System and method for assessing risk associated with a glucose state

• US 10,463,282 B2
• Filed: 10/04/2012
• Issued: 11/05/2019
• Est. Priority Date: 10/04/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Duke, David L., Soni, Abhishek S.
• Primary Examiner(s): Bloch, Michael R
• Application Number:
  US13/645,198
• Publication Number:
  US 20140100435A1
• Time in Patent Office: 2,588 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and method is provided for analyzing a glucose state. A method may include identifying a target glucose state and an initial glucose state. The method may include calculating a target return path for a transition from the initial glucose state to the target glucose state. The target return path may comprise at least one intermediate glucose state associated with the transition from the initial glucose state to the target glucose state. The target return path may be calculated based on a hazard associated with the at least one intermediate glucose state of the target return path.

Claims

1. A method of analyzing a glucose state of a person with diabetes, the method comprising:

detecting, by a continuous glucose monitoring (CGM) system computing device (CGM system computing device), the glucose state of the person based on at least one measured glucose value provided by a CGM glucose sensor, the detected glucose state including a glucose level of the person and a rate of change of the glucose level;

determining, by hazard analysis logic of the CGM system computing device, a target return path for a transition from the detected glucose state to a target glucose state, the target glucose state including a target glucose level and a target rate of change of the target glucose level, the target return path comprising at least one intermediate glucose state associated with the transition from the detected glucose state to the target glucose state;

computing, by the hazard analysis logic of the CGM system computing device, at least one risk metric associated with the detected glucose state based on the at least one intermediate glucose state of the target return path; and

adjusting, by the CGM system computing device, a therapy of the person to transition the person from the detected glucose state towards the target glucose state based on the target return path, the at least one risk metric, or both,

wherein the at least one risk metric associated with the detected glucose state includes a total estimated time for the person to transition from the detected glucose state to the target glucose state along the target return path and the total estimated time is computed based on a predetermined maximum acceleration of glucose and a number of intermediate glucose states along the target return path; and

wherein the at least one risk metric is further computed by a plurality of acceleration values of the predetermined maximum acceleration of glucose, wherein the predetermined maximum acceleration of glucose includes a positive value and a negative value of acceleration, and wherein the total estimated time is further computed based on using a plurality of acceleration values between the negative and the positive values.

2. The method of claim 1, wherein the at least one intermediate glucose state includes a plurality of intermediate glucose states each having an associated penalty value, the detected glucose state has an associated penalty value, and each penalty value includes a measure of a hazard.

3. The method of claim 2, further comprising an additional risk metric of the at least one risk metric, wherein the additional risk metric is associated with the detected glucose state and includes a cumulative penalty value comprising a sum of the penalty values associated with the plurality of intermediate glucose states and the penalty value associated with the detected glucose state.

4. The method of claim 2, further comprising an additional risk metric of the at least one risk metric, wherein the additional risk metric is associated with the detected glucose state and includes a mean penalty rate for the target return path, wherein the mean penalty rate is calculated based on a ratio between a sum of the penalty values associated with the target return path and the total estimated time to complete the transition from the detected glucose state to the target glucose state along the target return path.

5. The method of claim 2, further comprising an additional risk metric of the at least one risk metric, wherein the additional risk metric is associated with the detected glucose state and includes a maximum penalty value of the plurality of intermediate glucose states of the plurality of intermediate glucose state of the target return path.

6. The method of claim 1, wherein the adjusting, by the CGM system computing device, the therapy of the person to transition the person from the detected glucose state towards the target glucose state is based on the target return path.

7. The method of claim 1, wherein adjusting the therapy includes adjusting at least one of a basal rate and a bolus of an insulin treatment provided to the person.

8. The method of claim 1, further comprising:

comparing, by the hazard analysis logic, an additional risk metric of the at least one risk metric, wherein the additional risk metric includes a penalty value associated with the detected glucose state to a risk threshold; and

upon the additional risk metric exceeding the risk threshold, further adjusting the therapy of the person to transition the person from the detected glucose state towards the target glucose state along a second return path having at least one intermediate glucose state that is different from the target return path.

9. The method of claim 1, further comprising:

detecting a plurality of glucose states of the person to identify a trace of the detected glucose states of the person, each detected glucose state including a glucose level of the person and a rate of change of the glucose level.

10. The method of claim 1, wherein the target glucose state includes a target glucose level of 112.5 milligrams per deciliter and a target rate of change of zero milligrams per deciliter per second.

11. The method of claim 1, wherein at least one of the glucose level and the rate of change is estimated by the CGM system computing device based on the at least one measured glucose value weighted with a probability of accuracy of the CGM glucose sensor.

12. The method of claim 11, wherein the at least one of the glucose level and the rate of change is estimated with a recursive filter of the CGM system computing device.

13. The method of claim 11, wherein the computing the at least one risk metric associated with the detected glucose state includes an additional risk metric of the at least one risk metric, wherein the additional risk metric is based on a penalty value associated with the detected glucose state and on the probability of accuracy of the CGM glucose sensor.

14. The method of claim 1, wherein the target return path is determined by the computing device further based on a physiological limit of a glucose perturbation and the physiological limit comprises the predetermined maximum acceleration of glucose.

15. A non-transitory computer-readable medium comprising:

executable instructions such that when executed by at least one processor cause the at least one processor to;

detect a glucose state of a person based on at least one measured glucose value provided with a glucose sensor, the detected glucose state including a glucose level of the person and a rate of change of the glucose level;

determine a target return path for a transition from the detected glucose state to a target glucose state, the target glucose state including a target glucose level and a target rate of change of the target glucose level, the target return path comprising at least one intermediate glucose state associated with the transition from the detected glucose state to the target glucose state;

compute at least one risk metric associated with the detected glucose state based on the at least one intermediate glucose state of the target return path; and

adjust a therapy of the person to transition the person from the detected glucose state towards the target glucose state based on the target return path, the at least one risk metric, or both,

wherein the at least one risk metric associated with the detected glucose state includes a total estimated time for the person to transition from the detected glucose state to the target glucose state along the target return path and the total estimated time is computed based on a predetermined maximum acceleration of glucose and a number of intermediate glucose states along the target return path;

wherein the at least one risk metric is further computed by a plurality of acceleration values of the predetermined maximum acceleration of glucose, wherein the predetermined maximum acceleration includes a positive value and a negative value of acceleration, and wherein the total estimated time is further computed based on using a plurality of acceleration values between the negative and the positive values.

16. The non-transitory computer-readable medium of claim 15, wherein the at least one intermediate glucose state includes a plurality of intermediate glucose states each having an associated penalty value, the detected glucose state has an associated penalty value, and each associated penalty value includes a measure of a hazard.

17. The non-transitory computer-readable medium of claim 16, further comprising an additional risk metric of the at least one risk metric, wherein the additional risk metric is associated with the detected glucose state and includes at least one of a cumulative penalty value of the target return path, a mean penalty rate of the target return path, and a maximum penalty value for the plurality of intermediate glucose states of the target return path, wherein the cumulative penalty comprises a sum of the penalty values associated with the plurality of intermediate glucose states and the penalty value associated with the detected glucose state, and wherein the mean penalty rate is based on a ratio between the sum of the penalty values and the total estimated time to complete the transition from the detected glucose state to the target glucose state along the target return path.

18. The non-transitory computer-readable medium of claim 15, wherein the executable instructions further cause the at least one processor to adjust the therapy of the person to transition the person from the detected glucose state towards the target glucose state based on the target return path, wherein adjusting the therapy includes adjusting at least one of a basal rate and a bolus of an insulin treatment provided to the person.

19. The non-transitory computer-readable medium of claim 15, wherein the executable instructions further cause the at least one processor to estimate at least one of the glucose level and the rate of change of the glucose level based on the at least one measured glucose value weighted with an accuracy of the glucose sensor.

20. The non-transitory computer-readable medium of claim 19, wherein the executable instructions further cause the at least one processor to calculate a risk associated with the detected glucose state based on a penalty value associated with the detected glucose state and based on the accuracy of the glucose sensor.

21. The non-transitory computer-readable medium of claim 15, wherein the target return path is determined by at least one processor further based on a physiological limit of a glucose perturbation and the physiological limit comprises the predetermined maximum acceleration of glucose.