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Can full gene scans solve mysterious diabetes cases?

NCT ID NCT06570278

Diagnosis Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether whole genome sequencing (a complete scan of a person's DNA) can help doctors identify the cause of atypical diabetes—unusual cases that don't fit typical type 1 or type 2 diabetes. Researchers will compare this advanced genetic test to the current standard method in 1,020 adults. The goal is to see if the full genome scan finds more diabetes-related genetic changes and leads to changes in treatment.

What this could mean

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

Active substance
whole genome sequencing
What this could lead to
If successful, this could make diagnosing rare forms of diabetes more accurate, helping doctors choose the right treatment for each patient.
What could go wrong
This is an early-stage study focused on diagnosis, not treatment. The genetic findings may not always lead to changes in care, and the results may not apply to all diabetes patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,020 people

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

Started

Oct 2024

Expected to finish

Nov 2034

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: * Subjects ≥18 years with confirmed diabetes mellitus according to WHO criteria (World Health Organization: Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: Report of a WHO/IDF Consultation. Geneva, World Health Org., 2006.) * Age ≤ 45 years at diabetes diagnosis * Body mass index ≤ 35 kg/m² at diabetes diagnosis * Negative results of specific antibodies determination (GAD65, IA2, ZnT8) until the inclusion visit * Presenting atypical diabetes defined by at least one of the following: * Exocrine pancreatic disease * Familial history: diabetes diagnosed in a parent, child or sibling * Notion of familial consanguinity * Syndromic clinical features (dysmorphy, developmental delay, mental retardation…) or unusual abnormalities/features that are not part of diabetic complications or co-morbidities; * Early occurrence of microvascular complications (≤ 5 years after diabetes diagnosis) * Major insulinopenia at diagnosis (C peptide \< 0.2 nmol/L and/or documented ketosis) * Patient who conserved endogenous insulin secretion (positive C peptide value) but a need for insulin therapy initiation during the first year following diagnosis due to therapeutic failure of well conducted therapeutic intensification * Stated willingness to comply with all study procedures and availability for the duration of the study * Patient with a social security number in compliance with the French law (dispositions relatives aux recherches impliquant la personne humaine prévues aux articles L 1121-1 et suivants du Code de la Santé Publique) * Signed and dated informed consent form Exclusion Criteria: * Pregnant or breastfeeding woman, * Any contraindication to the study exams including known allergies or contraindication to contrasts for the scan * Patient with known monogenic diabetes (defined as identification of class 4 and 5 variants according to ACMG) * First or second-degree relatives with monogenic diabetes established by molecular genetics (class 4 and 5 variants according to ACMG) * Patient with known secondary diabetes (i.e. endocrine disorders such as Cushing syndrome, pancreatectomy, drug-induced diabetes) * Patient who had a bone marrow transplant * Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, * Individuals under legal protection (sauvegarde de justice).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus disease

As listed by the trial registrant

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

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

    26 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

  • Assistance Publique Hôpitaux de Paris, Bichat - Claude Bernard Hospital

    RECRUITING

    Paris, France

  • Assistance Publique Hôpitaux de Paris, Bicêtre Hospital

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, France

  • Assistance Publique Hôpitaux de Paris, Cochin Hospital

    RECRUITING

    Paris, France

  • Assistance Publique Hôpitaux de Paris, Lariboisière Hospital

    RECRUITING

    Paris, France

  • Assistance Publique Hôpitaux de Paris, Saint Antoine Hospital

    RECRUITING

    Paris, France

  • Assistance Publique Hôpitaux de Paris- La Pitié Salpêtrière Hospital

    RECRUITING

    Paris, France

  • Centre Hospitalier Sud Francilien

    RECRUITING

    Corbeil-Essonnes, France

  • Rennes University Hospital

    RECRUITING

    Rennes, France

  • Strasbourg University Hospital

    RECRUITING

    Strasbourg, France

  • University Hospital

    RECRUITING

    Amiens, France

  • University Hospital

    RECRUITING

    Angers, France

  • University Hospital

    NOT_YET_RECRUITING

    Nancy, France

  • University Hospital

    NOT_YET_RECRUITING

    Poitiers, France

  • University Hospital Bocage

    RECRUITING

    Dijon, France

  • University Hospital Bois Guillaume

    RECRUITING

    Rouen, France

  • University Hospital Cavale Blanche

    RECRUITING

    Brest, France

  • University Hospital Conception

    RECRUITING

    Marseille, France

  • University Hospital Haut Lévêque

    RECRUITING

    Bordeaux, France

  • University Hospital Jean Minjoz

    RECRUITING

    Besançon, France

  • University Hospital L'Archet

    NOT_YET_RECRUITING

    Nice, France

  • University Hospital Laennec

    RECRUITING

    Nantes, France

  • University Hospital Lapeyronie

    RECRUITING

    Montpellier, France

  • University Hospital Louis Pradel

    RECRUITING

    Lyon, France

  • University Hospital Michallon

    RECRUITING

    Grenoble, France

  • University Hospital Rangueil

    RECRUITING

    Toulouse, France

  • University Hospital Sud

    RECRUITING

    Lyon, France

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