ADAPTIVE INSULIN DELIVERY SYSTEM

• US 20100298685A1
• Filed: 05/21/2010
• Published: 11/25/2010
• Est. Priority Date: 05/22/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary A., Wei, Charles, Budiman, Erwin S.
• Application Number:
  US12/785,196
• Publication Number:
  US 20100298685A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A proactive system and method in which levels of glucose are monitored after a meal signal and compared to a safe range. If a monitored glucose level is outside the safe range, a post-prandial vertex of the glucose level is identified and an action is provided to more rapidly return the glucose level to a target level within the safe range than if no action was provided. In another aspect a control parameter in an IDM system is adjusted by determining a performance metric of the system as a function of the levels of glucose and a medication administration signal over a first window of time; and, if the performance metric is outside an expected range, adjusting the control parameter to adjust an amount of medication and to bring the performance metric inside the expected range.

Claims

1. A system for proactively monitoring glucose levels, the system comprising:

a sensor that measures an indication of glucose and provides levels of glucose over a monitoring time period;

a memory having stored therein a safe range of glucose;

a device that provides a meal signal indicating that a meal has been consumed, the device also providing a medication administration signal indicating an amount of medication and a time that it was administered;

a processor configured to receive the meal signal, levels of glucose, and the safe range, wherein upon receiving the meal signal, the processor is further configured to;

monitor the levels of glucose beginning after the meal signal;

compare the levels of glucose to the safe range;

if a monitored glucose level is outside the safe range, determine a post-prandial vertex of the glucose level, and

once the vertex is determined, provide an action to return the glucose level to a target glucose level within the safe range, wherein the action includes consideration of a user parameter.

2. The system for proactively monitoring glucose levels of claim 1, wherein the vertex is a peak and the action provided by the processor includes calculating a dose of medication sufficient to reduce the glucose level more rapidly to the target glucose level within the safe range and to decrease an amount of high glucose exposure than if the action was not taken.

3. The system for proactively monitoring glucose levels of claim 1, wherein the vertex is a valley and the action provided by the processor includes calculating an amount of carbohydrates sufficient to increase the glucose level more rapidly to the target glucose level within the safe range than if the action was not taken.

4. The system for proactively monitoring glucose levels of claim 1, wherein the vertex is a valley and the action by the processor includes calculating a reduction in a basal rate of a medication administration sufficient to raise the glucose level more rapidly to the target glucose level within the safe range than if the action was not taken.

5. The system for proactively monitoring glucose levels of claim 1, wherein the processor is configured to delay monitoring the levels of glucose for a selected time period after receiving the meal signal.

6. The system for proactively monitoring glucose levels of claim 1, wherein the the processor is configured to determine the vertex by comparing a first and a second glucose level trend, the vertex being at the point at which the first and second glucose level trends diverge.

7. The system for proactively monitoring glucose levels of claim 1, wherein the processor is configured to determine the vertex by comparing a first and a second glucose rate of change, the vertex being at the point at which the signs of the first and second glucose rate of change diverge.

8. The system for proactively monitoring glucose levels of claim 1, wherein the processor is further configured to:

identify a first and second set of sensed glucose readings over at least a portion of the monitoring time period to determine a first and second glucose level trend, the vertex being determined by comparing a first and a second glucose level trend, and to

calculate a first and second set of smoothed glucose values representative of the first and second set of sensed glucose readings prior to determining the first glucose level trend, and to determine the first and second glucose level trend as a function of first and second set of smoothed glucose values.

9. The system for proactively monitoring glucose levels of claim 8, wherein the first and second glucose level trend is a trend in a first and a second glucose rate of change.

10. The system for proactively monitoring glucose levels of claim 8, wherein the user parameter is selected from a group consisting of an insulin action time, a level of insulin-on-board, an insulin sensitivity factor

11. A method for proactively monitoring glucose levels, the method comprising:

measuring an indication of glucose and providing levels of glucose over a monitoring time period;

storing in a memory a safe range of glucose;

providing a meal signal indicating that a meal has been consumed;

providing a medication administration signal indicating an amount of medication and a time that it was administered;

receiving the meal signal, levels of glucose, and the safe range, wherein upon receiving the meal signal;

monitoring the levels of glucose beginning after the meal signal;

comparing the levels of glucose to the safe range;

if a monitored glucose level is outside the safe range, determining a post-prandial vertex of the glucose level, and

once the vertex is determined, providing an action to return the glucose level to a target glucose level within the safe range, wherein the action includes consideration of a user parameter.

12. The method for proactively monitoring glucose levels of claim 11, wherein the vertex is a peak and providing the action includes calculating a dose of medication sufficient to reduce the glucose level more rapidly to the target glucose level within the safe range and to decrease an amount of high glucose exposure than if the action was not taken.

13. The method for proactively monitoring glucose levels of claim 11, wherein the vertex is a valley and providing the action includes calculating an amount of carbohydrates sufficient to increase the glucose level more rapidly to the target glucose level within the safe range than if the action was not taken.

14. The method for proactively monitoring glucose levels of claim 11, wherein the vertex is a valley and providing the action includes calculating a reduction in a basal rate of a medication administration sufficient to raise the glucose level more rapidly to the target glucose level within the safe range than if the action was not taken.

15. The method for proactively monitoring glucose levels of claim 11, further comprising:

delaying monitoring the levels of glucose for a selected time period after receiving the meal signal.

16. The method for proactively monitoring glucose levels of claim 11, further comprising:

determining the vertex by comparing a first and a second glucose level trend, the vertex being at the point at which the first and second glucose level trends diverge.

17. The method for proactively monitoring glucose levels of claim 11, further comprising:

determining the vertex by comparing a first and a second glucose rate of change, the vertex being at the point at which the signs of the first and second glucose rate of change diverge.

18. The method for proactively monitoring glucose levels of claim 11, further comprising:

identifying a first and second set of sensed glucose readings over at least a portion of the monitoring time period to determine a first and second glucose level trend, the vertex being determined by comparing a first and a second glucose level trend; and

calculating a first and second set of smoothed glucose values representative of the first and second set of sensed glucose readings prior to determining the first glucose level trend, and to determine the first and second glucose level trend as a function of first and second set of smoothed glucose values.

19. The method for proactively monitoring glucose levels of claim 18, wherein the first and second glucose level trend is a trend in a first and a second glucose rate of change.

20. The method for proactively monitoring glucose levels of claim 18, wherein the user parameter is selected from a group consisting of an insulin action time, a level of insulin-on-board, and an insulin sensitivity factor.

21. A method for integrated diabetes management, comprising:

receiving at a controller a meal indication input;

receiving at the controller and after the meal indication input a first set of sensed glucose readings in a user from a continuous glucose sensor;

receiving at the controller a second set of sensed glucose readings in the user from the continuous glucose sensor, wherein the second set of sensed glucose readings begin later in time than the first set of sensed glucose readings and at least one of the second set of sensed readings is above a high glucose threshold;

recording the first and second set of glucose readings on a memory medium;

determining a first glucose level trend in the user as a function of the first set of glucose signals;

determining a second glucose level trend in the user as a function of the second set of glucose signals;

sending a signal indicative of a user glucose level peak from the controller to a display when the first glucose level trend and second glucose level trend diverge; and

wherein the signal includes an amount of insulin required to reduce an insulin action time necessary to reduce a third set of sensed glucose readings below the high glucose threshold and to minimize a high glucose exposure.

22. A method of claim 21, wherein the first glucose level trend is a first rate of change in the first set of sensed glucose readings in the user, and

wherein the second glucose level trend is a second rate of change in the second set of sensed glucose readings in the user.

23. A method of claim 22, further comprising:

calculating a first set of smoothed glucose values representative of the first set of sensed glucose readings prior to determining the first glucose level trend, wherein the first glucose level trend is determined as a function of first set of smoothed glucose values; and

calculating a second set of smoothed glucose value representative of the second set of sensed glucose readings prior to determining the second glucose level trend;

wherein the second glucose level trend is determined as a function of second set of smoothed glucose values.

24. A method of claim 23, wherein the first glucose level trend is a value in the second set of smoothed glucose values.

25. A method for adjusting a control parameter used in an integrated diabetes management (IDM) system, the method comprising:

storing in a memory a control parameter;

providing a medication administration signal representative of an amount of medication as a function of the control parameter;

measuring levels of glucose over a monitoring time period;

determining a performance metric as a function of the levels of glucose and the medication administration signal over a first window of time; and

,

if the performance metric is outside an expected range, adjusting the control parameter to adjust the amount of medication and to bring the performance metric inside the expected range.

26. The method for adjusting a control parameter of claim 25, wherein the expected range is determined as a function of an empirical series of performance metrics over a selected window of time.

27. The method for adjusting a control parameter of claim 26, wherein the selected window starts before a beginning of the first window.

28. The method for adjusting a control parameter of claim 26, wherein the first window at least partially overlaps the selected window in time.

29. The method for adjusting a control parameter of claim 26, wherein the first and selected window do not overlap in time.

30. The method for adjusting a control parameter of claim 25, wherein the performance metric includes an average glucose expected from a present time to a future time.

31. The method for adjusting a control parameter of claim 25, wherein the performance metric includes a slope of the levels of glucose over a selected window of time.

32. The method for adjusting a control parameter of claim 25, further comprising:

providing a control limit on the control parameter;

monitoring a set of control parameters;

determining one or more physiological events over a selected window of time;

if the one or more physiological events is outside an unacceptable level of physiological events, adjusting the control limit to avoid a further unacceptable physiological event.

33. The method for adjusting a control parameter of claim 32, wherein the control limit is determined as a function of a scatter of the set of control parameters over a selected time period.

34. The method for adjusting a control parameter of claim 32, wherein the unacceptable physiological events includes a number of hypoglycemic events in a user.

35. The method for adjusting a control parameter of claim 32, wherein the unacceptable physiological events includes a number of hyperglycemic events in a user.

36. The method for adjusting a control parameter of claim 25, further comprising:

if, over a selected window of time, consecutively computed insulin commands are negative for more than a predetermined duration, providing an alarm including an indication of a high likelihood of a hypoglycemic event.

37. The method for adjusting a control parameter of claim 36, further comprising:

providing a request to enter a manual glucose reading using a strip port, wherein the control parameter is adjusted as a function of the manual glucose reading.

38. The method for adjusting a control parameter of claim 37, further comprising:

if the manual glucose reading confirms the consecutively computed insulin command, providing a second alarm including a suggestion to ingest an amount of carbohydrates.

39. The method for adjusting a control parameter of claim 25, further comprising:

if, over a selected window of time, a first contiguous area formed by consecutively computed insulin commands exceeds a second area formed by an integral of a predetermined duration, providing an alarm including an indication of a high likelihood of a hypoglycemic event.

40. The method for adjusting a control parameter of claim 39, further comprising:

providing a request to enter a manual glucose reading using a strip port, wherein the control parameter is adjusted as a function of the manual glucose reading.

41. The method for adjusting a control parameter of claim 40, further comprising:

if the manual glucose reading confirms the consecutively computed insulin command, providing a second alarm including a suggestion to ingest an amount of carbohydrates.

42. A system for adjusting a control parameter used in an integrated diabetes management (IDM) system, the system comprising:

a memory having a control parameter stored thereon;

a device configured to provide a medication administration signal representative of an amount of medication as a function of the control parameter, the device being further configured to measure levels of glucose over a monitoring time period;

a processor configured to determine a performance metric as a function of the levels of glucose and the medication administration signal over a first window of time, such that,

if the performance metric is outside an expected range, the processor is further configured to adjust the control parameter to adjust the medication administration signal and to bring the performance metric inside the expected range.

43. The system for adjusting a control parameter of claim 42, the processor being further configured to determine the expected range as a function of an empirical series of performance metrics over second window of time.

44. The system for adjusting a control parameter of claim 43, wherein the selected window starts before a beginning of the first window.

45. The system for adjusting a control parameter of claim 43, wherein the first window at least partially overlaps the selected window in time.

46. The system for adjusting a control parameter of claim 43, wherein the first and selected window do not overlap in time.

47. The system for adjusting a control parameter of claim 42, wherein the performance metric includes an average glucose expected from a present time to a future time.

48. The system for adjusting a control parameter of claim 42, wherein the performance metric includes a slope of the levels of glucose over a selected window of time.

49. The system for adjusting a control parameter of claim 42, further comprising:

providing a control limit on the control parameter;

monitoring a set of control parameters;

determining one or more physiological events over a selected window of time;

if the one or more physiological events is outside an unacceptable level of physiological events, adjusting the control limit to avoid a further unacceptable physiological event.

50. The system for adjusting a control parameter of claim 49, wherein the control limit is determined as a function of a scatter of the set of control parameters over a selected time period.

51. The system for adjusting a control parameter of claim 49, wherein the unacceptable physiological events includes a number of hypoglycemic events in a user.

52. The system for adjusting a control parameter of claim 49, wherein the unacceptable physiological events includes a number of hyperglycemic events in a user.

53. The system for adjusting a control parameter of claim 42, further comprising:

if, over a selected window of time, consecutively computed insulin commands are negative for more than a predetermined duration, providing an alarm including an indication of a high likelihood of a hypoglycemic event.

54. The system for adjusting a control parameter of claim 53, further comprising:

providing a request to enter a manual glucose reading using a strip port, wherein the control parameter is adjusted as a function of the manual glucose reading.

55. The system for adjusting a control parameter of claim 54, further comprising:

if the manual glucose reading confirms the consecutively computed insulin command, providing a second alarm including a suggestion to ingest an amount of carbohydrates.

56. The system for adjusting a control parameter of claim 42, further comprising:

if, over a selected window of time, a first contiguous area formed by consecutively computed insulin commands exceeds a second area formed by an integral of a predetermined duration, providing an alarm including an indication of a high likelihood of a hypoglycemic event.

57. The system for adjusting a control parameter of claim 56, further comprising:

providing a request to enter a manual glucose reading using a strip port, wherein the control parameter is adjusted as a function of the manual glucose reading.

58. The system for adjusting a control parameter of claim 57, further comprising:

if the manual glucose reading confirms the consecutively computed insulin command, providing a second alarm including a suggestion to ingest an amount of carbohydrates.

59. A method for integrated diabetes management, comprising:

providing a controller with a control parameter;

sampling at the controller a first set of insulin delivery commands over a first window of time;

sampling at the controller a second set of insulin delivery commands over a second window of time, wherein the first and second insulin delivery commands provide information to deliver an amount of insulin and are determined as a factor of a difference between a sensed glucose value and a target glucose value and a control parameter;

determining a first performance metric as a function of the first set of insulin delivery commands;

determining a second performance metric as a function of the second set of insulin delivery commands;

adjusting the control parameter as a function of the first and second performance metric to generate an adjusted control parameter;

determining a future insulin delivery command as a function of the adjusted control parameter; and

graphically displaying information representative of the future insulin delivery command on a graphic display.

60. The method of claim 59, wherein the first and second insulin delivery commands are further determined as a factor of a difference between the latest CGM rate of change and a target rate of change.

61. The method of claim 60, further comprising:

delivering a first insulin amount to a user; and

delivering a second insulin amount to the user based on the second delivery command, wherein the second insulin amount is based on the difference between a present value of glucose and a target value of glucose.

62. The method of claim 61, wherein the present value is a present CGM value and the target value is a target CGM value.

63. The method of claim 61, wherein the present value is a present CGM rate of change, and the target value is a target CGM rate of change.

64. The method of claim 61, wherein the present value is a present insulin-on-board, and the target value is a target insulin-on-board.

65. The method of claim 61, further comprising:

tuning the target value to correlate to a time period or physical condition.

66. The method of claim 59, further comprising:

determining an insulin delivery command as a function of the performance metric and the adjusted control parameter;

prompting a user at a terminal to confirm the insulin delivery amount; and

delivering the insulin delivery amount to a user upon receiving a confirmation from the user at the terminal.