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Recruiting NCT07767461

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

Conditions: Contact Dermatitis, Type 1 Diabetes Mellitus

Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Steno Diabetes Center Copenhagen

Location: Steno Diabetes Center Copenhagen Copenhagen

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 Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07767461). StuddyBuddy aggregates publicly available trial information.