Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Location status: Recruiting
NCT Number: NCT07767461
The goal of this clinical trial is to ensure that contact dermatitis is not prohibiting any person with diabetes the access to the optimal treatment.
The main questions this study aims to answer are:
1. How many pediatric patients with contact dermatitis due to diabetes devices experience recurrence of contact dermatitis depending on which type of patch they use under their device. 2. Is one type of patch (silicone-based vs. hydrocolloid patch) better than the other at preventing contact dermatitis? The group being investigated is children and adolescents aged 2-18 years with contact dermatitis caused by either an insulin pump or a continuous glucose monitor.
The participants will be asked to do different surveys on well-being and they will go to three physical visits. At the visits the the following will happen:
* clinical skin examination * skin picture (of last used pump and sensor site as well as reportet skin reactions) * height and weight * blodsample (HbA1c and fillagrin mutations) * interview on skin reactions etc. * ultrasound of the skin * tape strips of the skin * EIS (transmit 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: From baseline to 3 months after and 6 months after.
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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