🏛️ Verified NIH Record • Updated 2025-06-30

TrialNet Pathway to Prevention of T1D (NCT00097292)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University of South Florida

🩺 Plain-English Summary (8th-Grade Level)

Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.

Who can join: Review the eligibility criteria below.

Location: Childrens Hospital of Orange County — Orange, California

Age range: 2 Years to 45 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (22 Sites)

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

📞 Contact the Study Coordinator

Phone: (800) 425-8361

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗