Real-World Evidence for Decisions in Diabetes

First REDDIE Stakeholder Meeting

Hamburg/Germany, 1 October 2023

REDDIE (Real-World Evidence for Decisions in Diabetes) aims to explore how real-world evidence can complement randomised controlled trials to improve the efficacy, safety, and value for money of technologies to prevent and treat diabetes. The ultimate goal of REDDIE is to integrate the project results (including the GRADE quality standard system) into new data-driven decision-making processes, especially for novel glucose-lowering medication and diabetes technology, including digital health innovations. To secure the best possible outcome of the project, expert stakeholders were invited to be a part of the first REDDIE Stakeholder meeting on the first of October, 2023.

The Stakeholder meeting was held in connection with the upcoming EASD annual meeting in Hamburg at the Hamburg Exhibition and Congress. The main objective of the meeting was to focus on REDDIE’s goal of developing standards to use real-world and synthetic data to bring technologies to people with diabetes. The meeting started with work package leaders bringing everyone up to speed and presenting the goal of each work package, where participants had the opportunity to ask questions to deepen their knowledge about REDDIE.

The chairs were Professor Pratik Choudhary, WP2 Leader from the University of Leicester, and Professor Amanda Adler, WP3 Leader from the University of Oxford. Five speakers, who are experts in real-world evidence, were invited to join the meeting and share their knowledge of real-world data. Jesper Kjær from the Danish Medicines Agency (DMA) opened the sessions with the topic of Big Data Workplan 2023-2025. Jesper shed more light on AI and eHealth in the work programme and at national competent authorities, including some activities where REDDIE is already involved and the benefits of this involvement on the project.

Afterwards, Professor Stefano del Prato from the European Diabetes Forum (EUDF) shared how to use RWE to reimburse new pharmacologic agents. The presentation focused on re-imagining how diabetes care is delivered and working together to make its diagnosis, treatment, and management better while using diabetes registries, RCTs, RWE studies and the current status of data we have. Catherine Cohet from the European Medicines Agency (EMA) explained how to use RWE for approval of new medicinal products. Many discussions arose around the EU dataspace and standardization guidelines to improve the current data approach and collection. Generating evidence for the use of digital tools in diabetes was a great topic presented by Peter Schwarz from the International Diabetes Federation (IDF). Peter argued that smart health is a disruptive innovation in the diabetes sector and explained the benefits of developing diabetes apps. The last speaker was Emel Mashaki Ceyhan from Novo Nordisk, who explained how to use RWE from an industry perspective. Emel shared more about unmet medical needs, different patient needs, the increasing number of clinical trials, limitations of RCTs and current trends in RWE utilization.

The opportunities to connect academic researchers with valuable stakeholders are not so often presented. The goal of the meeting was to ensure that the project results are constructed from as many different points of view to bring people with diabetes new innovations in their daily lives. The Stakeholder meeting brought new ideas on how to use Real World Evidence to improve decision-making around diabetes drugs and devices. We are looking forward to working with all relevant stakeholders through the next steps of the project.” explains Dr Julia Mader, Associate Professor of Internal Medicine and diabetology at the Medical University of Graz and coordinator of the REDDIE project.

The meeting finished with a short talk from Jan Wolf, a member of the Technical Standards Commission for Medical Devices, with his perspective on the mentioned topics and what is currently developing within the Czech Republic. As the REDDIE project progresses, we are looking forward to organizing more Stakeholder meetings, bringing regulators, HTA body representatives, patient associations and diabetes treatment guideline authors to help enable the best outcome from project REDDIE.