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Can we catch type 1 diabetes before it strikes?

NCT ID NCT06676566

Prevention Sponsor: Lund University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests whether screening children with a high genetic risk for type 1 diabetes, along with regular follow-up and family education, leads to an earlier diagnosis of the disease. Researchers will track 600 children to see if this approach prevents severe symptoms and diabetic ketoacidosis at diagnosis. They will also explore how weight gain, insulin resistance, and physical activity affect disease progression, and whether continuous glucose monitoring can replace traditional glucose tests. The study also examines the psychological impact of knowing a child's risk.

What this could mean

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

Active substance
Screening for islet autoantibodies, regular follow-up, and continuous glucose monitoring (CGM)
What this could lead to
If successful, this approach could help catch type 1 diabetes earlier in children, reducing severe complications and improving long-term health.
What could go wrong
The study is observational and may not prove that screening improves outcomes. It also requires long-term follow-up, and the psychological impact of knowing a child's risk is a concern.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Children who have been screened for genetic risk for type 1 diabetes at birth in the ASTR1D study and other children who have been screened for either genetic risk or islet autoantibodies in other studies.

Ages

0 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children 0 -10 years with high or moderate genetic risk of type 1 diabetes, measured by a combined analysis of HLA and non-HLA SNPs. Moderate genetic risk is defined as 8-10% risk of developing multiple islet autoantibodies before 6 years of age, and high genetic risk as over 10% risk of developing multiple islet autoantibodies before 6 years of age. * Children 0-18 years of age screened in other research studies or tested at a clinical site and found to have a single autoantibody (before stage 1 type 1 diabetes) or multiple islet autoantibodies without or with impaired glucose tolerance (stage 1 or 2 type 1 diabetes, respectively). * Children will be invited to participate in the current study if they have moderate or high genetic risk and 1) have participated in a prevention trial but have dropped out or the trial has ended 2) are not willing to participate in prevention trial. * Children screened and found to be positive for islet autoantibodies in other studies (TEDDY, TrialNet, Innodia etc) or in clinical settings but which have not progressed to stage 3 type 1 diabetes can also be invited to participate in the current study. Exclusion Criteria: * Stage 3 type 1 diabetes * Currently participating in a prevention study

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Stage 1 type 1 diabetes Stage 2 type 1 diabetes Stage 3 type 1 diabetes Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CRC Jan Waldenströms gata 35

    Malmö, 21428, Sweden

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