Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

NCT ID: NCT01216618

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-06-30

Brief Summary

The study is a prospective, multi-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Detailed Description

Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month.

There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.

Conditions

Diabetes Mellitus, Insulin-Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device

Subject starts with two clamps including device use follows by a clamp without device use

Group Type: EXPERIMENTAL

InsuPatch

Intervention Type: DEVICE

the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.

Control

Subject starts with clamps without device

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

InsuPatch

the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18- 65 years old (including = 18 years and =65 years)

2. Gender: men and women

3. BMI: 18-35 kg/m2

4. Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.

5. Diabetic subjects with HbA1c values below 9.5% (including 9.5%).

6. Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed

7. Subject is willing to comply with all specified follow-up evaluations -

Exclusion Criteria

1. Pregnancy

2. Breast feeding women.

3. Alcohol addiction

4. Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date

5. Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study

6. Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)

7. Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.

8. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.

9. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L

10. Psychological incompetence

11. Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.

12. Subjects with diminished skin integrity

13. Subjects with heat sensitivity

14. Subjects involved in or planed to participate in other studies

15. Subjects using other drugs therapies to control blood glucose level other than insulin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insuline Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mills-Peninsula Health Services

San Mateo, California, United States

Wolfson Medical Center

Holon, , Israel

Haddasah Medical Organization

Jerusalem, , Israel

Countries

United States; Israel

Related Links

http://www.insuline-medical.com

Sponsor's Official web site

Other Identifiers

G080106/A

Identifier Type: -

Identifier Source: org_study_id