Tailored Basal Insulin Delivery System and Method

• US 20080319384A1
• Filed: 06/25/2008
• Published: 12/25/2008
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Shapira, Gali, Yodfat, Ofer, Gescheit, Iddo
• Granted Patent: US 8,088,098 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• 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 5/14248 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Disclosed is a system to deliver insulin to a user'"'"'s body. The system includes a dispensing unit to deliver the insulin to the body, and a control mechanism to control delivery of basal insulin according to a predetermined basal infusion pattern, the basal infusion pattern selected from a plurality of predetermined basal infusion patterns. In some embodiments, selection of the basal infusion pattern may be based on one or more personal characteristics of the user.

Claims

1. A system to deliver insulin to a user'"'"'s body, the system comprising:

a dispensing unit to deliver the insulin to the body; and

a control mechanism to control delivery of basal insulin according to a predetermined basal infusion pattern, the basal infusion pattern selected from a plurality of predetermined basal infusion patterns.

2. The system of claim 1 wherein the selection of the basal infusion pattern is based on one or more personal characteristics of the user.

3. The system of claim 1 wherein the dispensing unit comprises:

a reservoir to hold the insulin;

a cannula having an end for placement within the user'"'"'s body; and

a pump to deliver the insulin from the reservoir to the cannula.

4. The system of claim 1 wherein the control mechanism to control delivery of the basal insulin comprises:

a processor configured to control delivery of the basal insulin by the pump according to the selected basal infusion pattern, the basal infusion pattern comprising a pre-defined sequence of basal infusion rate changes.

5. The system of claim 4 wherein the rate changes of the pre-defined sequence are defined at intervals of one hour or shorter.

6. The system of claim 4 wherein the pre-defined sequence comprises a pre-defined sequence of deviations from an average basal infusion rate.

7. The system of claim 1 wherein the control mechanism is further configured to:

time shift the basal infusion pattern based on the type of basal insulin to be held within a reservoir of the dispensing unit.

8. The system of claim 1 further comprising a user input interface in communication with the control mechanism, wherein the control mechanism is further configured to adjust the magnitude of the basal insulin delivered without disrupting the sequence of basal infusion rate changes defined by the basal infusion pattern in response to user input, entered through the user input interface, to increase or decrease the dosage of insulin delivered by the dispensing unit.

9. The system of claim 1 wherein the control mechanism comprises a basal infusion rate pattern mechanism to determine the basal infusion pattern based on one or more personal characteristics of the user.

10. The system of claim 9 wherein the basal infusion pattern mechanism is configured to determine the basal infusion pattern based on the one or more personal characteristics of the user, including one or more of:

age, body-mass index (BMI), bolus insulin requirements, sex, duration of diabetes, metabolic control, physical activity, sleep pattern, sleep duration, hemoglobin A1c values, age at manifestation of Diabetes Mellitus (DM), pyramidal insulin per kilogram, prandial insulin per day, total insulin per kilogram and total insulin per day.

11. The system of claim 9 wherein the basal infusion pattern mechanism configured to determine the basal infusion pattern is configured to:

select a basal infusion pattern from a plurality of pre-defined patterns based on the one or more personal characteristics of the user.

12. The system of claim 1 wherein the basal infusion pattern is selected based on the user'"'"'s age.

13. The system of claim 1 wherein the selected basal infusion pattern is determined based on physiological diurnal needs of basal insulin.

14. The system of claim 1 wherein the plurality of predetermined basal infusion patterns includes a biphasic pattern having a peak at a point of the pattern corresponding to a period of early morning and a peak at another point of the pattern corresponding to a period of late afternoon.

15. The system of claim 1 wherein the plurality of predetermined basal infusion patterns includes a monophonic pattern having a broad insulin peak at a point of the pattern corresponding to a period of around noon.

16. The system of claim 1 wherein the system is further configured to:

collect data regarding efficacy of the selected basal infusion pattern; and

adjust the selected basal infusion pattern based on the collected data.

17. The system of claim 1 wherein the control mechanism to control delivery of the basal insulin according to the selected basal infusion pattern is configured to:

determine the basal infusion pattern based on the one or more personal characteristics of the user; and

perform an evaluation of suitability of the determined basal infusion pattern based on glycemic status of the user.

18. The system of claim 17 wherein the control mechanism configured to perform the evaluation of the suitability of the determined basal infusion pattern is configured to:

evaluate the suitability of the determined basal pattern based on data representative of deviations of a user'"'"'s glucose level from a target zone.

19. The system of claim 17 wherein the control mechanism configured to perform the evaluation of the suitability of the determined basal infusion pattern is configured to:

evaluate the suitability of the determined basal pattern based on data representative of a user'"'"'s hemoglobin A1 C levels.

20. The system of claim 17 wherein the control mechanism is further configured to:

adjust the selected basal infusion pattern based on the evaluation indicating lack of suitability of the determined basal infusion pattern.

21. The system of claim 17 wherein the control mechanism is further configured to:

determine another basal infusion pattern based on the evaluation indicating lack of suitability of the basal infusion pattern.

22. The system of claim 21 wherein the control mechanism configured to determine the other basal infusion pattern based on the evaluation indicating lack of suitability is configured to:

select the other basal infusion pattern from the plurality of basal infusion patterns based on the evaluation indicating lack of suitability.

23. The system of claim 1 further comprising:

a remote control housed remotely from the dispensing unit.

24. The system of claim 1 further comprising:

a glucometer to measure blood glucose levels of the user.

25. The system of claim 24 wherein the control mechanism to control delivery of the basal insulin according to the selected basal infusion pattern further configured to:

control delivery of the basal insulin based, at least in part, on the measured blood glucose levels of the user.

26. The system of claim 1 further comprising:

a cradle unit securable to the body of the user, the cradle unit configured to receive at least the dispensing unit.

27. A method for delivering basal insulin to a body of a user, the method comprising:

determining a predetermined basal infusion pattern from a plurality of predetermined basal infusion patterns; and

delivering to the body of the user insulin based on the determined basal infusion pattern.

28. The method of claim 27 wherein determining the predetermined basal infusion pattern comprises:

selecting the basal infusion pattern for the user from a plurality of pre-determined basal infusion patterns based on one or more personal characteristics of the user.

29. The method of claim 27 further comprising:

receiving input regarding the one or more personal characteristics of the user.

30. The method of claim 27 further comprising:

performing an evaluation of suitability of the determined basal infusion pattern based on glycemic status of the user.

31. The method of claim 30 wherein performing the evaluation of the suitability of the determined basal infusion pattern comprises:

evaluating the suitability of the determined basal pattern based on data representative of deviations of a user'"'"'s glucose level from a target zone.

32. The method of claim 30 wherein performing the evaluation of the suitability of the determined basal infusion pattern comprises:

evaluating the suitability of the determined basal pattern based on data representative of a user'"'"'s hemoglobin A1C levels.

33. The method of claim 30 further comprising:

adjusting the determined basal infusion pattern based on the evaluation indicating lack of suitability of the determined basal infusion pattern.

34. The method of claim 30 further comprising:

determining another basal infusion pattern based on the evaluation indicating lack of suitability of the basal infusion pattern.

35. The method of claim 34 wherein determining the other basal infusion pattern based on the evaluation indicating lack of suitability is configured to:

selecting the other basal infusion pattern from the plurality of basal infusion patterns based on the evaluation indicating lack of suitability.

36. The method of claim 27 further comprising:

determining, based on insulin requirements of the user, whether to deliver a diluted insulin solution through a catheter delivering the insulin.

37. The method of claim 36 wherein determining whether to deliver the diluted insulin solution through the catheter comprises:

determining whether to deliver the diluted insulin solution through the catheter based on the determined basal infusion pattern.

38. The method of claim 28 wherein selecting the basal infusion pattern from a plurality of predetermined basal infusion patterns based on one or more personal characteristics of the user comprises:

selecting the basal infusion pattern based on one or more of;

age, body-mass index (BMI), bolus insulin requirements, sex, duration of diabetes, metabolic control, physical activity, sleep pattern, sleep duration, hemoglobin A1c values, age at manifestation of Diabetes Mellitus (DM), pyramidal insulin per kilogram, prandial insulin per day, total insulin per kilogram and total insulin per day.

39. An apparatus to deliver doses of basal insulin to a body of a user, the apparatus comprising:

a user interface to receive input regarding at least one characteristic of the user; and

a tailored basal insulin profile mechanism to select a basal infusion pattern for the user from a plurality of basal insulin infusion patterns based, at least in part, on the received input.

40. The apparatus of claim 39 further comprising:

a dispensing unit to deliver the basal insulin to the user'"'"'s body according to the selected basal infusion pattern.

41. The apparatus of claim 39 wherein the selected basal infusion pattern includes a pre-defined sequence of basal infusion rate changes for delivery of the basal insulin to the user'"'"'s body.

42. The apparatus of claim 41 wherein the rate changes of the selected basal infusion pattern are defined at intervals of one hour or shorter.

43. The apparatus of claim 41 wherein the pre-defined sequence of basal infusion rates includes a pre-defined sequence of deviations from an average basal infusion rate.

44. The apparatus of claim 39 wherein the tailored basal insulin profile mechanism is further configured to time shift the selected pattern based on the type of basal insulin to be used.

45. The apparatus of claim 39 wherein the tailored basal insulin profile mechanism configured to select the basal infusion pattern based on the input regarding the at least one characteristic of the user is configured to select the basal infusion pattern based on one or more of:

age, body-mass index (BMI), bolus insulin requirements, sex, duration of diabetes, metabolic control, physical activity, sleep pattern, sleep duration, hemoglobin A1c values, age at manifestation of Diabetes Mellitus (DM), pyramidal insulin per kilogram, prandial insulin per day, total insulin per kilogram and total insulin per day.

46. The apparatus of claim 39 wherein the tailored basal insulin profile mechanism configured to select the basal infusion pattern is configured to select the basal insulin infusion pattern based on the user'"'"'s age.

47. The apparatus of claim 39 wherein the tailored basal insulin profile mechanism is further configured to:

perform an evaluation of suitability of the selected basal infusion pattern based on glycemic status of the user.

48. The apparatus of claim 47 wherein the tailored basal insulin profile mechanism configured to perform the evaluation of the suitability of the determined basal infusion pattern is configured to:

evaluate the suitability of the selected basal pattern based on data representative of deviations of a user'"'"'s glucose level from a target zone.

49. The apparatus of claim 47 wherein the tailored basal insulin profile mechanism configured to perform the evaluation of the suitability of the selected predetermined basal infusion pattern is configured to:

evaluate the suitability of the selected basal pattern based on data representative of a user'"'"'s hemoglobin A1C levels.

50. The apparatus of claim 47 wherein the tailored basal insulin profile mechanism is further configured to:

adjust the selected basal infusion pattern based on the evaluation indicating lack of suitability of the determined basal infusion pattern.

51. The apparatus of claim 47 wherein the tailored basal insulin profile mechanism is further configured to:

select another basal infusion pattern based on the evaluation indicating lack of suitability of the basal infusion pattern.