Meter Accuracy

Just Joyce
By Just Joyce Latest Reply 2014-03-09 08:56:03 -0500
Started 2014-03-01 15:26:32 -0600

I found this article on http://www.dlife.com

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.

2003
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.

2013
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.

2014
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.

Sources
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.)


10 replies

lanykins
lanykins 2014-03-09 08:56:03 -0500 Report

I use the One Touch Ultra 2. This is after many years of other meters. I like this one but I keep an eye on the consistency of my numbers. If I doubt them I first use the control drops that com with the strips. Usually they are accurate. One time the results were all over the place. I called One Touch and after talking about all I had done, they replaced my meter. This helps me know I am staying on course.

haoleboy
haoleboy 2014-03-05 19:26:37 -0600 Report

I use the ReliOn Prime ($9/50 test strips are the kicker) seems accurate to me … I test with it immediately before getting my labs done and then compare to what the results are on their glucose test … so far (3 times) it has been within 10% of the lab. No complaints here.

PetiePal
PetiePal 2014-03-05 15:22:59 -0600 Report

I've been using OneTouch Ultra2 and Minis since diagnosis. They're covered as are strips at a good discount for me and it's what my endo recommends.

I did test the OneTouch Verio, the Verio (for iPad) and my Ultra 2 one day and did find differences.

So how are we to know which of our meters is MOST accurate? They test me with an Ultra 2 when I go to my endo lol.

Just Joyce
Just Joyce 2014-03-05 18:28:04 -0600 Report

I think the problem is that people are looking for an absolutely accurate meter. That is more than likely literally impossible. There are a lot of different meters on the market. None of them are going to be absolutely accurate.

The one I was tested with at the ER was a One Touch Verio. They were testing it. My reading with that meter was 45. My reading with my meter was 44. As long as I am close I am not concerned about accuracy being absolute.

tabby9146
tabby9146 2014-03-03 11:01:29 -0600 Report

Thanks Joyce! this was very helpful to me. the other day, I purchased a True Result meter. I asked my pharmacist and the person who works there (she is a nurse, worked as one for many yrs) what they recommend, and it was this one. So I am going to post about it, and see how many hav this one and what they think of it. I will be going to some of the sites listed, and read more. I had used my One Touch ultra mini from late 2008, at the time of diagnosis, until just the other day, so just over 5 yrs. I purchased another One Touch ultra mini two yrs later, to have a backup. They always seemed pretty good. I wish my new one was smaller though, and the time it takes for the result is quite a bit slower.

Type1Lou
Type1Lou 2014-03-02 12:15:36 -0600 Report

I upgraded meters last year to the Bayer Contour Next Meter which has a reputation for greater accuracy. Unfortunately, beginning in 2014, my insurer no longer covers the Contour Next strips so I've fallen back on my One-Touch Ultra meter which is about 3 years old. Just another way that insurers place obstacles in our efforts to gain better control…penny-wise and pound foolish!

JSJB
JSJB 2014-03-02 05:09:28 -0600 Report

Thanks Joyce, been using the same meter for the last 3 yrs. Will look for an upgrade when strips run out.

jigsaw
jigsaw 2014-03-01 19:08:28 -0600 Report

Excellent info Joyce! I knew that there were new standards in the works, but that's all I heard until now. Meter info can definitely be a critical factor, and I believe every person with diabetes should be utilizing one.
As a validation, my endo uploads my meter readings on each visit. This allows us to compare the meter to the laboratory results.
Good post, Invaluable info, and much appreciated!

jayabee52
jayabee52 2014-03-01 17:35:59 -0600 Report

Thanks Joyce for sharing that. When my supply of strips runs out maybe it would be time to upgrade to a new meter.

God's best to you and yours
James

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