[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653227":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":19,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":24,"collaborators":13,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":13,"studyType":42,"phases":13,"briefSummary":43,"conditions":44,"keywords":46,"overallStatus":51,"whyStopped":13,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":13},{"fullName":5,"class":6},"Queen Fabiola Children's University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Omnipod 5 uptake","Number and proportion of children and adolescents with type 1 diabetes initiating the Omnipod® 5 system during the first year following national reimbursement in Belgium, including the evolution of uptake over time.","From May 2025 to May 2026 (12 months following national reimbursement).",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Hybrid closed-loop (HCL) systems have become an increasingly important component of paediatric type 1 diabetes management by combining continuous glucose monitoring with automated insulin delivery. The Omnipod® 5 system is a tubeless HCL system that offers an alternative to conventional tubed insulin pumps.\n\nFollowing national reimbursement of Omnipod® 5 in Belgium in May 2025, the system became available as part of routine diabetes care. Its introduction provides an opportunity to evaluate how a newly reimbursed diabetes technology is adopted in real-world paediatric clinical practice.\n\nThis prospective observational study will follow children and adolescents with type 1 diabetes who initiate Omnipod® 5 as part of their routine diabetes care. Data generated during usual clinical follow-up will be collected prospectively from medical records, insulin pump platforms, and continuous glucose monitoring systems.\n\nNo study-specific intervention will be performed. The choice of Omnipod® 5 and all aspects of clinical management will remain under the responsibility of the treating diabetes team and will not be influenced by participation in the study. No additional examinations, blood tests, or study visits are required.\n\nThe study will provide real-world information on the implementation of a newly reimbursed HCL technology within a structured multidisciplinary paediatric diabetes programme.","Children and adolescents under 18 years of age with type 1 diabetes who are followed at the Paediatric Diabetes Centre of Queen Fabiola University Children's Hospital (HUDERF), Brussels, Belgium, and who initiate the Omnipod® 5 hybrid closed-loop system as part of routine clinical care during the study period.",[20],{"type":21,"name":22,"description":23,"armGroupLabels":13,"otherNames":13},"DEVICE","Tubeless Hybrid Closed-Loop Insulin Delivery System","A tubeless hybrid closed-loop insulin delivery system that combines a wearable insulin pump (Pod) with continuous glucose monitoring to automatically adjust insulin delivery. The system is used as part of routine clinical care in children and adolescents with type 1 diabetes.",{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Anissa Messaaoui","MD, PhD","100653227","omnipod-5-implementation-in-belgian-paediatric-diabetes-care-100653227",false,"NCT07785037","Omnipod 5 Implementation in Belgian Paediatric Diabetes Care","One-year Implementation of the Omnipod® 5 Hybrid Closed-loop System Following Reimbursement in Belgium: Real-world Experience From a Paediatric Diabetes Centre","O5-IMPACT","Inclusion Criteria:\n\nChildren and adolescents (\\\u003C16 years) diagnosed with type 1 diabetes. Followed at the Paediatric Diabetes Centre of HUDERF. Initiation of the Omnipod® 5 hybrid closed-loop system during the study period as part of routine clinical care (1\u002F05\u002F2025 au 30\u002F04\u002F2026) Written informed consent provided by the parent(s) or legal guardian(s), and assent from the child or adolescent when applicable, in accordance with Belgian regulations.\n\nExclusion Criteria:\n\nDecline participation or withdraw informed consent (or assent, when applicable).\n\nHave insufficient clinical or device data available for the planned analyses.","ALL","1 Year","16 Years",{"count":40,"type":41},200,"ESTIMATED","OBSERVATIONAL","This study will evaluate the introduction and use of the Omnipod® 5 hybrid closed-loop insulin delivery system in children and adolescents with type 1 diabetes following its reimbursement in Belgium.\n\nThe study will describe how quickly the system is adopted in routine paediatric diabetes care, which patients are offered this technology, and the reasons for choosing Omnipod® 5. It will also evaluate changes in the use of different insulin pump systems and assess diabetes control, safety, and continued use of Omnipod® 5 during follow-up.\n\nThe study is observational, meaning that participants will receive their usual diabetes care and their treatment will not be changed for research purposes. Information collected during routine diabetes follow-up, including glucose sensor, insulin pump, and medical record data, will be analysed. No additional examinations, blood tests, or hospital visits will be required for participation.",[45],"Type 1 Diabetes Mellitus",[47,48,49,50],"insulin patch pump","type 1 diabetes","paediatrics","real-life data","NOT_YET_RECRUITING","2026-08-20",{"date":54,"type":55},"2026-08-25","ACTUAL",{"date":57,"type":41},"2026-09-01",{"date":59,"type":41},"2027-12-31",{"name":5,"class":6}]