Our Blog / the diabetes online community on accuracy

WHY

People with diabetes are at risk from inaccurate blood glucose strips. The FDA acknowledges that there are substandard strips in the market but has no process to remove them and insure the integrity of blood testing supplies. Our goal is to bring some urgency to the FDA.

HOW

The diabetes community will bring public attention to speed the creation of a FDA response.

WHO

Community members will be recruited to join the effort.

WHEN

July  – depending on the ‘bandwidth’ of community members. Summer is tough; there are vacations, holidays, events, fireworks and BBQs. So we need to stretch-out to accommodate the lazy hazy days of summer.

WHAT

It is important to do this well.  Sadly, coordinated action is not the diabetes patient community norm. We will try to implement the best practices and lessons learned from the Spare a Rose campaign.

  • We will solicited personalized letters to FDA and Congress asking for FDA action.
  • We will ask for social media posting of these letters.
  • We will seek participation in social media channels. Blogs, Twitter, Linkedin, FB etc.
  • Letters will focus on a personal message about of accuracy matters to the writer.

Bennet Dunlap

5 Comments

  1. I really support this effort, but I would add to this effort a call for the CDC to become involved and to establish a National Glucose Meter Standardization Program (NGMSP) which would do for glucose meters what the CDC has done with the National Glycohemoglobin Standardization Program (see NGSP at http://www.ngsp.org) for the A1c test.

    It isn’t enough for the FDA to establish minimum standards. Our government has a public health duty to give us transparency into the accuracy of these test products. Such a program would establish a national reference standard for blood sugar testing and then evaluate glucose meter products against that standard on a regular basis just like the NGSP does with the A1c. Through the efforts of the NGSP, the accuracy of the A1c test has moved from +/- 15% in 2007 to it’s current level of +/- 6%. It is amazing how much transparency can influence industry to change.

    We have a right to know what meters are accurate rather than just accepting a minimum level of performance that still puts us in danger. And when we know which meters are accurate we can use that information to force industry to change.

    Reply
  2. As the father of three children with type one I feel it is critical we see test strip accuracy improved. When the life supporting injections you are making depend on that test it is most important we do all we can to insure for our children the best in blood testing technology and accuracy. Please join in the effort to see test strip accuracy improved. Thank you.

    Reply
  3. I took your quiz and one of your answers is wrong. It asks which of these numbers are “acceptable” And the answer is NONE of above (all listed were +/- 20%) – I’ve have wanted to know a simple answer to the question: “Which freaking meter is the most accurate?” for years.

    How to obtain that answer, without a huge oversight committee, and without having requirements on how accurate the meters be?

    Simple: Require, (by law), that the manufactures print, in at least 1/2″ high letters, with a Green Background that is in a black box (so everyone will know it, and see it) the Accuracy %. Now, I go up to the shelf and see 4 meters.

    One is $19.99, includes the meter and 50 strips (Yes, i it is out) – but is it accurate? In a GLANCE I can see ok, 20% Error

    But what about this one? It says only 5%, the strips cost $50 for 50 strips, but heck yeah, SOLD.

    Suddenly, HUGE amounts of money get poured into research and development of better meters – NOT by the tax payer, but by the companies – Of their OWN accord, because they KNOW they have to COMPETE on this area now.

    And, the law should also specify the way tests should be done to confirm that their meters are that accurate. (Random samples of multiple lots etc.)

    THIS would fix the problem cold. Instead of getting the law passed to be 15%, then having to fight again to go for 10 etc…

    -Chert

    Reply
  4. I might add that the law should say that the tests have to be done by independent labs.

    Also, do we need an oversight gov. agency to make sure the numbers are faked? No, not really. Why? Because let’s say a company says they are 95% accurate. But actual tests of their meters show 80% accurate. (Note: These tests will be by people who think they are wrong, or by companies they compete with etc.)

    These people/companies will be able to sue them under existing laws for false advertising. One could also put something into the new law that would give them a fine, or penalty for publishing incorrect numbers. I kind of like the idea that they no longer are allowed to sell meters in the US if they do that. However, I don’t think that is practical, and isn’t really required. If they are hit with a class action lawsuit for $10m-100m for false claims they will either go out of business on their own, or will correct the problem on their own.

    -Chert

    PS: I hope this idea can get routed to the right person. I’m not in favor of what this site is petitioning for, but rather with the INTENT of it. I think the change above would get a lot more people on board.

    PPS: Even some of the companies who make the meters/strips should be on board with the idea – if I make a 15% error meter and most make 20% – then I will be in favor of the law. It will make my competition have to put in money to catch up with me. If you try to create a regulating body over them, then ALL of the companies will fight it.

    Reply
  5. Chet

    Love the comments.

    Love your energy.

    Love that you share your ideas.

    The point of this site is to engage patient views AND to get those patient voices into the conversation that policy makers hear. They hear from lobbyists from industry, they hear from big advocacy scientists, they hear from health care provider lobbying groups. We, the folks who live with diabetes and do the vast majority of diabetes care, are out of the policy conversation.

    Please Please Please sent you thought to your representatives and the FDA!

    Please, if you are willing, send me a copy of that letter and I will include it as a form letter on the sample letter page so that others who share your nuisance perspective of strip safety can use it to share it with their representatives.

    Here is a link to find Congressional and FDA addresses:
    http://www.stripsafely.com/?page_id=283

    Love Ya Bro.

    Bennet

    Reply

So, what do you think ?