[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542069":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":28,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Adult women of childbearing age using a loop system.",null,"Adult women of childbearing age using the Minimed 780G loop system. Sixty-nine women of reproductive age will be recruited to assess variations in glycemic control across different stages of the menstrual cycle. Additionally, a subset of these women (n = 50) will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.",{"label":13,"type":10,"description":14,"interventionNames":10},"Adult men under 50 years old using a closed loop system.","A control group of 50 men will wear a wearable device to collect temperature, photoplethysmography, and accelerometry data.",[16],{"name":17,"affiliation":18,"role":19},"Lía Nattero, MD.PhD","Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)","PRINCIPAL_INVESTIGATOR",[21,25],{"name":22,"role":23,"phone":10,"phoneExt":10,"email":24},"Lía Nattero-Chávez, MD.PhD","CONTACT","marialia.nattero@salud.madrid.org",{"name":26,"role":23,"phone":10,"phoneExt":10,"email":27},"Esther De la calle, MD.","esther.delacalle@salud.madrid.org",[29],{"facility":30,"status":31,"city":32,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Lía Nattero-Chávez","RECRUITING","Madrid","28034","Spain","ES",{"type":37,"coordinates":38},"Point",[39,40],-3.70256,40.4165,{"lat":40,"lon":39},[43,45,47],{"name":30,"role":23,"phone":44,"phoneExt":10,"email":24},"635249182",{"name":46,"role":19,"phone":10,"phoneExt":10,"email":10},"Esther de La Calle, MD",{"name":48,"role":19,"phone":10,"phoneExt":10,"email":10},"Lía Nattero Chávez, MD.PhD",{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[52],{"name":53,"class":6},"Universitat Politècnica de València","100542069","impact-of-the-menstrual-cycle-in-reproductive-aged-women-with-type-1-diabetes-using-a-closed-loop-system-diabetexx1-100542069",false,"NCT06338072","Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX\u002F1).","Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.","DIABETEXX\u002F1","Inclusion Criteria:\n\n* Diagnostic criteria for DM1 according to ADA\n* Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system.\n* Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year.\n* Men under 50 years old.\n* Acceptance of participation in the study and signing of the informed consent\n\nExclusion Criteria:\n\n* Gestation\n* Use of hormonal contraceptives (including intrauterine devices)\n* Institutionalization, serious or terminal illness or renal replacement therapy.\n* Refusal to participate in the study or to sign the informed consent","ALL","18 Years","50 Years",{"count":66,"type":67},119,"ESTIMATED","OBSERVATIONAL","The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.",[71],"Type 1 Diabetes",[73],"type 1 diabetes, close loop system, women","2025-08-05",{"date":76,"type":77},"2025-08-07","ACTUAL",{"date":79,"type":77},"2024-03-03",{"date":81,"type":67},"2026-12-01",{"name":5,"class":6},1]