Barrier patches for diabetes-device contact dermatitis
What this study tests
StenoAD1 compares hydrocolloid and silicone-based patches underneath diabetes devices in children and adolescents with device-related contact dermatitis. Recurrence of dermatitis is the primary outcome.
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.
Latest dated source in the citation list: 2026-08-25. This is the source’s date, not a new review of every claim.
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?
- Children and adolescents aged 2–18 with contact dermatitis caused by an insulin pump or CGM. Participants must meet the study’s Danish-language and other participation requirements. 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 are posted in ClinicalTrials.gov as of 17 September 2026. This record describes the registered study plan, not demonstrated benefit or safety.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
- Recurrence of contact dermatitis, assessed at baseline, three months and six months.
The full picture
This assessor-masked randomized study plans 30 participants in Denmark, followed for six months. It compares Weloa Sensipatch with Hypafix skin-sensitive patches used beneath a pump or CGM. The registry names T1D in the study title and condition list; the detailed eligibility criteria focus on device-related dermatitis.1
The primary outcome is whether contact dermatitis recurs; time to recurrence is secondary. The study does not yet establish that either patch prevents dermatitis or works safely with every pump or sensor.1
The registry lists study start 2026-09-04 (estimated), primary completion 2027-05 (estimated) and study completion 2027-05 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
References
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ClinicalTrials.gov. NCT07767461. Last update posted 2026-08-25; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07767461 ↩ ↩2 ↩3
Sources
- [1]Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes (NCT07767461) · Trial registry · 2026-08-25 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.