Good news on the blood glucose meter accuracy front: the Diabetes Technology Society (DTS) is beginning work on a surveillance program to ensure that blood glucose meters and strips that have been cleared for sale in the United States continue to meet those accuracy standards even after they’re on the market. This issue was the focus of a DTS meeting in Washington DC last September – which I wrote about here – and the fact that the program is moving forward is, when it comes to patient safety, a really big deal.
Here’s the back story: while many people with diabetes (myself included) tend to assume that whatever number that pops up on their glucose meters is accurate, that’s not always the case. First of all, the FDA allows a certain margin of error when it evaluates whether or not to clear meters for sale. (The FDA has proposed tighter accuracy standards as part of its new draft guidance on meters and test strips – but a margin of error still does remain.) Second, once a meter has been cleared, it (and its test strips) are never reevaluated again. This means that the accuracy of a meter and its strips can drift downwards over time, but still be on the market. As these citations from the patient-driven website StripSafely.com make clear, plenty of meters on the market are far less accurate than the public (both patients and doctors alike) tends to assume.
The FDA currently finds out about quality and accuracy issues either through its own regular inspections of manufacturing facilities (which are supposed to occur about once every two years, but thanks to budgetary and logistical reasons, don’t always happen that frequently – especially with foreign manufacturers), or through adverse events reported by the public, which are supposed to be passed along to the FDA by the manufacturers themselves. In no situation does the FDA itself pull products off of store shelves to test them. This is obviously bad from a patient perspective, but it’s also bad for the FDA itself, since there’s no easy way for the cash-strapped agency to focus its resources to the products and companies that cause the greatest concern.
Enter the Diabetes Technology Society’s Surveillance Program for Cleared Blood Glucose Monitors. The program aims to do the work that the FDA logistically and legally cannot: it will buy meters and strips off store shelves, test them for accuracy, and publish the results for the public to see. With initial financial support from Abbott – the company that makes the Freestyle line of strips and meters – the program is in the process of establishing a steering committee (as well as recruiting other industry sponsors). According to DTS administrator, Yoram Tamir, the goal is to begin testing blood glucose meters in 2015.
The end product will likely be something like the reports published by Consumerlab.com, which is an independent company that pulls dietary supplements off store shelves and tests whether or not they contain what their labels claim (something that the FDA is also not able to do). This will be useful to all parties involved – as David Klonoff, MD, founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco explained in the program’s press release, “patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program.” What’s more, payers like insurance companies and CMS (the Centers for Medicare and Medicaid Services) – which waded into the issue of accuracy with its recently implemented competitive bidding mail order program for diabetes supplies – could hypothetically use the results of the DTS program to decide which meters and strips to cover. (This is a no-brainer to me: if a meter and its strips aren’t accurate, then how can they be covered as blood glucose testing equipment? You might as well be buying people toasters. Insurance companies, please take note!)
Even the FDA itself might be able to use the program’s results, potentially allowing manufacturers to make claims on product labels based on their scores, or even using the program’s results to help the agency zero in on companies and products whose accuracy appears to be headed south before adverse events occur. As Courtney Lias, Director of the Division of Chemistry and Toxicology Devices at FDA (that’s the division responsible for meters and strips) explained to me, the agency is quite interested in the program and hopes to be as involved in its development as federal ethics rules allow. “We would love to have better surveillance tools to help us focus our resources on areas that can best help patients,” she said. And, as she pointed out, the DTS results could potentially be a great compliment to the FDA’s own intention, as expressed in the draft guidance, to ask manufacturers to put accuracy information (from their premarket tests) on the front of packaging, to help consumers make better informed choices.
Now, of course, every good news story must come with some caveats, and there are a few. First, the program is still in its early stages, and currently Abbott is the only company contributing funding (note to the other manufacturers: this is a good bandwagon to get on). Second, it’s voluntary (though Klonoff is adamant about the need for it to eventually become mandatory, and many people have made similar suggestions in comments for the FDA’s draft guidance for blood glucose meters, which are currently under review – which hypothetically could lead to a regulation requiring that meters be evaluated on a regular basis post-market). Third, no one knows yet exactly what it will look like, or to what extent the FDA will be able to use it – let alone whether insurers or payers will recognize its value.
But whatever! I’m still psyched. DTS is in the process of putting together a steering committee, including at least one patient advocacy group. On behalf of all Americans with diabetes, I want to extend a huge thank you to Dr. Klonoff and DTS for working to make life for people with diabetes safer.
This is really cool and well need. Slightly concerned that this program is only sponsored by one manufacturer. This could lead to bias and would certainly make me skeptical of the results. Surely it should be all or none when it comes to this.
ALL or NONE, is a ridiculous assessment for something so crucially needed as a safety factor
in Diabetes Management. ALL or SOME, is a more reasonable, common sense outcome.