MELISSA's main objective is to provide a clinically validated, efficient and cost-effective AI-powered digital diabetes management solution to support insulin-treated people with diabetes and their healthcare providers by providing personalised treatment and care recommendations, with the primary goal of maintaining normal blood glucose levels, thus avoiding both hyper- and hypoglycaemia.
Existing (pre)clinically validated AI-driven solutions will be optimised, build upon and integrated into one digital platform. The goal is to accomplish better personalised day-to-day diabetes treatment and care including improved glucose control. This will be achieved in a sustainable and ethical fashion based on the needs of people living with insulin-treated diabetes. The platform will benefit people with diabetes to achieve self-management and glucose control. Healthcare providers will be able to take evidence-based decisions in providing optimal treatment with the aim to maintain glucose and to minimise risks of short- and long-term diabetes-related complications.
Once the AI-driven digital platform is set up, it will be validated in a clinical study involving insulin-treated people with diabetes from clinical centres based in four European countries: Denmark, Germany, Greece, and the Netherlands. Primary focus of the study will be the effectiveness in terms of assessing health outcomes and user experience of the platform compared to standard care currently available.
In order to reimagine the traditional power relationship between healthcare professionals and their patients (i.e. democratisation of healthcare), recommendations will be provided. Furthermore, clinical guidelines on the management of insulin-treated diabetes will be enhanced, based on the clinical study. This includes a cost-benefit analysis which investigates the potentials of people with diabetes to effectively and efficiently use information, innovative technology, and access to expertise for managing their condition and health.
To ensure health and digital literacy as well as patient empowerment, the MELISSA project will provide an extensive information and communication package about insulin-treated diabetes, diabetes management and glucose control for people with diabetes and their carers. Documentation regarding the MELISSA digital platform will also be provided. Furthermore, primary and secondary healthcare providers will receive dedicated training materials.
The project activities are managed in so-called work packages. MELISSA is set up around seven such work packages. Different partners take the lead on achieving different tasks within a particular work package while ensuring close collaboration with other institutions and across the different work packages.
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Work Package 1 - Project management and scientific coordination
Work package 1 provides a clear organisational framework, guidance, and all support mechanisms to enable a smooth project workflow in MELISSA and to ensure that objectives and milestones will be met on time.
Work package 2 develops the fully integrated, functioning, and technically validated platform MELISSA that will be used by people with diabetes treated with insulin during the clinical investigation as well as healthcare providers to support them.
Work package 3 provides insights into the user requirements and the psychological aspects of user adoption and retention in MELISSA, as well as the ethical aspects input of AI-powered software adoption.
Work package 4 is the clinical backbone of MELISSA. It includes planning and conducting a randomised controlled clinical trial with the objective to validate the AI-powered mobile application. It will support the self-management of insulin administration in people with diabetes of type 1 and 2 treated with multiple daily injections in a safe and protected clinical setting.
Work Package 5 - Value proposition, economic analysis, IP, exploitation
A clear understanding of the needs of different users and actors is the basis for MELISSA’s value proposition. This work package aims at gaining the understanding on the crucial issues that will allow a sound go-to-market strategy to realise the full potential of MELISSA. This includes a needs assessment - regulatory issues, economic analysis, care pathways and market analysis.
Work Package 6 – Project communication and dissemination
The communication and dissemination activities will follow a multidimensional, integrated and impact-oriented approach. They will assure optimal visibility and a wide outreach to relevant stakeholders.