Outdated Assumptions Regarding Labeling of isCGM Sensor Performance and Requirement for Self-Monitored Blood Glucose Confirmation: Comment on Reddy and Oliver

Reddy M , Oliver N : Self-monitoring of blood glucose requirements with the use of intermittently scanned continuous glucose monitoring. Diabetes Technol Ther, 2020; 22:235–238.

Reddy M , Oliver N : Self-monitoring of blood glucose requirements with the use of intermittently scanned continuous glucose monitoring: a follow-up analysis using real-life data. Diabetes Technol Ther, 2020 [Epub ahead of print]; DOI: 10.1089/dia.2020.0477

Hellmund R , Weitgasser R , Blissett D : Cost calculation for a flash glucose monitoring system for adults with type 2 diabetes mellitus using intensive insulin—a UK perspective. Eur Endocrinol, 2018; 14:86–92.

Alva S , Bailey T , Brazg R , et al.: Accuracy of a 14-day factory-calibrated continuous glucose monitoring system with advanced algorithm in pediatric and adult population with diabetes. J Diabetes Sci Technol, 2020 [Epub ahead of print]; DOI: 10.1177/1932296820958754

FDA summary 510(k) K193371. FreeStyle Libre 2 Flash Glucose Monitoring System. Safety and effectiveness information https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193371.pdf (accessed February 15, 2021 ).

Bailey T , Bode BW , Christiansen MP , et al.: The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther, 2015; 17:787–794.