Impact-Med

MDT BEN
Medtronic International Trading SARL

ACTION
Allies in Cardiovascular Trials Initiatives and Organized Networks Association-Coeur

PBY
PredictBy Research and Consulting S.L.

ECPO
The European Coalition for People Living with Obesity Company Limited by Guarantee

LEEDS
The Leeds Teaching Hospitals National Health Service Trust

LEEDS
Samsung Electronics (UK) Limited

Cardiometabolic diseases (hypertension, obesity, type 1 and type 2 diabetes, coronary artery disease, heart failure, atrial fibrillation and heart valve disease) often coexist, are frequently diagnosed late, and are among the leading causes of death and disability in Europe. Patients living with several of these conditions often face fragmented care: disconnected pathways, unequal access, and limited personalisation and digital support.

IMPACT-MED aims to design, develop and deploy a scalable, people-centred Multidisciplinary Cardio-Metabolic Care (MCMC) framework, supported by a clinically enriched digital ecosystem that combines mature (TRL > 8) and innovative (TRL > 5) technologies. By building a public-private collaboration that avoids siloed, institution-driven or industry-driven solutions, the project will enable a continuum of care tailored to each patient’s capacity (low, moderate or high) to cope with and manage their condition.

The project integrates solutions such as AI-based risk stratification, predictive algorithms, remote patient monitoring, advanced imaging, and patient-centred data collection tools (PROMs, PREMs and patient preferences). These support proactive, continuous care, empower patients and guide clinicians. The results will be shared with the wider MCMC community through an evidence-based observatory dashboard, together with expansion and sustainability guidelines and a regulatory strategy.

IMPACT-MED is built on three pillars:

1. Six specific objectives: co-creation and European synergies; an AI-empowered digital ecosystem; an evidence-based set of PROMs, PREMs and PPI; real-world evidence for personalised and cost-effective care; a regulatory pathway for adoption; and communication, dissemination and scale-up.
2. Four use cases, deployed and validated in clinical pilot sites.
3. Eight work packages, organised in four implementation phases.

Use Case 1 – SMART-BP: AI-based blood pressure management

Stratified Management using AI and Remote Technologies for Blood Pressure control. A hybrid care model combining remote blood pressure and heart rate variability monitoring, AI-based risk stratification and digital patient engagement tools for high-risk patients with uncontrolled hypertension. Randomised study of about 200 patients led by the Hospital Clínico San Carlos (Madrid).

Contributors: Medtronic Ibérica, SERMAS

Use Case 2 – Astrolabe: remote monitoring after myocardial infarction

A randomised study evaluating the clinical and organisational impact of remote monitoring and nurse-led triage in hypertensive post-MI patients, with the aim of reducing unnecessary in-person visits while maintaining safety. About 200 patients at APHP sites in France.

Contributors: Medtronic France, APHP, ACTION

Use Case 3 – EMPOWER-T1D: type 1 diabetes self-management

Integrated remote monitoring and personalised digital education for children and young people (0–25 years) with type 1 diabetes, using continuous glucose monitoring data to improve self-management and optimise healthcare use. Real-world study of about 800 patients at Leeds Teaching Hospitals.

Contributors: Medtronic International Trading, DigiBete, Leeds Teaching Hospitals

Use Case 4 – PRISM-T2D: precision phenotyping in type 2 diabetes

Precision phenotyping and integrated management of type 2 diabetes, combining quantitative multi-organ MRI, blood-based biomarkers, AI-based risk prediction and a patient app with telemedicine support, to guide personalised treatment and improve cardio-renal-metabolic outcomes. Randomised study of about 400 patients at Steno Diabetes Center North Denmark.

Contributors: Perspectum, Siemens Healthineers, Region Nordjylland, Aalborg University

• WP1 – Project coordination, IPR and data management (leader: UCBM). Coordination, risk and quality management, data governance, IPR, ethics and legal compliance.
• WP2 – Foundations for a people-centred MCMC (leader: BRIDG). State of the art and gap analysis, co-creation with patients and clinicians, requirements, use case definition, training and capacity building.
• WP3 – Integrated multidisciplinary clinical pathways (leader: Perspectum). Conceptual MCMC framework, medical and non-medical interventions, standardised tools and data collection methods.
• WP4 – Digital ecosystem for data integration and AI-enabled solutions (leader: CERTH). Architecture and data lake, interoperability (HL7 FHIR), digital tools and an AI-enhanced tool for PROMs, PREMs and PPI.
• WP5 – Implementation of MCMC in real-world settings (leader: Hict). Preparation, deployment and monitoring of the clinical pilot sites, guided by implementation science.
• WP6 – Clinical validation, health technology assessment and lessons learnt (leader: PredictBy). Study protocols and ethics approvals, clinical studies, KPI monitoring, cost-effectiveness analysis and the lessons-learnt observatory.
• WP7 – Dissemination, communication and policy briefs (leader: Happy Mondays). Communication plan, international stakeholder community, policy briefs and synergies with EU and IHI initiatives.
• WP8 – Exploitation, scalability, regulatory framework and sustainability (leader: Samsung Electronics UK). Market analysis, exploitation strategy, scalability and standardisation guidelines, and a regulatory pathway (MDR, GDPR, EHDS, AI Act).

• Integrated, people-centred care: demonstrating the feasibility of integrated healthcare solutions that address fragmented care across the cardiometabolic continuum.
• Patient empowerment: PROMs, PREMs and patient preferences embedded in routine care, supporting self-management and shared decision-making.
• Better support for clinicians: AI-supported decision tools, optimised workflows and training for healthcare professionals.
• Evidence for policy and reimbursement: real-world evidence, health technology assessment and cost-effectiveness analyses for each use case.
• Scale-up and sustainability: an evidence-based observatory dashboard, scalability and standardisation guidelines, and a regulatory strategy to support adoption across European healthcare systems.
• Alignment with EU priorities: the European Health Data Space, the AI Act, and other IHI and EU initiatives.