Clinical trial Recruiting at 19 sites Observational Ages 2 to 45

Pathway to Prevention of Type 1 Diabetes

Official title: TrialNet Pathway to Prevention of T1D

Run by University of South Florida · NCT00097292 · Data updated 2026-11-12

This study is trying to see if a simple blood test can help identify people at risk for type 1 diabetes so they can be monitored and potentially prevent the disease.

Quick facts

Study typeObservational
Ages2 Years to 45 Years
SexAll
Enrollment75000 (estimated)
SponsorUniversity of South Florida
Academic / other
Locations22 sites (Orange, California and 21 other locations)
StatusRecruiting
StartedFebruary 1, 2004
Main results expectedJuly 31, 2030
Study endsJuly 31, 2030
Registry record updatedJuly 1, 2025
Trial IDNCT00097292 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 2 to 45 with a family history of type 1 diabetes or those with known islet antibodies.

Probably not a fit

Patients who already have diabetes or are currently using medications for diabetes management will not benefit from this study.

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 aims to enhance understanding of the natural history and risk factors associated with type 1 diabetes (T1D) by screening individuals for diabetes-related autoantibodies. Participants undergo a simple blood test to identify the presence of these autoantibodies, which can indicate an increased risk of developing T1D. Those who test positive will receive further testing to assess their risk over the next five years, with follow-up visits scheduled based on their autoantibody status. The study is part of an international effort to develop prevention strategies for T1D.

Why it matters

Potential benefit: If successful, this study could lead to early identification and intervention strategies for individuals at risk of developing type 1 diabetes.

How similar studies have gone: Other studies have shown promise in understanding the risk factors for type 1 diabetes, making this approach a continuation of ongoing research rather than a completely novel concept.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
* Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
* Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies

Exclusion Criteria:

To be eligible a person must not:

* Have diabetes already
* Have previous or current use of medications for the control of hyperglycemia/diabetes.
* Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)
* Have known severe active diseases, and/or diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study

Where it's running

  • Childrens Hospital of Orange County
    Orange, California, United States
    Recruiting
  • University of California San Francisco
    San Francisco, California, United States
    Recruiting
  • Stanford University Medical Center
    Stanford, California, United States
    Recruiting
  • Barbara Davis Center for Childhood Diabetes
    Denver, Colorado, United States
    Recruiting
  • Yale University School of Medicine
    New Haven, Connecticut, United States
    Recruiting
  • University of Florida
    Gainesville, Florida, United States
    Recruiting
Show 16 more locations
  • Emory Children's Center
    Atlanta, Georgia, United States
    Recruiting
  • Riley Hospital for Children, Indiana University
    Indianapolis, Indiana, United States
    Recruiting
  • Joslin Diabetes Center
    Boston, Massachusetts, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • The Children's Mercy Hospital
    Kansas City, Missouri, United States
    Recruiting
  • Columbia University
    New York, New York, United States
    Recruiting
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Vanderbilt University
    Nashville, Tennessee, United States
    Recruiting
  • University of Texas Medical Center at Dallas
    Dallas, Texas, United States
    Recruiting
  • Baylor College of Medicine
    Houston, Texas, United States
    Recruiting
  • Benaroya Research Institute
    Seattle, Washington, United States
    Recruiting
  • Walter and Eliza Hall Institute
    Parkville, Victoria, Australia
    Recruiting
  • The Hospital for Sick Children
    Toronto, Ontario, Canada
    Recruiting
  • University of Turku
    Turku, Finland
    Suspended
  • Vita-Salute San Raffaele University
    Milan, Italy
    Suspended
  • University of Bristol
    Bristol, United Kingdom
    Suspended

Study contacts

  • Study coordinator: TrialNet Central Information Center general info
  • Phone: 1-800-425-8361

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.