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

NCT07767461 | Recruiting DMC

• 2 other identifiers: StenoAD116-0302-112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Contact Dermatitis; Type 1 Diabetes Mellitus

Keywords

skin barrier; contact dermatitis; T1D; Type 1 Diabetes Mellitus; Hydrocolloid patch; silicone-based patch; pediatric; device-related contact dermatitis; adhesive; children and adolescents

Outcome Measures

Primary Outcomes (1)

• Recurrence of contact dermatitis

  the binary outcome recurrence of contact dermatitis

  Assessments will be performed at baseline, 3 months, and 6 months.

Secondary Outcomes (1)

• Time in days to recurrence of contact dermatitis

  Baseline to 6 months after.

Study Arms (2)

Hydrocolloid patch as patch used in the Sandwitch method

EXPERIMENTAL

Other: hydrocolloid patch as patch used in the Sandwich method

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

ACTIVE COMPARATOR

Other: Silicone-based patch as patch used in the Sandwitch method

Interventions

hydrocolloid patch as patch used in the Sandwich method OTHER

We are testing the hydrocolloid patch called Weloa Sensipatch

Hydrocolloid patch as patch used in the Sandwitch method

Silicone-based patch as patch used in the Sandwitch method OTHER

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

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Dermatitis, Contact; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jannet Svensson, Professor

  Steno Diabetes Center Copenhagen

  STUDY CHAIR

Central Study Contacts

Anna K Berg, MD, PhD

CONTACT

+45 22 39 35 90; anna.korsgaard.berg@regionh.dk

Fiona Marie W Sorensen, MD

CONTACT

+45 50 11 01 31

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Principal Investigator

Model Details: This is a prospective study consisting of three in-person visits and two remote visits. Each participant will be enrolled in the study for a total of 6 months.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: September 4, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

DK (1)