RecruitingNot ApplicableNCT06310356

Continuous Glucose Monitoring for Women With Gestational Diabetes

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

386 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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-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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Freestyle Libre 3 and a medical device called Glucometer for people with gestational diabetes. The study is currently recruiting participants at 16 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFreestyle Libre 3

CGM

DEVICEGlucometer

SMBG


Locations(16)

Campbelltown Hospital

Sydney, CAMPBELLTOWN NSW, Australia

Royal Prince Alfred Hospital

Sydney, Camperdown NSW, Australia

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

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NCT06310356


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