EDENT1FI · European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception

EDENT1FI is a unique and timely project building and operationalising an open platform for general population screening of children/adolescents for type 1 diabetes (T1D) throughout Europe. The case is compelling: T1D is a common chronic disease affecting >1 in 300 children or adolescents. Decades of European research have signposted the step-wise nature of T1D development and generated tools for early diagnosis, monitoring and disease modification. EDENT1FI now positions Europe as the leader in early interception of T1D. Our goals are to identify individuals at earlier, pre-clinical stages, dramatically reducing clinical severity at T1D diagnosis and providing the opportunity for interventions with disease modifying therapies to delay or prevent clinical T1D. Spurred by the success of our collaborations in model European childhood screening activities and clinical networks in GPPAD and INNODIA, EDENT1FI will: establish harmonised islet autoantibody surveillance programmes to screen 200,000 children/adolescents across Europe; assess the psychosocial, medical and economic impact of screening in diverse European health systems/populations including underserved families; use state of the art metabolic sensors and biomarkers to optimise monitoring schedules for early-stage (pre-clinical) T1D aligned to maximising compliance and identifying disease progression strata; design SMART trials to expedite evaluation of disease modifying therapies; and inform and educate the public, healthcare professionals, and regulatory authorities of the new paradigms in T1D diagnosis and care. To achieve this, EDENT1FI assembles academic, clinical and industry expertise in screening, clinical care, biomarkers, machine learning, population outreach, ethics, regulatory affairs and policy to accelerate evidence-based early T1D screening into regular healthcare in Europe. The success of these activities will promote early diagnosis and prevention pathways for other chronic childhood diseases.