title: Performance of Cleared Blood Glucose Monitors.
abstract: Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ(2) = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ(2) = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences.
authors.affiliation: Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
authors.forename: David C
authors.initials: DC
authors.lastname: Klonoff
authors.affiliation: Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Prahalad
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D002138:Calibration; D003920:Diabetes Mellitus / Q000097:blood*; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D012015:Reference Standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose; D007328:Insulin
keywords: BG monitor; FDA; ISO; accuracy; glucose; performance