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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Have email access

Locations
Other Locations
Belgium
OLV Aalst-Asse
RECRUITING
Aalst
UZA
RECRUITING
Antwerp
ZNA Antwerpen
RECRUITING
Antwerp
Imelda Bonheiden
RECRUITING
Bonheiden
AZ St Jan Brugge
RECRUITING
Bruges
Erasme
RECRUITING
Brussels
AZ St Lucas Gent
RECRUITING
Ghent
UZ Gent
RECRUITING
Ghent
AZ Groeninge Kortrijk
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
AZ St Maarten Mechelen
RECRUITING
Mechelen
AZ Oostende
RECRUITING
Ostend
Vitaz
RECRUITING
Sint-niklaas
Contact Information
Primary
Katrien Benhalima, MD PhD
katrien.benhalima@uzleuven.be
+3216340614
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2027-02
Participants
Target number of participants: 386
Treatments
Experimental: continuous glucose monitoring
continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
Active_comparator: self monitoring of blood glucose with glucometer
self monitoring of blood glucose with glucometer, at least 2 days per week if treated with lifestyle and daily if additional treatment with insulin is started
Related Therapeutic Areas
Sponsors
Collaborators: General Hospital Groeninge, Université Catholique de Louvain, Vitaz, AZ Sint-Lucas Gent, AZ Sint-Lucas Brugge, Imelda Hospital, Bonheiden, University Hospital, Ghent, AZ St Maarten Mechelen, Centre Hospitalier Universitaire de Liege, AZ Oostende, Onze Lieve Vrouw Hospital, Erasme University Hospital, University Hospital, Antwerp, Ziekenhuis Netwerk Antwerpen (ZNA)
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov