MELISSA is structured into work packages (WPs) focused on different project aspects, and established a Patient Advisory- (PAC) and Communication Committee (CC). PAC meets regularly and provides valuable feedback to the MELISSA researchers and CC focusses on the wider public outreach. The AI-powered Adaptive Basal–Bolus Advisor (ABBA) - a self-learning system based on actor-critic, model-free reinforcement learning (RL) - was further optimised by leveraging both current and historical glucose values and incorporating insulin-on-board accounting, and extended to support PwD on MDI using SMBG. The updated ABBA was validated in silico using an FDA-accepted virtual population of people with type 1 and type 2 diabetes, showing ~5% increase in time spent in glycaemic range and reductions in times spent above and below range compared to standard bolus calculators. The goFOODTM food segmentation, recognition, and 3D reconstruction features were optimized, and goFOODTM was localized for each trial country’s eating habits. The system now consists of two forms, i.e. goFOODTMLite (only data collection) and the full version of goFOODTM (data collection & quantitative estimation of CHO). The MELISSA App integrating goFOODTM and ABBA designated for the clinical trial has been released on the Google Play store. Multilingual User Requirements Questionnaires for PwD and healthcare professionals have been developed and are being distributed, including at institutions requiring ethical approval for the PwD version. The clinical validation study design for MELISSA has been finalized, with the protocol written and submitted for ethics approval across all study sites. Ethics approval is pending at all sites and partial ethics approval has been granted in Denmark and Germany. Standard Operational Procedures have been finalised, the Data Management Plan completed and the data management system has been built in the RedCap platform. Contracts with manufacturers like Novo Nordisk (for NovoPen 6 and Echo Plus smartpens and provision of insulin), Dexcom (for G7 sensors and receivers), and Withings (activity tracker) have been made for communication with the MELISSA app. Several manuscripts have been published in scientific journals and abstracts have been presented at scientific conferences. The MELISSA solution has been analysed using the business canvas framework, establishing its value proposition and ensure alignment with the true needs of users. In addition, two ethics reports for providing feedback on the project have been delivered. In line with MELISSA’s fifth objective, a sub-study on (digital) health literacy and numeracy is ongoing in the Netherlands, Denmark, and Greece, while in Germany ethical approval is still pending. Finally, a feasibility study has been completed in Switzerland to demonstrate the feasibility of using ABBA in daily practice by PwD.
