EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents.

Summary

The EDENT1FI Master Protocol harmonizes islet autoantibody screening and metabolic staging for presymptomatic type 1 diabetes across eight European countries, targeting ~200,000 children and adolescents by 2028. Standardized confirmation, education, and registry-based follow-up aim to reduce DKA at diagnosis and enable disease interception.

Key Findings

• Master Protocol standardizes islet autoantibody screening, confirmation, and metabolic staging across eight countries.
• Target enrollment is ~200,000 children/adolescents aged 1–17 years (2023–2028).
• Registry-based follow-up and acceptability assessments aim to evaluate feasibility, DKA reduction, and care outcomes.

Clinical Implications

If implemented widely, pediatric screening and follow-up could reduce DKA at onset, lower acute healthcare utilization, and create pathways for preventative immunotherapy trials.

Limitations

• Protocol paper without outcomes; effectiveness and cost-effectiveness remain to be demonstrated
• Heterogeneity in healthcare systems may impact harmonized implementation

Future Directions

Report screening yield, DKA rates, and psychosocial outcomes; evaluate cost-effectiveness and pathways to implement preventative interventions for stage 2–3 conversion delay.