hydrocolloid patch as patch used in the Sandwich method: We are testing the hydrocolloid patch called Weloa Sensipatch
Silicone-based patch as patch used in the Sandwitch method: Hypafix skin-sensitive patch as patch used in the Sandwitch method
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
| Facility | City | Region | Status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen | Copenhagen | Denmark | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07767461 on ClinicalTrials.gov ↗ ← All trials in Denmark