Clinical evidence for high‐risk <scp>CE</scp> ‐marked medical devices for glucose management: A systematic review and meta‐analysis

High-risk devices for glucose monitoring or insulin dosing, in particular AID systems, improve glucose control safely, but evidence on diabetes-related end-organ damage is lacking due to short study durations. Methodological heterogeneity highlights the need for developing standards for future pre- and post-market investigations of diabetes-specific high-risk medical devices.