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