Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians

By Yerachmiel Latest Reply 2013-11-26 17:41:49 -0600
Started 2013-10-15 21:41:59 -0500

There are almost **NO** meters out there that actually give good readings!!! Reading these articles starts one thinking about how they can achieve any level of control if the best they can get is +/- 20% "most of the time". If a person has a blood sugar of 250, their meter could read anywhere from 200..300: imagine giving a correction 20% too high!!

Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians

The Diabetes Technology Society sponsored a meeting last week entitled, “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” The resounding answer from participants: No.

Clinicians, industry, academics and FDA agreed that certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market.

“The problem is that there are some blood glucose monitors on the market which perform less accurately than the standards would specify and it’s these standards which led them to be approved,” explained David Klonoff, a clinical professor of medicine at the University of California, San Francisco, in an interview.

FDA currently follows the International Organization for Standardization (ISO) 15197:2003, “Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus” when assessing blood glucose meter 510(k) pre-market applications. On May 15, ISO published a revised 15197:2013 standard, which has stricter accuracy guidelines for blood glucose meters, although FDA has yet to adopt it.

Blood Glucose Accuracy Problems Acknowledged by FDA

Experts Agree: Inaccurate Blood Glucose Monitors on the Market May Be
Putting Patients at Risk

More than 40% of the evaluated BG monitoring systems did not fulfill
the minimum accuracy requirements

The American Diabetes Association proposed standard allows
manufacturers to report the % values that fall within 15%, 10%, and
5% (ADA recommends 5%). NONE of the meters on the market today
approach the ADA standard and the most accurate meter has only 63%
acceptance values.

Factors Affecting Blood Glucose Monitoring: Sources of Errors in

Accuracy and Precision Evaluation of Seven Self-Monitoring Blood
Glucose Systems (Only 40% of evaluated SMBG systems meet the minimal
accuracy criteria requirement)

3 replies

Yerachmiel 2013-11-26 17:41:49 -0600 Report

PLEASE report any major problems with blood glucose readings or other things to the FDA: only in this way can we get these things fixed.

The other thing to do is to start posting on alll diabetes related sites that you had such ad such an experience.

And, mostly, make SURE to report to the companie(s) in quesrtion and send a copy of what you send them to the fda!!
My article on reporting said issues:

FDA site to report problems:

clancychick 2013-11-23 17:00:16 -0600 Report

I think they should be more accurate then they currently are. I had a high fasting level 3 months ago and I wanted to try and see if exercise and diet would achieve lowering my blood sugars and to check that by monitoring my blood. What I have found is that it did not matter what type of meter I used, whether the strips were from different containers etc- the fluctuation was huge. I could test simultaneously with 4 different meters a variety of strips and I never got the same reading twice and they would fluctuate up to 60 points even using the same meter and strips. That may not be a lot to some folks, but I am trying hard to not have to use medicine by seeing what increases and what does not increase my blood glucose level and how exercise helps etc. I think it has to be harder and more frustrating for someone on insulin to try to accurately gauge how much to use if the meters are not accurate.

Nick1962 2013-10-16 12:54:53 -0500 Report

We had this discussion a few weeks back and there are definitely 2 sides on this issue. I’m on the “don’t care – it’s just a tool” side. If you have a BG of 250, and have it pretty consistently, your meter isn’t going to help you get any control. At that point you should either be on meds or seriously looking at getting on a strict diet. If you’re hovering around the normal range, 20% only means 25 or less points high or low, which is certainly something I can live with.

Now, that said, if I were a T1 and really wanted that tight of control – I’d be shopping for the better and more accurate “tool” just like I do for my woodworking projects.

Others want the standard raised on a federal level, but I think that'll just add cost to a tool many of us use only as a guideline. I don't need a computer guided laser saw to cut 2x4 lumber.

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