Type 1 Diabetes Extension Study

Recruiting now

Conditions studied: Type 1 Diabetes Mellitus, T1DM, T1D

In brief

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.

Key facts

Study ID

NCT02734277

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

111

Starts

2016-08-18

Expected to finish

2028-08-01

Last updated by the study team

2026-06-29

Who can join

Age: 8 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Benaroya Research Institute — Seattle, Washington, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• University of Colorado School of Medicine: Barbara Davis Center for Diabetes — Aurora, Colorado, United States (enrolling)
• University of Iowa Health Care Division of Pediatric Endocrinology — Iowa City, Iowa, United States (enrolling)
• Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• UCSF School of Medicine — San Francisco, California, United States (enrolling)
• Indiana University Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Sanford Research — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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