Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis.

ABSTRACT:

Introduction

Medical devices, including high-risk medical devices, have greatly contributed to recent improvements in the management of diabetes. However, the clinical evidence that is submitted for regulatory approval is not transparent, and thus a comprehensive summary of the evidence for high-risk devices approved for managing diabetes in Europe is lacking. In the framework of the Coordinating Research and Evidence for Medical Devices group, we will, therefore, perform a systematic review and meta-analysis, which will evaluate the efficacy, safety and usability of high-risk medical devices for the management of diabetes.

Method and analysis

This study has been reported according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Pro

SUBMITTER: Bano A 

PROVIDER: S-EPMC10106051 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature