[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538987":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":65,"collaborators":67,"id":70,"slug":18,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized treatment","EXPERIMENTAL","We will test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase, based on the three months of observational data collected.",[13],"Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Personalized modifications to treatment to address menstrual cycle effects on glycemia","The study physician will examine glucose patterns measured using continuous glucose monitoring over a 3 month observational period to identify hypo- or hyperglycemia related to menstrual cycle phase or exercise, and will provide changes to insulin basal or bolus rates, carbohydrate ratios, post-exercise food intake or use of sleep mode on automated insulin delivery systems.",[9],[25],{"name":26,"affiliation":5,"role":27},"JANET K SNELL-BERGEON, PhD, MPH","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","3037246762","Janet.Snell-Bergeon@cuanschutz.edu",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Catherine Chartier-Logan, MPH","3037247505","Catherine.Chartier-Logan@cuanschutz.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-104.83192,39.72943,{"lat":50,"lon":49},[53,55,56,59,61,63],{"name":54,"role":30,"phone":31,"phoneExt":18,"email":32},"JANET K SNELL-BERGEON, PhD",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Sarit Polsky, MD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":18,"phoneExt":18,"email":18},"Cristy Geno, PhD",{"name":62,"role":58,"phone":18,"phoneExt":18,"email":18},"Bryan Bergman, PhD",{"name":64,"role":58,"phone":18,"phoneExt":18,"email":18},"Laura Pyle, PhD",{"type":66,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[68],{"name":69,"class":6},"The Leona M. and Harry B. Helmsley Charitable Trust","100538987",false,"NCT06297980","Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes","MERIT","Inclusion Criteria:\n\n* Women 18-45 who have had type 1 diabetes for at least 12 months\n* Premenopausal with either menstrual cycles or currently using oral contraceptives\n\nExclusion Criteria:\n\n* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy","FEMALE","18 Years","45 Years",{"count":80,"type":81},150,"ESTIMATED","INTERVENTIONAL",[84],"NA","The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.",[87,88,89,90],"Type 1 Diabetes","Hypoglycemia","Hyperglycaemia Due to Type 1 Diabetes Mellitus","Menstruation Disturbances",[92,93,94,95,96,97],"type 1 diabetes","menstrual cycle","exercise","hypoglycemia","hyperglycemia","glucose control","2026-06-15",{"date":100,"type":101},"2026-06-16","ACTUAL",{"date":103,"type":101},"2024-03-24",{"date":105,"type":81},"2027-10-31",{"name":5,"class":6},1]