[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542069":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":36,"armGroups":37,"interventions":32,"overallOfficials":44,"centralContacts":49,"locations":57,"responsibleParty":78,"collaborators":80,"id":83,"slug":32,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":32,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":60,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Time in range","To assess the influence of menstrual cycle phases on the glycemic control expressed as time in range (% of time between 70-180 mg\u002Fdl of interstitial glucose).","1 month",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Time below range","To assess the influence of menstrual cycle phases on the glycemic control expressed as time in below range (% of time \\\u003C 70 mg\u002Fdl of interstitial glucose).",{"measure":18,"description":19,"timeFrame":12},"Time above range","To assess the influence of menstrual cycle phases on time in above range (% of time \\>180 mg\u002Fdl of interstitial glucose).",{"measure":21,"description":22,"timeFrame":12},"Caloric intake","To assess the influence of changes in intake throughout the menstrual cycle",{"measure":24,"description":25,"timeFrame":12},"Temperature","To collect temperature using a wearable.",{"measure":27,"description":28,"timeFrame":12},"Photoplethysmography","To collect photoplethysmography using a wearable.",{"measure":30,"description":31,"timeFrame":12},"Accelerometry","To collect acelerometry using a wearable.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","CROSS_SECTIONAL","Patients of both genders, aged 18 or older, with type 1 diabetes and in their reproductive years, receiving care at the Endocrinology and Nutrition Department of Ramón y Cajal University Hospital in Madrid, and undergoing treatment with the Medtronic© MinimedTM 780G closed loop advanced system.",[38,41],{"label":39,"type":32,"description":40,"interventionNames":32},"Adult women of childbearing age using a loop system.","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":42,"type":32,"description":43,"interventionNames":32},"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.",[45],{"name":46,"affiliation":47,"role":48},"Lía Nattero, MD.PhD","Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)","PRINCIPAL_INVESTIGATOR",[50,54],{"name":51,"role":52,"phone":32,"phoneExt":32,"email":53},"Lía Nattero-Chávez, MD.PhD","CONTACT","marialia.nattero@salud.madrid.org",{"name":55,"role":52,"phone":32,"phoneExt":32,"email":56},"Esther De la calle, MD.","esther.delacalle@salud.madrid.org",[58],{"facility":59,"status":60,"city":61,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Lía Nattero-Chávez","RECRUITING","Madrid","28034","Spain","ES",{"type":66,"coordinates":67},"Point",[68,69],-3.70256,40.4165,{"lat":69,"lon":68},[72,74,76],{"name":59,"role":52,"phone":73,"phoneExt":32,"email":53},"635249182",{"name":75,"role":48,"phone":32,"phoneExt":32,"email":32},"Esther de La Calle, MD",{"name":77,"role":48,"phone":32,"phoneExt":32,"email":32},"Lía Nattero Chávez, MD.PhD",{"type":79,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[81],{"name":82,"class":6},"Universitat Politècnica de València","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":94,"type":95},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.",[99],"Type 1 Diabetes",[101],"type 1 diabetes, close loop system, women","2025-08-05",{"date":104,"type":105},"2025-08-07","ACTUAL",{"date":107,"type":105},"2024-03-03",{"date":109,"type":95},"2026-12-01",{"name":5,"class":6},1]