A handful of studies presented at this month’s meeting of the Diabetes Technology Society suggest that blood glucose meters, used by diabetics to regulate blood sugar, may not be as accurate as believed.
Researchers said during the meeting that the same devices that met the 95% accuracy standard required to win FDA clearance frequently fell short in post-market testing.
"There have been a lot of advances in the technology of the meters but we have not seen great strides in accuracy," FDA diabetes chief Katherine Serrano said told Kaiser Health News.
Researchers at the meeting presented at trio of studies questioning the real-world accuracy of blood glucose meters, including a pair of studies from German Institut für Diabetes Technologie researcher Dr. Guido Freckmann and a U.S. study by Ronald Brazg of the Rainier Clinical Research Center in Renton, Wash.
That may be a problem for device makers, especially since international standards for blood glucose meters have tightened. ISO standards require that blood glucose meters stray no more than 15% above or below the true value at least 95% of the time.
Serrano warned that medical device makers may not have much incentive to advance blood glucose metering technology, especially since new devices don’t have to undergo clinical testing before hitting the U.S. market.
