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NCT07785037 · ClinicalTrials.gov record · last posted 2026-08-25

Omnipod 5 Implementation in Belgian Paediatric Diabetes Care

Study acronym: O5-IMPACT
StatusNot Yet Recruiting
PhaseNot specified
Started2026-09-01
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07785037
Lead Sponsor Queen Fabiola Children's University Hospital
Conditions Type 1 Diabetes Mellitus
Enrollment 200 participants
Start Date 2026-09-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-25