[Diabetes-Talk] AAccuracy of glucose monitors

[Sally Maguire]

7.FDA-cleared blood glucose (BG) monitors not always accurate  In a series
of tests, only 6 of 18 BG monitoring systems that have been cleared by the
FDA consistently delivered levels of accuracy based on international and US
regulatory standards. "Many patients complain that their blood glucose
monitor system is not accurate," D Klonoff Mills Peninsula  said. Dr K and
team did a study with a consensus protocol for testing and metrics of
accuracy that were developed by an expert panel including: leading
clinicians, clinical chemists, patient advocates, and gov regulators from
FDA, CDC and NIH.  Systems were tested in 3 triple-masked studies with each
of 3 clinic sites testing a different set of 6 systems for each study. 1,035
adults with type 1 diabetes (T1D), T2D or prediabetes had capillary BG
level measured on 6 different systems as well as a reference capillary
sample prepared for plasma testing at a reference lab. On average each
monitor was tested by 115 subjects. Six of the 18 systems met the
predetermined accuracy standard in all 3 studies: Counter Next, Accu-Chek
Aviva Plus, Reli-On Confirm Micro , Advanced , FreeStyle Lite and Accu-Check
SmartView.  5 monitors met the accuracy standard in two studies, 3 met it in
one study and 4 did not meet the accuracy standard in any of the 3 studies.
The team concluded  that, in some cases, BG monitors may result in treatment
errors when patients depend on accurate results to determine  RX. Klonoff
says  "There is a role for post-market testing of some products, like [BG
monitors], after these products are cleared by FDA and are on the market,
Their performance in the real world might, in some cases, be different from
what it was at the time the product was originally tested for clearance
purposes.  The FDA needs to be granted more authority from the US Congress
to remove poorly performing products from the marketplace after they are
cleared." Supported by Abbott Diabetes Care. Klonoff reports he is a
consultant for (includes ) Ascensia and EOFlow, has received research
funding from Diasome, Lexicon and Novo Nordisk; and is an employee of the
Diabetes Technology Society. Diabetes Care;Healio 10/9/18