[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551513":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":55,"overallOfficials":66,"centralContacts":74,"locations":79,"responsibleParty":97,"collaborators":99,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":35,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":82,"whyStopped":35,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"volume of total gray matter measured with high-resolution morphometric MRI","The primary endpoint will be changes in total gray matter volume measured with high-resolution morphometric MRI (vox based morphometry method).\n\nIt will be measured at randomization (within 6 months of diagnosis) and 18 months after randomization in the intervention group (treatment of T1DM with SADI), in a control group of T1DM patients (treatment of T1DM with insulin pump and blood glucose sensor) and in a group of non-diabetic control subjects in the same age range.","at inclusion and at 18 months after inclusion",[14,17,20,23,26,29,32],{"measure":10,"description":15,"timeFrame":16},"Variation in other morphometric measures (localized gray matter, total and localized white matter, measurement of anatomical connectivity) and resting brain function (measurement of cerebral blood flow by arterial label spin ALS) will be compared between the two groups of diabetic children between randomization and the end of the 18-month intervention","at month 6 and 24 months after diagnosis of T1DM",{"measure":18,"description":19,"timeFrame":16},"Intelligence score","Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV)",{"measure":21,"description":22,"timeFrame":16},"glycemic variability indexes","Glycemic variability measured from data from continuous measurement of interstitial glycemia though the sensor worn by the patient. The standard deviation (SD) of the glycemic mean, the coefficient of variation (CV), the continuous overall net glycemic action (CONGA) 1 hour - 2 hours - 4 hours will be calculated from the full 72 hours recording closest to the visit. Their changes will be compared between the two measurement times between the groups.",{"measure":24,"description":25,"timeFrame":16},"Score of test \"attention go\u002Fnogo\" of KiTAP scale","Behavioral control assessment and focused attention test",{"measure":27,"description":28,"timeFrame":16},"Score on BRIEF ((behavioral assessment inventory) scale","behavioral assessment inventory",{"measure":30,"description":31,"timeFrame":16},"Score of Stroop big small et Stropp fruits scale","Assessment of inhibitory control",{"measure":33,"description":34,"timeFrame":16},"Score of Nepsy II scale","Auditory attention test",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NON_RANDOMIZED","PARALLEL","PREVENTION",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","The objective of the study is to evaluate neuroanatomical damage to the gray matter associated with the use of an AIDS system early after the diagnosis of type 1 diabetes in young children, according to their glycemic profile, and in comparison with an age-matched control subject.\n\nA prospective, multicenter case-control cohort study (type 1 diabetes vs. non-type 1 diabetes) involving two visits at 6 and 24 months after the diagnosis of type 1 diabetes and two parallel visits for the control group.\n\nThe AIDS system used is the \"mylife CamAPS\" app, marketed by CamDiab Ltd. (Class III), as well as the YpsoPump and the Dexcom glucose sensor, used in accordance with their respective indications.\n\nThe experimental group will consist of patients treated with an insulin therapy assistance device. To provide a reference group, a second control group consisting of children aged 5 to 8 years The expected benefits include early access to an automated insulin delivery system for study participants, as well as the demonstration of neurocognitive benefits from early use of automated aids, leading to changes in care practices.",[44,51],{"label":45,"type":46,"description":47,"interventionNames":48},"AIDS group","EXPERIMENTAL","patients with T1DM with automatized insulin delivery systems (AIDS)",[49,50],"Device: AIDS","Other: Brain MRI",{"label":52,"type":6,"description":53,"interventionNames":54},"Control group","age-matched control subjects without T1DM",[50],[56,63],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"DEVICE","AIDS","mylife CamAPS application, marketed by CamDiab Ltd, in conjunction with YpsoPump, marketed by Ypsomed, Dexcom blood glucose sensor, Orbit Infusion sets and Orbit Infusion sets and Orbit inserter (used in their indications)",[45],[62],"Brain MRI",{"type":6,"name":62,"description":64,"armGroupLabels":65,"otherNames":35},"To evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (AIDS use or not) and compared with an age-matched control subject",[45,52],[67,71],{"name":68,"affiliation":69,"role":70},"Jacques Beltrand, PHD","APHP","PRINCIPAL_INVESTIGATOR",{"name":72,"affiliation":69,"role":73},"Nathalie Boddaert, PHD","STUDY_CHAIR",[75],{"name":68,"role":76,"phone":77,"phoneExt":35,"email":78},"CONTACT","01 44 38 17 96","jacques.beltrand@aphp.fr",[80],{"facility":81,"status":82,"city":83,"state":35,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Hôpital Universitaire Necker Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":88,"coordinates":89},"Point",[90,91],2.3488,48.85341,{"lat":91,"lon":90},[94],{"name":95,"role":76,"phone":96,"phoneExt":35,"email":78},"Jacques Beltrand, PhD","+33 144381796",{"type":98,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[100,102],{"name":101,"class":6},"Fondation Francophone pour la Recherche sur le Diabete",{"name":103,"class":104},"mylife Diabetes Care AG","INDUSTRY","100551513","evaluation-of-neurodevelopmental-trajectories-in-children-according-to-the-glycemic-profile-associated-with-different-early-treatment-modalities-in-children-with-type-1-diabetes-t1dm-100551513",false,"NCT06461065","Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Early Treatment Using an Automated Delivery System in Children With Type 1 Diabetes","Assessment of Children's Neurodevelopmental Trajectories Based on Glycemic Profile Associated With Early Treatment Using an Automated Insulin Delivery System in Children With Type 1 Diabetes (T1D) - PROCEDE: A Pilot Study","PROCEDE","Inclusion Criteria:\n\n* 5 to 8 years old\n* Informed consent of parental guardians\n* Parents able to speak, understand and read French (verified by investigator)\n* Social security affiliation\n* Only for subjects with T1DM:\n\n  * Insulin pump treatment and Dexcom sensor wear\n  * Type 1 diabetes diagnosed less than 6 months ago\n  * Insulin dose ≥ 0.5 IU\u002Fk\u002Fday\n  * Patients agree to use the DEXCOM sensor\n\nExclusion Criteria:\n\n* History of neurological disease\n* History of child psychiatric disease\n* Prematurity (birth before 37 SA)\n* Wearing of internal metal parts contraindicating the performance of MRI\n* Severe skin disease preventing the use of an insulin pump sensor or catheter\n* Uncontrolled celiac disease\n* Uncontrolled autoimmune thyroiditis\n* Participation in another interventional research study or in the exclusion period thereof\n* Refusal to participate by a minor after information adapted to his\u002Fher age and abilities",true,"ALL","5 Years","8 Years",{"count":118,"type":119},50,"ESTIMATED","INTERVENTIONAL",[122],"NA","ore than half of all new cases of type 1 diabetes (T1D) are diagnosed within the first decade of life. It has been reported that early onset of this disease may be associated with a decline in cognitive performance in adulthood, primarily affecting memory or the ability to perform complex tasks that require planning (executive functions) or decision-making. Magnetic resonance imaging (MRI) of the brain has revealed alterations in the brain's neural network that parallel the decline in cognitive performance. It has been suggested that hypoglycemia, hyperglycemia, and glycemic variability could explain this phenomenon, as they lead to early structural changes in cortical gray and white matter in young patients after disease onset and in the months that follow. New automated closed-loop insulin delivery systems (SADI) have proven effective in drastically reducing the number of hypoglycemic and hyperglycemic episodes and glycemic variability in children with type 1 diabetes as young as 2 years old.English translation\n\nAlthough these treatments can be used from 2 years of age in patients who do not achieve their glycemic targets, their use from the time of diagnosis is not yet widely endorsed by scientific societies. Consequently, the use of these treatments in the weeks following diagnosis varies from one center to another and is often left to the prescribing physician's discretion. However, changes in recommendations from scientific societies, the current organization of healthcare in France, and the expertise developed by most pediatric teams are enabling patients to access these treatments increasingly soon after diagnosis, sometimes within days of diagnosis.",[125],"Diabetes",[125,127,128,129],"Children","insulin therapy","cognitive development","2026-10-02",{"date":132,"type":133},"2026-10-07","ACTUAL",{"date":135,"type":133},"2025-02-20",{"date":137,"type":119},"2030-03-20",{"name":5,"class":6},1]