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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

386

participants targeted

Target at P75+ for not_applicable

Timeline

15mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach

1 country

14 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Progress54%

Nov 2024Aug 2027

First Submitted

Initial submission to the registry

February 28, 2024

Completed

16 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed

8 months until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

February 28, 2024

Last Update Submit

April 28, 2026

Conditions

Gestational Diabetes

Keywords

gestational diabetescontinuous glucose monitoringearly gestational diabetes

Outcome Measures

Primary Outcomes (1)

a composite of pregnancy outcomes
Hence, the primary outcome is a binary variable, taking the value 1 if at least one of the adverse pregnancy outcomes occurs, or zero otherwise:preterm delivery \<37 weeks, large-for-gestational age infant, neonatal hypoglycaemia, (requiring intravenous dextrose), NICU admission (\>24h), respiratory distress (at least 4 hours of respiratory support with supplemental oxygen, CPAP, or intermittent positive-pressure ventilation during the first 24 hours after delivery), stillbirth or neonatal death, phototherapy for jaundice, birth trauma and shoulder dystocia
at delivery

Secondary Outcomes (56)

time in glucose range overnight between 70-95mg/dl
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range during the day between 70-95mg/dl
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range overnight between 63-140mg/dl
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation
time in glucoserange during the day between 63-140mg/dl
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range during the day between 54-95mg/dl
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
+51 more secondary outcomes

Study Arms (2)

continuous glucose monitoring

EXPERIMENTAL

continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3

Device: Freestyle Libre 3

self monitoring of blood glucose with glucometer

ACTIVE COMPARATOR

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

Device: Glucometer

Interventions

Freestyle Libre 3DEVICE

CGM

continuous glucose monitoring

GlucometerDEVICE

SMBG

self monitoring of blood glucose with glucometer

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Sites (14)

OLV Aalst-Asse

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

UZA

Antwerp, Belgium

RECRUITING

ZNA Antwerpen

Antwerp, Belgium

RECRUITING

Imelda Bonheiden

Bonheiden, 2820, Belgium

RECRUITING

AZ St Jan Brugge

Bruges, 8000, Belgium

RECRUITING

Erasme

Brussels, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

AZ St Lucas Gent

Ghent, Belgium

RECRUITING

AZ Groeninge Kortrijk

Kortrijk, 8510, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU de Liège

Liège, Belgium

RECRUITING

AZ St Maarten Mechelen

Mechelen, Belgium

RECRUITING

AZ Oostende

Ostend, Belgium

RECRUITING

Vitaz

Sint-Niklaas, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Katrien Benhalima, MD PhD

CONTACT

+3216340614 katrien.benhalima@uzleuven.be

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 15, 2024

Study Start

November 18, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing: Will not share

Locations

BE(14)

Continuous Glucose Monitoring for Women With Gestational Diabetes

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (56)

Study Arms (2)

continuous glucose monitoring

self monitoring of blood glucose with glucometer

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (56)

Study Arms (2)

continuous glucose monitoring

self monitoring of blood glucose with glucometer

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations