employing an asymmetrical lag methodology;

determining that the one or more lag parameters should be updated;

updating the one or more lag parameters;

receiving second sensor data from the analyte sensor;

calculating a second analyte level in the second medium using at least the second sensor data;

calculating a second analyte level rate of change using at least the second analyte level in the second medium; and

calculating a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

10. The method of claim 9 , wherein the asymmetrical lag approach decelerates a rate of change of falling analyte levels during a low blood analyte event and accelerates a rate of change of increasing analyte levels during recovery from the low blood analyte event.

11. A method of calculating an analyte level in a first medium using one or more measurements of an analyte level in a second medium, the method comprising:

receiving first sensor data from an analyte sensor;

calculating a first analyte level in the second medium using at least the first sensor data;

calculating a first analyte level rate of change using at least the first analyte level in the second medium;

calculating a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determining that the one or more lag parameters should be updated;

updating the one or more lag parameters, wherein updating the one or more lag parameters comprises using one or more of a first method and a second method to estimate one or more updated lag parameters;

receiving second sensor data from the analyte sensor;

calculating a second analyte level in the second medium using at least the second sensor data;

calculating a second analyte level rate of change using at least the second analyte level in the second medium; and

calculating a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

12. The method of claim 11 , wherein the first method is a ratio method.

13. The method of claim 11 , wherein the second method is a two-parameter method.

14. The method of claim 11 , wherein updating one or more lag parameters comprises using the first method during a first period and using the second method during a second period.

15. The method of claim 11 , wherein updating one or more lag parameters comprises using both the first and second methods.

16. The method of claim 15 , wherein using both the first and second methods comprises:

using the first method to estimate a first set of updated lag parameters;

using the second method to estimate a second set of updated lag parameters;

using the first set of updated lag parameters to calculate one or more first sensor measurements;

using the second set of updated lag parameters to calculate one or more second sensor measurements;

evaluating the one or more first sensor measurements and the one or more second sensor measurements by comparing the one or more first sensor measurements and the one or more second sensor measurements to one or more reference measurements; and

selecting the more accurate of (a) the one or more first sensor measurements and (b) the one or more second sensor measurements for display to a user.

17. An analyte monitoring system comprising:

an analyte sensor including an indicator element that exhibits one or more detectable properties based on a concentration of an analyte in proximity to the indicator element; and

a transceiver configured to:

receive first sensor data from the analyte sensor;

calculate a first analyte level in the second medium using at least the first sensor data;

calculate a first analyte level rate of change using at least the first analyte level in the second medium;

calculate a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determine that the one or more lag parameters should be updated;

update the one or more lag parameters;

receive second sensor data from the analyte sensor;

calculate a second analyte level in the second medium using at least the second sensor data;

calculate a second analyte level rate of change using at least the second analyte level in the second medium;

calculate a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters;

wherein the one or more lag parameters include one or more of an analyte diffusion rate and an analyte consumption rate.

18. The analyte monitoring system of claim 17 , wherein the first medium is blood, and the second medium is interstitial fluid.

19. The analyte monitoring system of claim 17 , wherein the transceiver is further configured to determine whether to dynamically update one or more of the lag parameters.

20. The analyte monitoring system of claim 19 , wherein the transceiver is further configured to dynamically update one or more of the lag parameters.

21. The analyte monitoring system of claim 20 , wherein dynamically updating one or more of the lag parameters comprises using a minimum deviation divergence method.

22. The analyte monitoring system of claim 17 , wherein the transceiver is further configured to dynamically update one or more of the lag parameters.

23. An analyte monitoring system comprising:

an analyte sensor including an indicator element that exhibits one or more detectable properties based on a concentration of an analyte in proximity to the indicator element; and

a transceiver configured to:

receive first sensor data from the analyte sensor;

calculate a first analyte level in the second medium using at least the first sensor data;

calculate a first analyte level rate of change using at least the first analyte level in the second medium;

calculate a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determine that the one or more lag parameters should be updated, wherein determining that the one or more lag parameters should be updated comprises determining that a period of time has passed since the one or more of the lag parameters have been updated;

update the one or more lag parameters;

receive second sensor data from the analyte sensor;

calculate a second analyte level in the second medium using at least the second sensor data;

calculate a second analyte level rate of change using at least the second analyte level in the second medium; and

calculate a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

24. The analyte monitoring system of claim 23 , wherein the one or more lag parameters include one or more of an analyte diffusion rate and an analyte consumption rate.

25. An analyte monitoring system comprising:

an analyte sensor including an indicator element that exhibits one or more detectable properties based on a concentration of an analyte in proximity to the indicator element; and

a transceiver configured to:

receive first sensor data from the analyte sensor;

calculate a first analyte level in the second medium using at least the first sensor data;

calculate a first analyte level rate of change using at least the first analyte level in the second medium;

calculate a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters, wherein calculating the first analyte level in the first medium comprises employing an asymmetrical lag methodology;

determine that the one or more lag parameters should be updated;

update the one or more lag parameters;

receive second sensor data from the analyte sensor;

calculate a second analyte level in the second medium using at least the second sensor data;

calculate a second analyte level rate of change using at least the second analyte level in the second medium; and

calculate a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

26. The analyte monitoring system of claim 25 , wherein the asymmetrical lag approach decelerates a rate of change of falling analyte levels during a low blood analyte event and accelerates a rate of change of increasing analyte levels during recovery from the low blood analyte event.

27. An analyte monitoring system comprising:

an analyte sensor including an indicator element that exhibits one or more detectable properties based on a concentration of an analyte in proximity to the indicator element; and

a transceiver configured to:

receive first sensor data from the analyte sensor;

calculate a first analyte level in the second medium using at least the first sensor data;

calculate a first analyte level rate of change using at least the first analyte level in the second medium;

calculate a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and one or more lag parameters;

determine that the one or more lag parameters should be updated;

update the one or more lag parameters, wherein updating the one or more lag parameters comprises using one or more of a first method and a second method to estimate one or more updated lag parameters;

receive second sensor data from the analyte sensor;

calculate a second analyte level in the second medium using at least the second sensor data;

calculate a second analyte level rate of change using at least the second analyte level in the second medium; and

calculate a second analyte level in the first medium using at least the second analyte level in the second medium, the second analyte level rate of change, and the updated one or more lag parameters.

28. The analyte monitoring system of claim 27 , wherein the first method is a ratio method.

29. The analyte monitoring system of claim 27 , wherein the second method is a two-parameter method.

30. The analyte monitoring system of claim 27 , wherein updating one or more lag parameters comprises using the first method during a first period and using the second method during a second period.

31. The analyte monitoring system of claim 27 , wherein updating one or more lag parameters comprises using both the first and second methods.

32. The analyte monitoring system of claim 31 , wherein using both the first and second methods comprises:

using the first method to estimate a first set of updated lag parameters;

using the second method to estimate a second set of updated lag parameters;

using the first set of updated lag parameters to calculate one or more first sensor measurements;

using the second set of updated lag parameters to calculate one or more second sensor measurements;

evaluating the one or more first sensor measurements and the one or more second sensor measurements by comparing the one or more first sensor measurements and the one or more second sensor measurements to one or more reference measurements; and

selecting the more accurate of (a) the one or more first sensor measurements and (b) the one or more second sensor measurements for display to a user.

33. A method of calculating an analyte level in a first medium using one or more measurements of an analyte level in a second medium, the method comprising:

receiving first sensor data from an analyte sensor;

calculating a first analyte level in the second medium using at least the first sensor data;

calculating a first analyte level rate of change using at least the first analyte level in the second medium;

calculating a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and a first set of one or more lag parameters;

calculating a second analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and a second set of one or more lag parameters;

comparing the first analyte level in the first medium to at least a reference measurement;

comparing the second analyte level in the first medium to at least the reference measurement; and

selecting whichever of the first analyte level in the first medium and the second analyte level in the first medium is closer to the reference measurement for display to a user.

34. An analyte monitoring system comprising:

an analyte sensor including an indicator element that exhibits one or more detectable properties based on a concentration of an analyte in proximity to the indicator element; and

a transceiver configured to:

receive first sensor data from the analyte sensor;

calculate a first analyte level in the second medium using at least the first sensor data;

calculate a first analyte level rate of change using at least the first analyte level in the second medium;

calculate a first analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and a first set of one or more lag parameters;

calculate a second analyte level in the first medium using at least the first analyte level in the second medium, the first analyte level rate of change, and a second set of one or more lag parameters;

compare the first analyte level in the first medium to at least a reference measurement;

compare the second analyte level in the first medium to at least the reference measurement; and

select whichever of the first analyte level in the first medium and the second analyte level in the first medium is closer to the reference measurement for display to a user.

Assignments (10)

Continuity (4)