A Review of Blood Glucose Monitor Accuracy

Abstract

The aim of this study was to assess the accuracy of blood glucose monitors (BGMs) from studies reported in the medical literature. A literature review was performed of publications between 2010 and 2017 that presented data about the accuracy of BGMs using ISO 15197 2003 and/or ISO 15197 2013 as target standards. We found 58 publications describing the performance of 143 unique BGM systems, 59 of which were Food and Drug Administration (FDA) cleared. When compared with non-FDA-cleared BGMs, FDA-cleared BGMs were significantly more likely to pass both ISO 15197 2003 (OR = 2.39, CI 1.45-3.92, P < 0.01) and ISO 15197 2013 standards (OR = 2.20, CI 1.51-3.27, P < 0.01). Newer meters were more likely to pass both ISO 15197 2003 and ISO 15197 2013 standards. Many of the studies were supported by BGM manufacturers, and when compared with independent studies, an FDA-cleared BGM was significantly more likely to pass in a manufacturer-supported study for both ISO 15197 2003 (OR = 22.4, CI 8.73-21.57, P < 0.001) and ISO 15197 2013 (OR = 23.08, CI 10.16-60.03, P < 0.001). BGM accuracy should be assessed independently following regulatory clearance to ensure accurate performance. Failure to meet performance levels mandated by standards can result in deleterious clinical and economic effects.

Keywords: Accuracy; Blood glucose; FDA; ISO; Monitor.