Test Strip Accuracy: We can speak up

John Crowley
By John CrowleyCA Latest Reply 2014-07-03 16:24:44 -0500
Started 2013-08-26 12:18:24 -0500

So I'm sure some of you have heard and some of you haven't heard about the current grassroots campaign to get the FDA to be more strict in their requirements and monitoring of test strip accuracy.

Did you know that for blood sugars over 75 mg/dl your meter only has to be within +/- 20% of your actual number to be FDA approved? (That means, for example, that a reading of 100 on your meter means your actual blood sugar is somewhere between 80 and 120.)

And recent studies have shown that many meters/strips on the market don't even meet those accuracy requirements. (Read more here: http://www.jdst.org/September2012/PDF/VOL-6-5...)

So people with diabetes have started a letter-writing campaign to get the attention of the FDA. That campaign is called Strip Safely (http://www.stripsafely.com/). Visit the website to learn how to let your voice be heard.

Also, there's a fun Diabetes Art Day, today, August 26, 2013, that you can use your used strips to create art that draws attention to this important issue. You can see some great creative examples here: http://www.diabetesartday.com/diabetes-art-da...

So speak up! Let the FDA know that you cannot make good food and medication choices if you can't trust the number on your meter.


24 replies

evaziem
evaziem 2014-07-03 16:16:34 -0500 Report

This is what I discovered:
I had NO idea that my glucose meter measurements may NOT be what the numbers show until my insurance changed me from Accu-chek to Prodigy.

I had some strips left so I used both and to my astonishment I discovered that from the SAME puncture my numbers vary between from a few to over 40 mg/dl of glucose!!!!!!!!!!!

The difference is not constant, it varies.
See this:
http://www.conexbridges.com/BGLtable.pdf
http://www.conexbridges.com/BGLplot.pdf
http://www.conexbridges.com/Differen.pdf

Copperchef
Copperchef 2014-07-03 08:51:40 -0500 Report

Recently, have had some heart arrhythmia problems,(A-Fib) and have had several and I mean several blood tests. My doctor ordered a blood glucose level each and everytime to make sure there were no outside factors aiding the arrhythmia. Seems my Freestyle meter is pretty accurate, as my doctor told me it is within 5% of my lab results.

Dr John
Dr John 2013-09-08 14:33:14 -0500 Report

Even the hospital glucose meters and test strips are NOT FDA approved for clinical use. I have found the Freestyle Lite to be about the best currently on the market. That is what I use.
John

forsakes alive
forsakes alive 2013-08-28 10:01:30 -0500 Report

This type of situation with the test strips is very true, I can say I have tested 3 times in a row and the numbers are within 15 to 20 ,considering each test done. It certainly would help to actually know the proper reading of the BS result taken. Question: Is the A1C actually correct or within the same percentile as the strips?

Nick1962
Nick1962 2013-08-27 16:17:30 -0500 Report

I think Iron brings up a good point (mostly). We complain when the government sticks their nose into things, yet here we go asking them to. Improved accuracy will drive up the cost on the one thing nearly every diabetic is pretty dependent on. Of course when strips become $3 each we’ll go on to blame “big pharma” for taking advantage of us.

We all test for different reasons. For some it’s deathly important, while for others, well, I wonder why they bother. If you’re seeing numbers in the 290’s (mg/dl) or the 60’s routinely, a 20% difference is important yes, but the problem lies more in how you got those numbers to begin with, not the meter.
I think mandating the +/- be within 15% is reasonable, but anything beyond that would be like mandating that every car on the road be equipped with 8 air bags and crash avoidance sensor technology.

I would go for the FDA offering a “certification” for manufacturers who can meet a “premium” level on unit/strips that can prove X% accuracy. If you want/need the premium unit then fine, but I can already see some insurance companies not picking up the extra cost, and a lot of people then opting for the “off brand” less accurate setup.

Right now, anyone needing that degree of accuracy is probably over testing or is a good candidate for a CGM. I think “big pharma” will eventually hear and start marketing more accurate stuff on their own, just to get ahead even if the FDA doesn’t get involved. I think it’s still more responsible of me to get my condition in a range where 20% doesn’t matter. For those who simply can’t get into that range, I think a one-time purchase CGM will become the more cost effective norm for them versus an $8-$12 daily outlay on strips.

Gabby
GabbyPA 2013-08-28 20:31:34 -0500 Report

You know how I feel about the FDA, and while I don't care for what they do, if they are going to do it anyway, then it would be nice if the makers were held to the standard they are given.

I suppose we would be none the wiser if they did it on their own. I am not sure. Free market can work several ways. Those of us who need cheap and those of us who desire accuracy. The market can be there for both and it's true, you get what you pay for.

I didn't read anywhere on the site a list of which meters and strips are the most accurate? Did you see that anywhere?

Nick1962
Nick1962 2013-09-03 09:54:50 -0500 Report

We set up groups and organizations like the FDA, ISO, Building Code Councils, EPA, etc. to serve as a broad reach protection group for the masses, and we expect those manufacturers governed by such to abide by the rules and limits we the public agreed upon. We all have different views on just how far they should be allowed to reach.

Starting on page 8 of the study, there is a table list of 34 of 43 manufacturers sampled. 9 couldn’t be tested because of an oxygen sensitivity variable that the manufacturer openly claimed can skew results.
Frankly, most “brand name” meters out there will have no trouble meeting a 15% standard with a little work if they don’t already. One or two of them listed should really not even be on the market because the accuracy of them is useless.

Setting up a mandate pretty much gives a manufacturer the option of improving by good faith efforts, or simply saying “OK, fine, but it’ll cost you”. You’re absolutely right that free market could handle this. If Consumer Reports repeated this study and published the results of 50 manufacturer’s units/strips, like they do with many products, units like the Seniorline gm210 would be off the market in a few months. In fact I can’t even find the manufacturer for this one anymore, and I suspect it’s because of this study – free market at work!

You and I have differing views on regulatory agencies, but we do agree that the free market is often a better filter for inferior products. Maybe instead of speaking up to the FDA we should be speaking up to the manufacturers directly (via consumer groups). This study laid a pathway for that.

IronOre
IronOre 2013-08-27 13:09:26 -0500 Report

I have to be honest with you. I have been a bit fed-up with the nonsense that is going around lately that more accurate test strps are needed for better diabetic control. Who started all this ???
With increased accuracy you will get increased cost, and who needs that ???
After 38 with with T1, I am a bit bewildered at the incredible testing that diabetics are doing to keep their readings within a very small range, when no knowledgable doctor would tell them that it is necessary.
What I have noticed is that the diabetics that are doing lots of testing are causing themselves problems, because they may make a correction when none is necessary. What I am saying is that one should only test after they have leveled off, and not when the reading is in the middle of an upward or downward slope, because this cause cause big probelms ~ taking additional insulin when none is needed is a big issue here.
I could go on and on here, about this issue . . . I am just ticked off at the nonsense that so many diabetics feel necessary to put themselves thru.
I you want more accurate test strips, then go buy the quality that doctors and clinics use in their office, and pay what they pay. But please stop pushing the price up.

silvie mae
silvie mae 2013-08-28 10:33:49 -0500 Report

What is being asked is that there is a plan in place to enforce The current FDA standards. Which is in my opinion necessary. I am fortunate to have a cgm, but not everyone can afford one.

John Crowley
John CrowleyCA 2013-08-27 15:11:25 -0500 Report

Fair points. There certainly can be cases of over testing. However, did you read the study that 42% of the meters tested failed to meet the somewhat loose requirements of +/-20%? That's concerning to me.

If someone tests and their meter reads 290, the range of their actual blood sugar is 232 and 348—and that's if their meter is within the required acceptable range. If almost half of the meters tested, didn't meet that requirement, that means the range could be even wider. Would you make different treatment decisions based on a say a 210 than a 350? Of course. And that's precisely the worry here.

No one wants to drive up prices. But we also don't want to be making treatment decisions based on bad information. Can't there be a middle ground?

evaziem
evaziem 2014-07-03 16:24:44 -0500 Report

See my data I collected and posted above. It starts "This is what I discovered:"

This is unacceptable!

Gabby
GabbyPA 2013-08-28 20:27:31 -0500 Report

My husband says, "right tool for the job" and if we have good tools, we will do a better job. I included in my FDA letter that I didn't want to seem ungrateful for how far we have come. I know compared to how many of you had to figure out your range not that long ago was much more difficult. But it is not that way anymore, and while I agree, micro managing our numbers is not always best, knowledge is power. I would like to have a more fact based knowledge when I test.

Getright65
Getright65 2013-08-27 08:05:22 -0500 Report

Are u saying that monitor are not. Reading right ?

John Crowley
John CrowleyCA 2013-08-27 09:49:39 -0500 Report

What this campaign is about is that there are issues with how accurate our meters and strips are. There will always be some degree of inaccuracy with a meter (a "perfectly" accurate meter and strips would be so expensive none of us could afford it). But we're learning that first of all the allowable range of inaccuracy is pretty large. And after a manufacturer is approved, the FDA has no program to check to make sure they are staying within the accuracy requirements.

joemonzo08
joemonzo08 2013-08-26 20:42:26 -0500 Report

I need to send one too. This just happened to me two hours ago and had to leave work early. Sugar read 95 but checked a few minutes later and it was 59

Gabby
GabbyPA 2013-08-26 17:14:11 -0500 Report

This is really a great way to get our voices heard. Thank you so much for finding all these great links and sites. I have taken the quiz (which was rather eye opening) and I have sent off a few letters to the FDA. Every little bit helps. Join in, make a noise.

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