Continuous Glucose Monitoring for Women With Gestational Diabetes

Recruiting now · Not applicable

Conditions studied: Gestational Diabetes

In brief

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

Key facts

Study ID

NCT06310356

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

386

Starts

2024-11-18

Expected to finish

2027-08-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Campbelltown Hospital — Sydney, CAMPBELLTOWN NSW, Australia (enrolling)
• Royal Prince Alfred Hospital — Sydney, Camperdown NSW, Australia (enrolling)
• OLV Aalst-Asse — Aalst, Oost-Vlaanderen, Belgium (enrolling)
• UZA — Antwerp, Belgium (enrolling)
• ZNA Antwerpen — Antwerp, Belgium (enrolling)
• Imelda Bonheiden — Bonheiden, Belgium (enrolling)
• AZ St Jan Brugge — Bruges, Belgium (enrolling)
• Erasme — Brussels, Belgium (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• AZ St Lucas Gent — Ghent, Belgium (enrolling)
• AZ Groeninge Kortrijk — Kortrijk, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• CHU de Liège — Liège, Belgium (enrolling)
• AZ St Maarten Mechelen — Mechelen, Belgium (enrolling)
• AZ Oostende — Ostend, Belgium (enrolling)
• Vitaz — Sint-Niklaas, Belgium (enrolling)

Full record on ClinicalTrials.gov

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