Steno Adhesive Study 1
| Registry | NCT07767461, acronym StenoAD1 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Steno Diabetes Center Copenhagen (Other) |
| Conditions | Contact Dermatitis, Type 1 Diabetes Mellitus |
| Interventions | hydrocolloid patch as patch used in the Sandwich method, Silicone-based patch as patch used in the Sandwitch method (Other) |
| Dates | start 2026-09-04 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-08-17, last updated 2026-08-25 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Contact Dermatitis All trials for Type 1 Diabetes Mellitus All trials of hydrocolloid patch as patch used in the Sandwich method All trials of Silicone-based patch as patch used in the Sandwitch method
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hydrocolloid patch as patch used in the Sandwitch method | Experimental | Other: hydrocolloid patch as patch used in the Sandwich method | |
| Hypafix skin-sensitive patch as patch used in the Sandwitch method | Active comparator | Other: Silicone-based patch as patch used in the Sandwitch method |
Sex: All, ages: 2 Years to 18 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen | Copenhagen | Denmark | Recruiting |