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

NCT01787318 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-04-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ePID closed loop system

Insulin pump controlled by closed loop unit and algorithm

DEVICE

InsuPatch

device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Stuart Weinzimer, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01787318 on ClinicalTrials.gov