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Massive study aims to uncover what triggers type 1 diabetes in kids

NCT ID NCT00279318

Knowledge-focused Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study followed over 8,600 children from birth to identify environmental factors—like infections or diet—that may trigger type 1 diabetes in those with genetic risk. Researchers tracked the appearance of diabetes-related autoantibodies and the development of the disease itself. The goal is to understand causes and eventually find ways to prevent or delay type 1 diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify what triggers type 1 diabetes in at-risk children, paving the way for future prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear triggers, and any prevention strategies would require many more years of research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

8,667 people

The number who actually took part.

Started

Sep 2004

Finished

Jun 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Childen up to 4 months of age with specified HLA are enrolled and followed longitudnally until 15 years of age

Ages

0 to 4 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newborns with high risk HLA in the general population or having a first- degree relative affected with T1DM * Newborns are less than 4 months of age Exclusion Criteria: * Have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes (e.g. steroids or insulin) * Refuses to have blood and stool samples stored at the NIDDK Repository

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

Contacts and locations

Locations

  • Augusta University

    Gainesville, Florida, 32608, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Diabetes Research Institute

    Munich, 80804, Germany

  • Lund University

    Malmö, 20502, Sweden

  • Pacific Northwest Research Institute

    Seattle, Washington, 98122, United States

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262, United States

  • Wellbeing Services County of Southwest Finland

    Turku, 20520, Finland

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