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

• Sponsor: Insuline Medical Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01216618
• Collaborator: (none)
• Enrollment: 55
• Locations: 3
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 18.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Device: InsuPatch	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device Subject starts with two clamps including device use follows by a clamp without device use	Device: 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.
No Intervention: Control Subject starts with clamps without device

Outcome Measures

Primary Outcome Measures

1. Efficacy [Up to 5 hours]

   Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.

2. Safety [Up to one month]

   frequency and severity of all treatment-related adverse events until the completion of the study.

Secondary Outcome Measures

1. pharmacokinetics [Up to 5 hours]

   Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test

2. Pharmacodynamic [Up to 5 hours]

   Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mills-Peninsula Health Services	San Mateo	California	United States	94401
2	Wolfson Medical Center	Holon		Israel
3	Haddasah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Insuline Medical Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor's Official web site

Publications

None provided.

• Responsible Party: Insuline Medical Ltd.
• ClinicalTrials.gov Identifier: NCT01216618
• Other Study ID Numbers: G080106/A
• First Posted: Oct 7, 2010
• Last Update Posted: Sep 4, 2014
• Last Verified: Jun 1, 2011

• Keywords provided by Insuline Medical Ltd.: MiniMed paradigm insulin pumps; insulin Lispro; Insulin Asprt.
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Sep 4, 2014