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 (StenoAD1)

August 23, 2026 updated by: Anna Korsgaard Berg, Steno Diabetes Center Copenhagen

Steno Adhesive Study 1

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fiona Marie W Sorensen, MD
  • Phone Number: +45 50 11 01 31

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Steno Diabetes Center Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrocolloid patch as patch used in the Sandwitch method
Other: hydrocolloid patch as patch used in the Sandwich method
We are testing the hydrocolloid patch called Weloa Sensipatch
Active Comparator: Hypafix skin-sensitive patch as patch used in the Sandwitch method
Other: Silicone-based patch as patch used in the Sandwitch method
Hypafix skin-sensitive patch as patch used in the Sandwitch method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of contact dermatitis
Time Frame: Assessments will be performed at baseline, 3 months, and 6 months.
the binary outcome recurrence of contact dermatitis
Assessments will be performed at baseline, 3 months, and 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Time in days to recurrence of contact dermatitis
Time Frame: Baseline to 6 months after.
Baseline to 6 months after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Investigators

  • Study Chair: Jannet Svensson, Professor, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 4, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 23, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StenoAD1
  • 16-0302-112 (Registry Identifier: Medical Research Ethics Committees)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are still investigating the possibilities under Danish ethical and data processing laws.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe