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Is early treatment for gestational diabetes overrated? new study investigates

NCT ID NCT04451915

Knowledge-focused Sponsor: University Hospital, Lille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether treating gestational diabetes early (before 24 weeks) is better than waiting until the standard 24-28 week screening. About 2,010 pregnant women with mild early high blood sugar will be randomly assigned to either start intensive treatment right away or wait for later screening. The goal is to see if waiting is just as safe for mothers and babies, which could simplify care and reduce unnecessary treatments.

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 could show that waiting to treat mild gestational diabetes is safe, potentially reducing unnecessary early treatments and stress for pregnant women.
What could go wrong
This is an early-stage study comparing two management strategies, not testing a new drug. The results may not apply to all women, and there is a chance that delaying treatment could increase risks for some.

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 2,010 people

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

Started

Nov 2020

Expected to finish

Jun 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.

Ages

18 years and older

Sex

Female participants only

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: * Pregnant woman * Singleton pregnancy * Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia). * First prenatal visit prior 20 weeks of gestation at the time of randomization. * Signed informed consent Exclusion Criteria: Diabetic follow-up started at time of inclusion * Pre-existing diabetes in pregnancy * Renal impairment * Hepatic insufficiency * History of bariatric surgery * Long time corticosteroids treatment * Insufficient understanding * Language difficulties * Lack of social Insurance * Person in emergency situation * Person under the protection of justice (tutelage/ curatorship) * Persons deprived of their liberty

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Conditions

The condition(s) this trial relates to.

disease gestational diabetes

As listed by the trial registrant

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

Gestational diabetes

How to take part

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

  1. The places running it

    10 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

  • CH ARRAS

    RECRUITING

    Arras, France

  • Ch Rene Dubos - Pontoise

    RECRUITING

    Pontoise, France

  • Chu Nimes Caremeau - Nimes 9

    RECRUITING

    Nîmes, France

  • Chu Site Sud (Saint Pierre) - St Pierre

    RECRUITING

    Saint-Pierre, France

  • Csapa / Hus / Hopital Civil - Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • Hop Claude Huriez Chu Lille

    RECRUITING

    Lille, 59037, France

  • Hopital Estaing - Chu63 - Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • Hopital Haut-Leveque - Chu - Pessac

    RECRUITING

    Pessac, 33604, France

  • Hopital Saint Vincent - Saint Antoine - Lille

    RECRUITING

    Lille, 59037, France

  • Hopital de Rangueil Chu Toulouse

    RECRUITING

    Toulouse, 31300, France

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