O5-IMPACT — Belgian pediatric Omnipod 5 uptake cohort
What this study tests
A planned 200-person Belgian observational cohort of pediatric Omnipod 5 adoption and routine-care outcomes. No results are posted. The registry contains conflicting age limits and a historical uptake window despite a not-yet-recruiting status; these research fields do not establish a pediatric product indication.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-08-25.
Most recent recorded citation date: 2026-08-25. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- The registry conflicts: structured ages 1–16, inclusion criteria under 16, and population description under 18. It describes T1D patients followed at the HUDERF pediatric center who started Omnipod 5 during routine care. The applicable study age and dates need clarification; no device-label age is inferred. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted in the registry as checked 17 September 2026. Enrollment figures are planned targets, not observed outcomes.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Number and proportion starting Omnipod 5 during the first year after the registry-reported Belgian reimbursement change; registered timeframe May 2025–May 2026
The full picture
What the study observes
O5-IMPACT is registered as a prospective observational cohort, targeting 200 participants at the Queen Fabiola pediatric diabetes service in Brussels. It examines uptake of Omnipod 5 after the registry-reported Belgian reimbursement change in May 2025. Routine clinical, pump and CGM records are to be analyzed; treatment choice stays with the clinical team and no additional examinations, blood tests or study visits are specified. This registry statement is not an independent audit of Belgian reimbursement rules.1
Age and timing conflicts
The structured age fields say 1–16 years, the inclusion criteria say under 16, and the population description says under 18. These are conflicting research descriptions, not permission to use the product at any of those ages. No single age limit is asserted here.1
The primary uptake window is May 2025–May 2026; the criteria specify initiation from 1 May 2025 through 30 April 2026. Yet the same record is labeled not yet recruiting, with an estimated study start of 1 September 2026. We retain that discrepancy rather than present a harmonized timeline. The last posted update is 25 August 2026, checked 17 September 2026; actual current enrollment is unconfirmed.1
Outcomes and limits
The registered primary outcome is the number and proportion initiating Omnipod 5 and how uptake changes over time. The description also proposes examining control, safety and continued use, but no outcome results are posted. A target of 200 is not an analyzed denominator, and an observational uptake cohort does not by itself establish a causal glycemic or safety benefit. Estimated completion is 31 December 2027, not a promised results date.1
References
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ClinicalTrials.gov. NCT07785037, last posted update 2026-08-25; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07785037 ↩ ↩2 ↩3 ↩4
Sources
- [1]NCT07785037 — Omnipod 5 Implementation in Belgian Paediatric Diabetes Care · Trial registry · 2026-08-25 — Original registry description and structured fields checked 17 September 2026; no posted results. Recruitment and estimated dates are registry statements, not direct site confirmation.