[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652011":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":16,"studyPopulation":16,"armGroups":27,"interventions":38,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":71,"collaborators":16,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":16,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":61,"whyStopped":16,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrence of contact dermatitis","the binary outcome recurrence of contact dermatitis","Assessments will be performed at baseline, 3 months, and 6 months.",[14],{"measure":15,"description":16,"timeFrame":17},"Time in days to recurrence of contact dermatitis",null,"Baseline to 6 months after.",{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":16,"timePerspective":16,"maskingInfo":23},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":24,"maskingDescription":16,"whoMasked":25},"SINGLE",[26],"OUTCOMES_ASSESSOR",[28,33],{"label":29,"type":30,"description":16,"interventionNames":31},"Hydrocolloid patch as patch used in the Sandwitch method","EXPERIMENTAL",[32],"Other: hydrocolloid patch as patch used in the Sandwich method",{"label":34,"type":35,"description":16,"interventionNames":36},"Hypafix skin-sensitive patch as patch used in the Sandwitch method","ACTIVE_COMPARATOR",[37],"Other: Silicone-based patch as patch used in the Sandwitch method",[39,43],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"hydrocolloid patch as patch used in the Sandwich method","We are testing the hydrocolloid patch called Weloa Sensipatch",[29],{"type":6,"name":44,"description":34,"armGroupLabels":45,"otherNames":16},"Silicone-based patch as patch used in the Sandwitch method",[34],[47],{"name":48,"affiliation":5,"role":49},"Jannet Svensson, Professor","STUDY_CHAIR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":16,"email":55},"Anna K Berg, MD, PhD","CONTACT","+45 22 39 35 90","anna.korsgaard.berg@regionh.dk",{"name":57,"role":53,"phone":58,"phoneExt":16,"email":16},"Fiona Marie W Sorensen, MD","+45 50 11 01 31",[60],{"facility":5,"status":61,"city":62,"state":16,"zip":16,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":16},"RECRUITING","Copenhagen","Denmark","DK",{"type":66,"coordinates":67},"Point",[68,69],12.56553,55.67594,{"lat":69,"lon":68},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Anna Korsgaard Berg","Researcher, Principal Investigator","100652011","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-100652011",false,"NCT07767461","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","Steno Adhesive Study 1","StenoAD1","Inclusion Criteria:\n\n* An type of contact dermatitis caused by an insulin pump or a continuous glucose monitor (CGM)\n* Age between 2-18 years prior to inclusion\n\nExclusion Criteria:\n\n* Inability to read and understand Danish\n* Cognitive impairment that may interfere with the ability to complete questionnaires in Danish or to participate in telephone or video follow-up visits","ALL","2 Years","18 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to ensure that contact dermatitis does not prevent any person with diabetes from accessing optimal diabetes treatment.\n\nThe main questions this study aims to answer are:\n\nHow 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?\n\nThe 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).\n\nParticipants 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:\n\nClinical 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",[94,95],"Contact Dermatitis","Type 1 Diabetes Mellitus",[97,98,99,95,100,101,102,103,104,105],"skin barrier","contact dermatitis","T1D","Hydrocolloid patch","silicone-based patch","pediatric","device-related contact dermatitis","adhesive","children and adolescents","2026-08-23",{"date":108,"type":109},"2026-08-25","ACTUAL",{"date":111,"type":88},"2026-09-04",{"date":113,"type":88},"2027-05",{"name":5,"class":6},1]