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Personalised Medicine in Diabetic Chronic Disease Management

Periodic Reporting for period 2 - PROMINENT (Personalised Medicine in Diabetic Chronic Disease Management)

Reporting period: 2019-09-01 to 2023-08-31

Diabetes is increasing rapidly from 415 million patients in 2015 to 642 million patients by 2040. As a result, it will become the leading disease worldwide, affecting 1 out of 10 persons globally and 3 out of 4 in low and middle income countries according to the International Diabetes Federation.

With increasing age in the population, adequate treatment of chronic diabetes becomes more and more important to avert the increasing illness and the societal burden. About half of the diabetic patients are at risk for renal and cardiovascular complications associated with an increased disease burden and death rate, the latter even surpassing the death rate in all treated cancer patients. To avoid this, current practice is to treat the patient for factors that increase the risk of that patient for bad outcome by lowering risk factors such as life style (high salt and protein intake, sedentary life etc), lowering of high blood glucose, high blood pressure, high cholesterol, and protein leakage in urine. Despite the successful treatment of these risk factors, most diabetic patients still show marked long-term effects of the disease such as a progressive loss of multiple organ function, in particular in the cardiovascular and renal systems.The major reason for the lack of treatment efficacy is the large variation in individual response to the treatment. Consequently, there is a huge unmet need in the treatment of this chronic disease.

Studies indicate that approximately half of the patients do not benefit from new registered drugs. Drugs are however registered for a disease (after doing clinical trials in large homogeneous patient group) and not for an individual patient with very different characteristics. Hence, chronic diabetic disease management is in need of increased attention for a more individual and dedicated approach of care. A huge step forward in chronic diabetes disease management is personalised/precision medicine. Personalised/precision medicine is defined as a medical approach which is tailored to the patient for prevention, prediction and treatment of disease using information about the patient’s genes, proteins and environment.

The largest hurdles in switching from a one treatment fits all concept to a one fit for each patient concept, is not only to define individual mechanisms of disease and find a drug for each mechanism, but also to implement the concept in practice. The latter is particularly difficult since multiple stakeholders are involved: academia, (pharma) industry, legislators, payers/Health Technology Assessors, doctors and not to forget patients. The COFUND PROMINENT programme brings prevention, prediction, and treatment together and aims to introduce personalized/precision medicine in chronic diabetes disease management. The programme therefore includes training 16 fellows distributed over the different stakeholder domains, and having them interact together and being trained together, so to understand each others' domain "problems" of introducing personalized/precision medicine. PROMINENT aims to educate the next-generation employers, who can perform high quality research, and who can subsequently have a major impact on scientific breakthroughs that foster the European society and economy.
The first year of the project focused on the recruitment and selection of the Early Stage Researchers. The main result achieved from this part was that 16 highly motivated and qualified Early Stage Researchers were selected.

During the second year of the project, the Early Stage Researchers started working on their training and projects.
Training: All fellows started with their training program which consist of general and specific training courses for that fellow. Next to that there is the specific PROMINENT training programme. Two Training Schools were developed: "Personalized medicine in diabetes practice" and "Regulatory aspects of personalized medicine: the basics", and the Early Stage Researchers participated in these Training Schools.
Research: A progress report of the research and PhD track of each fellow was composed and evaluated according to standard protocols. Each fellow was scored to be on track. All but one continued to the next stage in their research program. The first conference abstracts were submitted, presentations were given, and a paper was published.
We expect at the end of the project:
1. Well trained PhD students that are equipped for a high ranking job in their respective stakeholder environment (academia, industry, legislators, payers/Health Technology Assessors, healthcare)
2. A high level thesis for each fellow
3. Increased scientific knowledge on personalized/precision medicine in the treatment of diabetes
4. Template of a training program that can be used in other programmes
5. A high visibility of PROMINENT program and results so that society becomes aware of the importance