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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 is not prohibiting any person with diabetes the access to the optimal treatment.

The main questions this study aims to answer are:

1. How many pediatric patients with contact dermatitis due to diabetes devices experience recurrence of contact dermatitis depending on which type of patch they use under their device. 2. Is one type of patch (silicone-based vs. hydrocolloid patch) better than the other at preventing contact dermatitis? The group being investigated is children and adolescents aged 2-18 years with contact dermatitis caused by either an insulin pump or a continuous glucose monitor.

The participants will be asked to do different surveys on well-being and they will go to three physical visits. At the visits the the following will happen:

* clinical skin examination * skin picture (of last used pump and sensor site as well as reportet skin reactions) * height and weight * blodsample (HbA1c and fillagrin mutations) * interview on skin reactions etc. * ultrasound of the skin * tape strips of the skin * EIS (transmit harmless electrical signal through the skin)

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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

  • Any type of contact dermatitis due to either insulin pump or glucose sensor
  • Being between 2-18 years of age prior to inclusion

Exclusion criteria

  • Those who are unable to read and understand Danish and/or have impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and/or be reached by phone or videocall.

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: From baseline to 3 months after and 6 months after.

    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 17, 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.

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