[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442141":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":24,"locations":34,"responsibleParty":47,"collaborators":24,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":24,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":24,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexcom G System","ACTIVE_COMPARATOR","The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.",[13],"Device: Dexcom G System",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard care of gestational diabetes with self monitoring blood glucose (SMBG)","SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.",[18],"Device: Self monitoring blood glucose",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Continuous glucose monitoring system",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Self monitoring blood glucose","Standard Care",[15],[30],{"name":31,"affiliation":32,"role":33},"Sofia Amylidi-Mohr, MD","Uniuversity Hospital and University of Bern","PRINCIPAL_INVESTIGATOR",[35],{"facility":36,"status":24,"city":37,"state":24,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":24},"University Hospital of Bern, Inselspital","Bern","3010","Switzerland","CH",{"type":42,"coordinates":43},"Point",[44,45],7.44744,46.94809,{"lat":45,"lon":44},{"type":48,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100442141","utility-of-real-time-continuous-glucose-monitoring-in-the-care-of-gestational-diabetes-versus-standard-care-in-pregnancy-outcomes-100442141",false,"NCT05037526","Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes","Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care","DiP GlucoMo","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* GDM diagnosis between 24 0\u002F7- 28 0\u002F7 weeks of pregnancy by a 75g oral glucose test (oGTT)\n* Maternal age of 18 to 45 years,\n* Singleton gestation\n* Gestational age ≥ 24 0\u002F7 weeks and \\\u003C32 0\u002F7 weeks at enrollment.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to the sensor\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant\n* Participation in another study with investigational drug or product within the 30 days preceding and during the present study\n* Maternal age \\\u003C 18 years,\n* Multi-fetal gestations,\n* Known fetal structural or chromosomal anomalies\n* Chronic use of medications associated with hyperglycemia (steroids)\n* Planned preterm delivery\n* Overt diabetes mellitus type 1 or 2\n* HbA1c by study entry \\> 6.5%\n* History of bariatric surgery or other surgeries that induce malabsorption\n* Fetal growth restriction by study entry","FEMALE","18 Years","45 Years",{"count":61,"type":62},302,"ACTUAL","INTERVENTIONAL",[65],"NA","Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the \"key player\" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.",[68],"Gestational Diabetes","COMPLETED","2024-12-11",{"date":72,"type":62},"2024-12-16",{"date":74,"type":62},"2021-09-24",{"date":76,"type":62},"2024-10-30",{"name":5,"class":6},1]