Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes (StenoAD1)
Steno Adhesive Study 1
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
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Anna K Berg, MD, PhD
- Telefonnummer: +45 22 39 35 90
- E-mail: anna.korsgaard.berg@regionh.dk
Undersøgelse Kontakt Backup
- Navn: Fiona Marie W Sorensen, MD
- Telefonnummer: +45 50 11 01 31
Studiesteder
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Copenhagen, Danmark
- Rekruttering
- Steno Diabetes Center Copenhagen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Hydrocolloid patch as patch used in the Sandwitch method
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We are testing the hydrocolloid patch called Weloa Sensipatch
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Aktiv komparator: Hypafix skin-sensitive patch as patch used in the Sandwitch method
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Hypafix skin-sensitive patch as patch used in the Sandwitch method
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Recurrence of contact dermatitis
Tidsramme: Assessments will be performed at baseline, 3 months, and 6 months.
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the binary outcome recurrence of contact dermatitis
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Assessments will be performed at baseline, 3 months, and 6 months.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Time in days to recurrence of contact dermatitis
Tidsramme: Baseline to 6 months after.
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Baseline to 6 months after.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Jannet Svensson, Professor, Steno Diabetes Center Copenhagen
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Metaboliske sygdomme
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Hudsygdomme
- Hudsygdomme, eksem
- Dermatitis
- Ernæringsmæssige og metaboliske sygdomme
- Hud- og bindevævssygdomme
- Diabetes mellitus, type 1
- Dermatitis, kontakt
Andre undersøgelses-id-numre
- StenoAD1
- 16-0302-112 (Registry Identifier: Medical Research Ethics Committees)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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