In recent years there is mounting evidence that type 2 diabetes (T2D) is associated with cognitive impairment and dementia, which can be considered as a “new” long-term diabetic co-morbid complication with dramatic consequences for patients and their families and a significant impact for healthcare systems. At present there are no reported phenotypic indicators or reliable tests to identify T2D patients at risk of developing dementia. Since the retina is ontogenically a brain-derived tissue, we propose that the evaluation of retinal parameters related to either neurodegeneration or microvascular disease will be robust and valuable biomarkers to identify those T2D patients at higher risk of developing cognitive impairment and dementia. On this basis the overarching aims of the project are: 1) To investigate the common mechanisms involved in the pathogenesis of DR and cognitive impairment in the T2D. 2) To use the retina as a tool to identifying individuals with T2D at a higher risk of developing cognitive decline or dementia. Our multidisciplinary consortium (RECOGNISED) consist of top research leaders in the field belonging to 15 prestigious institutions as well as EATRIS, IDF-Europe and Alzheimer Europe and 3 SMEs. RECOGNISED will apply innovative approaches to identify the molecular mechanisms involved in the high prevalence of cognitive impairment and dementia in T2D population and will use this knowledge to characterize clinical phenotypes (personalized medicine) based on retinal functional and structural characteristics and serum biomarkers in order to stratify the risk and severity of cognitive decline. Previously collected data from registries, cohorts and biobanks will be appropriately exploited and robust new data will be generated that will guide clinical recommendations and open up new therapeutic strategies. Ultimately, RECOGNISED project will help to reduce the huge societal and economic burden associated with diabetes-related cognitive impairment.

DigiCare4You Consortium will jointly work with local stakeholders to deliver an intersectoral innovation involving digital tools for early screening, prevention and management of type 2 diabetes (T2D) and hypertension (HTN). An implementation study will be conducted, targeting more than 10,000 families in two Middle Income Countries (Albania and Bulgaria) and two High Income Countries (Greece and Spain), considering vulnerable groups. Schools will be used as an entry point to the community and building on an existing procedure for children’s periodic growth assessment (conducted via school nurses or in collaboration with local community health centres), parents/ caregivers will be screened via a non-invasive self-reported digital screening tool. Those identified at high risk for T2D will be referred for glycaemia testing and blood pressure (BP) measurements at local community health centres. Parents/ caregivers confirmed to have pre-diabetes or diabetes (and possibly high BP) will be invited to join a mHealth self-management intervention coordinated by the community healthcare workforce. The goal of this intervention is not only to improve the health status of the users, but also empower the entire family in adopting a healthy lifestyle. To this end, schools and communities will also be actively engaged to promote health literacy, well-being and support lifestyle changes creating a more supportive social and physical environment for the entire community. Regular monitoring will be ongoing during the implementation to allow corrective actions and ensure effective adaptation and uptake. Based on the study outcomes, the in-depth health economic evaluation and budget impact analysis, and data deriving from a Scalability Assessment and Decision-Support tool, national and international stakeholders will be invited to evaluate, through a series of webinars and workshops, the scalability potential of the DigiCare4You solution in other regions or countries in Europe.

The Feel4Diabetes project addresses “HCO5-2014: Global Alliance for Chronic Diseases: prevention and treatment of type 2 diabetes”. The aim of this project is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe. Methods: The PRECEDE-PROCEED Model will provide the theoretical framework for the development, implementation and evaluation of the Feel4Diabetes intervention. The framework has two phases, namely the PRECEDE and PROCEED phase. During the PRECEDE phase, the target population as well as behaviours related to type 2 diabetes and their determinants will be identified. Existing research programs and guidelines for type 2 diabetes prevention, policies, legislation, local infrastructure and human resources will also be recorded. Based on the knowledge gained from this phase, a low-cost and applicable in low-resource settings community-based intervention programme will be developed, with the active engagement of local stakeholders, providing access to the existing infrastructure and human resources wherever feasible. During the PROCEED phase, the intervention will be implemented and its process, impact, outcome, cost-effectiveness and scalability will be evaluated. The results of the intervention will be disseminated, aiming to embed it into policy and practice. Consortium: The Feel4Diabetes multidisciplinary consortium incorporates the necessary expertise on diabetes prevention, behaviours, nutrition, physical activity, policy and health economics. It consists of 10 partners from 7 universities, 1 research institute, 1 advocacy group and a small-medium enterprise, representing European low-middle income, high income and under socioeconomic crisis countries.

ASSESS-DHT will increase the adoption of trustworthy and effective Digital Health Technologies (DHT) across Europe, enabling a more coherent digital single market, for health systems and patients to access DHT from all over Europe and giving industry a European market. We will develop a new assessment framework, beyond the existing models, capable of uniform HTA adoption across Europe, addressing new assessment challenges in Digital Therapeutics, AI and telehealth. Our consortium comprises 4 HTA bodies, the European Observatory on Health Systems and Policies, 5 academic and not for profit organisations with expertise in EU Regulation, DHT development and assessment methodologies, data protection, data quality, interoperability and cybersecurity. Patients and health professionals are included through the International Diabetes Federation and European Society of Cardiology. We include the DHT industry through companies with products for us to assess through a formal methodology mimicking actual HTA assessments – 3 as partners, some through an open call and industry-wide consultation via DIGITAL EUROPE. We will engage healthcare payers and ministries through our Advisory Board. We will co-create our overarching assessment framework with specialised pathways for different categories of DHT specified through a novel evidence-based typology. We will cater for phased adoption (going beyond fast track models like DiGA), complex life-cycles, iteratively developed AI, consolidated in a comprehensive HTA assessment manual plus specific guides in topics like cybersecurity. We will develop a sustainable repository containing the ASSESS-DHT framework, pathways and unambiguous criteria, a semantically searchable evidence library, checklists and tools to support companies with evidence generation, evidence of health system value from DHT, and online communities of practice.

Clinical trials increase in size, complexity and costs. This is fuelled with the need to demonstrate effects in more complex therapeutic areas, and to detect subgroups with different benefit and safety responses. Complexities, rigid clinical control, physical distance and (perceived) burden put patient engagement under pressure. (S)low recruitment and retention compromise efficiency, generalisability and validity of traditional, site-centred trials. Remote Decentralized Clinical Trials (RDCTs) and hybrid approaches address these challenges. RDCTs are an operational strategy for technology-enhanced clinical trials, which enable (semi-)continuous data collection and real-world evidence generation, increase patient recruitment and retention and decrease patient and investigator burden and costs. Trials brought to the home of patients. Paradigmatic changes in EU clinical trial design are required to fully benefit from the digital era. Yet, the feasibility of running RDCTs needs to be rigorously demonstrated toge