Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Copenhagen, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recurrence of contact dermatitis

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

    the binary outcome recurrence of contact dermatitis

Secondary outcomes

  1. Time in days to recurrence of contact dermatitis

    Time frame: Baseline to 6 months after.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna K Berg, MD, PhD

CONTACT

[email protected]

+45 22 39 35 90

Fiona Marie W Sorensen, MD

CONTACT

+45 50 11 01 31

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Steno Adhesive Study 1

Acronym: StenoAD1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.