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TrialNet Pathway to Prevention of T1D

University of South Florida · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association · NCT00097292

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–45 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
75000
US sites recruiting
17
Study start
February 1, 2004
Record last updated
July 1, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Diabetes Mellitus, Type 1

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Childrens Hospital of Orange County

    Orange, CA 92868

    Site contact: Marissa Erickson · 714-509-8613 · merickson@choc.org

  • University of California San Francisco

    San Francisco, CA 94143-0434

    Site contact: Karen Ko · 844-813-8273 · clinicalresearch@diabetes.ucsf.edu

  • Stanford University Medical Center

    Stanford, CA 94305-5208

    Site contact: Trudy Esrey, RD · 650-498-4450 · tesrey@stanford.edu

  • Barbara Davis Center for Childhood Diabetes

    Denver, CO 80262

    Site contact: Brenda Bradfield · 303-724-8595 · brenda.bradfield@CUANSCHUTZ.EDU

  • Yale University School of Medicine

    New Haven, CT 06519

    Site contact: Lori Carria · 203-737-3595 · lori.carria@yale.edu

  • University of Florida

    Gainesville, FL 32601-0296

    Site contact: Jennifer Hosford · 352-294-5759 · jennifer.hosford@peds.ufl.edu

  • Emory Children's Center

    Atlanta, GA 30322

    Site contact: Xiaomiao Lan-Pidhainy, RN · 404-712-0051 · xlanpid@emory.edu

  • Riley Hospital for Children, Indiana University

    Indianapolis, IN 46202

    Site contact: Maria Spall · 866-230-8486 · malnicho@iu.edu

  • Joslin Diabetes Center

    Boston, MA 02215

    Site contact: Nora Bryant · 617-309-4141 · nora.bryant@joslin.harvard.edu

  • University of Minnesota

    Minneapolis, MN 58944

    Site contact: Beth Pappenfus · 612-624-2922 · papp0086@umn.edu

  • The Children's Mercy Hospital

    Kansas City, MO 64111

    Site contact: Cassandra McClain · 816-960-8877 · clmcclain@cmh.edu

  • Columbia University

    New York, NY 10032

    Site contact: Jamie R Hyatt · 212-851-5425 · jh4470@cumc.columbia.edu

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, PA 15213

    Site contact: Kelli DeLallo, RN · 412-692-5210 · kelli.delallo@chp.edu

  • Vanderbilt University

    Nashville, TN 37232

    Site contact: Faith Brendle, RN · 615-936-8638 · faith.brendle@vanderbilt.edu

  • University of Texas Medical Center at Dallas

    Dallas, TX 75390-8858

    Site contact: Lindsay Harter · 214-648-4725 · Lindsay.Harter@UTSouthwestern.edu

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Sandra Pena · 832-822-3380 · sypena@texaschildrens.org

  • Benaroya Research Institute

    Seattle, WA 98101-2795

    Site contact: Katie Bennett · 206-341-8945 · diabetes@benaroyaresearch.org

Study contacts (from the official record)

  • TrialNet Central Information Center general info · 1-800-425-8361
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TrialNet Pathway to Prevention of T1D (NCT00097292) | Bored Studies