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Tracks relatives of people with type 1 diabetes for early signs of the disease

Screens relatives of people with type 1 diabetes for antibodies that signal future risk.

Key facts

Who runs it
University of South Florida
Where
Milan, ItalySee the siteAlso in 5 other countries, 21 sites
Trial code
Registry title
TrialNet Pathway to Prevention of T1D
Status
Recruiting
People taking part
75,000 people, planned
Started
1 Feb 2004
Expected to end
31 Jul 2030
Type of study
Observational, 2 groups
Record updated
1 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for relatives of people with type 1 diabetes, and for others known to have islet antibodies. It screens them for diabetes risk and follows them over time.

Age
2 to 45 years old. Extended relatives: 2 to 20 years old.
Sex
Men and women can join.
Disease stage
People who do not have diabetes yet. Relatives of people with type 1 diabetes, or people with 1 or more islet antibodies.
Earlier treatment
People cannot have used medicines for diabetes or high blood sugar. They cannot be using drugs that suppress or change the immune system now. Topical and inhaled ones are fine.
Biomarker or test result
Non-relatives must have 1 or more islet antibodies. Relatives are tested for these antibodies in the blood.

Main reasons for not taking part

  • Already has diabetes
  • Previous or current use of medicines for high blood sugar or diabetes
  • Currently using immune-suppressing or immune-changing drugs (topical and inhaled are fine)
  • Known severe active diseases
  • Diseases likely to limit life expectancy or lead to long-term immune-suppressing treatment

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have previous or current use of medications for the control of hyperglycemia/diabetes
  • Have diabetes already
  • 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
  • To be eligible a person must not:
  • Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 45 years old?

Where in Italy

Also in 5 other countries, 21 sites

  • Vita-Salute San Raffaele UniversityMilan, ItalyNo longer taking part

About the trial

What the trial wants to find out

Rationale:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Annual Re-Testing/Annual Metabolic Monitoring

    Participants will be monitored annually for risk of type 1 diabetes.

  • Semi-Annual Metabolic Monitoring

    Participants will be monitored every six months for risk of type 1 diabetes

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
TrialNet Pathway to Prevention of T1D
Plain-language title
Tracks relatives of people with type 1 diabetes for early signs of the diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT00097292, who can take part
Record updated
1 July 2025