Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
| Status: | Archived |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
| End Date: | March 2011 |
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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