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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

RecruitingNAAges 2 Years - 18 YearsAllSteno Diabetes Center Copenhagen
NCT07767461 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ph

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📋 Eligibility rules (as published)
Inclusion Criteria: * An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM) * Age between 2-18 years prior to inclusion Exclusion Criteria: * 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
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What it tests

  • hydrocolloid patch as patch used in the Sandwich method
  • Silicone-based patch as patch used in the Sandwitch method
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Where

1 site
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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