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14 Responses

  1. tmana
    tmana August 22, 2013 at 7:08 am | | Reply

    “The patient discussion has definitely created some momentum here. If manufacturers are unsure or unsupportive, they can see how important this is to their customer base.”

    Sorry, but as long as insurance and programs like Medicaid/Medicare are paying for the bulk of test strips, they are the customer base — not us, not our doctors or healthcare providers, but the companies who actually lay out the dollars for the niggardly few test strips they believe we require to maintain the minimum allowable standard of health.

    This will only change when we, the patients, are bearing the full brunt of the cost load, as well as the full brunt of the health load, of blood glucose testing.

  2. Tim Steinert
    Tim Steinert August 22, 2013 at 9:09 am | | Reply

    I’m sorry, but so much of what these folks from the FDA are saying is: the companies will WANT to be able to boast about their strips. That’s not a good enough incentive for me to have confidence in a company’s product. If cars have to have crash tests and seat belt tests, strips need standards that MUST be met or they are absolutely no good to us and should not be approved for use and allowed to be sold– wherever they come from.

    You can bet that companies whose strips are rejected will fix the problems or get out of the business.

  3. Kevin McMahon
    Kevin McMahon August 22, 2013 at 9:41 am | | Reply

    A blood glucose meter is subject to an incredibly long list of influences that most other lab devices are not. Asking for more accuracy is important. However, patients should also be asking themselves if they are doing everything else in their power to live up to the self-care standard (e.g. – washing fingers to remove residual sugar before lancing, checking at the appropriate times including pre and post prandial, verifying their carb counting accuracy, checking blood sugar on a frequency appropriate for their therapy, performing at least weekly review of blood sugar patterns, active participation in remote monitoring of dependents, adherence to prescribed medication dosing, care to ensure viability of insulin and test strips, etc…

    I’ve saved the best for last. NOBODY uses control solution to verify the quality of the test strips and meter being used. I can say that with confidence having probably reviewed more readings from more patients than just about anyone in the field of diabetes.

    So yes improving accuracy is a good thing but let’s not lose sight of the many facets of diabetes care that are under the patient”s control while blaming the FDA and device manufacturers.

    1. Benjol
      Benjol August 22, 2013 at 10:26 pm | | Reply

      Have you seen how much the control solution costs, and how long it lasts?!

  4. Brian (bsc)
    Brian (bsc) August 22, 2013 at 10:08 am | | Reply

    It is good to hear that the FDA is listening, although whether or not they will act and it will be enough remains to be seen. One thing I noticed is that you wrote that they mentioned a surveillance program. I don’t believe that is a NIST program, that is the National Glycohemoglobin Standardization Program (NGSP) program funded by the CDC (www.ngsp.org). That program does independent testing of A1c methods and labs and has been instrumental in providing transparency into the actual ongoing accuracy of the A1c test. Since it’s the NGSP started it’s certification program in 2006 it has successfully drive the accuracy of the A1c down from +/- 15% in 2007 to the current level of +/- 6%. A program like the NGSP is vital to ensuring transparency into actual deployed meter/strip accuracy.

  5. Molly
    Molly August 22, 2013 at 10:25 am | | Reply

    Kevin,
    In response to your post, yes I’m sure all of us with diabetes would be happy to comply with extremely accurate carb counting, washing hands before checking, and of course checking at “appropriate times.” I know as a perfectly perfect patient the 22 times on average I check a day meet that requirement at least half of the time. However, I’m also a person who lives a regular life with type 1 diabetes. Sometimes I check after using an alcohol prep swab in the car (because it’s convenient), sometimes I check pool side fresh from the water without washing my hands (because I’m swimming), and sometimes I under or overestimate carbohydrate counts (because I’m eating out and unable to measure my food.) Since blood glucose testing is meant to be used in everyday life it should also be able to be accurate in the midst of it.
    Just to note, I use control solutions once a month as a routine check, so hopefully that will dispel the myth that NOBODY does this.
    I understand the pursuit of perfection; however for myself and my patients, I’m really happy when we’re able to meet most of your standards some of the time.
    If you do have diabetes, please enlighten me as to how you are able to implement such meticulous procedures. I’m all ears.
    Fondly,

  6. Megan
    Megan August 22, 2013 at 11:07 am | | Reply

    So let me get this straight, you are partially blaming us, the patients using these devices, for its inaccuracy? So when I wash my hands and get numbers that are so different from each other and those numbers make me react differently, how am I suppose to control my disease? How am I suppose to know if I really am safe to drive, take care of my baby, go for a walk, go to sleep? A reading of 80 is a lot different to me than a reading of 100. Some of us are so sensitive to insulin that those differences are a big difference. I wash my hands before testing, I check my BG when I am suppose to and when I feel like I need to or when my Dexcom alerts me, I count carbs as well as I can, because it is not an exact science especially since packaged foods are allowed to be inaccurate as well for nutritional content, and I do the best I can with the tools I have. The tools I use to control my disease need to be accurate, period. No excuses. Is my insulin pump allowed to be inaccurate and just give me however much insulin it feels like? No, no way! So why is my glucometer allowed to be inaccurate?

  7. Wayne Brown
    Wayne Brown August 22, 2013 at 11:20 am | | Reply

    Thanks for sharing, this is a great topic.

  8. Molly
    Molly August 22, 2013 at 12:07 pm | | Reply

    I would also like to add that if test strips aren’t going to be incredibly accurate and great, they should at least be less expensive. How is it fair that a product can make so much money and yet not be THAT good?

  9. Bennet
    Bennet August 22, 2013 at 2:00 pm | | Reply

    Amy

    Thanks for sharing Diabetes Mine’s FDA representatives’ conference call notes. The FDA has been busy this week in the diabetes world!

    I, and a few others, also had a brief discussion by phone earlier this week with Courtney and Katie. While it was productive and began a much-needed dialogue with the community, it did not quiet our unease. Until these calls, there had been no mention of a FDA action plan for tighter regulatory processes. We’re glad that they have been formulating a surveillance program and look forward to seeing this plan solidified and implemented, but concerned that it took the Diabetes Technology Society meeting and a public advocacy campaign for them to speak up about the program.

    The StripSafely campaign is the perfect example of what happens when an empowered and enlightened community raises a collective voice to facilitate change. And we are asking for change: post-market enforcement of the current accuracy standards for glucose test strips and meters.

    We are not looking for vague assurances or the promise of future plans; we are asking for our devices to meet the current standards, in the market, on our fingers, that FDA promised. The 4.2 million people using glucose meters for insulin dosing decisions need the FDA’s protection.

    We would all love tighter standards. Those standards, however, are in regulatory no man’s land and they may or may not be what we are hoping for. As the FDA’s representative explained: “We not at liberty to say exactly what the new parameters are until approved, but they will be tighter.”

    But what good are the accuracy standards if they are not currently met?

    Bennet

  10. Scott S
    Scott S August 22, 2013 at 6:56 pm | | Reply

    The FDA’s response is much as I expected (that’s not a criticism, incidentally), and on the ISO standards, I noted in my recent post that they will likely adopt the new ISO standards pending a public comment period required by law. As for reporting of adverse events, I understand what they’re saying, but they could be more honest in what patients with diabetes can do about that; for example, voluntary (patient) reporting. Also, they note there’s not a set limit of events that would trigger investigation, but I’d like to see more clarity from FDA on the TYPES of adverse events which could trigger an investigation.

    As for post-market analysis, the comment that these must be prescheduled is misleading. Its not ALL trade agreements, but specifically with China, which are really the main source of the problem IMHO. What can the FDA do to insist on the ability to monitor? For example, just because a trade agreement mandates investigations must be pre-scheduled doesn’t mean the FDA has to award approvals in those cases; post-marketing analysis can go into their decision-making, but is that happening today? It doesn’t appear to be the case, but only FDA can answer. There was no mention of the recent Medicare issue, which I think is aggravating the problem, and I get that its a different government agency, but I’d love to know what the FDA thinks about that.

  11. Lisette
    Lisette September 14, 2013 at 6:16 pm | | Reply

    I know this is off topic but since there is much response here, I thought I would put it out there. We need a campaign for restaurants of “know your carbs”. I know there’s the calorie king and other apps, but what is critical is being accurate with the carbs. I know there are states that require chain restaurants to have calorie info, but for our lives what us critical is how much insulin to give and that all depends on the carbs we are eating. So until all restaurants have carbohydrate info prominently displayed, we are at risk at miscalculation and worse. Please if you are reading this and can contact your favorite restaurant, legislature or anyone else who can start this movement, please do so. Tell them calculating our carbs means calculating our lives.

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