REDDIE

Randomised controlled trials (RCTs) are the cornerstone of evidence-based medicine. However, the digitisation of real-world data (RWD), including data from devices, wearables, and electronic health records in large national registries, provides opportunities to demonstrate the efficacy and safety of innovative technologies, including drugs, devices, diagnostics, and digital health. These data are particularly relevant to long-term conditions such as diabetes mellitus, where drugs, lifestyle interventions, and digital technologies often work together. To better utilise RWD in diabetes for regulatory decision-making, the development of standards, guidance and an assessment of the efficacy-to-effectiveness gap is needed. REDDIE (Real-World Evidence for Decisions in Diabetes) aims to explore how RWD can complement RCTs to improve the efficacy, safety, and value for money of technologies to prevent and treat diabetes. The overall aim of REDDIE is to support the use of RWD in diabetes and health-related research, which will maximise Europe’s scientific expertise and know-how to benefit people with diabetes, resulting in safer, more efficient, and cost-effective interventions.