NCT07767461Recruiting
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
Steno Adhesive Study 1
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to ensure that contact dermatitis does not prevent any person with diabetes from accessing optimal diabetes treatment. The main questions this study aims to answer are: How many pediatric patients with diabetes device-related contact dermatitis experience recurrence of contact dermatitis depending on the type of patch used underneath their device? Is one type of patch (silicone-based or hydrocolloid) more effective than the other at preventing contact dermatitis? The study population consists of children and adolescents aged 2-18 years with contact dermatitis (CD) caused by either an insulin pump or a continuous glucose monitor (CGM). Participants will be asked to complete questionnaires about their well-being and attend three in-person study visits. During these visits, the following assessments will be performed: Clinical skin examination Skin photographs of the most recently used insulin pump site, CGM site, and any reported skin reactions Measurement of height and weight Blood sample for measurement of long-term blood glucose (HbA1c) and filaggrin gene mutations Interview about skin reactions and related symptoms Skin ultrasound Tape stripping of the skin Electrical impedance spectroscopy (EIS), a non-invasive technique that transmits a harmless electrical signal through the skin
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 4 Sept 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 1 diabetes
- NCT number
- NCT07767461
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 4 Sept 2026 to the primary completion date, 31 May 2027
- 1 site in 1 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 illness
- Cognitive impairment that may interfere with the ability to complete questionnaires in Danish or to participate in telephone or video follow-up visits
Other
- Inability to read and understand Danish
Who the study is looking for
- An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)
- Age between 2-18 years prior to inclusion
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.