[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652011":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":52,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrocolloid patch as patch used in the Sandwitch method","EXPERIMENTAL",null,[13],"Other: hydrocolloid patch as patch used in the Sandwich method",{"label":15,"type":16,"description":11,"interventionNames":17},"Hypafix skin-sensitive patch as patch used in the Sandwitch method","ACTIVE_COMPARATOR",[18],"Other: Silicone-based patch as patch used in the Sandwitch method",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"hydrocolloid patch as patch used in the Sandwich method","We are testing the hydrocolloid patch called Weloa Sensipatch",[9],{"type":6,"name":25,"description":15,"armGroupLabels":26,"otherNames":11},"Silicone-based patch as patch used in the Sandwitch method",[15],[28],{"name":29,"affiliation":5,"role":30},"Jannet Svensson, Professor","STUDY_CHAIR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Anna K Berg, MD, PhD","CONTACT","+45 22 39 35 90","anna.korsgaard.berg@regionh.dk",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":11},"Fiona Marie W Sorensen, MD","+45 50 11 01 31",[41],{"facility":5,"status":42,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"RECRUITING","Copenhagen","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],12.56553,55.67594,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Anna Korsgaard Berg","MD, PhD","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* Any type of contact dermatitis due to either insulin pump or glucose sensor\n* Being between 2-18 years of age prior to inclusion\n\nExclusion Criteria:\n\n* Those who are unable to read and understand Danish and\u002For have impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and\u002For be reached by phone or videocall.","ALL","2 Years","18 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nThe main questions this study aims to answer are:\n\n1. 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.\n2. 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.\n\nThe 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:\n\n* clinical skin examination\n* skin picture (of last used pump and sensor site as well as reportet skin reactions)\n* height and weight\n* blodsample (HbA1c and fillagrin mutations)\n* interview on skin reactions etc.\n* ultrasound of the skin\n* tape strips of the skin\n* EIS (transmit harmless electrical signal through the skin)",[75,76],"Contact Dermatitis","Type 1 Diabetes Mellitus",[78,79,80,76,81,82,83,84,85,86],"skin barrier","contact dermatitis","T1D","Hydrocolloid patch","silicone-based patch","pediatric","device-related contact dermatitis","adhesive","children and adolescents","2026-08-11",{"date":89,"type":90},"2026-08-17","ACTUAL",{"date":92,"type":69},"2026-09-04",{"date":94,"type":69},"2027-05",{"name":5,"class":6},1]