There's a lot of renewed chatter about glucose meter accuracy in diabetes tech and regulatory circles right now -- and not just the usual complaints about why the FDA doesn't require a higher level of accuracy for approval of new products.
Even though the FDA is (finally) considering tightening standards on meter accuracy requirements, new studies are showing that our meters are not even meeting the existing standards over time, in the years that we continue to use them long after the original product was reviewed by FDA.
A recent Diabetes Technology Society meeting, which brought together a big group of scientists, doctors, regulatory and pharma folk, focused on the issue of inaccurate glucose monitors on the market and how to potentially enforce improved meter quality.
Until recently, the international standard for blood glucose monitors (the ISO standard) required that 95% of results within range or slightly elevated be within +/- 20% of the true value. New standards approved internationally in mid-May pushed that accuracy requirement up to +/- 15%, and the FDA is currently reviewing whether it will adopt this same stricter standard as formal guidance here in the U.S. A decision could be announced by the end of 2013.
However, studies show that 25% or more of the meters already on the market don't even meet the existing accuracy standards, and that pre-market accuracy requirements are not sufficient because there's no way to make sure these products remain accurate once they're on the shelves for PWDs to buy.
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Things look to get even worse thanks to the federal government's push to expand competitive bidding that encourages cost-analysis of medical products rather than quality assurance.
According to the DTS organizers, FDA officials acknowledged at the meeting that meter accuracy over time is a problem to be addressed, but the agency doesn't know what to do about it (?!)
"We have a problem, particularly with some low-cost glucose meters," said DTS president Dr. David Klonoff, who teaches at the University of California, San Francisco. "The problem is that there are some blood glucose monitors on the market which perform less accurately than the standards would specify and it's these standards which led them to be approved."
Panelists at the meeting reviewed several studies suggesting that meters don't consistently meet accuracy standards after getting FDA approval, including:
- A study presented by Guido Freckmann, MD, of the Institut fÃ¼r Diabetes Technologie in Germany, published in the Journal of Diabetes Science and Technology, that evaluated 34 self-monitoring blood glucose systems and found that seven did not meet current accuracy standards
- Another of Freckmann's studies showing considerable variability between SMBG test strip lots with three of the five systems studied, and only two systems met accuracy standards with each test strip lot
- A third report, by Ronald Brazg of the Rainier Clinical Research Center in Renton, WA, which found that just three of seven SMBG systems tested consistently met current accuracy standards
The FDA's diabetes branch chief, Katherine Serrano, said at the meeting that the federal government is aware of accuracy problems with meters on the market. But she said 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. (Whoa - shaking my head here!)
It's also worth noting that the European Association for the Study of Diabetes (EASD) is calling for an overhaul in how it reviews and approves diabetes technology. We've all observed how the market overseas often sees new D-tech long before we do here Stateside because of the FDA's stricter regulatory process; we PWDs tend to envy them. So it's intriguing to see the diabetes leaders overseas pushing for stricter regulatory guidance like that in the U.S.
Pushing Junky Meters?
But what makes the situation in the U.S. even more scary is looking ahead at what's happening with Medicare. The new shortlist of Medicare-approved suppliers includes just 18 manufacturers that the federal government deemed worthy; most of these meters available "at low cost" are models we haven't heard of in the U.S. mainstream. And did you know that for meters made overseas, there's not even a way to report "adverse effects" the way you might see here... as in, there's no phone number listed on the back of the meter to call, so you simply can't report problems. Meaning, the manufacturer -- assuming they even do keep in touch with the FDA post-market -- isn't lying when it says there are "no issues" with a particular device being sold.
This is what our fellow PWDs on Medicare will be facing on a large scale starting July 1, and as we know, what happens with Medicare is often a predicate for new procedures in the private insurance market... probably even more so these days as we enter the new world of cost-conscious health care reform.
Our own Wil Dubois, a type 1 himself who works as an educator at a clinic in New Mexico, has seen this problem up close and personal as he has more than 100 patients impacted by this already. He's reviewed the list of new Medicare-approved suppliers, and reports that he hasn't heard of half (or more) of these meters. Many are made in India and in Asia (as the FDA pointed out), and it's very difficult to assess their quality.
We asked him for his thoughts here, and his initial response was laced with profanity. Then, he offered this:
"This is a crime. Some of our most vulnerable citizens are being forced into using seriously outdated technology platforms from companies most people have never heard of. Accuracy? Quality control? Customer service? Help lines for people having trouble in the middle of the night? I have my doubts. The majority of the meters covered by Medicare going forward appear to be the old-fashioned manual coding meters that historically have given patients so much trouble, and many completely lack the ability to download to computers, a standard practice at most medical offices and clinics that treat people with diabetes. From a clinical perspective, this new bid process for meters is a complete train wreck, and I predict that this kind of penny-pinching will cost lives. We also can't forget that Medicare is a often a mirror the private insurance companies look into to see their own future. What effects seniors today will affect all of us tomorrow. This is just the tip of the iceberg."
So, we repeat: YIKES!
Right now, there's no apparent solution proposed, not from the Diabetes Technology Society nor the FDA.
In early June, I was part of a discussion among D-advocates and bloggers on this topic, organized by Roche Diabetes. In that talk, Bennet Dunlap made the astute observation that meters and diabetes devices don't have what many other medications do -- post-market studies of test strips to ensure safety. Seriously, do random checks of these supplies to make sure they're meeting the standards. Wouldn't post-market surveillance of meters and strips be a great way for the FDA to keep tabs on accuracy after a device or vial of strips hits the shelves, even if the study period were short-term? We think so.
Since that Roche conference call, there've been some good viewpoints posted in the D-Community about this issue, notably David Edelman's report at DiabetesDaily. There was also some criticism about a recent New York Times article on this topic, which many (including us) feel pushed the cost-aspect of meters and overlooked the important point about quality assurance.
But now, the Diabetes Advocates group is working on an initiative to better address this issue from the patient perspective and get others involved to help bring more attention to it. Here's what we think can be done:
- Pushing Congress: there's a legislative effort to delay the Medicare changes from starting July 1, and for legislators and Medicare officials to re-examine the competitive bidding system to ensure quality. 227 members of the U.S. House have signed on to a letter. Nothing has happened on that yet, but those of us in the patient community can contact our lawmakers to push for this delay. Squeaky wheels have more chance to be heard and oiled than silent ones... You can contact Congressional members the traditional way, or even try their Twitter accounts!
- Lobbying manufacturers to push for change on their end, so that more is required in the regulatory process than just an "honesty statement." Many already believe that our lack of post-market surveillance is a problem, and we can contact our diabetes device manufacturers to tell them we want them to call for this change. How to find them? Start with the number listed on the back of your device (assuming yours has one!)
- Telling diabetes organizations that we need their help in advocating about this. Raising funds for diabetes research is super-important, but the legislative agendas that national advocacy groups are pushing mean nothing if PWDs are more at risk of using sub-par tools that can lead to problems. This is important stuff, too! Hey, JDRF and ADA, AADE and AACE and so on... we need your voices on this!
- UPDATED ON JULY 1: The Diabetes Advocates group has announced the creation of a new social media campaign called StripSafely, which encourages people to "test" their knowledge on this accuracy issue and also advocate for change through social media and letter-writing. Please, take a look and help spread the word!
What do you all think about this issue of compromised BG meter accuracy, and what are your ideas for addressing it?