NCT07785037Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT07785037
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Sept 2026 to the primary completion date, 1 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Decline participation or withdraw informed consent (or assent, when applicable).
- Have insufficient clinical or device data available for the planned analyses.
Who the study is looking for
- Children and adolescents (\<16 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 (1/05/2025 au 30/04/2026) 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.
Age in the registry: 1 year to 16 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.