Method system and device for assessing insulin sensitivity

• US 9,872,959 B2
• Filed: 12/21/2015
• Issued: 01/23/2018
• 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:
  US14/975,935
• Publication Number:
  US 20160106918A1
• Time in Patent Office: 764 Days
• Field of Search: None
• 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 device based on a determined insulin sensitivity (IS), comprising:

receiving, via a subcutaneous glucose sensing apparatus, a first parameter corresponding to a first insulin dose value administered by an insulin dispensing apparatus in a subcutaneous tissue of a patient;

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

sensing a glucose concentration value, via the glucose sensing apparatus, via a cannula that is penetrating and residing in skin of the patient, residing in the subcutaneous tissue;

receiving a second parameter corresponding to the glucose concentration value from the glucose sensing apparatus;

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 dispensing apparatus;

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

delivering an insulin bolus via the cannula coupled to the insulin dispensing apparatus.

2. The method of claim 1 wherein the first kinetic model comprises a one-compartment kinetic model applied to obtain the plasma insulin concentration using a calculation including a first order absorption rate constant, a first order elimination rate constant, and a distribution volume.

3. The method of claim 2 further comprising utilizing in the calculation a time course accounting for continuous subcutaneous insulin infusion at a constant rate.

4. The method of claim 1 further comprising adhering the insulin delivery device directly to the skin of a patient.

5. The method of claim 1 further comprising coupling a glucose sensing device directly to a top inner portion of a housing of the insulin delivery device at a side farthest from a skin surface, such that the glucose sensing device is coupled only to the top inner portion and not inner walls of the housing.

6. The method of claim 1 further comprising providing a glucose sensing device for receiving a test strip, the glucose sensing device being coupled to a housing of the insulin delivery device, the housing having an opening such that the test strip is placeable into the glucose sensing device.

12. The method of claim 6 further comprising extracting blood from a body, placing the blood on a test strip, and inserting the test strip into the glucose sensing device via the opening.

7. A method for determining an insulin dose to be administered by an insulin delivery device based on a determined insulin sensitivity (IS), comprising:

receiving, via an insulin delivery device which comprises a housing containing therein a glucose sensing apparatus and an insulin dispensing apparatus, and having a cannula extending from the housing, a first parameter corresponding to a first insulin dose value administered by the insulin dispensing apparatus in a subcutaneous tissue of a patient;

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

sensing a glucose concentration value, via the glucose sensing apparatus, via the cannula that is penetrating and residing in skin of the patient, residing in the subcutaneous tissue;

receiving a second parameter corresponding to the glucose concentration value from the glucose sensing apparatus;

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 dispensing apparatus; and

delivering the second insulin bolus value via the cannula.

8. The method of claim 7 further comprising reevaluating the insulin sensitivity (IS) after a predetermined period of time since a last food bolus via an insulin sensitivity assessment feature.

9. The method of claim 7 further comprising coupling a glucose sensing device directly to a top inner portion of the housing farthest from a skin surface, such that it is coupled only to the top inner portion and not inner walls of the housing.

10. The method of claim 7 further comprising providing a glucose sensing device for receiving a test strip, the glucose sensing device being coupled to the housing, the housing having an opening such that the test strip is placeable into the glucose sensing device.

11. The method of claim 10 further comprising placing the test strip into the glucose sensing device via the opening.

13. The method of claim 7 wherein the first kinetic model comprises a one-compartment kinetic model applied to obtain the plasma insulin concentration using a calculation including a first order absorption rate constant, a first order elimination rate constant, and a distribution volume.

14. The method of claim 13 further comprising utilizing in the calculation a time course accounting for continuous subcutaneous insulin infusion at a constant rate.

15. The method of claim 7 further comprising adhering the insulin delivery device directly to the skin of a patient.