Continuous Glucose Monitoring for Women With Gestational Diabetes

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.

Conditions

• Gestational Diabetes

Interventions

DEVICE

Freestyle Libre 3

CGM

DEVICE

Glucometer

SMBG

Sponsors & Collaborators

• University Hospital, Antwerp

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• Onze Lieve Vrouw Hospital

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Vitaz

  collaborator OTHER

• Centre Hospitalier Universitaire de Liege

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• AZ Sint-Lucas Gent

  collaborator OTHER

• AZ Sint-Lucas Brugge

  collaborator OTHER

• AZ St Maarten Mechelen

  collaborator UNKNOWN

• Imelda Hospital, Bonheiden

  collaborator OTHER

• AZ Oostende

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2027-02-28

Completion

2027-08-31

Countries

• Belgium

Study Locations