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 type | Observational |
|---|---|
| Ages | 2 Years to 45 Years |
| Sex | All |
| Enrollment | 75000 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 22 sites (Orange, California and 21 other locations) |
| Status | Recruiting |
| Started | February 1, 2004 |
| Main results expected | July 31, 2030 |
| Study ends | July 31, 2030 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT00097292 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
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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
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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.
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Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes
This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.
-
Tirzepatide for type 1 diabetes patients who are overweight or obese
This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.
-
Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes
This study tests an oral insulin tablet (SCD0503) against subcutaneous insulin and placebo to see how it behaves in the blood and helps control blood sugar in adults with type 1 diabetes.
-
Genetic risk score and progression to insulin in type 1 diabetes
This study tests whether a genetic risk score can predict which people with type 1 diabetes will need insulin progression over three years.
-
Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes
This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.
-
Diabetes multimorbidity and a voice diary app to help self-manage
This study tests whether the Fabla-diabetesMM audio diary app is feasible and helpful for older adults with type 1 or type 2 diabetes who also have additional chronic conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.