Type 1 diabetes (T1D) is one of the main health challenges, with 6 million European citizens affected. Today, T1D accounts for a severe economic burden on healthcare and labour force. To bring advanced therapy in type T1D to patients, a scalable source of pancreatic islets for transplantation is needed. The objective of the ISLET project is to build and implement a new and innovative program for the production and marketing of human pluripotent stem cell (hPSC)-derived advanced therapy medicinal products (ATMPs) for treatment of EU citizens with T1D. To achieve this, ISLET gathers a constellation of experts to establish a transferable GMP-compliant manufacturing program based on improved and standardised protocols for generation and characterisation of future ATMPs. Furthermore, to make a product closer to the “golden standard” human pancreatic islet, ISLET will develop islet-like clusters composed of isolated hPSC-derived alpha and beta-like cells, and advance strategies for safe, up-scaled production and a quantitative go/no-go assessment of therapeutic quality. Specifically, to overcome the lack of robust qualitative and quantitative assays to assess islet function, ISLET will introduce a novel quality control concept for predicting the therapeutic efficacy by quantitative proteomics and lipidomics as part of the ATMP development chain - a concept that will be widely applicable. A commercial route for exploitation of HESC derived ATMPs for T1D treatment with EU will be developed. Finally, a professionally supported dual plan for public engagement in the fields of stem cell therapy and diabetes is rounding up the project.

Type 1 diabetes is a rare but highly challenging chronic condition which often leads to lowered life expectancy and greatly diminished quality of life even amongst those patients who are the most diligent and proactive in the practice of disease self-management. In recent years, there has been a growing movement of ‘patient innovators’ leading the development of self-built or ‘do-it-yourself’ artificial pancreas systems (DIYAPS), which help to automate day-to-day decision making needed for successful self-management. There is prima facie evidence to suggest that such systems can lead to improvements in glucose outcomes that far exceed those offered by the most state-of-the-art commercially available solutions. The aim of this RISE project is to tap into the expertise and knowledge shared by these communities by bringing together an intersectoral and interdisciplinary research team consisting of patient innovators, academic researchers, healthcare professionals (HCPs) and NGOs to establish an empirical evidence base surrounding the impact of DIYAPS. The exciting programme of research includes training and networking for participating staff designed to encourage inter-disciplinary thinking and broaden career horizons, while the dissemination and public outreach activities will ensure that project findings reach key stakeholders, such as policymakers, HCPs and industry, both within Europe and beyond. The key outcomes of this project will include a new model of knowledge co-creation and an evidence-base surrounding the potential scale-up of DIYAPS solutions that will have profound implications for those living with chronic conditions, their families, as well as healthcare systems and European society as a whole.

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.