Real-World Evidence for Decisions in Diabetes

About REDDIE

Randomised controlled trials (RCT) 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 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, a 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 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.

We thus aim to engage with stakeholders such as regulatory and HTA authorities and co-develop evidentiary standards for the collection, assessment, and acceptability of RWD. We will then develop and validate state-of-the art modelling techniques using synthetic data derived from large national registries to better assess outcomes of interventions using RWD.

We will use data from four large national registries to elucidate the gap between outcomes in RCTs and RWD studies, and understand the factors that affect this gap. Finally, we will test the ability of machine learning to facilitate the better use of RWD. REDDIE will generate standards for RWD use for the evaluation of medicines and other interventions by regulatory authorities and HTA bodies.

Our vision

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 and treatment.

REDDIE Members

14 leading international players from academic, clinical and industrial backgrounds from seven countries will leave their mark in this field by investigating the possibilities of using real-world data.

Timeline

01/01/2023

Start of REDDIE

Link to News and Press release

02/01/2023

Pre-Kick-Off Meeting, virtual

13/02/2023 - 15/02/2023

Kick-off Meeting in Graz, Austria

01/10/2023

Stakeholder Meeting in Hamburg, Germany

22/04/2024 - 23/04/2024

Consortium Meeting in Hillerød, Denmark

31/12/2026

End of the project