Using continuous glucose monitoring for women with gestational diabetes

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 386 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 14 sites (Aalst, Oost-Vlaanderen and 13 other locations)
• Trial ID: NCT06310356 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Aalst, Oost-Vlaanderen and 13 other locations

• OLV Aalst-Asse — Aalst, Oost-Vlaanderen, Belgium (Recruiting)
• Uza — Antwerp, Belgium (Recruiting)
• ZNA Antwerpen — Antwerp, Belgium (Recruiting)
• Imelda Bonheiden — Bonheiden, Belgium (Recruiting)
• 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

Conditions Gestational Diabetes; gestational diabetes; continuous glucose monitoring; early gestational diabetes