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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 386 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 16 sites (Sydney, CAMPBELLTOWN NSW and 15 other locations) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | February 2027 |
| Study ends | August 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT06310356 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
- Study coordinator: Katrien Benhalima, MD PhD
- Email: katrien.benhalima@uzleuven.be
- Phone: +3216340614
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Early Glucose Patterns in Pregnant Women at Risk for GDM
This study tests whether continuous glucose monitoring in early pregnancy can detect dysglycemia before GDM is diagnosed, in women with and without known risk factors.
-
Probiotic-augmented therapy for gestational diabetes
This trial tests whether adding multistrain probiotics to metformin, insulin, or their combination can improve blood sugar control and inflammation in pregnant women with gestational diabetes.
-
Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
-
How sleep, lifestyle, and metabolism relate to pregnancy outcomes in gestational diabetes
This project will see if sleep quality, anxiety, eating and activity habits, and metabolic markers relate to blood sugar control and birth outcomes in pregnant people with gestational diabetes.
-
Pre-eclampsia risk in pregnancies after oocyte donation
We will follow pregnant women who used donated eggs and women who used their own eggs to see if pregnancies after oocyte donation lead to a higher risk of pre-eclampsia.
-
Mobile-based obstetric monitoring for hypertension and diabetes during pregnancy
A mobile app-based program lets pregnant people with high blood pressure or gestational diabetes track BP and glucose at home and share results with their care team to guide care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.