[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DCB Research AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100653112","early-pregnancy-glucose-profiles-in-women-with-and-without-gdm-risk-factors-early-glow-100653112",false,"NCT07783178","EARLY Pregnancy GLucose prOfiles in Women With and Without GDM Risk Factors: EARLY-GLOW","EARLY-GLOW","Inclusion Criteria:\n\n* Female sex\n* Aged ≥18 years at inclusion\n* Pregnant with singleton ≤12 GW\n* Willingness to wear a CGM device for 12-16 weeks\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pre-existing type 1 or type 2 diabetes mellitus or known prediabetes\n* Diagnosis of GDM during current pregnancy\n* Known allergy to adhesive materials or sensor components\n* Inability to follow procedures or insufficient knowledge of project languages (German, French or English)\n* Inability to give consent.",true,"FEMALE","18 Years",{"count":20,"type":21},48,"ESTIMATED","OBSERVATIONAL","Background:\n\nGestational diabetes mellitus (GDM) is associated with increased maternal and neonatal complications, including macrosomia, preeclampsia, and long-term metabolic consequences for both mother and child. Current screening methods, primarily the oral glucose tolerance test (OGTT), are typically performed between 24 and 28 weeks of gestation and may miss earlier metabolic alterations. Continuous glucose monitoring (CGM) offers a detailed assessment of glucose dynamics and could potentially identify subtle dysglycemia before GDM becomes clinically apparent.\n\nObjective:\n\nThe EARLY-GLOW study aims to characterize glucose patterns during early pregnancy and identify CGM-derived thresholds for early dysglycemia in women with and without established risk factors for GDM. The study seeks to determine whether specific combinations of glucose level and duration of hyperglycemic exposure can distinguish women at increased risk of GDM before routine diagnosis. Additionally, it will explore the relationship between glucose profiles and modifiable lifestyle factors such as diet, physical activity, sleep, and stress, while evaluating the feasibility, usability, and acceptance of CGM technology during pregnancy.\n\nStudy Design:\n\nEARLY-GLOW is a prospective, decentralized, observational pilot study conducted in Switzerland from July 2026 to June 2027. The study will recruit 48 pregnant women with singleton pregnancies at approximately 12 weeks of gestation. Participants will be stratified into two equal groups: women with at least one recognized GDM risk factor and women without risk factors.\n\nMethods:\n\nParticipants will wear a blinded Dexcom G7 CGM continuously from approximately gestational week 12 until routine OGTT screening between weeks 24 and 28 (up to 16 weeks of monitoring). During the study, participants will periodically record fasting blood glucose measurements, dietary intake, meal photographs, sleep quality, physical activity, stress, and well-being through REDCap questionnaires. In the final two weeks of follow-up, participants may additionally use an unblinded FreeStyle Libre 3 CGM to assess user experience. Pregnancy outcomes will be collected approximately six weeks postpartum.\n\nEndpoints:\n\nThe primary endpoint is the identification of CGM-derived thresholds combining glucose concentration and duration of exposure that best discriminate between women with and without GDM risk factors. Secondary outcomes include the frequency and duration of hyperglycemic events, time above and below glucose target range, glycemic variability, postprandial glucose excursions, nocturnal glucose patterns, correlations with lifestyle factors, and device adherence and usability.",[25],"Gestational Diabetes",[27,28,29,30],"gestational diabetes","risk factors","decentralizes study","dysglycaemia","RECRUITING","2026-08-24",{"date":34,"type":35},"2026-08-26","ACTUAL",{"date":37,"type":35},"2026-08-19",{"date":39,"type":21},"2027-04-30",{"name":41,"class":42},"DCB Research AG","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100537763","trajectories-in-insulin-sensitivity-across-menstrual-cycles-in-women-with-type-1-diabetes-100537763","NCT06282055","Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes","Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes","TIMES","Inclusion criteria:\n\n* Female sex\n* Between 18 and 40 years at inclusion\n* Menarche at least one year prior to study inclusion\n* Regular menstrual cycle (at least one menstrual cycle in the last 40 days)\n* Average menstrual cycle length between 21 and 38 days\n* Difference in length between consecutive menstrual cycles of at most 7 days\n* Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year\n* Actively using an AID system for their diabetes management at least six months prior to study inclusion\n\nExclusion criteria:\n\n* Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception\n* Pregnancy until two months postpartum (ongoing or planned)\n* Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping\n* Known Polycystic Ovary Syndrome (PCOS)\n* Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs\n* Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis).\n* Participation in an interventional study within two months preceding and during the present study","40 Years",{"count":54,"type":21},350,"Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.",[57],"Diabetes Mellitus, Type 1",[59,60,61,62,63,64],"Menstrual cycle","Trajectories","Women","Insulin sensitivity","Glycaemia","Insulin need","2025-12-02",{"date":67,"type":35},"2025-12-03",{"date":69,"type":35},"2025-11-20",{"date":71,"type":21},"2027-09-15",{"name":41,"class":42},""]