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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.
Mills-Peninsula Health Services
San Mateo, California, United States
Wolfson Medical Center
Holon, Israel
Haddasah Medical Organization
Jerusalem, Israel
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.
Time frame: Up to 5 hours
Safety
frequency and severity of all treatment-related adverse events until the completion of the study.
Time frame: Up to one month
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
Time frame: 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
Time frame: Up to 5 hours
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