protocolSection identificationModule nctId: NCT06310356, orgStudyIdInfo id: CORDELIA, briefTitle: Continuous Glucose Monitoring for Women With Gestational Diabetes, acronym: CORDELIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: University Hospital, Antwerp, collaborators name: General Hospital Groeninge, collaborators name: Onze Lieve Vrouw Hospital, collaborators name: AZ Delta, collaborators name: Ziekenhuis Netwerk Antwerpen (ZNA), collaborators name: Vitaz, collaborators name: Centre Hospitalier Universitaire de Liege, collaborators name: Erasme University Hospital, collaborators name: Université Catholique de Louvain, collaborators name: Centre Hospitalier Mouscron, collaborators name: University Hospital, Ghent, collaborators name: AZ Turnhout, collaborators name: AZ Sint-Lucas Gent, collaborators name: AZ St- Jan Brugge, collaborators name: AZ St Maarten Mechelen, collaborators name: Imelda Hospital, Bonheiden, descriptionModule briefSummary: 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 17 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., conditionsModule conditions: Gestational Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 386, type: ESTIMATED, armsInterventionsModule interventions name: Freestyle Libre 3, interventions name: Glucometer, outcomesModule primaryOutcomes measure: a composite of pregnancy outcomes, secondaryOutcomes measure: time in glucose range overnight between 70-95mg/dl, secondaryOutcomes measure: time in glucose range during the day between 70-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 63-140mg/dl, secondaryOutcomes measure: time in glucoserange during the day between 63-140mg/dl, secondaryOutcomes measure: time in glucose range during the day between 54-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 54-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 63-120mg/dl, secondaryOutcomes measure: time in glucose range during the day between 63-120mg/dl, secondaryOutcomes measure: hypoglycemia <54mg/dl, secondaryOutcomes measure: hypoglycemia <50mg/dl, secondaryOutcomes measure: hypoglycemia <63mg/dl, secondaryOutcomes measure: hypoglycemia <70mg/dl, secondaryOutcomes measure: standard deviation, secondaryOutcomes measure: Coefficient of Variance, secondaryOutcomes measure: mean amplitude of glycemic excursions, secondaryOutcomes measure: glucose time overnight >100mg/dl, secondaryOutcomes measure: glucose postprandial time >120mg/dl, secondaryOutcomes measure: glucose postprandial time >140mg/dl, secondaryOutcomes measure: glucose time >180mg/dl, secondaryOutcomes measure: mean HbA1c, secondaryOutcomes measure: Glucose management indicator, secondaryOutcomes measure: timing of start insulin treatment, secondaryOutcomes measure: mean insulin dose, secondaryOutcomes measure: mean gestational weight gain, secondaryOutcomes measure: rate of postpartum hemorrhage, secondaryOutcomes measure: rate of macrosomia, secondaryOutcomes measure: rate of baby >4.5Kg, secondaryOutcomes measure: rate of Small-for-gestational age infant, secondaryOutcomes measure: rate of cesarean section, secondaryOutcomes measure: rate of instrumental delivery, secondaryOutcomes measure: rate of perineal inury, secondaryOutcomes measure: rate of labor inductions, secondaryOutcomes measure: rate of preeclamspia, secondaryOutcomes measure: rate of gestational hypertension, secondaryOutcomes measure: rate of fetal malformation, secondaryOutcomes measure: rate of miscarriage, secondaryOutcomes measure: rate of polycythemia, secondaryOutcomes measure: rate of neonatal hypoglycemia, secondaryOutcomes measure: Treatment satisfaction, secondaryOutcomes measure: Quality of life based on Short Form (SF-36) score, secondaryOutcomes measure: dietary intake, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: fear for hypoglycaemia, secondaryOutcomes measure: fear for hyperglycaemia, secondaryOutcomes measure: symptoms of depression, secondaryOutcomes measure: symptoms of anxiety, secondaryOutcomes measure: user-friendliness of CGM, secondaryOutcomes measure: user-friendliness of CGM compared to oral glucose tolerance test (OGTT), secondaryOutcomes measure: duration of breastfeeding, secondaryOutcomes measure: rate of hypercholesterolemia, secondaryOutcomes measure: night glucose time in range between 70-180mg/dl, secondaryOutcomes measure: day glucose time in range between 70-180mg/dl, secondaryOutcomes measure: day glucose time in range <70mg/dl, secondaryOutcomes measure: night glucose time in range <70mg/dl, secondaryOutcomes measure: night glucose time in range >180mg/dl, secondaryOutcomes measure: day glucose time in range >180mg/dl, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLV Aalst-Asse, city: Aalst, state: Oost-Vlaanderen, zip: 9300, country: Belgium, contacts name: Inge Van Pottelbergh, MD PhD, role: CONTACT, geoPoint lat: 50.93604, lon: 4.0355, locations facility: UZA, city: Antwerp, country: Belgium, contacts name: Niels Bochanen, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, locations facility: ZNA Antwerpen, city: Antwerp, country: Belgium, contacts name: Astrid Morrens, MD, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, locations facility: Imelda Bonheiden, city: Bonheiden, zip: 2820, country: Belgium, contacts name: Da Hae Lee, MD, role: CONTACT, geoPoint lat: 51.02261, lon: 4.54714, locations facility: AZ St Jan Brugge, city: Brugge, zip: 8000, country: Belgium, contacts name: Sara Vandewalle, role: CONTACT, geoPoint lat: 51.20892, lon: 3.22424, locations facility: Erasme, city: Brussel, country: Belgium, contacts name: Tiphaine Carton, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UCL, city: Brussel, country: Belgium, contacts name: Fabian Lurquin, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UZ Gent, city: Gent, zip: 9000, country: Belgium, contacts name: Joke Marlier, MD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ St Lucas Gent, city: Gent, country: Belgium, contacts name: Inge Van Boxelaer, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ Groeninge Kortrijk, city: Kortrijk, zip: 8510, country: Belgium, contacts name: Ellen Heyns, MD, role: CONTACT, geoPoint lat: 50.82803, lon: 3.26487, locations facility: UZ Leuven, city: Leuven, country: Belgium, contacts name: Katrien Benhalima, MD PhD, role: CONTACT, email: katrien.benhalima@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, locations facility: CHU de Liège, city: Liège, country: Belgium, contacts name: JC Philips, role: CONTACT, geoPoint lat: 50.63373, lon: 5.56749, locations facility: AZ St Maarten Mechelen, city: Mechelen, country: Belgium, contacts name: Kathleen Bollaerts, role: CONTACT, geoPoint lat: 51.02574, lon: 4.47762, locations facility: Centre Hospitalier Mouscron, city: Mouscron, country: Belgium, contacts name: Philippe Oriot, role: CONTACT, geoPoint lat: 50.74497, lon: 3.20639, locations facility: AZ Delta Roeselare, city: Roeselare, country: Belgium, contacts name: Xavier-Philippe Aers, role: CONTACT, geoPoint lat: 50.94653, lon: 3.12269, locations facility: Vitaz, city: Sint-Niklaas, country: Belgium, contacts name: Peter Coremans, role: CONTACT, geoPoint lat: 51.16509, lon: 4.1437, locations facility: AZ Turnhout, city: Turnhout, country: Belgium, contacts name: Joke Cuypers, MD, role: CONTACT, geoPoint lat: 51.32254, lon: 4.94471, hasResults: False