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Finger-prick test could make type 1 diabetes screening child's play

NCT ID NCT06984185

Diagnosis Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This study is testing whether a combined autoantibody test on a drop of blood from a finger prick (dried on special paper) can detect type 1 diabetes as accurately as the standard blood draw from a vein. The researchers will enroll 106 children newly diagnosed with type 1 diabetes. If the finger-prick test works well, it could pave the way for easier, at-home screening for children at risk of developing the disease.

What this could mean

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

Active substance
combined autoantibody test (3 Screen) and immunoreactive trypsin assay on blotting paper
What this could lead to
If validated, this simple finger-prick test could make early screening for type 1 diabetes much easier and more accessible, especially for children at risk.
What could go wrong
This is a small validation study in children already diagnosed with diabetes, not a large screening trial. The test may not perform as well in real-world, pre-symptomatic screening.

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 106 people

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

Started

Nov 2025

Expected to finish

Dec 2027

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

Pediatric patients (1-18 years) with suspicion of type 1 diabetes at stage 3

Ages

1 year 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 aged over 1 year and under 18 years * BMI \<30.0 kg/m2 * With a diagnosis of stage 3 type 1 diabetes (clinical and laboratory criteria, metabolic acidosis, ketone levels) * Child's consent and no parental opposition Exclusion criteria * Patients with T2D or monogenic diabetes with a known familial history * Patients with cystic fibrosis * History of liver or kidney disease, or pancreatitis * Any progressive disease (other than T2D)

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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

    1 site. 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

  • Femme Mère Enfant Hospital, Hospices Civils de Lyon

    RECRUITING

    Bron, Rhône, 69500, France

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