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23 Responses

  1. Scott E
    Scott E June 20, 2013 at 4:30 am | | Reply

    I wonder if the lack of accuracy is due to the meters or the strips. If I got my meter from the first batch off the assembly line (before they got lackadasical in production), would the constantly renewed batch of strips give me inaccuracies, or am I one of the lucky ones who got a “good” meter?

    Just a thought. I’d rather have my meter, which may be at fault but consistently so, be the problem rather than the strips which are constantly replenished and highly variable.

    Of course, given the choice, I expect both to work and to work well.

    1. Bruce Miller
      Bruce Miller June 20, 2013 at 5:25 am | | Reply

      I participated in a study comparing the Accu-Chek Aviva that was OK for yeas and the most accurate on the consumer market. Until they changed the chemistry of the test strips (now called Plus).

      These are horribly off. Both in precision (repeatability) and accuracy (how close to a lab value it is).
      Using both Roche control solutions and finger stick samples. The issue with most of these meters is that they are not linearly off so a simple correction factor can be added to have a reliable number. This is even within the same batches of strips.

      I tested over 300 strips from >5 batches and sorely aghast at the poor results.

      As a tightly control insulin dependent diabetic and striving to maintain normal healthy levels of 83-85 mg/dL and an A1c ±4.6% I opted to purchase a lab quality meter out of pocket. Nearly $450 for meter and first micro-curvettes, but worth every penny if I am going to remain in control. As a research scientist keeping track of data is important to me so running all the comparison tests were worthwhile. For me anyway a no brainer – achieve and maintain tight control and avoid complications or slack off and follow much looser ADA guidelines and with luck slow down some of the compilations.

      After a 10 month study comparing meters it seems that the Abbot Labs FreeStyle is now the most accurate consumer grade meter on the market. Medicare will cover the supplies for this and Part B supplemental coverage will cover the co-pay. Abbot also offers what they call the “FreeStyle” promise that users will never have more than a $15 co-pay per month.

      I have now disposed of my 3 Accu-Chek meters and now have a new FreeStyle for travel and general use when my lab quality meter is too ponderous to deal with.

      1. Leighann of D-Mom Blog
        Leighann of D-Mom Blog June 20, 2013 at 10:07 am | | Reply

        I don’t believe you can use the Freestyle Promise Program is you are on Medicare. Not 100% sure on that, but I’m pretty sure.

        1. Bruce Miller
          Bruce Miller June 20, 2013 at 11:01 am |

          Correct if Medicare is already covering re-reimbursement or cost then this does not apply.

      2. Beth
        Beth June 20, 2013 at 7:49 pm | | Reply

        Does the accuracy of the FreeStyle apply to the FreeStyle Lite also?

      3. Stu
        Stu June 21, 2013 at 10:30 am | | Reply

        Good luck with your Abbott meters…hopefully there won’t be a high level mandatory global FDA recall like they had on the Insulinx. I’m very certain that your experience with the Aviva meter was an exception and NOT the rule. The “Plus” test strips were rebranded after Maltose was removed from the strips due to the very very slim possibility of an issue with diabetics on dialysis. Accu-Chek is made in the USA, and Abbott FreeStyle is made in China.

  2. Mike Ratrie
    Mike Ratrie June 20, 2013 at 5:25 am | | Reply

    Scary stuff!

    Why doesn’t the FDA have some input into how Medicare makes its choices on “approved” meters?

  3. Gretchen
    Gretchen June 20, 2013 at 6:02 am | | Reply

    I think regs are different in different states. In Vermont, if I want mail-order strips, I have to pick one of those unknown suppliers. But if I go to the drugstore, I can get my regular strips.

  4. Noah
    Noah June 20, 2013 at 4:56 pm | | Reply

    I’m having to change suppliers, as my current supplier of test-strips won’t be stocking Wavesense strips, somehow due to the upcoming Medicare changes.

  5. Bob Fenton
    Bob Fenton June 20, 2013 at 5:06 pm | | Reply

    Thanks Mike, Excellent information needed by Medicare patients. First they reduce the number of test strips people can use depending on type of diabetes and for type 2 the treatment therapy, and now they want people to use poorer quality test strips and meters. Where is it going to end?

  6. Type 1 Electrical Engineering Student
    Type 1 Electrical Engineering Student June 21, 2013 at 1:25 am | | Reply

    Thank you for writing this article. This is one of the best articles I have read over the years on Diabetes Mine!

  7. WD Shaneyfelt
    WD Shaneyfelt June 21, 2013 at 11:35 am | | Reply

    Distressed of course! However Medicare patients must see their Doctor every 90 days and most Doctors require Blood draws which are sent to a lab. The returns of the tests show A1c and a normal BG number. Of course we the patient have no way of knowing what the accuracy of the Lab instruments might be but it’s the best information that we have available and we have the ability to check our own meter after the blood draw. Of course I understand that it’s not the best but I’ll bet it’s within the 15 to 20%. I have accomplished that check for many years. Testing is equal to the difference between life and death. And I lived before TESTing using Ohms Law was available. What Diabetics have today is great when we consider 50 plus years ago.

  8. Jonathan Clark
    Jonathan Clark June 22, 2013 at 8:44 am | | Reply

    Good article, and interesting comment from FDA, “the FDA is limited in its response because some manufacturers are in Asia, and the agency must rely on the manufacturers’ own studies related to accuracy.”

    Most FDA approved drugs are manufactured overseas and the FDA has to inspect and certify the facilities, so how can they not have oversight capabilities on meters/strips?

  9. Jonathan Clark
    Jonathan Clark June 22, 2013 at 8:55 am | | Reply

    Good article, and interesting comment from FDA, “the FDA is limited in its response because some manufacturers are in Asia, and the agency must rely on the manufacturers’ own studies related to accuracy.”

    Most FDA approved drugs are manufactured overseas and the FDA has to inspect and certify the facilities, so how can they not have oversight capabilities on meters/strips?

    Several thoughts on other points and comments.
    Just because something is made in the USA does not make it superior to something made in China or India or any other country. I would never buy a toilet made in the US as Japanese made toilets are far superior.
    Lab results will differ from your meter as one tests whole blood and the other is plasma.
    FDA working with Medicare on approved meters I don’t agree with. If a meter system is approved by the FDA that should be all that is needed. Should the transportation department be forced to work with the FDA to outfit cars to know if you have recently taken a drug that causes sleepiness and prevent you from driving?

  10. Alan
    Alan June 22, 2013 at 4:42 pm | | Reply

    Thanks for a very insightful article on an important issue.

    The logical next step is that the list of 18 manufacturers gets progressively smaller in the name of cost-saving until ultimately you are left with a single cheap supplier.

    But surely such a ridiculous situation could never arise?

    Unfortunately it already has!

    In New Zealand the drug buying agency, Pharmac, which is responsible for funding blood glucose meters, proposed last year a sole-suppply agreement with iSens, a Korean manufacturer. So as of March this year if you are diagnosed with diabetes (any type) you get a meter from iSens, from their Caresens brand. No Freestyle, no Accu-chek, nothing else. Take it or leave it! And, with a few exceptions, existing diabetics have had funding removed for their existing meters so are now forced to use the Caresens meters.

    Despite reports of inconsistent and inaccurate readings, missed hypos and overdosing of insulin due to artificially high readings, the funding agency is happy to rely on small-scale, laboratory-controlled tests funded by the manufacturer.

    The comments posted above by Will Dubois have a chilling ring to them for those of us in New Zealand. While the policymakers carry on with blind faith that he’s wrong it’s the diabetics that will face the consequences if he is right.

  11. Veronika Jason
    Veronika Jason June 30, 2013 at 4:07 am | | Reply

    Good article, and interesting comment from FDA, “the FDA is limited in its response because some manufacturers are in Asia, and the agency must rely on the manufacturers’ own studies related to accuracy.”

    what about the big brands like Freestyle wchich is made in China, although its an American brand!! how can we make sure of the accuracy, what will be the FDA opinion?

  12. Ana J. Cox
    Ana J. Cox July 1, 2013 at 8:56 pm | | Reply

    If studies show that 25% or more of the meters already on the market don’t even meet the existing accuracy standards, then what’s the whole point of selling all these meters? How would one know the right one to buy then?

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  14. Zeke T
    Zeke T September 27, 2013 at 3:43 pm | | Reply

    The Freestyle is still covered by Medicare Part B, but instead of getting it from Medicare’s list of suppliers (mail orders), this can be refilled at local pharmacies that have Medicare contracts such as CVS, RIte- Aide, Kroger, Target, K-Mart, and most leading pharmacies nationwide. Just bring your Freestyle strip prescription from your doctor and you can continue to get the quality and top- of the market accuracy you deserve and have come to trust.

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