Standardizing the Accuracy and Performance Evaluation Metrics of Integrated Continuous Glucose Monitors in the Asia-Pacific Region

Abstract

Diabetes is a growing public health burden across the Asia-Pacific (APAC) region. The increasing use of continuous glucose monitoring (CGM) holds significant potential to improve glycemic control and safety outcomes in individuals with diabetes. However, CGM devices in APAC vary widely in technical performance, clinical validation, and regulatory oversight, posing risks of inaccurate readings and treatment errors, especially for nonadjunctive integrated CGM (iCGM) systems. This review synthesizes the literature and regional insights on CGM regulatory frameworks, accuracy standards, and unmet needs. The authors highlight the U.S. Food and Drug Administration (FDA) iCGM standards as the most stringent global standards. Adopting FDA iCGM criteria alongside the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reporting recommendations, with contextual modifications for diverse epidemiological, infrastructural, and socioeconomic settings in APAC, is explored. A phased, regionally coordinated approach is proposed, incorporating voluntary benchmarks, capacity-building for lower-resourced regulators, regulatory reliance mechanisms, and shared postmarketing surveillance platforms. Emphasis is placed on multistakeholder collaboration and region-specific validation studies. Harmonizing iCGM regulatory standards in APAC is anticipated to enhance device accuracy, safety, and interoperability, improve diabetes care, and streamline regulatory processes, serving as a model for regulatory excellence for other emerging medical technologies.