Maintaining glycemic control during exercise

• US 9,199,031 B2
• Filed: 12/25/2008
• Issued: 12/01/2015
• Est. Priority Date: 12/26/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Gescheit, Illai
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/810,864
• Publication Number:
  US 20100286601A1
• Time in Patent Office: 2,532 Days
• Field of Search: 604 65- 67, 6048901-8921, 604/503, 604/504, 600/316, 600/347, 600/365
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/056 with active exercise
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Abstract

Devices, apparatuses and methods for controlling blood-glucose levels during exercise are described. For example, an insulin infusion apparatus can include a control module to regulate a rate of therapeutic fluid release into a body of a patient based on a determined therapeutic fluid requirement profile, and a dispensing unit to release therapeutic fluid at the regulated rate. The methods and devices can be implemented by receiving a first value corresponding to a first glucose concentration before an exercise activity of a user; receiving a second value corresponding to a second glucose concentration after the exercise activity for the user; determining a glucose concentration change based on a difference between the second value and the first value; modifying a basal rate based on a comparison of the glucose concentration change with a predetermined threshold value; and, recording the modified basal rate in a computer-readable memory device.

Claims

1. A computer-implemented method for modifying insulin basal rate delivery to adapt to a user'"'"'s exercise activity, comprising:

receiving a first value corresponding to a first glucose concentration before an exercise activity of a user;

receiving a second value corresponding to a second glucose concentration after the exercise activity of the user;

determining a glucose concentration change based on a difference between the second value and the first value;

modifying a basal rate based on a comparison of the glucose concentration change with a predetermined threshold value;

advising the user to consume carbohydrates if the modified basal rate is insufficient to compensate for the exercise activity;

determining a recommended amount of carbohydrates wherein the modified basal rate is set to a minimum, and the recommended amount of carbohydrates is determined by calculating;

Carb=CIR*[(Basal_min*t_exercise)+(Δ

/IS*T))*t_exercise−

Basal*t_exercise]

wherein;

Carb represents the recommended amount of carbohydrates,

CIR represents the user'"'"'s carbohydrate to insulin ration,

Basal_min represents the minimum basal rate,

t_exercise represents an exercise parameter associated with the exercise activity,

Δ

represents the glucose concentration change,

IS represents the user'"'"'s insulin sensitivity,

T represents a duration of the exercise activity, and

Basal represents the user'"'"'s basal rate;

delivering insulin to the body of the user according to the modified basal rate; and

wherein at least one of receiving the first value, receiving the second value, determining, advising, and modifying is performed by one or more computer processors.

2. The computer-implemented method of claim 1, further comprising:

receiving first data corresponding to the exercise activity; and

recording, in a memory, information relating the received first data corresponding to the exercise activity to data representative of the modified basal rate determined for the exercise activity.

3. The computer-implemented method of claim 2, further comprising:

receiving second data corresponding to another exercise activity;

retrieving from memory, based on the received second data, data representative of another modified basal rate determined for the other exercise activity, the data representative of the other modified basal rate being related to the other exercise activity using another recorded information; and

changing the delivering so as to deliver insulin to the body of the user according to the retrieved data representative of the other modified basal rate.

4. The computer-implemented method of claim 2, further comprising:

reducing the basal rate prior to the exercise activity based on a change basal factor corresponding to the received first data.

5. The computer-implemented method of claim 4, wherein modifying the basal rate comprises decreasing the basal rate by (basal−

X*basal)−

Δ

/(IS*T) based on a determination that the glucose concentration change is greater than the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

6. The computer-implemented method of claim 4, wherein modifying the basal rate further comprises increasing the basal rate by (basal−

X*basal)+|Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

7. The computer-implemented method of claim 2, wherein at least a portion of the first data is selected based on one or more physiological parameters of the user.

8. The computer-implemented method of claim 7, wherein the one or more physiological parameters correspond to at least one of:

a heart rate, a ventilation rate, a body temperature, steps of the user per period of time.

9. The computer-implemented method of claim 2, wherein the first data corresponds to a Borg scale.

10. The computer-implemented method of claim 1, wherein modifying the basal rate comprises decreasing the basal rate by

11. The computer-implemented method of claim 1, wherein modifying the basal rate comprises increasing the basal rate by |Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user, and

T represents a duration of the exercise activity.

12. The computer-implemented method of claim 1, further comprising instructing the user to fast prior to the exercise activity.

13. The computer-implemented method of claim 1, wherein modifying the basal rate is based on one or more user-specific factors selected from the group consisting of:

IS, TBG, CIR, RI, and duration of the exercise activity, where IS represents insulin sensitivity of the user, TBG represents the target blood glucose levels of the user, CIR represents the carbohydrate-to-insulin ratio corresponding to the amount of carbohydrate balanced by one unit of insulin, and RI is the residual insulin of the user.

14. The computer-implemented method of claim 1, further comprising:

modifying the basal rate upon termination of the exercise activity based on a predetermined configuration, the predetermined configuration selected from at least one of;

a basal rate prior to the exercise activity, a basal rate pre-programmed by the user, and a new basal rate manually selected by the user after the exercise activity.

15. The computer-implemented method of claim 1, further comprising:

providing a recommendation to the user corresponding to a food adjustment based on the glucose concentration change.

16. The computer-implemented method of claim 1, further comprising:

presenting the modified basal rate to the user in a form of at least one of;

a percent of the basal rate prior to the modification and a number of units of insulin.

17. A computer-implemented method for modifying insulin basal rate delivery to adapt to a user'"'"'s exercise activity, comprising:

receiving a first value corresponding to a first glucose concentration before an exercise activity of a user;

receiving a second value corresponding to a second glucose concentration after the exercise activity of the user;

determining a glucose concentration change based on a difference between the second value and the first value;

modifying a basal rate based on a comparison of the glucose concentration change with a predetermined threshold value;

advising the user to consume carbohydrates if the modified basal rate is insufficient to compensate for the exercise activity;

determining a recommended amount of carbohydrates wherein the recommended amount of carbohydrates is determined by calculating;

Carb=(RI_activity*CIR)−

(t_activity*Basal′

*CIR)

 

wherein;

Carb represents the recommended amount of carbohydrates,

RI_activity represents the user'"'"'s residual insulin at the exercise activity'"'"'s initiation,

CIR represents the user'"'"'s carbohydrate to insulin ration,

t_activity represents an exercise parameter associated with the exercise activity, and

Basal′

represents the user'"'"'s exercise basal rate;

delivering insulin to the body of the user according to the modified basal rate; and

wherein at least one of receiving the first value, receiving the second value, determining, advising, and modifying is performed by one or more computer processors.

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

receiving first data corresponding to the exercise activity; and

recording, in a memory, information relating the received first data corresponding to the exercise activity to data representative of the modified basal rate determined for the exercise activity.

19. The computer-implemented method of claim 18, further comprising:

receiving second data corresponding to another exercise activity;

retrieving from memory, based on the received second data, data representative of another modified basal rate determined for the other exercise activity, the data representative of the other modified basal rate being related to the other exercise activity using another recorded information; and

changing the delivering so as to deliver insulin to the body of the user according to the retrieved data representative of the other modified basal rate.

20. The computer-implemented method of claim 18, further comprising:

reducing the basal rate prior to the exercise activity based on a change basal factor corresponding to the received first data.

21. The computer-implemented method of claim 20, wherein modifying the basal rate comprises decreasing the basal rate by (basal−

X*basal)−

Δ

/(IS*T) based on a determination that the glucose concentration change is greater than the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

22. The computer-implemented method of claim 20, wherein modifying the basal rate further comprises increasing the basal rate by (basal−

X*basal)+|Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

23. The computer-implemented method of claim 18, wherein at least a portion of the first data is selected based on one or more physiological parameters of the user.

24. The computer-implemented method of claim 23, wherein the one or more physiological parameters correspond to at least one of:

a heart rate, a ventilation rate, a body temperature, steps of the user per period of time.

25. The computer-implemented method of claim 18, wherein the first data corresponds to a Borg scale.

26. The computer-implemented method of claim 17, wherein modifying the basal rate is based on one or more user-specific factors selected from the group consisting of:

IS, TBG, CIR, RI, and duration of the exercise activity, where IS represents insulin sensitivity of the user, TBG represents the target blood glucose levels of the user, CIR represents the carbohydrate-to-insulin ratio corresponding to the amount of carbohydrate balanced by one unit of insulin, and RI is the residual insulin of the user.

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

modifying the basal rate upon termination of the exercise activity based on a predetermined configuration, the predetermined configuration selected from at least one of;

a basal rate prior to the exercise activity, a basal rate pre-programmed by the user, and a new basal rate manually selected by the user after the exercise activity.

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

providing a recommendation to the user corresponding to a food adjustment based on the glucose concentration change.

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

presenting the modified basal rate to the user in a form of at least one of;

a percent of the basal rate prior to the modification and a number of units of insulin.

30. The computer-implemented method of claim 17, wherein modifying the basal rate comprises decreasing the basal rate by

31. The computer-implemented method of claim 17, wherein modifying the basal rate comprises increasing the basal rate by |Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user, and

T represents a duration of the exercise activity.

32. The computer-implemented method of claim 17, further comprising instructing the user to fast prior to the exercise activity.

33. A computer-implemented method for modifying insulin basal rate delivery to adapt to a user'"'"'s exercise activity, comprising:

receiving a first value corresponding to a first glucose concentration before an exercise activity of a user;

receiving a second value corresponding to a second glucose concentration after the exercise activity of the user;

determining a glucose concentration change based on a difference between the second value and the first value;

modifying a basal rate based on a comparison of the glucose concentration change with a predetermined threshold value;

advising the user to consume carbohydrates if the modified basal rate is insufficient to compensate for the exercise activity;

determining a recommended amount of carbohydrates wherein the modified basal rate is set to a minimum, and the recommended amount of carbohydrates is determined by calculating;

Carb=(RI_activity*CIR)−

(t_activity*Basal′

*CIR)+(t_activity*Basal_min*CIR)

wherein;

Carb represents the recommended amount of carbohydrates,

RI_activity represents the user'"'"'s residual insulin at the exercise activity'"'"'s initiation,

CIR represents the user'"'"'s carbohydrate to insulin ration,

t_activity represents an exercise parameter associated with the exercise activity,

Basal′

represents the user'"'"'s exercise basal rate, and

Basal_min represents the minimum basal rate;

delivering insulin to the body of the user according to the modified basal rate; and

wherein at least one of receiving the first value, receiving the second value, determining, advising, and modifying is performed by one or more computer processors.

34. The computer-implemented method of claim 33, further comprising:

receiving first data corresponding to the exercise activity; and

recording, in a memory, information relating the received first data corresponding to the exercise activity to data representative of the modified basal rate determined for the exercise activity.

35. The computer-implemented method of claim 34, further comprising:

receiving second data corresponding to another exercise activity;

retrieving from memory, based on the received second data, data representative of another modified basal rate determined for the other exercise activity, the data representative of the other modified basal rate being related to the other exercise activity using another recorded information; and

changing the delivering so as to deliver insulin to the body of the user according to the retrieved data representative of the other modified basal rate.

36. The computer-implemented method of claim 34, further comprising:

reducing the basal rate prior to the exercise activity based on a change basal factor corresponding to the received first data.

37. The computer-implemented method of claim 36, wherein modifying the basal rate comprises decreasing the basal rate by (basal−

X*basal)−

Δ

/(IS*T) based on a determination that the glucose concentration change is greater than the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

38. The computer-implemented method of claim 36, wherein modifying the basal rate further comprises increasing the basal rate by (basal−

X*basal)+|Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user,

T represents a duration of the exercise activity,

X represents the change basal factor, and

basal represents the basal rate.

39. The computer-implemented method of claim 34, wherein at least a portion of the first data is selected based on one or more physiological parameters of the user.

40. The computer-implemented method of claim 39, wherein the one or more physiological parameters correspond to at least one of:

a heart rate, a ventilation rate, a body temperature, steps of the user per period of time.

41. The computer-implemented method of claim 34, wherein the first data corresponds to a Borg scale.

42. The computer-implemented method of claim 33, wherein modifying the basal rate is based on one or more user-specific factors selected from the group consisting of:

IS, TBG, CIR, RI, and duration of the exercise activity, where IS represents insulin sensitivity of the user, TBG represents the target blood glucose levels of the user, CIR represents the carbohydrate-to-insulin ratio corresponding to the amount of carbohydrate balanced by one unit of insulin, and RI is the residual insulin of the user.

43. The computer-implemented method of claim 33, further comprising:

modifying the basal rate upon termination of the exercise activity based on a predetermined configuration, the predetermined configuration selected from at least one of;

a basal rate prior to the exercise activity, a basal rate pre-programmed by the user, and a new basal rate manually selected by the user after the exercise activity.

44. The computer-implemented method of claim 33, further comprising:

providing a recommendation to the user corresponding to a food adjustment based on the glucose concentration change.

45. The computer-implemented method of claim 33, further comprising:

presenting the modified basal rate to the user in a form of at least one of;

a percent of the basal rate prior to the modification and a number of units of insulin.

46. The computer-implemented method of claim 33, wherein modifying the basal rate comprises decreasing the basal rate by

47. The computer-implemented method of claim 33, wherein modifying the basal rate comprises increasing the basal rate by |Δ

|/(IS*T) based on a determination that the glucose concentration change is less than a negative of the predetermined threshold value, wherein

Δ

represents the glucose concentration change,

IS represents insulin sensitivity of the user, and

T represents a duration of the exercise activity.

48. The computer-implemented method of claim 33, further comprising instructing the user to fast prior to the exercise activity.