[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630813":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":10,"responsibleParty":33,"collaborators":37,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":56,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":10},{"fullName":5,"class":6},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Grup A",null,"No Ab. Negative screening test.",{"label":13,"type":10,"description":14,"interventionNames":10},"Grup B - at risk T1D","Only one positive Ab.",{"label":16,"type":10,"description":17,"interventionNames":10},"Grup C - Stage 1, 2 T1D","Two positive Ab",[19],{"name":20,"affiliation":21,"role":22},"Bibiana S Quirant, PhD","Germans Trias i Pujol Research Institute | IGTP","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Concepción V Fors, PhD","CONTACT","+34 607 07 25 92","cviolanf.mn.ics@gencat.cat",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Fabiana G dos Santos, PhD","+34679080950","fganem@idiapjgol.org",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Fabiana Sherine Ganem dos Santos","Co-Investigator",[38,40],{"name":21,"class":39},"UNKNOWN",{"name":41,"class":39},"Institut de Recerca Germans Trias i Pujol","100630813","the-t1dwatch-study-a-screening-for-type-1-diabetes-autoantibodies-in-children-for-early-detection-and-intervention-100630813",false,"NCT07492550","The T1DWATCH Study: a Screening for Type 1 Diabetes Autoantibodies in Children for Early Detection and Intervention.","T1D WATCH Study, a Comprehensive Screening for Type 1 Diabetes Autoantibodies in Children: A Proactive Approach to Early Detection and Intervention","T1DWATCH","Inclusion Criteria:\n\n* Age corresponding to one of the predefined screening groups:\n\n  * Young children: 2-6 years\n  * Older children: 7-10 years\n* Attendance at routine pediatric visits within the Preventive Activities and Health Promotion Programme in Childhood in Catalonia (\"Creixer amb Salut\") at the specified ages (2-10 years)\n* Written informed consent provided by parents or legal guardians\n\nExclusion Criteria:\n\n* Presence of primary immunodeficiency\n* Current treatment with immunosuppressive therapy\n* Ongoing participation in another clinical trial\n* Refusal to participate or inability to comply with study procedures","ALL","2 Years","10 Years",{"count":54,"type":55},2200,"ESTIMATED","3 Years","OBSERVATIONAL","This study aims to identify early-stage type 1 diabetes (T1D) in children aged 2-6 and 8-10 years through autoantibody (Ab) screening, genetic and immunological analyses, and to evaluate the effectiveness of educational interventions, as well as the feasibility and acceptability of their implementation.\n\nIt is a prospective cohort study involving 2,169 children attending primary healthcare centres in the Barcelonès area. Eligible participants will be those engaged in routine paediatric preventive programe with parental informed consent. The screening process consists of three visits: Visit 1: Capillary blood collection for 3 T1D related Ab (3-screen ELISA). Visit 2: Confirmation of positive results through a new venous blood sample to determine single T1D related Ab and metabolic tests (fasting glucose, HbA1c, C-peptide), HLA, imme cell study. Visit 3: Risk stratification based on Ab presence: Group A (negative), Group B (one positive Ab, at risk of T1D), and Group C (two positive Ab, diagnosed at stage 1 or 2). Immunological and metabolic changes will be monitored, and screening effectiveness will be assessed in terms of sensitivity, specificity, and false positive\u002Fnegative rates. The association between HLA genotype and Ab positivity will be analysed using logistic regression. A cost-effectiveness analysis will be conducted alongside a qualitative evaluation of parents' and stakeholders' perceptions regarding the screening process.This study will provide evidence to optimise early T1D detection and its implementation in primary care.",[60],"Diabete Type 1",[62,63,64,65,66,67],"Diabetes TYPE 1","Children","Autoantibodies","Screening","Primary Health Care","Autoimmunity","NOT_YET_RECRUITING","2026-03-25",{"date":71,"type":72},"2026-03-31","ACTUAL",{"date":74,"type":55},"2026-05",{"date":76,"type":55},"2027-12-30",{"name":35,"class":6}]