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

Sponsor
Steno Diabetes Center Copenhagen
Study ID
NCT07767461
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • hydrocolloid patch as patch used in the Sandwich method — OTHER
    We are testing the hydrocolloid patch called Weloa Sensipatch
  • Silicone-based patch as patch used in the Sandwitch method — OTHER
    Hypafix skin-sensitive patch as patch used in the Sandwitch method

Study Details

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

Key Dates

First listed
Aug 17, 2026
Start date
Sep 4, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hydrocolloid patch as patch used in the Sandwitch method
  • Active Comparator: Hypafix skin-sensitive patch as patch used in the Sandwitch method

Primary Outcome Measure

Recurrence of contact dermatitis [ Time Frame: Assessments will be performed at baseline, 3 months, and 6 months. ]

Central Contacts

  • Anna K Berg, MD, PhD
    +45 22 39 35 90
    [email protected]
  • Fiona Marie W Sorensen, MD
    +45 50 11 01 31

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