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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
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* Device: InsuPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18- 65 years old (including = 18 years and =65 years) Gender: men and women BMI: 18-35 kg/m2 Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart. Diabetic subjects with HbA1c values below 9.5% (including 9.5%). Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed Subject is willing to comply with all specified follow-up evaluations - Exclusion Criteria: Pregnancy Breast feeding women. Alcohol addiction Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L Psychological incompetence Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant. Subjects with diminished skin integrity Subjects with heat sensitivity Subjects involved in or planed to participate in other studies Subjects using other drugs therapies to control blood glucose level other than insulin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Subject starts with two clamps including device use follows by a clamp without device use | Device: InsuPatch<br>* the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.<br>|
| No Intervention: Control<br>Subject starts with clamps without device | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 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. | Up to 5 hours | 
| Safety | frequency and severity of all treatment-related adverse events until the completion of the study. | Up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics | 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 | Up to 5 hours | 
| Pharmacodynamic | Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test | Up to 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.