Pediatric Diabetics Type 1 Using InsuPatch
|ClinicalTrials.gov Identifier: NCT01368978|
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : September 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: InsuPatch||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Test (with the InsuPatch device)
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
|No Intervention: Control (without the InsuPatch device)|
- Efficacy [ Time Frame: one year ]Insulin will be taken during the clamp and will be measured for concentration.The concentration of insulin during the first hour will be compared between the two arms for efficacy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368978
|United States, Connecticut|
|New Haven, Connecticut, United States|
|Principal Investigator:||Eda Cengiz, MD||Yale University|