RecruitingNCT02734277

Type 1 Diabetes Extension Study


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

111 participants

Start Date

Aug 18, 2016

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 35 Years

Inclusion Criteria2

  • Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
  • Ability to sign informed consent/assent (as applicable for children).

Exclusion Criteria2

  • 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.

Locations(12)

UCSF School of Medicine

San Francisco, California, United States

Stanford University

Stanford, California, United States

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

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Indiana University Riley Hospital for Children

Indianapolis, Indiana, United States

University of Iowa Health Care Division of Pediatric Endocrinology

Iowa City, Iowa, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Sanford Research

Sioux Falls, South Dakota, United States

Benaroya Research Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT02734277


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