Continuous Glucose Monitoring for Women With Gestational Diabetes
ConditionGestational Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Freestyle Libre 3
DeviceCGM
Glucometer
DeviceSMBG
Treatment groups
386 Participants
are divided into 2 treatment groupsGroup A: continuous glucose monitoringExperimental treatment 1 intervention
Group B: self monitoring of blood glucose with glucometerActive comparator 1 intervention
Trial outcomes
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
Time frame
at deliverySecondary outcomes
1
time in glucose range overnight between 70-95mg/dl
time in range from 00 till 6am between 70-95mg/dl
Time frame
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks2
time in glucose range during the day between 70-95mg/dl
time in range from 06 am til 00 between 70-95mg/dl
Time frame
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks3
time in glucose range overnight between 63-140mg/dl
time in range from 00 till 6am between 63-140mg/dl
Time frame
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation4
time in glucoserange during the day between 63-140mg/dl
time in range from 06 am til 00 between 63-140mg/dl
Time frame
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Antwerp
Collaborator
General Hospital Groeninge
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
Ziekenhuis Netwerk Antwerpen (ZNA)
Collaborator
Vitaz
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
Erasme University Hospital
Collaborator
Université Catholique de Louvain
Collaborator
University Hospital, Ghent
Collaborator
AZ Sint-Lucas Gent
Collaborator
AZ Sint-Lucas Brugge
Collaborator
AZ St Maarten Mechelen
Collaborator
Imelda Hospital, Bonheiden
Collaborator
AZ Oostende
Collaborator
Royal Prince Alfred Hospital, Sydney, Australia
Collaborator
Campbelltown Hospital/SWSLHD
Collaborator
Source ClinicalTrials.gov