Back to search results

TrialNet Pathway to Prevention of Type 1 Diabetes

This observational study, called the Pathway to Prevention, is looking to better understand how Type 1 Diabetes (T1D) develops. There are no specific interventions or treatments being tested. Instead, researchers are studying people who are at higher risk for T1D to learn more about the disease's natural progression. The main goal is to see who develops T1D over time. You might be able to join if you are between 2 and 45 years old and have a close family member with T1D, or if you are 2-20 years old and have an extended family member with T1D. This study aims to gather information that can help develop future prevention and early treatment strategies for T1D.

Study design
This is an observational study with a planned enrollment of 75,000 participants. It involves screening and ongoing monitoring.
What's involved
You would undergo a simple blood test for screening. If autoantibodies are present, you may have additional testing, including an Oral Glucose Tolerance Test (OGTT) and HbA1c measurement. Monitoring is provided once or twice annually depending on your risk level.
Compensation
Not stated in the trial record.
Follow-up
Monitoring for the development of type 1 diabetes is provided once or twice annually depending on risk level.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00097292

TrialNet Pathway to Prevention of T1D

Recruiting
Not specifiedAges 2–45Observational
University of South Florida
~75,000 participants
Updated 2025-07-01 on ClinicalTrials.gov

At a glance

Recruiting sites
19 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of type 1 diabetes
Measured over Monitoring is provided once or twice annually depending on risk level

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes MellitusIslet antibodies

Where it's being run

22 sites across 19 states
California3
Texas2
Colorado1
Connecticut1
Florida1
Georgia1
Indiana1
Massachusetts1

Study leadership

  • Kevan Herold, M.D. · STUDY_CHAIR · Yale University

Who to contact

TrialNet Central Information Center general info
1-800-425-8361
Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Development of type 1 diabetesMonitoring is provided once or twice annually depending on risk level

    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.