Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes — IPCL  

Type 1 Diabetes Clinical Trial

Official title: Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes

Status Completed

Clinical Trial Summary

This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.

Clinical Trial Description

This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT01787318
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: Phase 0
• Start date: January 2013
• Completion date: December 2015