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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Subject starts with two clamps including device use follows by a clamp without device use |
|
| Control | No Intervention | Subject starts with clamps without device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InsuPatch | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills-Peninsula Health Services | San Mateo | California | 94401 | United States | ||
| Wolfson Medical Center |
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| Label | URL |
|---|---|
| Sponsor's Official web site | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| Holon |
| Israel |
| Haddasah Medical Organization | Jerusalem | Israel |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |