Performance of Cleared Blood Glucose Monitor Systems

Abstract

Many blood glucose monitor systems (BGMs) do not pass international standards of accuracy, even when they have been previously cleared by the FDA. Patients rely on BGM data to make treatment decisions, and inaccuracy can lead to reduced glycemic control and insulin dosing errors. In order to assess the accuracy of these BGMs and identify trends that might explain these results, we performed a literature review of publications between 2010 and 2017 that present 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 FDA-cleared. When compared with non-FDA cleared BGMs, FDA-cleared BGMs were significantly more likely to pass both the 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). We also found that newer meters were more likely to pass each ISO standard for both ISO 15197 2003 (OR: 1.06, CI: 1.06-1.07, p<0.001, odds ratio reported for a one-year period) and ISO 15197 2013 standards (OR=1.06, CI: 1.03-1.06, p<0.01, odds ratio reported for a one year period). Newer meters tend to favor using the test strip enzyme glucose dehydrogenase (GDH) compared to glucose oxidase (GOX), which correlates to an increased likelihood of passing ISO 15197 2003 (OR=0.23, CI: 0.13-0.38, p<0.001) and ISO 15197 2013 (OR=0.24, CI: 0.15-0.35, p<0.001). We note that many of these 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). We conclude that BGM accuracy should be assessed independently, both prior to FDA clearance and again during additional surveillance studies, to ensure accurate performance over time in real-world settings. Failure to do so can result in deleterious clinical and economic effects. Disclosure F.G. King: None. D.T. Ahn: None. V. Hsiao: None. T. Porco: None. D.C. Klonoff: Consultant; Self; Ascensia Diabetes Care, Lifecare, Intarcia Therapeutics, Inc., Voluntis USA, Novo Nordisk Inc., Onduo, Trividia Health, Inc., American Diabetes Association, The Endocrine Society, American Association of Diabetes Educators.