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Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

NCT00891995 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2016-12-30

Study results available
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Summary

The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

Conditions

Interventions

DEVICE

Closed loop

Closed loop therapy for up to 4 to 6 days

DEVICE

Home glucose monitoring

Standard diabetes management using a home glucose meter.

DEVICE

Insulin pump

Insulin pump use for 2 years

DEVICE

Continuous glucose monitor

Continuous glucose monitor use for 2 years

Sponsors & Collaborators

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Roy W Beck, M.D., Ph.D. · Jaeb Center for Health Research

  • Jay S. Skyler, M.D., M.A.C.P. · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

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 NCT00891995 on ClinicalTrials.gov