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Pathway to Prevention of Type 1 Diabetes

TrialNet Pathway to Prevention of T1D

Observational University of South Florida · NCT00097292

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
Enrollment75000 (estimated)
Ages2 Years to 45 Years
SexAll
SponsorUniversity of South Florida Academic / other
Locations22 sites (Orange, California and 21 other locations)
Trial IDNCT00097292 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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 performed: 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.

Eligibility criteria

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 this trial is running

Orange, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1"at risk" for developing type 1 diabetesT1DMT1Djuvenile diabetesType 1 Diabetes TrialNetTrialNet
Last reviewed 2026-06-13 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.