Time averaged basal rate optimizer

• US 10,112,011 B2
• Filed: 06/17/2014
• Issued: 10/30/2018
• Est. Priority Date: 07/19/2013
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Peyser, Thomas A.
• Primary Examiner(s): Flick, Jason
• Application Number:
  US14/307,219
• Publication Number:
  US 20150025495A1
• Time in Patent Office: 1,596 Days
• Field of Search: 604504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, a controller module, and optionally a single point glucose monitor are provided. Integration may be manual, semi-automated and/or fully automated.

Claims

1. A method for optimizing a basal rate profile for use with continuous insulin therapy, comprising:

providing a programmed basal rate profile for insulin therapy, wherein the basal rate profile comprises an insulin delivery schedule that includes one or more blocks of time, and wherein each block of time defines an insulin delivery rate;

periodically or intermittently updating the programmed basal rate profile based on a retrospective analysis of continuous glucose sensor data over a predetermined time window; and

adjusting the basal rate profile of the updated programmed basal rate profile in response to real time continuous glucose sensor data indicative of actual or impending hyperglycemia or hypoglycemia, wherein adjusting comprises dynamically increasing or decreasing the basal rate of the updated programmed basal rate profile in real time in response to real time continuous glucose sensor data indicating actual hyperglycemia, impending hyperglycemia, actual hypoglycemia, or impending hypoglycemia.

2. The method of claim 1, wherein the programmed basal rate profile is pre-programmed by a patient or healthcare provider.

3. The method of claim 1, wherein the basal rate profile is selected by a user from a list of predetermined basal rate profiles.

4. The method of claim 1, further comprising iteratively repeating the providing and periodically or intermittently updating, wherein the programmed basal rate profile is an updated basal rate profile from a previous iteration.

5. The method of claim 4, wherein the previous iteration is from about one day to one week previous to the iteration.

6. The method of claim 1, wherein the basal rate profile consists of a single rate of insulin infusion over 24 hours.

7. The method of claim 1, wherein the basal rate profile comprises a plurality of rates associated with different time blocks spanning 24 hours.

8. The method of claim 1, wherein the retrospective analysis comprises a time-averaging of the continuous glucose sensor data.

9. The method of claim 1, wherein the periodically or intermittently updating the programmed basal rate profile is further based on a retrospective analysis of insulin data over a predetermined time window.

10. The method of claim 9, wherein the retrospective analysis comprises a time-averaging of the insulin data.

11. The method of claim 1, wherein the predetermined time window is about 3 days to about 7 days.

12. The method of claim 1, wherein the periodically or intermittently updating is performed once a day.

13. The method of claim 1, wherein the periodically or intermittently updating is triggered by an event.

14. The method of claim 1, wherein the periodically or intermittently updating is triggered based on a recognized pattern in the data.

15. The method of claim 14, wherein the recognized pattern comprises a measure of glycemic variability.

16. The method of claim 1, wherein the updated basal rate profile more closely matches the patients'"'"' daily insulin dosing requirements as compared to the programmed basal rate profile, wherein the updated basal rate profile more closely matching the patients'"'"' daily insulin dosing requirements is quantified by a measure of glycemic variability.

17. The method of claim 1, wherein periodically or intermittently updating the basal rate profile comprises providing upper or lower limits for insulin delivery.

18. The method of claim 17, wherein adjusting comprises controlling insulin delivery within the upper and lower limits.

19. An integrated system for monitoring a glucose concentration in a host and for delivering insulin to a host, comprising:

a continuous glucose sensor, wherein the continuous glucose sensor is configured to substantially continuously measure a glucose concentration in a host, and to provide continuous sensor data associated with the glucose concentration in the host;

an insulin delivery device configured to deliver insulin to the host, wherein the insulin delivery device is operably connected to the continuous glucose sensor; and

a processor module configured to

provide a programmed basal rate profile for insulin therapy, wherein the basal rate profile comprises an insulin delivery schedule that includes one or more blocks of time, and wherein each block defines an insulin delivery rate,

periodically or intermittently update the programmed basal rate profile based on a retrospective analysis of continuous glucose sensor data over a predetermined time window, and

adjust the basal rate profile of the updated programmed basal rate profile in response to real time continuous glucose sensor data indicative of actual or impending hyperglycemia or hypoglycemia, wherein the adjustment comprises dynamically increasing or decreasing the basal rate of the updated programmed basal rate profile in real time in response to real time continuous glucose sensor data indicating actual hyperglycemia, impending hyperglycemia, actual hypoglycemia, or impending hypoglycemia.

20. The system of claim 19, wherein the programmed basal rate profile is pre-programmed by a patient or healthcare provider.

21. The system of claim 19, wherein the basal rate profile is selected by a user from a list of predetermined basal rate profiles.

22. The system of claim 19, wherein the processor is further configured to iteratively repeat the providing and the periodically or intermittently updating, wherein the programmed basal rate profile is an updated basal rate profile from a previous iteration.

23. The system of claim 22, wherein the previous iteration is from about one day to one week previous to the iteration.

24. The system of claim 19, wherein the basal rate profile consists of a single rate of insulin infusion over 24 hours.

25. The system of claim 19, wherein the basal rate profile comprises a plurality of rates associated with different time blocks spanning 24 hours.

26. The system of claim 19, wherein the retrospective analysis comprises a time-averaging of the continuous glucose sensor data.

27. The system of claim 19, wherein the periodically or intermittently updating the programmed basal rate profile is further based on a retrospective analysis of insulin data over a predetermined time window.

28. The system of claim 27, wherein the retrospective analysis comprises a time-averaging of the insulin data.

29. The system of claim 19, wherein the predetermined time window is about 3 days to about 7 days.

30. The system of claim 19, wherein the periodically or intermittently updating is performed once a day.

31. The system of claim 19, wherein the periodically or intermittently updating is triggered by an event.

32. The system of claim 19, wherein the periodically or intermittently updating is triggered based on a recognized pattern in the data.

33. The system of claim 32, wherein the recognized pattern comprises a measure of glycemic variability.

34. The system of claim 19, wherein the updated basal rate profile more closely matches the patients'"'"' daily insulin dosing requirements as compared to the programmed basal rate profile, wherein the updated basal rate profile more closely matching the patients'"'"' daily insulin dosing requirements is quantified by a measure of glycemic variability.

35. The system of claim 19, wherein periodically or intermittently updating the basal rate profile comprises providing upper or lower limits for insulin delivery.

36. The system of claim 35, wherein optionally adjusting comprises controlling insulin delivery within the upper and lower limits.