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It\u2019s difficult to make the FDA\u2019s new guidance on blood glucose test strips<\/strong> sound sexy, but I\u2019m going to try. Imagine this situation: you\u2019re sitting in front of a fire with your boyfriend\/girlfriend\/spouse\/lover\/partner, relaxing on some soft cushions or maybe a bearskin rug. The lights are low. Candles twinkle. Wine glasses are in hand. Soft jazz is playing. As you look at your boyfriend\/girlfriend\/spouse\/lover\/partner, your heart quickens. He\/she\/it moves in for a kiss. Your body begins to tremble. Your pulse races. Your head is dizzy; you feel a light mist of sweat on your skin. Now you try to pull him\/her closer, but your hand\u2019s kind of shaking, the sweat is actually dripping down your back, and you realize that you\u2019re not exactly <\/em>sure where you are or why you\u2019re sitting on a bearskin rug. . . Wait a second. This isn\u2019t romance. It\u2019s a low blood sugar!<\/p>\n \u201cHow did this happen?\u201d you ask yourself, stuffing your face with a chocolate-dipped strawberry. You tested your blood sugar right before dinner. You dosed your insulin off of that number. Could it be that your glucometer was wrong?<\/p>\n That, in a nutshell, is a gamble all of us take every single day. Whether it\u2019s a romantic Friday night or just an office coffee break, people with type 1 diabetes (and insulin-dependent type 2s) are constantly making calculations of insulin \u2013 an incredibly dangerous medication \u2013 that could literally kill us if we get them wrong. We need the numbers on our glucometers to be right. And that\u2019s why the FDA\u2019s approach toward glucose test strips matters.<\/p>\n With that out of the way, here\u2019s what just happened: in early January 2014, the Food and Drug Administration came out with new draft guidance for blood glucose test strips<\/a>\u00a0and their accompanying meters. An FDA guidance document, when finalized, is a summary of the FDA\u2019s current thinking on what information the FDA will look for when deciding whether to give FDA clearance to a manufacturer for its meters and strips. It\u2019s kind of like getting a list of test questions before your exam, so that you know how to prepare ahead of time.<\/p>\n I listened in on a phone call last week run by Courtney Lias, who is the Director of the Division of Chemistry and Toxicology Devices at FDA, and whose responsibilities include devices used for diabetes management, including blood glucose meters, Artificial Pancreas device systems, and continuous glucose monitoring systems (CGMs). I had met her earlier this year at the Diabetes Technology Society\u2019s September meeting about test strips<\/a>\u00a0and was impressed by how sincerely she seemed to listen to the concerns of people with diabetes. Last week’s call reaffirmed that.<\/p>\n The FDA\u2019s new draft guidance does not address post-market surveillance issues (for more on those, visit StripSafely.com), but it is important nonetheless, for reasons I shall now attempt to bullet point (this is not a comprehensive list of what they do; for the truly dorky among you, check out the links below):<\/p>\n For the full details, see the above links.<\/p>\n Now, to answer a couple questions:<\/p>\n Q: Why are the accuracy requirements different? Why can\u2019t they be the same for home and hospital use?<\/em><\/p>\n A: The basic answer was that the FDA doesn\u2019t think that manufacturers would be able to produce the volume of strips needed to meet the lay public\u2019s demands at those levels of accuracy. But as Lias put it, \u201cWith the technological advances in manufacturing that manufacturers may develop in order to meet this healthcare providers\u2019 criteria, we hope they might apply some of that to the lay population and drive the accuracy better for both populations.\u201d<\/p>\n To that point, I think it is important for us as patients to request that language be added to the draft guidance documents that makes this ultimate goal \u2013 5-10% accuracy for all <\/em>meters \u2013 explicit. The hope would be that eventually these higher standards could be phased in to apply to all meters. More on how to comment below.<\/p>\n Q: Will these new standards drive prices up?<\/em><\/p>\n A: No, the FDA does not believe that they will, thanks to competitive forces and market demand.<\/p>\n Q: What about all the meters that are already on the market? What happens to those?<\/em><\/p>\n A: Those meters will not be required to get new clearance under these proposed higher standards, so the short answer to that question is: nothing. They\u2019ll still be on the market. However, Lias believes that technological advancements would mean that they would eventually be phased out. And \u2013 this is important \u2013 she said that if we want to see these standards apply to ALL meters on the market, not just new ones, we should make that point in the public comments.<\/strong><\/p>\n Q: What effect will this have on health insurance reimbursement policies (particularly Medicare)? How much interaction does FDA have with CMS?<\/em><\/p>\n A: The FDA has not worked directly with CMS or other payers in the development of this guidance; however, CMS has indicated that it often looks to FDA clearance for guidance on coverage decisions. So while they\u2019re not directly linked, raising the bar for FDA clearance could raise the bar on the type of strips that could be reimbursed. \u201cThese new guidance documents are also meant to provide more standardization \u2013 especially the lot release criteria part of document \u2013 to attempt to get more consistency, so there\u2019s not this alleged discrepancy between different meters,\u201d Lias explained. And, she concluded, \u201cWe\u2019re happy to hear suggestions on that area as well.\u201d<\/p>\n Q: I find this issue fascinating and desperately wish I could have heard last week’s call. What can I do?<\/em><\/p>\n A: Call (888) 567-0443 and you can hear the whole hour-long recording of it. True story!<\/p>\n WHAT YOU CAN DO:<\/strong><\/p>\n For those who don\u2019t know how this process works, after the FDA publishes a draft guidance document, it has to open that document for 90 days of public comment before it issues a final guidance document. Those comments can come from anyone \u2013 industry, healthcare providers, professional organizations, or you or me. And I think we should comment! If you\u2019re game, here\u2019s what I\u2019d consider including in your letter (the deadline for comments is April 7):<\/p>\n Comments can be submitted online independently for both the point-of-care (hospital) and over-the-counter (home) guidance documents. \u00a0The deadline is April 7, 2014. If in doubt as to which guidance document to choose, I\u2019d suggest submitting them for both.<\/p>\n Submit comments online for over-the-counter (home) meters here: http:\/\/www.regulations.gov\/#!submitComment;D=FDA-2013-D-1446-0001<\/a><\/p>\n\n
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