Type 1 Diabetes MellitusO5-IMPACTNCT07785037
Omnipod 5 Implementation in Belgian Paediatric Diabetes Care
An observational study of Type 1 Diabetes Mellitus, run by Queen Fabiola Children's University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Tubeless Hybrid Closed-Loop Insulin Delivery System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study 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.
Who may be able to join
- 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.
Who cannot join
- Decline participation or withdraw informed consent (or assent, when applicable).
- Have insufficient clinical or device data available for the planned analyses.
About this study
Official title: One-year Implementation of the Omnipod® 5 Hybrid Closed-loop System Following Reimbursement in Belgium: Real-world Experience From a Paediatric Diabetes Centre
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.
Read the detailed description
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.
Following 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.
This 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.
No 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.
The study will provide real-world information on the implementation of a newly reimbursed HCL technology within a structured multidisciplinary paediatric diabetes programme.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Tubeless Hybrid Closed-Loop Insulin Delivery System
- Keywords
- insulin patch pump, type 1 diabetes, paediatrics, real-life data
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless Hybrid Closed-Loop Insulin Delivery SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From May 2025 to May 2026 (12 months following national reimbursement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anissa Messaaoui, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785037
- Sponsor's protocol ID
- HUB20260605
- Acronym
- O5-IMPACT
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Implementation of the Omnipod® 5 Hybrid Closed-loop System Following Reimbursement in Belgium: Real-world Experience From a Paediatric Diabetes Centre
- ClinicalTrials.gov ID
- NCT07785037
- Acronym / sponsor ID
- O5-IMPACT / HUB20260605
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- insulin patch pump, type 1 diabetes, paediatrics, real-life data
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Following 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.
This 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.
No 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.
The study will provide real-world information on the implementation of a newly reimbursed HCL technology within a structured multidisciplinary paediatric diabetes programme.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Decline participation or withdraw informed consent (or assent, when applicable).
- Have insufficient clinical or device data available for the planned analyses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tubeless Hybrid Closed-Loop Insulin Delivery SystemA 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. | Device | – |
Primary outcome
Omnipod 5 uptake
Time frame: From May 2025 to May 2026 (12 months following national reimbursement).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Queen Fabiola Children's University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omnipod 5 uptake (time frame: From May 2025 to May 2026 (12 months following national reimbursement).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.