Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps—Literature Review and Consensus Report

Abstract

Background:

The use of Continuous Glucose Monitoring (CGM) devices has significantly improved diabetes management. However, several limitations persist, including the great variation in accuracy, inconsistent study designs, and variations in regulatory approval standards. Therefore, the need for regulatory harmonization, robust validation, and transparent data reporting is crucial.

Methods:

The current consensus report was developed through a structured, multi-phase process to comprehensively assess these challenges. A literature review of databases such as PubMed, Scopus, and the Saudi Digital Library, focusing on publications from 2016 to 2024, evaluated evidence on CGM devices in terms of performance and clinical outcome, with priority given to regional data, randomized controlled trials (RCTs), and systematic reviews. A multidisciplinary panel reviewed the literature, engaging in structured discussions. Recommendations were formulated using the Delphi method, ensuring consensus and alignment with global standards while addressing regional challenges.

Results and Recommendations:

The resulting recommendations advocate for aligning Saudi regulatory standards with international frameworks like Food and Drug Administration iCGM criteria, Medical Device Regulation (MDR)-aligned criteria, establishing and enforcing minimum performance criteria, including dynamic testing for glucose fluctuations, strengthening local post-market surveillance capacity, mandating transparent data reporting by manufacturers, and facilitating comprehensive clinical education and cross-sector collaboration.