Actively Recruiting
TrialNet Pathway to Prevention of T1D
Led by University of South Florida · Updated on 2025-07-01
75000
Participants Needed
22
Research Sites
1382 weeks
Total Duration
On this page
Sponsors
U
University of South Florida
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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
Official Title
TrialNet Pathway to Prevention of T1D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 2 to 45 years old with an immediate family member (child, parent, or sibling) who has type 1 diabetes
- Individuals 2 to 20 years old with an extended family member (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling) who has type 1 diabetes
- Individuals aged 2 to 45 years who are not family members but have one or more islet antibodies
You will not qualify if you...
- Having a current diagnosis of diabetes
- Previous or current use of medications to control high blood sugar or diabetes
- Current use of immunosuppressive or immunomodulatory drugs (topical and inhaled agents allowed)
- Having severe active diseases or conditions likely to limit life expectancy or require chronic immunosuppressive or immunomodulatory treatment during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 22 locations
1
Childrens Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143-0434
Actively Recruiting
3
Stanford University Medical Center
Stanford, California, United States, 94305-5208
Actively Recruiting
4
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
Actively Recruiting
5
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32601-0296
Actively Recruiting
7
Emory Children's Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Riley Hospital for Children, Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 58944
Actively Recruiting
11
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
12
Columbia University
New York, New York, United States, 10032
Actively Recruiting
13
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
University of Texas Medical Center at Dallas
Dallas, Texas, United States, 75390-8858
Actively Recruiting
16
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
17
Benaroya Research Institute
Seattle, Washington, United States, 98101-2795
Actively Recruiting
18
Walter and Eliza Hall Institute
Parkville, Victoria, Australia, 3050
Actively Recruiting
19
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G-1x8
Actively Recruiting
20
University of Turku
Turku, Finland, FIN-20520
Suspended
21
Vita-Salute San Raffaele University
Milan, Italy, +39-02-2643 2818
Suspended
22
University of Bristol
Bristol, United Kingdom, BS10 5NB UK
Suspended
Research Team
T
TrialNet Central Information Center general info
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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