A novel flash glucose monitoring system in patients with diabetes mellitus type 1 and 2: which are the pieces of evidence for payer decision-makers?

A rigorous health technology assessment is necessary to evaluate a new technology. However, healthcare regulatory agencies have less restrictive rules about medical devices, despite some recent warnings about this relevant matter. The evaluation should have at least two key issues, which require attention. The first one is its effectiveness, and the second one is its economic sustainability. In this paper, we deal with a novel glucose-sensing technology as a case study to examine the matter in depth. An evidence-based point of view is used to highlight this important issue.