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Work packages

Screening Work package 1

Work Package 1 (WP1) focuses on establishing screening programs for early-stage Type 1 Diabetes (T1D) across Europe. Recognizing the significance of islet autoantibody testing, WP1 aligns with international consensus and EMA recommendations to utilize 2 or more islet autoantibodies as biomarkers for patient selection in clinical trials. Leveraging insights from the Fr1da study in Germany and the Autoimmunity Screening in Kids (ASK) study in Colorado, WP1 aims to develop, introduce, and evaluate regionally adapted screening models. The screening, performed with capillary blood, will connect with clinical diabetes centers for staging, education, support, monitoring, and treatment.

WP1 will vary screening ages, explore combined testing for autoimmune diseases, and allow flexibility in screening protocols. It will coordinate ethics approvals, monitor implementation, and record results in a central database. Additionally, WP1 includes an educational training program, coping strategies, and the evaluation of novel technologies for screening impact. The expansion of the recently established registry, EDENT1FI-R, integrated into WP1, aims for inclusivity, data harmonization, and driving discoveries in biomarkers for clinical disease trajectories.

Impact of screening Work package 2

In WP2 of the EDENT1FI project, the focus is on evaluating the impact of screening the general population for Type 1 Diabetes (T1D). This involves establishing an Ethics Advisory Board (EAB) to address ethical considerations associated with early-stage T1D screening. The project assesses psychological aspects based on the experience of EDENT1FI partners and gathers data on anxiety and distress related to screening. Questionnaires are employed to measure the psychological burden, anxiety levels, and the acceptability, quality, and practicality of the screening approach across different regions.

The assessment includes potential socioeconomic and financial impacts, addressing the cost-effectiveness of the screening program, and considering short-term and long-term economic implications. Led by the industry, the economic analysis aims to evaluate the cost profile of screening and monitoring, calculating the cost per quality-adjusted life-year (QALY) gained over a lifetime horizon. This comprehensive evaluation informs decisions about the implementation and efficiency of T1D screening within healthcare systems.

Monitoring Work package 3

In WP3 of the EDENT1FI project, the focus is on establishing an effective monitoring and care program for individuals identified through early-stage Type 1 Diabetes (T1D) screening, aiming to understand the risk and rate of progression to clinical disease. The tiered follow-up pathways are based on risk and participant preference, incorporating education into the signs and symptoms of diabetes and linking with healthcare systems. To enhance adherence, the project evaluates novel monitoring approaches, including a simplified capillary Oral Glucose Tolerance Test (OGTT) for home use and Continuous Glucose Monitoring (CGM). The use of CGM involves wireless technology and real-time measurement of interstitial glucose, showing promise for staging and monitoring early-stage T1D.

Additionally, biomarkers, such as the Proinsulin:C-Peptide (PI:CP) ratio, are explored for their potential as predictors of progression rate. The project also addresses external factors, such as virus infections, and collects samples for downstream omics analyses. The data analysis involves dedicated artificial intelligence expertise, employing machine learning techniques to analyze diverse data sets, predict progression trajectories, and identify biological markers and responses to perturbation. Privacy and data governance are ensured, aligning with the EDENT1FI Data Management Plan.

Master protocol Work package 4

In WP4 of the EDENT1FI project, the focus is on developing a roadmap for the introduction of preventive and disease-modifying therapies in Type 1 Diabetes (T1D) to the general population, particularly targeting early-stage T1D. The project aims to overcome the challenges of large and lengthy trials by implementing innovative trial designs, including a Master protocol and platform study design with adaptive elements. Protocols for different T1D stages or risk strata identified in WP3 will be developed, incorporating inclusion/exclusion criteria, randomization procedures, mechanistic sampling timetable, and arrangements for masking. The use of Adaptive and SMART study designs, widely used in other medical fields, will be explored to efficiently select between multiple interventions and tailor treatments based on individual response.

The project emphasizes the importance of rapidly responsive outcome measures, modelling disease-risk strata, and predicting optimal combinations of therapies. Collaboration with WP3 and access to relevant data will inform the adaptation of progression rates and algorithms to trial models. The final goal is to design intervention trials in collaboration with the INNODIA iVZW platform and industry partners, ensuring review by the Patient Advisory Committee (PAC) for valuable input from individuals living with or at risk of diabetes and their families.

Communication Work package 5

In WP5 of the EDENT1FI project, the focus is on the implementation of screening strategies for Type 1 Diabetes (T1D) throughout Europe, emphasizing effective communication and dissemination. Communication tools will be developed to convey the importance of early detection of T1D to stakeholders, including the general public, healthcare professionals, regulators, and policymakers. Targeted messaging will be tailored to different audiences, leveraging existing materials and partnerships with learned societies and organizations. As evidence emerges from other work packages, communication messages will evolve, incorporating novel insights and guidance from regulators, ethics experts, and the Patient Advisory Committee (PAC).

The project aims to engage with local screening partners to adapt materials for specific regions, ensuring alignment with the overall communication strategy. Additionally, formal guidance documents will be generated for healthcare professionals on screening, monitoring, and managing individuals in early stages of T1D. The project will seek endorsement from regulators and policymakers, drawing on the expertise of C-path and leveraging industry partners' regulatory departments. Ultimately, the goal is to introduce cost-effectiveness data and disease trajectory information to European policymakers and local healthcare systems, proposing roadmaps for the integration of T1D screening, thus ensuring the long-term legacy of EDENT1FI.

Project management Work package 6

In WP6 of the EDENT1FI project, the Coordination Team consisting of KULeuven, Sanofi, HMGU, and JDRF will play a crucial role in providing effective project management and governance direction. This includes leading the data management team (HMGU), coordinating the exploitation strategy (Sanofi), and assisting in communication, dissemination, and implementation in close connection with WP5. The governance model will be implemented to ensure collaborative, efficient, and transparent project monitoring and coordination.

Virtual meetings will be promoted to limit ecological footprint, with hybrid formats for annual meetings. The governance structure reflects the public-private nature and consortium composition, fostering collaboration, preventing scientific silos, and facilitating decision-making processes and risk assessment. A specific task involves developing a sustainability plan for EDENT1FI, exploring options and preparing a business plan for the project's legacy, akin to the non-profit entity established in INNODIA for safeguarding the work's legacy.