During the project thus far (51 months), the primary focus has been to implement clinical studies and collect data, integrate multimodal datasets for assessing type-2 diabetes patient staging, prognosis, and treatment monitoring, and develop an innovative Digital Twin tool for improving individualized healthcare.
This included the following important steps:
1. Design of the study including the clinical procedures and sampling protocols, data management and transfer, quality control and dynamic imaging algorithms, and data protection and handling procedures; and
2. Preparation and submission of ethics protocols, including patient questionnaires, informed consent forms, specialized training by clinicians, and Medical Device Regulation (MDR) documentation for the RSOM for all sites;
3. Completion of first timepoint achieving the targeted patient cohort through the Estonian Biobank, and initiation of first timepoint for the TUM-led study, which has been expanded to a multi-center study;
4. Integration of omics profiles, optoacoustic (RSOM) dynamic and static data (images and raw data), and advancing pipelines that will be used to refine and validate the Digital Twin.
5. Close work with an external Ethics Expert and Clinical Research Organization to ensure that all ethics, especially those concerning data protection and potential implications of project results, are understood, discussed and complied with by the Consortium;
6. Design and implementation of the structure and data access procedures of the central database;
To exploit and disseminate the current set of results, several actions were taken, including:
1. Frequent and open communication within the General Consortium, Management and Steering Committee (MSC), and Dissemination-Exploitation-Communication Committee (DECC);
2. Management and update of the Dissemination, Exploitation and Communication plan;
3. In-depth market strategy and stakeholder engagement initiated and continuously in progress to ensure clinical uptake and facilitate exploitation of identified IP;
3. Maintaining the project website and social media accounts (Twitter, LinkedIn, BlueSky), with frequent posts and organized Twitter campaigns lining up with important international awareness days;
4. Publication of nine peer-reviewed papers (6 in RP3, including one in Nature) and extensive participation in workshops and conferences by consortium members;
5. Participation in public outreach events and through media press releases ; and,
6. Collaboration with Complementary Grants and joint (1st) International Symposium for Digital Twins in Healthcare in 2024.
In the final stage of the project, the project will focus on continuing to integrate biomarker identification with deep molecular phenotyping in correlation studies and begin assessing disease progress with the start of the second timepoint of the clinical trials.
