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RECRUITING
NCT06310356
NA

Continuous Glucose Monitoring for Women with Gestational Diabetes

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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

Interventions

DEVICE

Freestyle Libre 3

CGM

DEVICE

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