Method system and device for assessing insulin sensitivity

• US 9,244,077 B2
• Filed: 06/25/2008
• Issued: 01/26/2016
• 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: Yodfat, Ofer, Shapira, Gali, Gescheit, Iddo
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US12/145,942
• Publication Number:
  US 20080319381A1
• Time in Patent Office: 2,771 Days
• Field of Search: None
• US Class Current: 1/1
• 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 an insulin dose to be administered by an insulin delivery patch unit based on a determined insulin sensitivity (IS), comprising:

providing a remote control unit, a subcutaneous glucose sensing apparatus, and the insulin delivery patch unit wherein the insulin delivery patch unit comprises a first housing and a second housing; and

receiving a first parameter corresponding to a first insulin dose value administered by the insulin delivery patch unit 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 glucose concentration value from the glucose sensing apparatus that is a continuous glucose monitoring device;

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

determining a second insulin dose value based on the determined insulin sensitivity to be administered by the insulin delivery patch unit; and

reevaluating the insulin sensitivity (IS) after a predetermined period of time since a last food bolus via an insulin sensitivity assessment feature located in the remote control unit; and

delivering an insulin bolus via a cannula coupled to the second housing, wherein the first housing contains all electronic and driving elements of the insulin delivery patch and the second housing contains an insulin reservoir.

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 1, wherein the insulin sensitivity (IS) is periodically reevaluated.

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

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

6. The method of claim 5, wherein the recommendation is provided as a message displayed on a graphical user interface.

7. The method of claim 6, wherein the user has an option to accept or reject the determined insulin sensitivity value (IS), and wherein the user is recommended to pay a visit to a practitioner to change the settings on a pump, and perform a further test to evaluate a diabetic state.

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

9. The method of claim 1, 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.

10. A system for determining an insulin dose to be administered by an insulin delivery patch unit based on a determined insulin sensitivity (IS) comprising:

providing a remote control unit, a subcutaneous glucose sensing apparatus, and the insulin delivery patch unit wherein the insulin delivery patch unit comprises a first housing and a second housing, and at least one processor configured for receiving a first parameter corresponding to a first insulin dose value administered by the insulin delivery patch unit in a subcutaneous tissue; and

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 value from the glucose sensing apparatus that is a continuous glucose monitoring device;

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

determining a second insulin dose value based on the determined insulin sensitivity to be administered by the insulin delivery patch unit; and

reevaluating the insulin sensitivity (IS) by the at least one processor via an insulin sensitivity assessment feature is located in the remote control unit after a predetermined period of time since a last food bolus; and

delivering an insulin bolus via a cannula coupled to the second housing, wherein the first housing contains all electronic and driving elements of the insulin delivery patch and the second housing contains an insulin reservoir.

11. The system of claim 10, wherein the at least one processor is further configured for determining the second parameter by applying a second kinetic model to a glucose concentration measured in the subcutaneous tissue.

12. The system of claim 10, wherein the insulin sensitivity (IS) is periodically reevaluated by the at least one processor.

13. The system of claim 10, wherein the at least one processor is further configured for providing a recommendation to a user to validate the determined insulin sensitivity value (IS).

14. The system of claim 13, wherein the recommendation is provided as a message displayed on a graphical user interface.

15. The system of claim 14, wherein the user has an option to accept or reject the determined insulin sensitivity value (IS), and wherein the user is recommended to pay a visit to a practitioner to change the settings on a pump, and perform a further test to evaluate a diabetic state.

16. The system of claim 10, wherein the determined insulin sensitivity value is accepted automatically.

17. The system of claim 10, 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.

18. A system for determining an insulin dose to be administered by an insulin delivery patch unit based on a determined insulin sensitivity (IS), the system consisting essentially of:

providing a remote control unit, a subcutaneous glucose sensing apparatus, and the insulin delivery patch unit wherein the insulin delivery patch unit comprises a first housing and a second housing and at least one processor; and

receiving a first parameter corresponding to a first insulin dose value administered by the insulin delivery patch unit 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 glucose concentration value from the glucose sensing apparatus that is a continuous glucose monitoring device;

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

determining a second insulin dose based on the determined insulin sensitivity to be administered by the insulin delivery patch unit; and

reevaluating the insulin sensitivity (IS) by the at least one processor via an insulin sensitivity assessment feature is located in the remote control unit after a predetermined period of time since a last food bolus; and

delivering an insulin bolus via a cannula coupled to the second housing, wherein the first housing contains all electronic and driving elements of the insulin delivery patch and the second housing contains an insulin reservoir.