NCT07492550Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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. It 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/negative 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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2200 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- May 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Fabiana Sherine Ganem dos Santos
- Diseases
- Type 1 diabetes
- NCT number
- NCT07492550
What you commit to
- Study type: Observational
- Planned participants: 2200
- From May 2026 to the primary completion date, 30 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with immunosuppressive therapy
Other
- Presence of primary immunodeficiency
- Ongoing participation in another clinical trial
- Refusal to participate or inability to comply with study procedures
Who the study is looking for
- Age corresponding to one of the predefined screening groups:
- Young children: 2-6 years
- Older children: 7-10 years
- 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)
- Written informed consent provided by parents or legal guardians
Age in the registry: 2 years to 10 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.