The New York Times reports today that the rise in the use of home glucose monitors, also in hospitals, is pushing the Food and Drug Administration toward a possible crack-down on accuracy standards. Some of you might say it’s about time, considering that current standards allow a margin for error of up to 20%, which can make a huge difference in the choices we make on food, exercise, and in particular insulin doses.
And who among us hasn’t been frustrated by odd or inconsistent BG readings, or readings from different fingerstick meters that don’t seem to match up? (Don’t get me started on continuous glucose monitors!)
The NY Times reports that last month, the FDA started pressuring the International Organization for Standardization, which sets the standards,to tighten them. If that group refuses to act, the FDA “may instead recognize other (higher) performance standards” on its own, according to a June letter from agency commissioner Dr. Margaret Hamburg.
Get this: a recent study by government researchers comparing tests from five different popular meters found that results varied by as much as 32 percent. And a similar student project found “that almost all of the meters were off from one another by 60 to 75 points.” As a person who depends on my meter for health and well-being, all I can say to that is: O.M.G.
Quotable from the story:
“Manufacturers have long complained that any requirement to improve accuracy would lead them to raise prices, which would discourage use.”
Um, not so sure about that. Otherwise small competitors like AgaMatrix, with its WaveSense meters, wouldn’t be able to play in the market at all. In fact, this call-out is a great opportunity for the WaveSense folks, whose innovative new method for testing blood glucose is proven to be doubly as accurate as the industry standard — “by detecting and correcting errors caused by differences in blood samples and environmental conditions.” Their Jazz meter is also the only model on the market that calculates your glucose variability (standard deviation), “which many experts believe to be a better indicator of control than A1C testing.”
Not to blantantly plug the WaveSense guys here. But this FDA crack-down may be the wake-up call some of the big manufacturers need on improving glucose meter accuracy, finally. I’m just sayin’…
this threat of raising prices coming on the heals of the news that you reported about a 900% markup on test strips? i think that a little competitive marketing would be in order… i think that the pharmaceutical machine has destroyed that one productive aspect of capitalism in america
I certainly agree, especially considering the approximate 900% markup over manufacturing costs on the test strips (at least according to your interview with David Lazurus not too long ago), and what kind of accuracy is this premium cost giving us? 80% … that’s not sufficient at that level of pricing, they need to step up, maybe this is a sign that the gravy-train days are coming to an end? BTW, I agree, AgaMatrix’ products are much more accurate, especially at the low end of the testing range … proof can be found in the FDA inserts which show the standard deviation at various testing ranges!
I must confess that, while I appreciate cool gadgets and can understand the excitement that smart phone users feel over apps, I don’t give a hoot what it looks like if it’s more accurate. OK, maybe I do give hoot (as I do recall my ridiculous book size accucheck from ’86) but you get my point
We just got a Jazz meter… my daughter really likes it because it’s small, pink and it seems really accurate!
Bravo to the Jazz meter company
ugh – bummer news; and my hubby cut it out of the NYT first thing this morning. My Doc (and Minimed) recently switched me to the One Touch Ultralink (compatible with Paradigm pump) bc the previous meter was thought to have too wide a margin of error. Feh.
Just checked out that Jazz meter – looks nice but those readings look HUGE — no hiding your numbers from anyone, I guess!
Lkg fw to better technology. Funny that the daughter of an investigator for a state Senator did the project that resulted in some governmental heat. Am really hoping this is like a whistle-blow – TIME OUT!!!!
And what happens if the respective meter’s accuracies and reproducibilities are already maxed out [as bad as that might be for a lot of them] and have little to no chance of cost-effectively being improved? You going to remove the only tool diabetics have to self-monitor because the numbers are are not always right? No measurements suck a lot worst than occasional bad measurements and if you mandate accuracy and reproducibility comparable to clinical labs that is what you might very well get.
I would like to get one for my husband… where can I purchase one? I looked online and could not find anyplace…
Not only are the Wavesense meters more accurate, but the strips are much less expensive… Amazon sells strips for the Keynote at $18 for a box of 50…
Finally. This is something that should have happened a long time ago. I do hope this means that innovative companies like AgaMatrix will gain some foothold in the market. I know that using their meters was a big factor in dropping my A1C.
Last night I felt kinda low. Not about to pass out low – just a little shakey. Imagine my surprise when my meter read 25. That is lower than I have ever been before. With the limited brain power I had left I tested again and found that I was 42, tested again and I was 41. Now low is low, but there is a big difference for me between 25 and 42! Meters that become less accurate when you are high or low are pretty much pointless in the hands of most diabetics.
It’s about time. I wonder if more accurate meters will eliminate some “I’m doing everything right and the numbers are still wrong” problems.
Agree heartily with mollyjade; feel like I’m doing well looking at my 30 and 90 day averages (along with a big congratulations for day-to-day readings), and get nailed at the MD’s with the A1c. “Well, it’s not as well controlled as it could be”.
Argh!
And what about the standards for insulin potency? Think those are allowed to range also but I’m not sure.
Early 2008, my insurance company started shipping me a brand of strips manufactured by a 3rd party company to be used with my meters that linked to my Paradigm pump. Shortly thereafter, my sugars were regularly exceeding 450, even when I often felt like I was going into insulin shock; and when my sugars felt normal (or slightly elevated), I rec’d results < 60. It wreaked havoc on my life for weeks, so I conducted a test one weekend across my 3 meters by putting a drop of blood on the 3rd party test strips for each meter. Meter 1 showed 399, Meter 2 showed 36 and Meter 3 showed 240.
I went to Walgreens and bought a new One Touch meter and strips to run comparisons against my 3 meters. Initially, the new meter gave me a result that matched meter #2 the closest, so I though Meter#2 was the only one still working. But I kept running tests throughout the day and rec’d completely random and invalid results across all 3 monitors.
Interestingly, the 3 meters previously worked fine w/ the strips originally manufactured by the meter company. It wasn’t until I started receiving strips manufactured by a 3rd party that I started to experience the problems. So it wasn’t a problem with the meter, but a problem w/ the test strips designed by another company to work with a meter they didn’t manufacture.
My sugar meter & strips are the only tools I have, and though I instinctively knew something wasn’t right for awhile, I trusted my medical equipment was properly working. Hindsight is 20/20.
I wrote a letter to Minimed to give them a “heads up”. I didn’t contact the 3rd party strip manufacturer or my insurance company, but felt an incredible amount of frustration with both. I was grateful not to have ended up in a coma from insulin shock or ketoacidosis.
Here is more information on the accuracy of home glucose meters: http://www.newsinferno.com/archives/9578#more-9578
Great news!
I think that these monitors can be off by as much as 20 percent putting patients at risk for dangerously low blood sugars, which can cause seizures, brain damage, and death.
It makes you wonder sometimes when you see some strange numbers. On Sunday mine started at 238, then jumped to 311 later on. I knew it was high then because I was having problems seeing. A few hours later, it was down to 90; had to check twice because I couldn’t believe it.
I always wonder about drastic changes like that in one day; oh well,…
I was so glad to find out about this about this new monitor because I have gotten so frustrated with the other monitors that are so hard to use plus you can get different readings when you do use them and feel like your sugar is low but the monitor doesn’t accurately denote this. I am going to call and order one of these. I have tried one touch ultra and freestyle. I have been diagnosed with type two for 3 years now and have my A1c in the 6 range. I am currently taking Metformin.
I agree – it is about time.
Isn’t there also some fudge room allowed by the FDA on food labeling? About they only have to be within a certain percentage of the actual value? There’s another monkey wrench to wrestle with.