There are almost **NO** meters out there that actually give good readings!!! Reading these articles starts one thinking about how they can achieve any level of control if the best they can get is +/- 20% "most of the time". If a person has a blood sugar of 250, their meter could read anywhere from 200..300: imagine giving a correction 20% too high!!
Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians
The Diabetes Technology Society sponsored a meeting last week entitled, “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” The resounding answer from participants: No.
Clinicians, industry, academics and FDA agreed that certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market.
“The problem is that there are some blood glucose monitors on the market which perform less accurately than the standards would specify and it’s these standards which led them to be approved,” explained David Klonoff, a clinical professor of medicine at the University of California, San Francisco, in an interview.
FDA currently follows the International Organization for Standardization (ISO) 15197:2003, “Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus” when assessing blood glucose meter 510(k) pre-market applications. On May 15, ISO published a revised 15197:2013 standard, which has stricter accuracy guidelines for blood glucose meters, although FDA has yet to adopt it.
Blood Glucose Accuracy Problems Acknowledged by FDA
Experts Agree: Inaccurate Blood Glucose Monitors on the Market May Be
Putting Patients at Risk
More than 40% of the evaluated BG monitoring systems did not fulfill
the minimum accuracy requirements
The American Diabetes Association proposed standard allows
manufacturers to report the % values that fall within 15%, 10%, and
5% (ADA recommends 5%). NONE of the meters on the market today
approach the ADA standard and the most accurate meter has only 63%
Factors Affecting Blood Glucose Monitoring: Sources of Errors in
Accuracy and Precision Evaluation of Seven Self-Monitoring Blood
Glucose Systems (Only 40% of evaluated SMBG systems meet the minimal
accuracy criteria requirement)
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