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
An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)
Age between 2-18 years prior to inclusion
Inability to read and understand Danish
Cognitive impairment that may interfere with the ability to complete questionnaires in Danish or to participate in telephone or video follow-up visits
Parallel
hydrocolloid patch as patch used in the Sandwich method
Other interventionWe are testing the hydrocolloid patch called Weloa Sensipatch
Silicone-based patch as patch used in the Sandwitch method
Other interventionHypafix skin-sensitive patch as patch used in the Sandwitch method
Recurrence of contact dermatitis
the binary outcome recurrence of contact dermatitis
Time in days to recurrence of contact dermatitis
Click on the lead sponsor to view all of their trials.