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Tighter standards for glucose meters

By Editor
22nd March 2016
Latest news, Medical devices

People with diabetes will benefit from new quality standard for self-testing glucose monitoring systems.

The revised guidelines for the devices was published in 2013 by the International Organization for Standardization (ISO).

They were developed to ensure results are accurate and consistent for people who have diabetes.

Blood glucose metering companies have until May 2016 to comply with the new standards.

Project leader for ISO 15197, Dr Alan Cariski, said: “More accurate glucose measurements will help patients to better regulate their diabetes through more informed treatment decisions that may affect, for example, dietary intake and medication dose, especially insulin.”

The new guidelines differ from the previous version, which was laid out in 2003, on the following points:

  • Increased accuracy for glucose meter systems, in particular for glucose values greater than 75 mg/dl (4,2 mmol/l)
  • Manufacturers of glucose meter systems must ensure their technology enables accuracy to improve from +-20% to +-15%
  • The new version accounts for 99% of results, as opposed to 95% for the previous one
  • For the first time, the standard provides formal acceptance criteria for accuracy as regards testing by patients and assessment of interferents (including hematocrit).

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