[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628527":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Institute of Mother and Child, Warsaw, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous glucose monitoring","EXPERIMENTAL","Neonates undergo continuous glucose monitoring (CGM), with real-time glucose values visible to the clinical team. CGM data may be used to support the detection and clinical management of neonatal hypoglycaemia in accordance with the study protocol.",[13],"Device: Dexcom ONE Continuous Glucose Monitoring System",{"label":15,"type":16,"description":17,"interventionNames":18},"Blood glucose testing based on standard care procedures","ACTIVE_COMPARATOR","Detection and management of neonatal hypoglycaemia are based on standard care procedures, as defined by the local protocol. Additionally, neonates undergo continuous glucose monitoring (CGM) in masked mode. CGM values are not visible to the clinical team and do not guide clinical decision-making.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Dexcom ONE Continuous Glucose Monitoring System","The Dexcom ONE continuous glucose monitoring system is applied to all participants. Following randomisation, CGM data are either available in real time to the clinical team (intervention group) or recorded in masked mode and not available to the clinical team, and therefore do not influence clinical management (control group).",[15,9],null,[27],{"facility":28,"status":25,"city":29,"state":25,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Institute of Mother and Child","Warsaw","01-211","Poland","PL",{"type":34,"coordinates":35},"Point",[36,37],21.01178,52.22977,{"lat":37,"lon":36},[40,45,48,51,54,56],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Aleksandra H Symonides-Pomianek","CONTACT","+48 22 32 77 406","aleksandra.symonides@imid.med.pl",{"name":46,"role":42,"phone":43,"phoneExt":25,"email":47},"Paweł Krajewski, MD, PhD, Assoc. Prof.","pawel.krajewski@imid.med.pl",{"name":49,"role":50,"phone":25,"phoneExt":25,"email":25},"Aleksandra H Symonides-Pomianek, MD","PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},"Agata Majewska, MD, PhD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":25,"phoneExt":25,"email":25},"Maciej Rączka, MD",{"name":46,"role":53,"phone":25,"phoneExt":25,"email":25},{"type":50,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Aleksandra Symonides-Pomianek","Resident Physician in Neonatology","100628527","continuous-glucose-monitoring-in-newborns-of-mothers-with-insulin-treated-gestational-diabetes-mellitus-100628527",false,"NCT07462793","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial","COMET-GDM","Inclusion Criteria:\n\n* Maternal age of 18 years or older\n* Singleton pregnancy\n* Insulin-treated gestational diabetes mellitus\n\nExclusion Criteria:\n\n* Multifetal pregnancy\n* Congenital malformations or metabolic defects in the newborn\n* Preterm birth (defined as birth \\\u003C37 weeks of gestation)\n* Smoking during pregnancy\n* Preeclampsia, fetal growth restriction\n* Perinatal asphyxia\n* Congenital infections in the newborn\n* Adverse skin reactions (eczema, wounds) in the planned sensor insertion area",true,"ALL","1 Minute","30 Minutes",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.",[80,81],"Neonatal Hypoglycemia","Gestational Diabetes Mellitus (GDM)",[83,84,85,86],"gestational diabetes mellitus","neonatal hypoglycemia","insulin-treated gestational diabetes","neurodevelopmental outcomes","NOT_YET_RECRUITING","2026-03-08",{"date":90,"type":91},"2026-03-10","ACTUAL",{"date":93,"type":74},"2026-03",{"date":95,"type":74},"2027-12",{"name":5,"class":6},1]