Method System and Device for Assessing Insulin Sensitivity

• US 20080319381A1
• 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: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Shapira, Gali, Yodfat, Ofer, Gescheit, Iddo
• Granted Patent: US 9,244,077 B2
• Time in Patent Office: Days
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A method and a system for determining insulin sensitivity (IS) is described. In one aspect the method and the system can be implemented by receiving a first parameter corresponding to an insulin dose in a subcutaneous tissue; applying a first kinetic model to obtain a plasma insulin concentration based on the first parameter; receiving a second parameter corresponding to a plasma glucose concentration; determining the insulin sensitivity (IS) based on the plasma insulin concentration and the second parameter.

Claims

1. A method for determining insulin sensitivity (IS), comprising:

receiving a first parameter corresponding to an insulin dose in a subcutaneous tissue;

applying a first kinetic model to obtain a plasma insulin concentration based on the first parameter;

receiving a second parameter corresponding to a plasma glucose concentration;

determining the insulin sensitivity (IS) based on the plasma insulin concentration and the second parameter.

2. The method of claim 1, wherein the second parameter is determined by applying a second kinetic model to a glucose concentration measured in the subcutaneous tissue.

3. The method of claim 2, wherein the glucose concentration in the subcutaneous tissue is measured using at least one of a glucometer and a Continuous Glucose Monitor (SCGM).

4. The method of claim 1, wherein the insulin sensitivity (IS) is determined using one or more of conventional plasma glucose-plasma insulin dynamics models.

5. The method of claim 4, wherein the dynamics models comprise at least one of the Homeostatic Model Assessment (HOMA), and Quantitative Insulin Sensitivity Check Index (QUICKI).

6. The method of claim 1, wherein the insulin sensitivity (IS) is periodically reevaluated.

7. The method of claim 1, wherein the insulin sensitivity (IS) is reevaluated after a predetermined period of time since a last food bolus.

8. The method of claim 1, wherein the insulin dose in the subcutaneous tissue is a basal insulin dose.

9. The method of claim 1, further comprising providing a recommendation to a user to validate the determined insulin sensitivity value (IS).

10. The method of claim 9, wherein the recommendation is provided as a message displayed on a graphical user interface.

11. The method of claim 10, wherein the user has an option to accept or reject the determined insulin sensitivity value (IS).

12. The method of claim 1, wherein the determined insulin sensitivity value is accepted automatically.

13. The method of claim 1, further comprising selecting an insulin bolus based on the determined insulin sensitivity value (IS) and delivering the insulin bolus to a user.

14. The method of claim 13, wherein the insulin bolus is delivered using a remotely controlled skin securable pump, such that the pump is connectable to and disconnectable from the user'"'"'s body.

15. The method of claim 2, wherein the glucose concentration in the subcutaneous tissue is measured using a glucometer integrated into a remote control unit.

16. A system for determining insulin sensitivity (IS) comprising at least one processor configured for:

receiving a first parameter corresponding to an insulin dose in a subcutaneous tissue;

applying a first kinetic model to obtain a plasma insulin concentration based on the first parameter;

receiving a second parameter corresponding to a plasma glucose concentration;

determining the insulin sensitivity (IS) based on the plasma insulin concentration and the second parameter.

17. The system of claim 16, wherein the second parameter is determined by applying a second kinetic model to a glucose concentration measured in the subcutaneous tissue.

18. The system of claim 17, wherein the glucose concentration in the subcutaneous tissue is measured using at least one of a glucometer and a Continuous Glucose Monitor (SCGM).

19. The system of claim 16, wherein the insulin sensitivity (IS) is determined using one or more of conventional plasma glucose-plasma insulin dynamics models.

20. The system of claim 19, wherein the dynamics models comprise at least one of the Homeostatic Model Assessment (HOMA), and Quantitative Insulin Sensitivity Check Index (QUICKI).

21. The system of claim 16, wherein the insulin sensitivity (IS) is periodically reevaluated.

22. The system of claim 16, wherein the insulin sensitivity (IS) is reevaluated after a predetermined period of time since a last food bolus.

23. The system of claim 16, wherein the insulin dose in the subcutaneous tissue is a basal insulin dose.

24. The system of claim 16, wherein the at least one processor is further configured for providing a recommendation to a user to validate the determined insulin sensitivity value (IS).

25. The system of claim 24, wherein the recommendation is provided as a message displayed on a graphical user interface.

26. The system of claim 25, wherein the user has an option to accept or reject the determined insulin sensitivity value (IS).

27. The system of claim 16, wherein the determined insulin sensitivity value is accepted automatically.

28. The system of claim 16, wherein the at least one processor is further configured for selecting an insulin bolus based on the determined insulin sensitivity value (IS) and delivering the insulin bolus to a user.

29. The system of claim 28, wherein the insulin bolus is delivered using a remotely controlled skin securable pump, such that the pump is connectable to and disconnectable from the user'"'"'s body.

30. The system of claim 17, wherein the glucose concentration in the subcutaneous tissue is measured using a glucometer integrated into a remote control unit.