RecruitingNot ApplicableNCT07767461

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


Sponsor

Steno Diabetes Center Copenhagen

Enrollment

30 participants

Start Date

Sep 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Silicone-based patch as patch used in the Sandwitch method and hydrocolloid patch as patch used in the Sandwich method for people with contact dermatitis and type 1 diabetes mellitus. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERhydrocolloid patch as patch used in the Sandwich method

We are testing the hydrocolloid patch called Weloa Sensipatch

OTHERSilicone-based patch as patch used in the Sandwitch method

Hypafix skin-sensitive patch as patch used in the Sandwitch method


Locations(1)

Steno Diabetes Center Copenhagen

Copenhagen, Denmark

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NCT07767461


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