# US 9,872,959 B2 · Method system and device for assessing insulin sensitivity

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- Number: US 9,872,959 B2
- Document ID: US9872959B2
- Status: Granted
- Kind: B2
- Application number: 14/975,935
- Filed: 2015-12-21
- Published: 2016-04-21
- Granted: 2018-01-23
- Earliest claimed: 2007-06-25
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Ofer Yodfat; Gali Shapira; Iddo Gescheit
- Web page: https://patentgrep.com/patent/US9872959B2

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- G01N 33/66: involving blood sugars, e.g. galactose
- G16H 20/17: delivered via infusion or injection
- G16H 50/50: for simulation or modelling of medical disorders
- A61M 5/14248: {of the skin patch type}
- A61M 2005/14296: {Pharmacokinetic models}
- A61M 2230/20: Blood composition characteristics
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 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.

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 7)

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.

### Claim 10 (depends on 7)

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.

### Claim 11 (depends on 10)

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

### Claim 12 (depends on 6)

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.

### Claim 13 (depends on 7)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 7)

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