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Continuous Glucose Monitoring for Women with Gestational Diabetes
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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 open-label multi-centric RCT with 14 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.
Official title: Continuous Glucose Monitoring for Women with Gestational Diabetes: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
386
Start Date
2024-11-18
Completion Date
2027-02
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
Freestyle Libre 3
CGM
Glucometer
SMBG
Locations (14)
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium
UZA
Antwerp, Belgium
ZNA Antwerpen
Antwerp, Belgium
Imelda Bonheiden
Bonheiden, Belgium
AZ St Jan Brugge
Bruges, Belgium
Erasme
Brussels, Belgium
UZ Gent
Ghent, Belgium
AZ St Lucas Gent
Ghent, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège
Liège, Belgium
AZ St Maarten Mechelen
Mechelen, Belgium
AZ Oostende
Ostend, Belgium
Vitaz
Sint-Niklaas, Belgium