New Standards for Meters
The new International Performance Standard is ISO 15197:2013 but many people are currently using non-ISO2013 compliant meters. People will need to change their meters before May 2016 because gradually the test strips will no longer be available as meters not meeting the new 2013 standards are removed by manufacturers.
On March 14, 2013, the European Association of Diabetes (EASD) issued a press release stating that the current system for meter approval was unacceptable. The press release goes on to state that it is vital that glucose meters, insulin pumps and other devices used in diabetes are subject to proper regulations so that people with diabetes can manage their diabetes safely… this led to the new 2013 accuracy standards (ISO: 15197:2013)
What’s the difference in standards?
The 2003 ISO guidelines specified that 95% of the test results must be within a 20% error margin on samples over 4.2mmol/l or within above or below 0.83mmol/l on samples below 4.2mmol/l. The 2013 standard specifies a tighter 15% error margin for samples above 5.5mmol/l and above or below 0.83mmol/l for samples below 5.5mmol/l.
The 2013 tighter accuracy standards (ISO: 15197:2013) were drawn up, requiring that 95% of blood glucose results should reach the following standard:
Within ± 0.83 mmol/L of laboratory results at concentrations of under 5.6 mmol/L (Within ± 15 mg/dl of laboratory results at concentrations of under 100 mg/dL)
Within ± 15% of laboratory results at concentrations of 5.6 mmol/L (100 mg/dL) or more
By the end of May 2016, these new standards are being implemented which is a tighter range than the older 2003 ISO guidelines.
Some meters that meet the new guidance include:
As far as blood glucose meters have come in the last 40 years, rarely do two finger prick tests show the same result, even with the same blood sample and meter. This continues to be a frustrating part of diabetes management, and the all you can do is try to use the same meter as much as possible, if it seems out do check its accuracy with control solution (available from your meter company customer services)
Blood Glucose Accuracy
Even with the new standards, the table below shows acceptable variation of levels that fall within the new guidelines. The new standard requires meters to meet the accuracy guidelines 95% of the time.