Consensus statement on standardizing CGM evaluation metrics in Latin America: an expert approach.

Abstract

Background: Latin America has no accepted performance standards for continuous glucose monitoring (CGM) technology evaluation. This has resulted in the emergence of various CGM devices in the market that do not meet strict quality, accuracy, reliability or safety standards. CGM systems are crucial for managing diabetes, as they provide frequent glucose measurements and help detect hypoglycemia or hyperglycemia episodes or even predict these events. Ensuring the reliability and accuracy of CGM devices is essential for patient safety. This consensus statement aims to establish a consensus-driven framework of expert recommendations regarding the metrics that should be evaluated to achieve high standards in CGM devices.

Materials and methods: A modified Delphi methodology was employed, engaging endocrinologists, pediatric endocrinologists and diabetologists from Latin America. Experts participated in multiple rounds of surveys and discussions to reach consensus on key characteristics measures, including accuracy thresholds, clinical validation protocols, and post-market surveillance requirements. Quantitative and qualitative data were analyzed to ensure robust recommendations.

Results: The expert panel identified major gaps in existing CGM regulations and established 12 key recommendations and one checklist to align Latin American standards with international best practices. These included the implementation of minimum accuracy thresholds, the adoption of standardized clinical validation protocols, and the enforcement of post-market surveillance measures. The panel also emphasized the importance of patient education, healthcare provider involvement in decision-making, and accessibility to enhance CGM adoption and usability. We underscore the necessity of these measures to improve patient outcomes, patient safety, and regulatory consistency in the region, while also enhancing CGM reliability and accuracy.

Conclusion: This consensus statement highlights the urgent need for a standardized metrics to evaluate CGM devices in Latin America. Implementing standardized accuracy requirements, rigorous validation protocols, and enhanced patient education will ensure device reliability, improve clinical outcomes, and foster a more equitable healthcare landscape for diabetes management in the region.