NCT01216618

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Insuline Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-10-07
• Last updated: 2014-09-04

Locations

3 sites across 2 countries: United States, Israel