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ClinicalTrials.gov ID

NCT06310356

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

386Estimated

Last Update Posted

Jun 9, 2026Actual

Start Date

Nov 18, 2024Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Aug 2027Estimated

Official Title

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

Brief 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.

Detailed Description

At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.

• Gestational Diabetes

• Freestyle Libre 3
• Glucometer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
• A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).
• Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
• Participation in an interventional Trial with an investigational medicinal product or device
• Multiple pregnancy
• History of bariatric surgery
• Known allergy to the adhesives used with the continuous glucose monitoring

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

University Hospital, AntwerpOTHER

General Hospital GroeningeOTHER

Onze Lieve Vrouw HospitalOTHER

Ziekenhuis Netwerk Antwerpen (ZNA)OTHER

VitazOTHER

Centre Hospitalier Universitaire de LiegeOTHER

Erasme University HospitalOTHER

Université Catholique de LouvainOTHER

University Hospital, GhentOTHER

AZ Sint-Lucas GentOTHER

AZ Sint-Lucas BruggeOTHER

AZ St Maarten MechelenUNKNOWN

Imelda Hospital, BonheidenOTHER

AZ OostendeUNKNOWN

Royal Prince Alfred Hospital, Sydney, AustraliaOTHER

Campbelltown Hospital/SWSLHDUNKNOWN

katrien.benhalima@uzleuven.be