Type 1 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of the Effect of lnsuPatch on the Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII)
This study is a prospective, single-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.
Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the
inclusion/exclusion criteria as outlined below and who provide written Informed Consent will
be enrolled in the study.
The study will consist of an outpatient enrollment visit and two admissions(One clamps with
the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her
own control.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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