Preclinical type 1 diabetes (T1D) research has made important advances in recent years, but less progress has been made in translating findings from in vitro and animal models into effective clinical interventions. INNODIA aims to achieve a breakthrough in the way in which we study T1D to enable us to move closer towards prevention and cure of T1D. To this end, INNODIA joins together the leading European experts from the fields of basic and clinical T1D research, four leading pharmaceutical companies with strong expertise in the discovery and development of diabetes medicines and the two leading public organizations involved in T1D research into one comprehensive collaborative consortium. The clinicians in INNODIA oversee T1D registries and have access to large populations of children and adults with T1D and family members at increased risk of developing the disease. The basic science researchers are experts in beta-cell pathophysiology, immunology, biomarker discovery, bioinformatics, systems biology and clinical trial design. INNODIA will accelerate understanding of T1D through coordinated studies of unique clinical samples and translation-oriented preclinical models. This should deliver novel biomarkers and interventions for testing in appropriately designed trials, to be developed in active collaboration with regulators and patients. INNODIA provides access to unique historical biorepositories and will create the Clinical Sample Network, a clinical EU infrastructure to recruit T1D subjects at diagnosis and at-risk relatives. These individuals will be deep-phenotyped and will provide biosamples, allowing the establishment of a ‘living biobank’ of subjects consented for recall. They will be characterized using standardized clinical, genetic and metabolic phenotyping procedures, including prospective, longitudinal sample collection to facilitate novel biomarker discovery. Diverse biological samples (blood, plasma, serum, urine, stools, etc.) will be collected at

Building on the strong foundations of INNODIA, with its unique, Europe-wide clinical and basic research network for the study of type 1 diabetes (T1D), we propose in INNODIA HARVEST an ambitious program which aims to prevent and arrest T1D via focused objectives targeting consolidation and innovation. First, we will consolidate the INNODIA clinical network as the reference point for conducting studies to prevent or arrest T1D. We will transform our standardized clinical and bioresource platforms into a high-performance clinical trial network, running academic and industry-driven trials alongside small, mechanism-centric, biomarker-rich intervention trials to examine pathobiological pathways to T1D. INNODIA HARVEST will conduct two large studies to arrest T1D at its onset, one academia-driven, beta-cell focused (VER-A-T1D, verapamil) and one industry-driven, immune-focused (Iscalimab-study). We will exploit our original INNODIA Master Protocol allowing novel adaptive trial design to introduce combination therapies that build on complementary mechanisms. Second, we will extend our study design strategy by introducing novel biomarkers, both clinical (continuous glucose monitoring) and experimental (microbiome analysis) to deconvolute disease heterogeneity and identify new endpoints to accelerate identification of effective therapeutics. Third, we will use ‘disruptors’ in small mechanistic studies to channel innovation from clinic to basic research through a reverse immunology and reverse beta-cell biology approach. Finally, we will implement new discovery pipelines for future therapeutics, exploiting tools such as iPSC-derived islet-like cells to promote next generation target identification and drug development. As in INNODIA, the voice of people living with T1D and their families will hold a central place in INNODIA HARVEST to drive implementation of new, patient-proximal outcomes, shape our clinical trials, and bring about a meaningful change in disease perspective. A major objective of INNODIA Harvest is the execution of at least two new phase 2 trials (studying Verapamil (VER-A-T1D) or Iscalimab (CCFZ533X2207)). Considering the expected time to first patient-in as preparations for trial start can only be initiated after the start of the Action and possible fluctuating recruiting rates, due to the intercurrent COVID epidemic, there is a risk that INNODIA HARVEST will not be able to completely finalize the clinical trials, fully analyse the biomarkers collected and publish the results in the initially proposed 24 months duration. To ensure the finalization of the clinical trials and corresponding full execution of the given budget including eligibility of EFPIA in-kind contribution we propose to extend the duration of the Action from 24 to 36 months.

TYPE 1 DIABETES is one of the most COMMON CHRONIC diseases in children with a RAPID increase in number of cases particularly in young children. Type 1 diabetes is associated with LIFE-LONG dependency on insulin administration. POOR glucose control leads to diabetes COMPLICATIONS, e.g. eye, heart, kidney disease, including BRAIN changes in young children. Episodes of VERY LOW glucose levels may be life threatening and are a major complication. The ARTIFICIAL PANCREAS addresses the problem of LOW and HIGH glucose levels by delivering insulin BELOW and ABOVE pre-set amounts according to real-time sensor GLUCOSE levels, combining glucose SENSOR, insulin PUMP, and CONTROL ALGORITHM. The Artificial pancreas promises to TRANSFORM management of type 1 diabetes but EVIDENCE supporting its use during FREE LIVING in YOUNG CHILDREN is MISSING. The project evaluates the biomedical, psychosocial, and cost effectiveness of NOVEL INDIVIDUALISED artificial pancreas in young children aged 1 to 7 years with type 1 diabetes. Following a PILOT (n=24), in the MAIN study (n=94) half of the participants (n=47) will be treated over 12 MONTHS by the ARTIFICIAL PANCREAS and the other half (n=47) by STATE-OF-THE-ART PREDICTIVE LOW GLUCOSE MANAGEMENT insulin pump therapy. Each treatment will last ONE YEAR. QUALITY OF LIFE will be assessed and semi-structured INTERVIEWS conducted to understand the impact on daily life. HEALTH TECHNOLOGY ASSESSMENT will support reimbursement. The project will OPTIMISE artificial pancreas and SPEARHEAD SYSTEM-WIDE improvements in health care quality and health outcomes in YOUNG CHILDERN with TYPE 1 DIABETES who live with the disease LONGEST. By IMPROVING THERAPEUTIC OUTCOMES, the project will CHANGE clinical practice and INFLUENCE national and international treatment guidelines making the artificial pancreas WIDELY ACCEPTABLE as the state-of-art treatment modality in young children.

The project “Peer Education for health in jail” aims to implement a dynamic of health education, in different European prisons, in term of improving prisoners’ quality of life and contributing to the reduction of social and health inequalities due to detention. The project targets to enable each prison health care team partner to set up a group of Inmates Health Contact. Inmates Health Contact is a group of prisoners that receive health training from the prison health care team. That training focus on various sensible health topics such as: hepatitis, AIDS, tuberculosis, nutrition, hygiene, scabies, communication.... Inmates Health Contact group is trained to become resource persons for their peers. Their mission is not only to be resources, but also to set up awareness campaigns according to the reality of their prison. They organize prevention campaigns, actions and projects around topics chosen according to the health problems in their prison, in order to promote the quality of their health. Health education is an important issue in jail. Living conditions are difficult (promiscuity, bad quality of buildings/blocks), and health risks are significantly presents (high prevalence of tuberculosis, HIV, drugs abuses, suicide). Therefore, it is important to combat these risks and enable inmates to evolve in a healthy environment in order to preserve their integrity and their social reintegration. Hygiene, physical and social well being, and entrepreneurial spirit, are basic skills that prisoners has not often the opportunity to develop or maintain. This project is then an opportunity to develop these skills.To enable the integration and the follow-up of the group Inmates Health Contact, in a prison, the project “Peer Education for health in jail” develops a training programme for medical personnel partners. Thus, these health care teams will be able to establish and train Inmates Health Contact to public health issues. The training of medical will concentrate on health education, procedures to establish an Inmate Health Contact group, group motivation, analysis of group facilities and barriers, project management and sharing experience.The project therefore, includes two groups of participants: the prison health care team (doctors and nurses) and the group of Inmates Health Contact of the same prison.In this project, eleven members of two health care teams from France and Luxembourg will be involved. Each health care team will be responsible for the establishment of an Inmates Health Contact group in his establishment. At the end of the project three results are expected: 1. A group of Inmates Health Contact is established in the prisons and implements projects that the group is trained for, such as sensitizing on health thematic (poster and flyers on prevention, sensitization via evening debates, advocacy ...). 2. The group of Inmates Health Contact is known and recognized in the prison by the medical staff, management team and other inmates. Prisoners are aware of Inmates Health Contact actions and consider them as the group of resources for advises access to prevention materials, or reorientation to skilled services.3. The health Care teams carry out continuous training and management of the Inmates Health Contact groups. They can help the Inmate health Contact group methodologically and scientifically (theoretical knowledge) and reinforce the group to implement projects and set up different activities. In this way, a real collaboration between health care team and prisoners which facilitates the reaching of healthy and respectful environment.With these results, a series of impacts are expected:- First of all, the participants (health care teams and Inmates Health Contacts) have the opportunity to acquire new knowledge and skills from training, and put it in practice through different projects. - The project also has an impact on prisons partners. In fact, the Inmates Health Contact group and health care teams work together to improve a healthy lifestyle and a healthy prison population. - With the project “Peer Education for health in jail” we also aim to present the advantages and opportunities of educational/pedagogy by actions and participation, health education by peers, and thus motivate other prisons, and other health care teams to form news Inmates Health Contact groups.