RECRUITING

TrialNet Pathway to Prevention of T1D

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

TrialNet Pathway to Prevention of T1D

Quick Facts

Study Start:2004-02
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00097292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Months to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  2. * Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
  3. * Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.
  1. * Have diabetes already
  2. * Have a previous history of being treated with insulin or oral diabetes medications.
  3. * Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
  4. * Have any known serious diseases

Contacts and Locations

Study Contact

TrialNet Central Information Center general info
CONTACT
1-800-425-8361

Principal Investigator

Kevan Herold, M.D.
STUDY_CHAIR
Yale School of Medicine

Study Locations (Sites)

Childrens Hospital of Orange County
Orange, California, 92868
United States
University of California San Francisco
San Francisco, California, 94143-0434
United States
Stanford University Medical Center
Stanford, California, 94305-5208
United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
United States
Yale University School of Medicine
New Haven, Connecticut, 06519
United States
University of Florida
Gainesville, Florida, 32601-0296
United States
Emory Children's Center
Atlanta, Georgia, 30322
United States
Riley Hospital for Children, Indiana University
Indianapolis, Indiana, 46202
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
University of Minnesota
Minneapolis, Minnesota, 58944
United States
The Children's Mercy Hospital
Kansas City, Missouri, 64111
United States
Columbia University
New York, New York, 10032
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
University of Texas Medical Center at Dallas
Dallas, Texas, 75390-8858
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Benaroya Research Institute
Seattle, Washington, 98101-2795
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Kevan Herold, M.D., STUDY_CHAIR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2004-02
Study Completion Date2025-07

Study Record Updates

Study Start Date2004-02
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • "at risk" for developing type 1 diabetes
  • T1DM
  • T1D
  • juvenile diabetes
  • Type 1 Diabetes TrialNet
  • TrialNet

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1