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NCT02734277Recruiting

Type 1 Diabetes Extension Study

National Institute of Allergy and Infectious Diseases (NIAID)

Start Date

8/18/2016

Completion Date

8/1/2028

Summary

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: * follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.

Detailed Description

Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include: * Overall health assessments * Blood and urine collections * Mixed meal tolerance test (MMTTs) for certain participants, per protocol.

Eligibility Criteria

Age Range: 8 years to 35 years

Inclusion Criteria: * Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study. * Ability to sign informed consent/assent (as applicable for children). Exclusion Criteria: * Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or * Inability to comply with the study visit schedule and required assessments.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Type 1 Diabetes MellitusT1DMT1D

Locations

UCSF School of Medicine

San Francisco, California 94143

United States

Stanford University

Stanford, California 94305

United States

University of Colorado School of Medicine: Barbara Davis Center for Diabetes

Aurora, Colorado 80045

United States

Yale University

New Haven, Connecticut 06519

United States

Emory University

Atlanta, Georgia 30322

United States

Indiana University Riley Hospital for Children

Indianapolis, Indiana 46202

United States

University of Iowa Health Care Division of Pediatric Endocrinology

Iowa City, Iowa 52242

United States

Joslin Diabetes Center

Boston, Massachusetts 02215

United States

University of Minnesota

Minneapolis, Minnesota 55454

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

Sanford Research

Sioux Falls, South Dakota 57104

United States

Benaroya Research Institute

Seattle, Washington 98101

United States