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New trial aims to improve pregnancy outcomes with smart glucose monitoring

NCT ID NCT06310356

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a continuous glucose monitor (CGM) can improve pregnancy outcomes for women with gestational diabetes compared to standard finger-prick testing. About 386 women from Belgium and Australia will be randomly assigned to use either a CGM or a regular glucometer. The goal is to see if CGM reduces complications like early delivery, large babies, or newborn health issues.

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 386 people

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

Started

Nov 2024

Expected to finish

Aug 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: * At least 18 years of age at the time of signing the Informed Consent Form (ICF) * Singleton pregnancy * Diagnosed with gestational diabetes before 29.6 weeks of pregnancy * Needs to be able to understand and speak Dutch, French or English. * Have email access Exclusion Criteria: * Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes * A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician). * Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin) * Participation in an interventional Trial with an investigational medicinal product or device * Multiple pregnancy * History of bariatric surgery * Known allergy to the adhesives used with the continuous glucose monitoring

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Conditions

The condition(s) this trial relates to.

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

    16 sites in 2 countries. 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

  • AZ Groeninge Kortrijk

    RECRUITING

    Kortrijk, 8510, Belgium

  • AZ Oostende

    RECRUITING

    Ostend, Belgium

  • AZ St Jan Brugge

    RECRUITING

    Bruges, 8000, Belgium

  • AZ St Lucas Gent

    RECRUITING

    Ghent, Belgium

  • AZ St Maarten Mechelen

    RECRUITING

    Mechelen, Belgium

  • CHU de Liège

    RECRUITING

    Liège, Belgium

  • Campbelltown Hospital

    RECRUITING

    Sydney, CAMPBELLTOWN NSW, 2560, Australia

  • Erasme

    RECRUITING

    Brussels, Belgium

  • Imelda Bonheiden

    RECRUITING

    Bonheiden, 2820, Belgium

  • OLV Aalst-Asse

    RECRUITING

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, Camperdown NSW, 2050, Australia

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • UZA

    RECRUITING

    Antwerp, Belgium

  • Vitaz

    RECRUITING

    Sint-Niklaas, Belgium

  • ZNA Antwerpen

    RECRUITING

    Antwerp, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.