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16 Responses

  1. Bennet
    Bennet March 24, 2010 at 6:55 am | | Reply

    WoHoo I’m D-blogger buddy and that sound like a Colbert ‘Friend of the Show’ to me. LOL

    Thanks for keeping this in the spotlight Amy.

    Please everyone, drop the FDA a little note.

  2. Michael Ratrie
    Michael Ratrie March 24, 2010 at 9:42 am | | Reply

    Amy,

    Call me a cynic, but as good as the Accu-Chek white paper sounds, it might also just fit the way they are currently doing things and/or planning to go. Also, it could raise ‘barriers to entry’ by innovators (like those submitting on your awesome “2010 Design Challenge”).

    Now my little pet peeve on “expiration dates”. The Accu-Chek dates are hard coded. No tests beyond the date on the vial, period. Wouldn’t it be nice instead to have the meter able to determine if the strip is viable?

    Fair Winds,
    Mike

  3. DS
    DS March 24, 2010 at 11:37 am | | Reply

    If my BG were at 53, I wouldn’t be able to smile like that woman. But I get the point. Until the standards are raised, though, much of testing involves Dead Reckoning, for me. That means that I might base my trust on a reading, based on what the last and before last readings were…similar to sea navigation before the GPS was invented.

    My pet peeve is that the instruments are being made with increasingly cheap materials, and the prices are going up, and accuracy fluctuates from stick to stick…sometimes by 50 units–hey, what’s going on here?

  4. Tara
    Tara March 24, 2010 at 2:20 pm | | Reply

    I’m a recent Diabetic, I had no idea that the glucose monitors had such a wide error margin. This scares me especially since I’m trying to get my insulin under control.

  5. tmana
    tmana March 24, 2010 at 3:26 pm | | Reply

    Let the insulin-ignorant T2 ask some baby questions here.

    I get the impression from some of the T1s and other insulin-users that a 1 unit correction should lower blood glucose about 50mg/dl? (I imagine this depends on the person; I’m just doing some “ballpark math”.) And similarly, I get the impression that unless you’re on a pump, corrections of smaller than 1 unit, maybe 1/2 unit, are not easily administered?

    Those two premises would suggest that for reasonable correction calculation, there should never be more than 25 mg/dl absolute error in a meter — even if the correct reading is 490 mg/dl. That translates to +/- 5% error at 500 mg/dl. The same percentage error at 100 mg/dl would be 5 mg/dl, which is a more comfortable margin of error for those of us who prefer to keep tight control (range 80-120 mg/dl), regardless of whether or not we use exogenous insulin.

    I don’t know enough about how the human body responds to hypoglycemia to ask the right questions about the low end of the scale — but again, any margin greater than 5-10 points, especially at the hypoglycemic/euglycemic border, can result in an incorrect therapeutic response.

  6. Sara
    Sara March 24, 2010 at 5:17 pm | | Reply

    I can’t read the small print, but is it 53 mg/dL or could it possibly be 5.3 mmol?

  7. Sajabla
    Sajabla March 24, 2010 at 5:29 pm | | Reply

    It’s absolutely 5.3 mmol. I zoomed in using my browser.

    I think the ad is risky and eye catching. It doesn’t bother me. The fact is, with 20% within the acutal the acceptable range, having the meter read wrong could be just as life threatening as having knives thrown at you.

    Ok, slight exaggeration. I just don’t understand why there needs to be an uproar over this ad. It’s pretty and it makes it’s point. That’s advertising, no? Plus, it’s getting attention, another plus.

  8. Monique
    Monique March 24, 2010 at 11:19 pm | | Reply

    Hiya

    It seems to be a Canadian ad (judging by the .ca on the website) which makes it 5.3mmol/L which translates to around 96mg/dl. Not quite diabetes perfection, so I wouldn’t be encouraging him to throw it either!

    Good job Amy on raising awareness of an incredible issue. Can’t believe there are no standards on these seemingly basic aspects to testing that affect every single person (with d) and every single meter..

    Particularly when there are so many guidelines are based on the number and treated as gospel: do not exercise if over 16mmol/L (288mg/dl), if ambo’s visit you at home for an errr middle of the night seizure, they won’t take you into hospital if you test over 4mmol/L (72), etc etc

    Monique Hanley

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  10. Will
    Will March 25, 2010 at 3:58 pm | | Reply

    I have a lot of concerns with these changes in accuracy:

    Will test strips soon be $5 a piece instead of the already outrageous $1 a piece?

    Will those $5 test strips fail more often, requiring more frequent sticks as well as the extra expense?

    What about the price of meters?

    Will more companies just simply get out of the meter business because the standards are too high? (further driving up prices)

    Will meters become more difficult to use? (“We are sorry. You must insert a new lancet before meter can be operated…”).

    You see accuracy. I see more control being taken away from me about how I use my meter.

  11. SteveS
    SteveS March 26, 2010 at 12:10 pm | | Reply

    Hearing from “experts” that a 20% error margin is just fine for us non-experts is only demonstrating that said experts have a knowledge gap regarding patients, and have heard too much propaganda from manufacturers. I am not sure if there is any sort of medical analysis equipment currently in use where an error margin as large as 20% is considered permissible. What the 20% error margin allows is a considerable reduction in cost of both the meter and the test strips, as compared to some more accurate technology that would cost more to produce. The argument that manufacturers don’t want to spend R&D funds and then raise the production costs on a very profitable product makes considerably more sense to me than the explanation that users are either not interested or don’t need any more than 20% accuracy.
    HemoCue makes a smallish (about the size of a paperback) meter that works similarly to typical BG meters. However, it achieves the same accuracy as the most sophisticated lab analysis equipment. It’s expensive and requires a 5 uL sample, but perhaps it’s possible to develop something that relaxes the accuracy to 5%, uses a smaller sample size, and has a lower production cost. As a matter of fact, David Mendosa reported in early 2006 that HemoCue was about to file a 510(k) on a consumer version of their meter. It had the same lab-standard accuracy as their larger meter, and was expected to sell for about $70.
    http://www.diabeteshealth.com/read/2006/02/01/4515/hemocue-is-coming/
    I have always wondered what happened to this product. It does show that 4 years ago, one manufacturer found it feasible to create a far more accurate meter aimed at the high end of the consumer market. Given advances in technology from 4 years ago, I can’t believe that a meter like this is not an achievable goal.

  12. Tell the FDA: +/-20% BG meter accuracy is not enough! « Luke's D Day

    [...] to post below: Amy Tenderich (Diabetes Mine) has posted a couple updates on this issue, including a white paper released by Roche and an interview with Ellen Ullman, mother to a son with type 1 and the only patient advocate at [...]

  13. vivasls
    vivasls March 29, 2010 at 2:35 pm | | Reply

    Regarding recommendation #3 around safeguards- In the Ultra’s operating manual it says that if you don’t have enough blood you could get “an error message or a false reading”! Yikes. I think I’d rather have an error message!

  14. Cary
    Cary March 31, 2010 at 11:43 am | | Reply

    Does anyone have a clue as to what it would take to get from 20% to 10% accuracy? Is there a technical limitation of the strip? Meter? Both?

    Do we need more blood? Longer wait time? I’d easily cough up much more blood (and money) for +/- 5-10% accuracy.

  15. Scott K. Johnson
    Scott K. Johnson April 6, 2010 at 9:48 pm | | Reply

    I too am amazed that there are so many variables in what we have been trained to think of as accurate.

    Is it any wonder why we go high or low when the math we’re using could be off so much? And this stuff doesn’t even address the trillion other variables we deal with.

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