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Moving to Better Meter Accuracy: Understanding the standards then and now
By Bennet Dunlap
For many of us, a blood glucose meter is the compass we use to navigate diabetes self-management. An inaccurate meter can result in missing the right direction with diabetes care.
A recent survey from the American Association of Diabetes Educators (AADE) shows that people with both type 1 and type 2 diabetes experienced health problems as a result of blood testing inaccuracy. Their report goes on to say that, "…more than two-thirds were not aware that many meters available today do not meet global standards for accuracy."1
Those standards can be more than a little confusing. Maybe for the 2/3 of us who are not fully aware of them, it isn't our fault. Here is a quick look at the standards followed by simple suggestions to help you be sure you have the right meter system.
The global accuracy standard is set by the International Organization for Standardization, commonly called ISO. In 2003, the ISO standard required meters to be within a range of +/- 20%, 95% of the time. The "many meters available today," mentioned above were approved to meet the 2003 standard. This includes many for sale at your local pharmacy right now.
In 2013 ISO tightened their standard to +/- 15% over 100 mg/dl and within 15 points under 100, 95% of the time.2 Those 15 points are +/- 15% at 100 mg/dl, 20% at 75 mg/dl, 30% at 50 mg/dl, and worse below that. The standard gets worse in hypos where accuracy matters.
Knowing these new standards were coming, some meter system introduced in the past 18 months meet the new standards. However, in the USA the FDA has not adopted the new standard and not all meter systems currently for sale meet the 2013 standards.
In 2010, the FDA started a process to consider tighter accuracy standards. As the 2013 ISO standard was being considered, the FDA spoke for tighter global accuracy standards, particularly in the hypo range. They were not successful in that effort but the FDA is not required to follow ISO.
On January 7, 2014, the FDA shared proposals for new accuracy standards in the US that are tighter than those adopted by ISO in 2013. The FDA split the proposed rules for in-hospital meter systems3 from those used at home.4 The self-management standards that are similar to the new ISO rules for home use but tighter than ISO in the under 100 range. The proposed standard is +/15% through the full range 95% of the time. The in-hospital standards are even tighter.
What is important
All that ISO / FDA stuff can seem like so much gibberish. It is perfectly reasonable to not understand it all. What matter is this:
• Meter systems are becoming more accurate globally.
• If you have been using the same meter system for a long time, it is a good idea to talk with your care team about an upgrade.
• You don't need to know all the gibberish. Talk about accuracy with your physician, diabetes educator, or pharmacist.
• Ask for training to help you understand how to use a meter as a tool to live healthier with your diabetes.
• Be sure they prescribe, by name, a meter meeting more accurate 2013 standards.
• Get the system they prescribe.
• You may need to do the same thing again, in a year or two, when meters that comply with new FDA regulations come to market.
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
Last Modified Date: February 04, 2014
All content on dLife.com is created and reviewed in compliance with our editorial policy.
1. AADE. Research Highlights the Need to Ensure Accuracy And Patient Choice of Diabetes Testing Supplies. http://www.diabeteseducator.org/About/Media/1.... (Accessed 01/2014.)
2. ISO. In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. https://www.iso.org/obp/ui/#iso:std:iso:15197.... (Accessed 01/2014.)
3. FDA. Blood Glucose Monitoring Test Systems for Prescription Point-of- Care Use Draft Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/D.... (Accessed 01/2014.)
4. FDA. Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use Draft Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/D.... (Accessed 01/2014.)
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