Clinical trial Recruiting at 8 sites Observational Ages 8 to 35

Long-term effects of immunomodulatory treatments in Type 1 Diabetes

Official title: Type 1 Diabetes Extension Study

Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT02734277 · Data updated 2026-11-12

This study looks at people with Type 1 Diabetes who have tried certain treatments to see how long they can still make insulin and how their immune system changes over time.

More Type 1 Diabetes Mellitus trials

Quick facts

Study typeObservational
Ages8 Years to 35 Years
SexAll
Enrollment111 (estimated)
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
NIH
Locations12 sites (San Francisco, California and 11 other locations)
StatusRecruiting
StartedJune 8, 2016
Main results expectedAugust 2028
Study endsAugust 2028
Registry record updatedSeptember 18, 2026
Trial IDNCT02734277 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals who have previously participated in an Immune Tolerance Network approved Type 1 Diabetes study.

Probably not a fit

Patients with medical conditions that could interfere with the trial or those unable to comply with the study schedule may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows participants who previously took part in selected Type 1 Diabetes Mellitus studies involving immunomodulatory agents. It aims to assess how long these individuals continue to produce insulin and how changes in their immune system over time relate to insulin production. Participants may have follow-up visits ranging from one to five years, which will include health assessments, blood and urine collections, and mixed meal tolerance tests for certain individuals. The findings could inform the development of improved therapies for Type 1 Diabetes in the future.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and therapies for managing Type 1 Diabetes.

How similar studies have gone: Other studies involving immunomodulatory treatments in Type 1 Diabetes have shown promise, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • UCSF School of Medicine
    San Francisco, California, United States
    Recruiting
  • Stanford University
    Stanford, California, United States
    Recruiting
  • University of Colorado School of Medicine: Barbara Davis Center for Diabetes
    Aurora, Colorado, United States
    Recruiting
  • Indiana University Riley Hospital for Children
    Indianapolis, Indiana, United States
    Recruiting
  • University of Iowa Health Care Division of Pediatric Endocrinology
    Iowa City, Iowa, United States
    Recruiting
  • Joslin Diabetes Center
    Boston, Massachusetts, United States
    Recruiting
Show 6 more locations
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • Benaroya Research Institute
    Seattle, Washington, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Completed
  • Emory University
    Atlanta, Georgia, United States
    Withdrawn
  • Children's Mercy Hospital
    Kansas City, Missouri, United States
    Completed
  • Sanford Research
    Sioux Falls, South Dakota, United States
    Completed

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.