[Diabetes-Talk] AAccuracy of glucose monitors

[Bridgit Kuenning-Pollpeter]

Since the invention of the home meter, it's been known that the accuracy isn't as great as an A1-C. That's why it's so important we see a specialist on a regular basis and have our A1-C tested. Some meters are of course better than others. But, I will say, in my 30 plus years of being diabetic, using several types of meters, I've never had the accuracy so far off it didn't match closely to my A1-Cs 😊

Bridgit

-----Original Message-----
From: Diabetes-Talk <diabetes-talk-bounces at nfbnet.org> On Behalf Of Sally Maguire via Diabetes-Talk
Sent: Friday, October 26, 2018 9:22 AM
To: acb-diabetics <acb-diabetics at acblists. org> <acb-diabetics at acblists.org>
Cc: Sally Maguire <1.sally at comcast.net>; rich Gill <Rgz06 at att.net>; Milo442.mm at gmail.com; diabetes-talk at nfbnet.org; miriam Plautz <s4health at astound.net>
Subject: [Diabetes-Talk] AAccuracy of glucose monitors

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

 

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