Omnipod 5 Implementation in Belgian Paediatric Diabetes Care
ConditionType 1 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-16
SponsorQueen Fabiola Children's University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tubeless Hybrid Closed-Loop Insulin Delivery System
DeviceA 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From May 2025 to May 2026 (12 months following national reimbursement).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: