TrialNet Pathway to Prevention of T1D

Conditions

• Diabetes Mellitus, Type 1

Eligibility Criteria

Sex

ALL

Age

2 Years - 45 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Feb 1, 2004

Status verified

Jun 2025

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

75,000 participants (estimated)

Arms

• Arm: Annual Re-Testing/Annual Metabolic Monitoring
  Participants will be monitored annually for risk of type 1 diabetes.
• Arm: Semi-Annual Metabolic Monitoring
  Participants will be monitored every six months for risk of type 1 diabetes

Primary Outcome Measure

Development of type 1 diabetes [ Time Frame: Monitoring is provided once or twice annually depending on risk level ]

Central Contacts

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

Locations (17)

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