Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Location status: Recruiting
NCT Number: NCT07767461
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
Interested in participating?
Request Info2 year–18 year
All sexes
Interventional
Not applicable
Copenhagen, Denmark
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We are testing the hydrocolloid patch called Weloa Sensipatch
Hypafix skin-sensitive patch as patch used in the Sandwitch method
Time frame: Assessments will be performed at baseline, 3 months, and 6 months.
the binary outcome recurrence of contact dermatitis
Time frame: Baseline to 6 months after.
Contact information is provided by the study sponsor or research team.
Anna K Berg, MD, PhD
CONTACT
Fiona Marie W Sorensen, MD
CONTACT
Steno Diabetes Center Copenhagen
Other
Steno Adhesive Study 1
Acronym: StenoAD1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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