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
| NCT ID | NCT07767461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Contact Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-09-04 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-09-04 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Jannet Svensson, Professor
STUDY CHAIR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT07767461 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Contact Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07767461 currently recruiting?
Yes, NCT07767461 is actively recruiting participants. Contact the research team at anna.korsgaard.berg@regionh.dk for enrollment information.
Where is the NCT07767461 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07767461 clinical trial?
NCT07767461 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Jannet Svensson, Professor at Steno Diabetes Center Copenhagen. The trial plans to enroll 30 participants.