![]() ![]() “This study in Diabetes Care demonstrated that FDA-cleared BGMs did not consistently perform up to the standards for which they were cleared in the cases 12 of 18 products studied,” lead author Dr. While the end result does create a list of winners and losers, the bigger takeaway is that the majority of meters underperformed - an indictment of the whole category. Finally, this study was triple blinded, which eliminated the possibility of systematic bias based on BGM brand.” Testing performed by health care professionals tends to lead to more accurate results than when subjects test themselves, which could lead to a higher level of accuracy in this study compared with other studies where subjects self-test. Also, the protocol was developed by an impartial expert panel. “All strips and monitors were purchased from commercial suppliers without the manufacturers’ knowledge to avoid positive bias that could occur if a manufacturer were to have an opportunity to submit their best performing strips or monitors for testing. “To our knowledge, this is the largest accuracy study of FDA-cleared BGMs using a consensus protocol created with input from the FDA ever reported in the literature,” researchers wrote in the study. The study, published in Diabetes Care, took a lot of steps to make its results as credible as possible. The four worst performing meters were Philosys’s Gmate Smart, Advocate Redi-Code, BioSense Medical’s Solus V2, and HDI/Nipro’s TRUEtrak. The other five consistently accurate meters were Roche Accu-Chek Aviva Plus and Accu-Chek SmartView, Walmart ReliOn Confirm Micro, AgaMatrix’s CVS Advanced and Abbott’s Freestyle Lite. The best performing meter was Ascensia Diabetes Care’s Contour Next, which was accurate 100 percent of the time at two sites and 99 percent of the time at the third. Results were considered accurate if they were within 15 percent of the lab value, and meters were considered consistently accurate if 91 out of 100 readings or more were accurate. Participants also had their glucose tested at a reference laboratory. Each individual participant used six different meters, with different meters assigned to different participants such that 100 participants at each site used each meter. The complex study included 1,035 subjects spread across three sites. Five were compliant in two out of three sites, three in just one, and four failed in all three sites. Of the 18 BCGs tested, only six were consistently accurate in each of three test sites. In a triple-blinded, multisite, independent study, researchers have found that only one third of commercially available FDA-cleared blood glucose meters in the United States could consistently perform to an accuracy standard close to, but actually more lenient than, the FDA’s. ![]()
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