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Medical Forum / Diseases and Disorders / Diabetes / July 2009FDA Cracking Down on Accuracy of Glucose Monitors
http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-glucose-mon itors.html 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 its 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. > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-... > The New York Times reports today that the rise in the use of home [quoted text clipped - 4 lines] > difference in the choices we make on food, exercise, and in particular > insulin doses. I was diagnosed before home bg testing, and I know for sure that bg testing, even despite it's guaranteed 20% tolerance (really, comparing my lab tests with my fingerstick tests it's closer to 5% for my meter), is way better than the urine testing they taught me as a kid. I fear that if some congressperson hears about the 20% number, that he'll whine until the FDA "cracks down" and bans all existing glucose meters and we'll be back to urine testing only again. Stone knives and bearskins. Tim. Tim, my meter is very accurate when compared to the veinous blood test given to me. I dont think that congress is banning meters, I cant imagine what life was like for diabetics before meters. It must have been so much harder to manage and control. Whatever the discrepancy might be, it is in the ballpark and it is better to have an idea than to have no idea at all. Loretta -- I > Tim, my meter is very accurate when compared to the veinous blood test > given to me. The thing is, different people have different expectations of accuracy. People expect that if they check their bank balance twice a few minutes apart, that they should see the exact same numbers. But when they see on bg meter say "82" and another say "85" - and maybe they've been misled to believe that 82 actually means something different than 85 - some people start to get worried. I always do fingerstick checks with my meters before and after my regular lab blood tests and compare the numbers, too. I'm very satisfied with the resulting accuracy. The one thing that's guaranteed to make the meter give me a wrong answer, is to have something sticky on my fingers (very common now that I have three little kids!) I'd be surprised if better meter accuracy addresses this problem, maybe the new meters will just flash "ERR" more. > I dont think that congress is banning meters, I'm sure that some congressperson will get quoted in the news real soon, saying how it's awful that his elderly grandma can't tell the difference between 82 and 85, and he's gonna do something about it. What can a congressman do? Lean on the FDA to regulate, and for FDA regulate means to stop the sale of something. > I cant imagine what > life was like for diabetics before meters. It must have been so much > harder to manage and control. Been there, done that. Stone knives and bearskins. (Go watch "The City on the Edge of Forever"). Tim. > >http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-... > > The New York Times reports today that the rise in the use of home [quoted text clipped - 14 lines] > meters and we'll be back to urine testing only again. Stone knives and > bearskins. LOL. I remember my first glucose meter...it seemed the size of a book andI think it ran on coal! They've come a long way. I've used One Tocuh meters exclusively for years now. My endo's nurse said that of all the meters people bring in the One Touch is the most accurate when comparing to labs. Kurt >> >http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-... >> > The New York Times reports today that the rise in the use of home [quoted text clipped - 14 lines] >> meters and we'll be back to urine testing only again. Stone knives and >> bearskins. > LOL. I remember my first glucose meter...it seemed the size of a book > andI think it ran on coal! They've come a long way. My mother's first BG meter was very expensive, about the size of a deck of cards, and very heavy. You put a drop of blood on a test strip and waited for it to change colour. The colour then had to be matched against a colour chart to get a very approx indication of BG. She wasn't very good with gadgets, so I had to learn how to use it on myself, and then teach her. That was decades before I became diabetic. That early familiarity with BG meters was what led me decades later to pick up one out of simple curiosity when they were on very cheap offer in a local supermarket. Only to discover scary things about my postprandial BGs which my doctor's blind adherence to the dumb diabetic diagnostic guidelines of the time had failed to spot! That led to my diagnosis probably years before my A1C or morning fasting BG would have become bad enough for my doc to take notice. Even though I'd been complaining for years about what I now know were typical diabetic complications. Unfortunately I was also old, and they were also typical complications of getting old.  SignatureChris Malcolm > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-glucose-mon itors.html > The New York Times reports today that the rise in the use of home [quoted text clipped - 4 lines] > in the choices we make on food, exercise, and in particular insulin > doses. Whether that would be a bane or blessing might be determined by what it takes to get there. If all the equipment costs twice as much to increase the accuracy, is it really worth it? > > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of- > glucose-monitors.html [quoted text clipped - 9 lines] > takes to get there. If all the equipment costs twice as much to increase > the accuracy, is it really worth it? The key phrase is "up to 20%" which is NOT the same as all meters having a 20% error rate. In other words; the 20% figure is the high error rate, not the average, and does not say that there are no accurate meters out there. You may want to look at Consumer Reports evaluations of BG meters, but note you have to register to see the evaluations. Accuracy is one of the things they evaluate. http://www.consumerreports.org/ Search "blood glucose meter ratings" The One-Touch UltraMini is at the top of their ratings list, in both Consistency and Accuracy. -- ==== Tecknomage ==== Be mindful that happiness isn't based on possessions, power, or prestige, but on relationships with people we love and respect. Remember that while money talks, CHOCOLATE SINGS! > http://www.consumerreports.org/ > > Search "blood glucose meter ratings" > > The One-Touch UltraMini is at the top of their ratings list, in both > Consistency and Accuracy. It's certainly at the top of my list in carry-around-ability. Fits in my running pack nicely & even in my pocket if necessary. Few bells & no whistles, but it does the job. bj >> > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of- >> glucose-monitors.html [quoted text clipped - 25 lines] > The One-Touch UltraMini is at the top of their ratings list, in both > Consistency and Accuracy. I will look at that - previously they never considered accuracy in their reports. : >> > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of- : >> glucose-monitors.html [quoted text clipped - 25 lines] : > The One-Touch UltraMini is at the top of their ratings list, in both : > Consistency and Accuracy. : I will look at that - previously they never considered accuracy in their : reports. My understanding o fthe article was that the lack of accuracy might be important in hospitals where the small metersa re being used in place of the more heavy duty ones that hospitals generally use(or have used). The meteres we use are intended for home use and may well not require the precision of meters beign used , say during surgery. Wendy > : > On 22 Jul 2009 00:30:24 GMT, ray <ray@zianet.com> wrote: : > > : >> On Tue, 21 Jul 2009 13:40:03 -0500, fda wrote: : >> [quoted text clipped - 38 lines] > > Wendy For someone attempting to maintain 'tight control' I'd dispute that. The difference between 83 and 101 is quite significant if the true value is 92 - which would be well within the accuracy limits of most meters. "My understanding o fthe article was that the lack of accuracy might be important in hospitals where the small metersa re being used in place of the more heavy duty ones that hospitals generally use(or have used). The meteres we use are intended for home use and may well not require the precision of meters beign used , say during surgery." Hospital meters have more functions related to record keeping and other such. The guts of the meter and the strips are the same as home meters. On 7/22/09 4:58 AM, in article 50vd65lll05st1cognguuaolme0f2polsa@4ax.com, >>> http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of- >> glucose-monitors.html [quoted text clipped - 32 lines] > relationships with people we love and respect. > Remember that while money talks, CHOCOLATE SINGS! Strange. I found the One Touch the most inaccurate meter I ever used. Dumped in less than a month. SignatureMartha T2 Canada 1500mg. Metformin, 4mg. Avandia 50mcg. Synthroid, Advair, Singulair > On 7/22/09 4:58 AM, in article > 50vd65lll05st1cognguuaolme0f2polsa@4ax.com, "Tecknomage" [quoted text clipped - 38 lines] > Strange. I found the One Touch the most inaccurate meter I ever used. > Dumped in less than a month. Might I ask - how do you know? On 7/22/09 11:36 AM, in article 7cp4hfF25h7a5U65@mid.individual.net, "ray" >> On 7/22/09 4:58 AM, in article >> 50vd65lll05st1cognguuaolme0f2polsa@4ax.com, "Tecknomage" [quoted text clipped - 40 lines] > > Might I ask - how do you know? I compared it to my old meter and the results from the lab. My old meter was always dead on the lab. One Touch was nowhere near. SignatureMartha T2 Canada 1500mg. Metformin, 4mg. Avandia 50mcg. Synthroid, Advair, Singulair > On 7/22/09 11:36 AM, in article 7cp4hfF25h7a5U65@mid.individual.net, "ray" > [quoted text clipped - 45 lines] > I compared it to my old meter and the results from the lab. My old meter was > always dead on the lab. One Touch was nowhere near. Wondering if you meter using folks have access to standards and a means to calibrate your meters. Simple PH needed to be set up in my lab life . Bill SignatureGarden in shade zone 5 S Jersey USA http://prototype.nytimes.com/gst/articleSkimmer/ > On 7/22/09 11:36 AM, in article 7cp4hfF25h7a5U65@mid.individual.net, "ray" > [quoted text clipped - 46 lines] > was > always dead on the lab. One Touch was nowhere near. it also could have been possible that your OT meter was set on mg/dL instead of mmol, which OT sent out a statement there was an issue with the meter switching on accident. the meter might not have been calibrated correctly or yes, it is possible to have a bad meter. I've had a few of them in my time. Not once did I ever have a problem with Lifescan replacing the meter next day to my home free of charge often with extra strips to replace the ones I wasted. I'll stand behind my OT any day of the week. pico blvd. On 7/23/09 8:09 AM, in article m2%9m.12642$501.3493@newsfe13.iad, "pico" >> On 7/22/09 11:36 AM, in article 7cp4hfF25h7a5U65@mid.individual.net, "ray" >> [quoted text clipped - 61 lines] > > pico blvd. In Canada, meters are sold only in mml. The ones I have owned can not be switched. Furthermore, you would have to be some kind of idiot not to immediately notice the difference between mg/dL and mml. I am not an idiot nor am I a newbie. I've been fighting this disease for 22 years. Just admit that there are other meters beside the OT. SignatureMartha T2 Canada 1500mg. Metformin, 4mg. Avandia 50mcg. Synthroid, Advair, Singulair > On 7/23/09 8:09 AM, in article m2%9m.12642$501.3493@newsfe13.iad, "pico" > [quoted text clipped - 74 lines] > idiot nor am I a newbie. I've been fighting this disease for 22 years. > Just admit that there are other meters beside the OT. It's also possible to be calibrated to whole blood or plasma - a difference which is not so profound. I am a T2 medical technologist (ASCP). Accuracy and precision are important to me both in the lab and in my life with my meter. It is important to use the control material provided by the manufacturer to check the accuracy of any meter on a periodic basis. This will pick up drifts in accuracy. I have found the age of test strips can also affect accuracy. The older they get the greater the possibility there could be a discrepancy between what they are reading and what they should read. Never use strips beyond the expiration date. That is asking for problems. As has been stated previously I also compare my meter readings at the time of draw for lab work to see how well they compare. Keep in mind, however, there is a difference between plasma and whole blood readings so they will not and should not be exactly the same. I have been using an Ultra II and have had good luck with it. And oh yes, the meters are measuring the blood glucose in the peripheral circulation and if you squeeze hard to get blood out of your finger you are introducing another source of error by forcing interstitial fluid out along with the blood. In short, meters are only as good as how the user uses them and the care and practice in their use. Twenty percent error would mean the user made a lot of errors in care and use and also was using a meter that was never checked along with test strips that were most likely out of date. I found some out- dated strips that had fallen behind stuff. I tried them. They were about 20 percent off from the fresh strips I was currently using. I tossed them. > http://www.diabetesmine.com/2009/07/fda-cracking-down-on-accuracy-of-... > The New York Times reports today that the rise in the use of home [quoted text clipped - 4 lines] > difference in the choices we make on food, exercise, and in particular > insulin doses. > I am a T2 medical technologist (ASCP). Accuracy and precision are > important to me both in the lab and in my life with my meter. It is [quoted text clipped - 10 lines] > the same. I have been using an Ultra II and have had good luck with > it. And oh yes, the meters are measuring the blood glucose in the ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ > peripheral circulation and if you squeeze hard to get blood out of ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ > your finger you are introducing another source of error by forcing ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ > interstitial fluid out along with the blood. ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ Wow. It'd be nice if my doctor had *told* me this or the peeps at the "Diabetes Education" thing I went to that cost a boatload of money had mentioned that. Thanks for the heads up. I play bass and my caluses make getting blood out of my fingers difficult at times. Signaturehttp://www.milksucks.com/pus.asp "I believe there are more instances of the abridgement of freedom of the people by gradual and silent encroachments by those in power than by violent and sudden usurpations.... The means of defense against foreign danger historically have become the instruments of tyranny at home." -James Madison |
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