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NCT07785037
Omnipod 5 Implementation in Belgian Paediatric Diabetes Care
Conditions: Type 1 Diabetes Mellitus
Sex: All
Ages: 1 Year – 16 Years
Healthy volunteers: No
Enrollment: 200
Sponsor: Queen Fabiola Children's University Hospital
Summary
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.
The 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.
The 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.
Eligibility Criteria
Inclusion Criteria:
Children and adolescents (\
Source: ClinicalTrials.gov (NCT07785037). StuddyBuddy aggregates publicly available trial information.