About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Freestyle Libre 3
- Glucometer
Treatment groups
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Antwerp
Collaborator
General Hospital Groeninge
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
Ziekenhuis Netwerk Antwerpen (ZNA)
Collaborator
Vitaz
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
Erasme University Hospital
Collaborator
Université Catholique de Louvain
Collaborator
University Hospital, Ghent
Collaborator
AZ Sint-Lucas Gent
Collaborator
AZ Sint-Lucas Brugge
Collaborator
AZ St Maarten Mechelen
Collaborator
Imelda Hospital, Bonheiden
Collaborator
AZ Oostende
Collaborator
Royal Prince Alfred Hospital, Sydney, Australia
Collaborator
Campbelltown Hospital/SWSLHD
Collaborator