Possible Impacts of New Accuracy Standards of Self-Monitoring of Blood Glucose

Abstract

Self-monitoring of blood glucose (SMBG) was an integral part of reduction of complication rates in the landmark Diabetes Control and Complications Trial (DCCT) in Type 1 diabetes. However, the accuracy and standardized reporting of SMBG devices remains a key concern, with the 2003 version of International Organization for Standardization (ISO) 15197 standards allowing for 5 % of readings to fall outside of the acceptable ranges. A recently revised 2013 version of the ISO 15197 standards includes stricter accuracy standards, with a 36-month transition period recommended before compliance becomes mandatory. These new accuracy standards will have implications not only for manufacturers of currently available and future devices but also for the end-users, who may face rising costs and necessary measures to improve patient error rates associated with SMBG in routine clinical practice.