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Baby blood test could predict type 1 diabetes risk

NCT ID NCT07670143

Knowledge-focused Sponsor: IRCCS San Raffaele 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to identify newborns with a high genetic risk of developing type 1 diabetes. Researchers will screen 50,000 infants using a simple genetic test to find those with a greater than 10% risk. The goal is not to treat diabetes, but to find eligible babies for future prevention trials that could stop the disease before it starts.

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 screening could identify at-risk infants early and help test ways to prevent type 1 diabetes before it starts.
What could go wrong
This is an observational study, not a treatment trial. It only identifies risk; it does not prevent or treat diabetes. Many screened infants may never develop the disease.

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 50,000 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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

This study includes infants aged between 0 and 6 weeks, both male and female.

Ages

0 to 6 weeks

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: * Screening is performed between the ages of 0 and 6 weeks. * Consent form signed by parents/guardian. Exclusion Criteria: * Infants aged above 6 weeks. * Refusal to participate in the study

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A. O. U. Maggiore della Carità di Novara

    Novara, Novara, 28100, Italy

  • ASST Lecco - Ospedale Manzoni

    Lecco, Lecco, 23900, Italy

  • Clinica Mangiagalli

    Milan, Milano, 20122, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Milano, 20132, Italy

  • Ospedale Filippo Del Ponte

    Varese, Varese, 21100, Italy

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