Clinical trial Recruiting at 16 sites Interventional Ages 18 and up Women only

Using continuous glucose monitoring for women with gestational diabetes

Official title: Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial

Run by Universitaire Ziekenhuizen KU Leuven · NCT06310356 · Data updated 2026-11-12

This study is testing whether using a continuous glucose monitor can help women with gestational diabetes manage their blood sugar better during and after pregnancy compared to regular blood sugar checks.

More Gestational Diabetes trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment386 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations16 sites (Sydney, CAMPBELLTOWN NSW and 15 other locations)
StatusRecruiting
StartedNovember 18, 2024
Main results expectedFebruary 2027
Study endsAugust 2027
Registry record updatedJune 9, 2026
Trial IDNCT06310356 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18 and older, diagnosed with gestational diabetes before 29.6 weeks of pregnancy, who can communicate in Dutch, French, or English.

Probably not a fit

Patients with a history of type 1 or type 2 diabetes, multiple pregnancies, or certain medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of continuous glucose monitoring (CGM) in women diagnosed with gestational diabetes (GDM), including those diagnosed early in pregnancy. Participants will be randomly assigned to either use a CGM device (Freestyle Libre 3) throughout their pregnancy or continue with standard self-monitoring of blood glucose using a glucometer. The study aims to assess glucose levels and outcomes during and after pregnancy, with follow-up glucose tolerance tests conducted postpartum. The trial is conducted across multiple centers in Belgium, ensuring a diverse participant pool.

Why it matters

Potential benefit: If successful, this study could lead to improved management of gestational diabetes, potentially enhancing maternal and fetal health outcomes.

How similar studies have gone: Other studies have shown promising results with continuous glucose monitoring in managing diabetes, but this specific approach for early gestational diabetes is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Campbelltown Hospital
    Sydney, Campbelltown Nsw, Australia
    Recruiting
  • Royal Prince Alfred Hospital
    Sydney, Camperdown NSW, Australia
    Recruiting
  • OLV Aalst-Asse
    Aalst, Oost-Vlaanderen, Belgium
    Recruiting
  • Uza
    Antwerp, Belgium
    Recruiting
  • ZNA Antwerpen
    Antwerp, Belgium
    Recruiting
  • Imelda Bonheiden
    Bonheiden, Belgium
    Recruiting
Show 10 more locations
  • AZ St Jan Brugge
    Bruges, Belgium
    Recruiting
  • Erasme
    Brussels, Belgium
    Recruiting
  • UZ Gent
    Ghent, Belgium
    Recruiting
  • AZ St Lucas Gent
    Ghent, Belgium
    Recruiting
  • AZ Groeninge Kortrijk
    Kortrijk, Belgium
    Recruiting
  • UZ Leuven
    Leuven, Belgium
    Recruiting
  • CHU de Liège
    Liège, Belgium
    Recruiting
  • AZ St Maarten Mechelen
    Mechelen, Belgium
    Recruiting
  • AZ Oostende
    Ostend, Belgium
    Recruiting
  • Vitaz
    Sint-Niklaas, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.