Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00097292 · ClinicalTrials.gov registry record

TrialNet Pathway to Prevention of T1D

A clinical trial of Diabetes Mellitus, Type 1, sponsored by University of South Florida.

Recruiting
Registry status
75,000
Enrollment target
20
Study locations

NCT00097292: Recruiting study of Diabetes Mellitus, Type 1, sponsored by University of South Florida.

NCT00097292 is a study of Diabetes Mellitus, Type 1 that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 75,000 participants, above the 631-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (11786% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00097292, a study of Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by University of South Florida.

RECRUITING
Registry status
75,000 participants
Enrollment target
20
Study locations

Study Summary

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 offe

Primary Outcome

The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.

Conditions Studied

Diabetes Mellitus, Type 1

Study Locations (20)

California

  • Childrens Hospital of Orange County - Orange
  • University of California San Francisco - San Francisco
  • Stanford University Medical Center - Stanford

Texas

  • University of Texas Medical Center at Dallas - Dallas
  • Baylor College of Medicine - Houston

Colorado

  • Barbara Davis Center for Childhood Diabetes - Denver

Connecticut

  • Yale University School of Medicine - New Haven

Florida

  • University of Florida - Gainesville

Georgia

  • Emory Children's Center - Atlanta

Indiana

  • Riley Hospital for Children, Indiana University - Indianapolis

Massachusetts

  • Joslin Diabetes Center - Boston

Trial Details

FieldValue
Enrollment Target 75,000 participants
Start Date 2004-02-01
Est. Completion 2030-07-31
University of South Florida

252 total trials

What NCT00097292 shows while recruiting

NCT00097292 is an observational study that tracks outcomes without assigning an intervention. Its 75,000 participants enrollment target places it among the larger protocols in the corpus, above the 631-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (11786% higher).

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 0 interventions.

NCT00097292 names 20 study sites across 17 states, led by California, Texas, Colorado.

Frequently Asked Questions

What is clinical trial NCT00097292 about?

NCT00097292 is a clinical study titled "TrialNet Pathway to Prevention of T1D". 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...

What is the current status of trial NCT00097292?

This trial is currently recruiting. The enrollment target is 75,000 participants. The study started on 2004-02-01. Estimated completion is 2030-07-31.

What conditions does trial NCT00097292 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.

Who is sponsoring clinical trial NCT00097292?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00097292 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Diabetes Mellitus, Type 1

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00097292's enrollment target sits among peer trials

75,000 1st of 118 higher than 118 of 118 other Diabetes Mellitus, Type 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02402244 · 75,000 participants

    Project: Every Child for Younger Patients With Cancer

  • NCT02803242 · 75,000 participants

    COPD Patient-Powered Research Network

  • NCT04611568 · 75,000 participants · NA

    War on Melanoma™ Public Health & Education Campaign

  • NCT00063063 · 80,000 participants

    Generic Database of Very Low Birth Weight Infants

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT00097292

Source: ClinicalTrials.gov NCT00097292, the US trial registry maintained by the National Library of Medicine. NCT00097292 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.