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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-17

No results posted yet for this study

Summary

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)

Conditions

Interventions

OTHER

hydrocolloid patch as patch used in the Sandwich method

We are testing the hydrocolloid patch called Weloa Sensipatch

OTHER

Silicone-based patch as patch used in the Sandwitch method

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

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Jannet Svensson, Professor · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-04
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767461 on ClinicalTrials.gov