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Clinical trial Recruiting at 1 site Interventional Ages 2 to 18

Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

Official title: Steno Adhesive Study 1

Run by Steno Diabetes Center Copenhagen · NCT07767461 · Data updated 2026-11-12

This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

Quick facts

Study typeInterventional
Ages2 Years to 18 Years
SexAll
Enrollment30 (estimated)
SponsorSteno Diabetes Center Copenhagen
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedSeptember 4, 2026
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedAugust 25, 2026
Trial IDNCT07767461 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children and adolescents aged 2-18 with contact dermatitis caused by an insulin pump or CGM, who can read Danish.

Probably not a fit

Those without patch-related dermatitis or whose dermatitis does not recur with either patch type may not experience a benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study follows children and adolescents aged 2-18 with dermatitis caused by insulin pumps or CGMs to compare two patch types. Participants will wear either silicone-based or hydrocolloid patches under their devices and complete questionnaires while undergoing three in-person assessments, including skin exams and photographs. The goal is to see which patch better prevents recurrence of contact dermatitis and to understand any impact on well-being. The trial is conducted at Steno Diabetes Center Copenhagen and uses a sandwich method involving the patch materials. Data will help inform safer, more comfortable device use for pediatric patients with type 1 diabetes.

Why it matters

Potential benefit: If a patch type proves more effective, participants may experience fewer dermatitis flares and improved comfort with diabetes devices.

How similar studies have gone: Similar approaches have explored skin-protective patches, but direct pediatric comparisons for device-related dermatitis are limited, making this a relatively novel investigation.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Steno Diabetes Center Copenhagen
    Copenhagen, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.