[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658398":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":87,"studyPopulation":87,"armGroups":94,"interventions":103,"overallOfficials":87,"centralContacts":117,"locations":128,"responsibleParty":143,"collaborators":87,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":87,"studyType":158,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":166,"whyStopped":87,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":87},[9],{"measure":10,"description":10,"timeFrame":11},"The variability of the \"time in range\" (%) parameter (70-140 mg\u002FdL) between M0 and M3.","From enrollment to 3 months",[13,16,19,21,23,26,28,31,34,37,39,41,44,46,48,51,54,56,58,61,63,67,70,73,76,78,80,83,85],{"measure":14,"description":15,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (\u003C70 mg\u002FdL)","The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (\\\u003C70 mg\u002FdL)",{"measure":17,"description":18,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg\u002FdL)","The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (\\>140 mg\u002FdL)",{"measure":20,"description":20,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: glycemic variability (%)",{"measure":22,"description":22,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: mean glucose level (mg\u002FdL)",{"measure":24,"description":25,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg\u002FdL","The variability of other CGM parameters between M0 and M3: number of glucose excursions \\>200 mg\u002FdL",{"measure":27,"description":27,"timeFrame":11},"The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)",{"measure":29,"description":29,"timeFrame":30},"The variability of CGM parameters between M0 and M6: \"time in range\" (%) (70-140 mg\u002FdL)","From enrollment to 6 months",{"measure":32,"description":33,"timeFrame":30},"The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (\u003C70 mg\u002FdL),","The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (\\\u003C70 mg\u002FdL),",{"measure":35,"description":36,"timeFrame":30},"The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg\u002FdL),","The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (\\>140 mg\u002FdL),",{"measure":38,"description":38,"timeFrame":30},"The variability of CGM parameters between M0 and M6: glycemic variability (%),",{"measure":40,"description":40,"timeFrame":30},"The variability of CGM parameters between M0 and M6: mean glucose level (mg\u002FdL),",{"measure":42,"description":43,"timeFrame":30},"The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg\u002FdL","The variability of CGM parameters between M0 and M6: number of glucose excursions \\>200 mg\u002FdL",{"measure":45,"description":45,"timeFrame":30},"The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)",{"measure":47,"description":47,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): \"time in range\" (%) (70-140 mg\u002FdL)",{"measure":49,"description":50,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (\u003C70 mg\u002FdL),","The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (\\\u003C70 mg\u002FdL),",{"measure":52,"description":53,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg\u002FdL)","The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (\\>180 mg\u002FdL)",{"measure":55,"description":55,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)",{"measure":57,"description":57,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg\u002FdL)",{"measure":59,"description":60,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg\u002FdL","The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions \\>200 mg\u002FdL",{"measure":62,"description":62,"timeFrame":11},"The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)",{"measure":64,"description":65,"timeFrame":66},"The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps","The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps","From enrollment to 3 months and 6 months",{"measure":68,"description":69,"timeFrame":66},"The variability of CGM parameters according to body composition (body fat percentage)","The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg",{"measure":71,"description":72,"timeFrame":66},"The variability of CGM parameters according to body composition","The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg",{"measure":74,"description":75,"timeFrame":66},"The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)","The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg",{"measure":77,"description":77,"timeFrame":66},"The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg",{"measure":79,"description":79,"timeFrame":66},"The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)",{"measure":81,"description":81,"timeFrame":82},"The variability of CGM parameters according to nutritional intake : carbohydrates (kg)","From enrollment to 3 months ans 6 months",{"measure":84,"description":84,"timeFrame":66},"The variability of CGM parameters according to nutritional intake : fats (kg)",{"measure":86,"description":86,"timeFrame":66},"The variability of CGM parameters according to nutritional intake : proteins (kg)",null,{"allocation":89,"interventionModel":90,"interventionModelDescription":87,"primaryPurpose":91,"observationalModel":87,"timePerspective":87,"maskingInfo":92},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":93,"maskingDescription":87,"whoMasked":87},"NONE",[95],{"label":96,"type":97,"description":98,"interventionNames":99},"Non-diabetic patient with cystic fibrosis","EXPERIMENTAL","Children aged 10 to 17 years diagnosed with cystic fibrosis (CF). Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT).\n\nPatients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+).",[100,101,102],"Device: Continuous Glucose Monitoring","Other: Eating Habits Questionnaire","Other: Use of an actigraphy watch",[104,109,113],{"type":105,"name":106,"description":107,"armGroupLabels":108,"otherNames":87},"DEVICE","Continuous Glucose Monitoring","Upon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6).",[96],{"type":6,"name":110,"description":111,"armGroupLabels":112,"otherNames":87},"Eating Habits Questionnaire","A 7-day dietary diary will be completed at M0, M3, and M6.",[96],{"type":6,"name":114,"description":115,"armGroupLabels":116,"otherNames":87},"Use of an actigraphy watch","Participants will wear an actigraphy watch during 7 days at M0, M3 and M6",[96],[118,124],{"name":119,"role":120,"phone":121,"phoneExt":122,"email":123},"Kévin PERGE, Dr","CONTACT","04 72 11 88 90","+33","kevin.perge@chu-lyon.fr",{"name":125,"role":120,"phone":126,"phoneExt":122,"email":127},"Philippe REIX, Prof","04 27 85 54 70","philippe.reix@chu-lyon.fr",[129],{"facility":130,"status":87,"city":131,"state":87,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Hôpital Femme Mère Enfant (HFME)","Bron","69677","France","FR",{"type":136,"coordinates":137},"Point",[138,139],4.91303,45.73865,{"lat":139,"lon":138},[142],{"name":125,"role":120,"phone":126,"phoneExt":122,"email":127},{"type":144,"investigatorFullName":87,"investigatorTitle":87,"investigatorAffiliation":87,"oldNameTitle":87,"oldOrganization":87},"SPONSOR","100658398","reproducibility-of-continuous-glucose-monitoring-cgm-in-the-assessment-of-glucose-metabolism-disorders-in-children-with-cystic-fibrosis-100658398",false,"NCT07851831","Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis","CGMUCODIAB","Inclusion Criteria:\n\n* Patients aged 10 to 17 years\n* Diagnosed with cystic fibrosis (CF)\n* Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est\n* Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)\n\nExclusion Criteria:\n\n* Patients with treated or untreated diabetes\n* Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy\n* Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings\n* Refusal of the patient and\u002For the legal guardian(s) to participate in the study\n* Pregnant, parturient, or breastfeeding women\n* Persons deprived of liberty by a judicial or administrative decision\n* Persons undergoing psychiatric care\n* Persons admitted to a healthcare or social institution for purposes other than research\n* Persons not affiliated with a social security scheme or beneficiaries of a similar scheme","ALL","10 Years","17 Years",{"count":156,"type":157},30,"ESTIMATED","INTERVENTIONAL",[89],"Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.",[162],"Glucose Metabolism Disorders in Cystic Fibrosis",[164,165,106],"Cystic Fibrosis","Glucose metabolism disorders","NOT_YET_RECRUITING","2026-09-25",{"date":169,"type":170},"2026-10-01","ACTUAL",{"date":172,"type":157},"2026-11",{"date":174,"type":157},"2028-05",{"name":5,"class":6},1]