By: Maureen Kingsley

Courtney Harper, director of the division of chemistry and toxicology devices at CDRH, the division that hosted the meeting, cited 12,000 measurement errors reported each year by users of blood glucose meters (BGMs) and said that the meeting was “a way for FDA to try to take a new approach to addressing that problem in addition to some other issues we’d been hearing about.”

 

Those other issues include some users attempting tight glycemic control with the meters. Harper said that hospitals are “trying more actively to manage patients into a more normal blood-sugar range,” and that some hospitals are using BGMs to do that. Participants at the FDA meeting discussed whether BGMs are accurate enough for that type of use. “In some cases,” Harper said, “for the ranges they’re trying to drive these patients into, the meters may have enough imprecision that they can’t possibly” get a patient into the target range. “For example,” she said, “If someone is trying to get a patient to between 80 and 120 mg/dl blood glucose, but the meter used has greater than 20% inaccuracy, then you could never ensure that you could get something so tight.”

 

Mark Vreeke, vice president of R&D at Pepex Biomedical Inc. (Saint Louis, MO), and a participant at the meeting, added, “I think some of the home users of BGMs are attempting this, too: to get a tighter range on their glucose levels.” He explained that, in this case, “tighter” usually means “lower.” What people consider normal glycemic range varies, “but it may be between 70 and 110 mg/dl,” he said. “The ‘gotcha’ is that at the low end of that range, meter accuracy is not all that great. So if you’re trying to do tight glycemic control, you’re going to be hitting the location where the meters tend to have the least accuracy.”

 

Most BGM stakeholders at the meeting seemed to agree that the specification for BGM accuracy should be tightened—possibly from 20% to 15%, Vreeke said.

 

Another issue raised at the meeting was the problem of meter interferences—things like patient dehydration or anemia, which can affect BGM readings, Harper explained. Vreeke mentioned the problem of the “one in ten-thousand or one in one-hundred-thousand outlier.” This issue was raised at the meeting, but “there really was no consensus on how to resolve it, since these are single-use-strip devices. You can’t completely test one of these devices before sending it out into the marketplace. It’s something companies will have to continue to work on,” he said.

 

Hospital use of BGMs in general is an ongoing issue: “Glucose meters and test strips are a lot less expensive” than more-accurate methods of measuring blood glucose in a hospital setting, Harper said. “The convenience and cost-effectiveness of BGMs is attractive to hospitals, so that’s something we really need to work with people to try to address, and something we were very glad to get some good feedback on at the meeting,” she added.

Industry response to the meeting has been generally positive. “We have seen some definite response from the industry in terms of its apparent willingness to agree that there do need to be some changes” made to BGM accuracy and use, Harper said. “We have seen a willingness to discuss [these issues], and we really do appreciate that on the part of industry.”

 

FDA’s next step, Harper said, is to publish some guidance for industry on which all stakeholders will be invited to comment. (She did not offer a date on which that initial document would be released.) After the period for comments is closed, FDA will make “revisions as necessary” to the guidance document, Harper said, then eventually finalize it “so people have some clarity and predictability.” 

 

FDA is viewing this post-meeting period as a time of “comprehensive evaluation” and “proactive outreach effort,” she said.

 

Vreeke added that the meeting itself was “very productive” with “a lot of discussion.” He said FDA put on a very high-quality meeting, with a variety of stakeholders present, including a patient advocate. “FDA was very thorough, very impressive.”