[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537763":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":27,"armGroups":28,"interventions":34,"overallOfficials":23,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":67,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":23,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":50,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"DCB Research AG","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Identify clusters in trajectories across the menstrual cycle","1. Insulin sensitivity across the menstrual cycle\u002Fmenstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints).\n2. Glycemia measures across the menstrual cycle\u002Fmenstrual cycle phases:\n\n   * Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV)\n   * Mean glucose and mean fasted glucose\n   * High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI)\n3. Insulin administration measures across the menstrual cycle\u002Fmenstrual cycle phases:\n\n   * Basal and bolus insulin dosage\n   * Total daily dose (TDD)\n   * Basal\u002Fbolus ratio","6 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.","2\\. Manual Insulin Adjustment Techniques:\n\n* Frequency and classification (e.g., timing, magnitude) of manual insulin adjustments.\n* Impact of adjustment techniques on glycemic outcomes.",{"measure":18,"description":19,"timeFrame":12},"To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle","Identification and characterization of distinct clusters in glycemic metrics, insulin administration and insulin sensitivity representing unique patterns across distinct menstrual cycle phases (early follicular phase, late follicular phase, peri-ovulation, early luteal, mid luteal and late luteal phase)",{"measure":21,"description":22,"timeFrame":12},"To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.","Predictive Factors:\n\no Identification of demographic, clinical, or physiological predictors (e.g., premenstrual cycle syndrome (PMS) score or age group) that significantly correlate with primary outcomes.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.",[29],{"label":30,"type":23,"description":31,"interventionNames":32},"Women with T1D","Women living with T1D who are willing to share their diabetes management and menstrual cycle data.",[33],"Other: No intervention",[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":23},"No intervention","Observational prospective longitudinal data collection",[30],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Stefanie Hossmann, MSc","CONTACT","+41794217376","stefanie.hossmann@dcberne.com",{"name":46,"role":42,"phone":23,"phoneExt":23,"email":47},"Martina Rothenbühler, PhD","martina.rothenbuehler@dcberne.com",[49],{"facility":5,"status":50,"city":51,"state":23,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Bern","3010","Switzerland","CH",{"type":56,"coordinates":57},"Point",[58,59],7.44744,46.94809,{"lat":59,"lon":58},[62,64],{"name":41,"role":42,"phone":63,"phoneExt":23,"email":44},"041794217376",{"name":46,"role":42,"phone":23,"phoneExt":23,"email":47},{"type":66,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[68,70,72,74],{"name":69,"class":6},"The Danish Diabetes Association",{"name":71,"class":6},"Heart and Diabetes Center North Rhine-Westphalia",{"name":73,"class":6},"University of Bristol",{"name":75,"class":6},"Emory University","100537763","trajectories-in-insulin-sensitivity-across-menstrual-cycles-in-women-with-type-1-diabetes-100537763",false,"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","FEMALE","18 Years","40 Years",{"count":88,"type":89},350,"ESTIMATED","OBSERVATIONAL","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.",[93],"Diabetes Mellitus, Type 1",[95,96,97,98,99,100],"Menstrual cycle","Trajectories","Women","Insulin sensitivity","Glycaemia","Insulin need","2025-12-02",{"date":103,"type":104},"2025-12-03","ACTUAL",{"date":106,"type":104},"2025-11-20",{"date":108,"type":89},"2027-09-15",{"name":5,"class":6},1]