Contact Dermatitis, Type 1 Diabetes Mellitus
Conditions
Keywords
skin barrier, contact dermatitis, T1D, Type 1 Diabetes Mellitus, Hydrocolloid patch, silicone-based patch, pediatric, device-related contact dermatitis, adhesive, children and adolescents
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
Interventions
OTHERhydrocolloid patch as patch used in the Sandwich method
We are testing the hydrocolloid patch called Weloa Sensipatch
OTHERSilicone-based patch as patch used in the Sandwitch method
Hypafix skin-sensitive patch as patch used in the Sandwitch method
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a prospective study consisting of three in-person visits and two remote visits. Each participant will be enrolled in the study for a total of 6 months.
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of contact dermatitis | Assessments will be performed at baseline, 3 months, and 6 months. | the binary outcome recurrence of contact dermatitis |
Secondary
| Measure | Time frame |
|---|---|
| Time in days to recurrence of contact dermatitis | Baseline to 6 months after. |
Countries
Denmark
Contacts
CONTACTAnna K Berg, MD, PhD
CONTACTFiona Marie W Sorensen, MD
STUDY_CHAIRJannet Svensson, Professor
Steno Diabetes Center Copenhagen
Outcome results
None listed