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Accurate Diabetes Testing Matters

Discussion in 'Parents of Children with Type 1' started by badshoe, Jul 24, 2013.

  1. badshoe

    badshoe Approved members

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    Blood glucose test strips are at the center of diabetes life. Many of patients in the diabetes community are concerned about compromised test strips. I doubt that anything we can say is a clearer illustration of our community's need for highly accurate glucose testing than this FDA Warning Letter which in part says:

    People with diabetes are at risk from inaccurate strips. Let's change that.
    Join us in the StripSafely campaign and share your feelings about accurate diabetes testing with policy makers.

    [​IMG]

    Bennet & Kimball Dunlap
 Consultant, Writer, Creator - Your Diabetes May Vary
 RN Diabetes Advocate

    Kerri Sparling
Creator, Editor, Consultant - www.Sixuntilme.com

    Christel Marchand Aprigliano 
Diabetes Advocate, Connector & Innovator - www.thePerfectD.com

    Kelly L. Close
 Editor in Chief - www.diaTribe.us

    Cherise Shockley
Founder and CEO - Diabetes Community Advocacy Foundation

    Scott Johnson
 Diabetes Advocate, Writer, Speaker, Consultant - www.ScottsDiabetes.com

    Manny Hernandez
 Diabetes Advocate, Nonprofit Executive - Diabetes Hands Foundation

    Mila Ferrer
 Diabetes Advocate-Writer-Tv Host- Translator - www.Jaime-DulceGuerrero.com

    Lorraine Sisto
 Diabetes Community Advocate - www.ThisIsCaleb.com

    Meri Schuhmacher
Advocate - www.OurDiabeticLife.com

    Emily Coles
Head of Communities | Diabetes Hands Foundation

    Aliza Chana Zaleon http://alizawithdiabetes.com

    David Edelman
 www.DiabetesDaily.com

    Asha Agar Brown
 www.wearediabetes.org

    Scott Strumello
 http://blog.sstrumello.com

    Mike Hoskins
 www.DiabetesMine.com

    Kelly Kunik
 www.diabetesaliciousness.blogspot.com

    Tim Brand
Writer/Creator/Editor www.bleedingfinger.com

    Camille LoParrino 
Health Literacy Coach
 Happy Medium Ensemble

    Nicole Johnson, DrPH
Miss America 1999, JDRF International Board, Type 1 since 1993!

    Simon Carter
 www.ManageBGL.com

    Chris Leach 
Insulin Nation

    Anna McCollister-Slipp 
Co-Founder, Galileo Analytics
T1D Patient Advocate

    (Want to add your name? Email MeToo@StripSafely.com)
     
    Last edited by a moderator: Jul 24, 2013
  2. Jeff

    Jeff Founder, CWD

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    As the parent of a child with type 1 (though she is no longer a child of course), I am deeply concerned about the impact of the CMS decision on reimbursement levels for glucose test strips. As we can clearly see in the FDA letter to a US-based low cost provider, there are serious issues related to accuracy and reliability with these test strips and, more importantly, there is no process in place to ensure that a manufacturer, once approved, will continue to deliver product that meets the minimum accuracy requirements.

    We, the type 1 community, have to take this development very seriously. The data we receive from glucose monitoring is critical to good decision making regarding insulin dosing. Absent accurate and reliable data, we run the risk of returning to care standards from decades ago.

    I urge everyone to reach out to Bennet and support his Strip Safely campaign.

    [And yes, full disclosure, CWD remains part of J&J, and J&J's LifeScan division is significantly impacted by this decision. My interest in this is not, however -- I am and always will be the parent of a child with type 1 diabetes.]
     
  3. badshoe

    badshoe Approved members

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    Thanks Jeff.

    As a fellow parent, I know that Children With Diabetes is always your and our first concern.

    Like you, I think parents of CWDs have a unique role in advocating for people who may be too young to advocate for themselves.

    Friends, Please learn more about strip accuracy and write policy makers. That is what the campaign at www.StripSafley.com is all about, Learn and Act. (OK with a snarky name for the campaign, may as well have some fun along the way.) Take the quiz and test you strip safety knowledge.

     
  4. Lakeman

    Lakeman Approved members

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    I was wondering just how inaccurate the meter/strips were and according to the article they are accurate about 95% of the time. Which I would agree is too low.

    However, I read a paragraph in the linked source which says:

    "meters that met 20% standards several years ago but probably couldn?t meet 40% standards in post market analyses today"

    Does this mean that a few years ago meters were acceptable if they were inaccurate 20% of the time? That does not seem right. Does this mean that there are meters out there that are inaccurate 40% of the time? That does not seem possible.

    I am also wondering about what the FDA can do about this problem. There seems to be a claim that they can't do a anything about it - which on the surface is also incredible. In contrast the letter from the FDA to the manufacturer seems quite obviously to be doing a lot to correct the fault.
     
  5. MHoskins2179

    MHoskins2179 Approved members

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    @Lakeman:

    Right now, meters have to be within 20% of the lab standard 95% of the time. So, that means that basically, most of the time, the meters anyone is using are allowed to pretty much always be 20% off.

    This is the same standard that's been in place since the 80s, which is very scary in itself given how far we've come with technology and medical devices.

    But the real issue is that the meters are only forced to meet this standard at the time they're being reviewed for FDA approval to enter the market, not at any point afterward once they're on the shelves. So, in theory, the meters and strips out there could be even more off, and there's no real post-market surveillance to ensure they're meeting the standard of +/-20%.

    Some of that recent research and meter checking shows that many of the FDA-approved meters don't meet that standard, and actually fall far below that accuracy requirement in a random sampling.

    Even if tighter accuracy standards are adopted, and that may be coming soon, there's a bigger issue at work here and that's what this Strip Safely initiative is about.
     
  6. badshoe

    badshoe Approved members

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    Lakeman

    Rock solid question.

    I think you may be referring to this quote of Dr. Barry Ginsberg. It came from a piece by diaTribe that sadly is not freely available.
    The key word is postmarket. Another quote on postmarket from the Diabetes Technical Society meeting may help. "I don't think manufacturers are fudging data, but simply that the studies are performed under ideal conditions" aka not the real world. So they get approved under ideal conditions not the real world that postmarket studies would replicate. As parents we could care less about ideal conditions, we live in the real (also known as sticky) world of kids.

    Dr. Ginsberg has a very good paper, "Factors Affecting Blood Glucose Monitoring: Sources of Errors in Measurement," that I recommend to people looking to get a more detailed understanding of meter accuracy. It is publicly available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769960/

    Hope all that helps.

    Thanks for the great question.

    StripSafely!
     
    Last edited: Jul 24, 2013
  7. Lakeman

    Lakeman Approved members

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    I most certainly do want accurate strips and do in fact rely on strips a great deal.

    Based on what you are saying, and I greatly appreciate your saying it, the FDA warning letter linked above is irrelevant since it includes zero indication that the strips in question failed to meet that standard. The letter can be summed up by saying that the manufacturer had four complaints that it did not respond to in the way the FDA wants it to. The letter also fails to indicate that there is a lack of post market testing.

    I would also point out that while there is a claim by the FDA that there is no way to test the strips after they are on the market you have astutely referenced random sampling, meter checking and research that is obviously a test of post market strips. From the very nature of the political language coming from the FDA and the obvious organized campaign designed to influence policy I smell something fishy here on the part of the FDA.

    Does anyone else doubt the veracity of the claim that the FDA cannot presently test meters or strips after market. Clearly that should be a part of the process that would have been thought of years ago. Reading the FDA warning letter it is clear that they go to great depths to micromanage an enormous amount of what manufactures do - do they really not have any knowledge whatsoever about the accuracy of strips post market? Are they really expecting us to believe that they have no means to regulate manufacturers on how strips perform post market?

    For example in a quick google search the second link I found includes this paragraph:

    "Post-approval Studies The FDA can request post-approval studies, which are conditions of approval studies mandated by the FDA. Because of the rapid life cycle of devices, postapproval studies can be requested earlier in the approval process. Recently, the FDA Division of Post-Market Surveillance has taken over the authority and review of these types of studies."
    http://www.ispor.org/news/articles/dec05/fda_perspective1.asp

    Not only does this paragraph show us that there are post market studies on medical devices but it also tells us that they have an entire division responsible for such studies. Does this entire division ignore strips and meters?

    I have to wonder if we are not being manipulated.

    It is worth saying again that I am with all of you in having a deep desire for accurate strips. And after reading that warning letter from the FDA it is clear that if I ever get an inaccurate strip all I have to do is complain and it will cause a great headache for the manufacturer.

    How about we compare different companies among ourselves and agree to buy what we deem to be the best, shun the bad ones, and complain when appropriate.

    Digging deeper I found this article:
    http://www.diabetesmine.com/2013/06/they-said-what-about-diabetes-meter-accuracy.html

    In it the author does indicate that there is post market testing but quotes the FDA as saying that they cannot test meters that are manufactured in Asia. Now that makes sense! And about that odd language in the Stripsafely link that talks about competitive bidding and low income people. Light is shed on that too - it seems that Medicare has a list of approved providers and a majority of them are in Asia.

    It seems that what we do not need is a way for the FDA to test strips/meters post market but what we need is for Medicare to make a list that includes mostly US manufacturers that are subject to the regulations enforced by the FDA.

    I have looked at this very briefly and readily admit I may have incomplete information so if corrections need to be made I welcome input so we can have a clearer understanding.
     
  8. badshoe

    badshoe Approved members

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  9. Cookie Monster

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    Thanks for bringing this to everyone's attention. I believe it is the single biggest issue currently facing diabetics. Not just in the US but around the world as funders try to cut costs.

    To add to the comments above another issue is that the original tests that lead to meters/strips getting approval are themselves open to manipulation. Not only are the studies usually funded by the manufacturer but the meters and strips used are selected by the manufacturer. Thus the manufacturer can cherry-pick which meters and strips are used for the study to ensure approval.

    This has been highlighted by diabetes technology experts in numerous articles such as this one from the Journal of Diabetes Science & Technology which includes the following,

    "Once the meter has approval, the quality of the batches is only evaluated by the manufacturers themselves. For an insider, it is quite clear that choosing a ?good? batch of test strips is of high relevance so that a SMBG meter can pass any test (e.g., for approval). Therefore, the quality of batches should be checked by random samples by an independent institution as well."

    That article is from 2007 so this is hardly a new problem. Sadly the situation hasn't changed since then.

    There are studies where meters and strips have been purchased through normal channels and the performance of many, particularly low-cost meters, has fallen well below the manufacturer's studies.

    If you are concerned about what may happen if cost becomes the only concern of the funding agencies you only have to look to New Zealand. Here the government agency that decides what medicines and devices are funded have entered a sole-supply agreement with a low-cost Asian manufacturer, iSens. Since March this year, all diabetics, with a small number of exceptions, have only had access to the Caresens brand of iSens meters. There are huge concerns over their accuracy with many reports of missed hypoglycaemic episodes and overdosing of insulin due to artificially high readings leading to hypos. When these are brought to the attention of the funding agency they dismiss the concerns while pointing to the manufacturer-funded studies. Without any independent post-market testing New Zealand diabetics are being used as reluctant guinea pigs.
     
  10. mamattorney

    mamattorney Approved members

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    Thanks for posting; this is concerning. Four letters from me went out in today's mail to the FDA and my elected officials.
     
  11. badshoe

    badshoe Approved members

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    Yay!

    If anyone wants to join in and wants some sample letters to get started there are some here: http://www.stripsafely.com/?page_id=2
     
  12. wilf

    wilf Approved members

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    Would it be helpful for people from outside the US to be writing letters?
     
  13. badshoe

    badshoe Approved members

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    Sorry Wilf I was in DC and missed this.

    The dockets have officially closed but FDA is willing to take comments still. Yes a letter form outside the USA is fine. I would just add a short comment about how FDA has influence on devices sold around the world and boom it is relevant.

    Thanks for joining Lorraine and I for DSMA Live 'Rents last week. Wonderful conversation. It was a privilege to get to talk instead of type with you.

    Bennet
     

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