For years now the U.S. agency that regulates everything dear to those of us with diabetes has had a Web site stuffed full of data. It was great. If you could find what you were looking for.
There aren't any FDA accuracy standards.
Now the U.S. Food and Drug Administration has pulled together its scattered resources in a new site, FDA Diabetes Information. Wisely, the new site focuses on the areas that the agency regulates, since it has specific information not available elsewhere.
"The most valuable part of our site is the access to the FDA databases," says Public Health Advisor Laurie Mendelson of the FDA's Center for Devices and Radiological Health. She coordinated most of the site's content.
"If you dig thorough the drug section you will find access to FDA databases that contain information on effectiveness of the drug," Laurie says. "The site itself also gives links to some of the guidance documents that show the public how the FDA makes its decisions."
This is the FDA's first disease-specific site. The agency launched it in May at the same time its Office of Women's Health launched Take Time to Care...About Diabetes, which is "the overlay of the agency-wide diabetes site," says Dr. Susan Wood, director of the office.
Her office focused on diabetes "because of the large impact that it has and the fact that it does affect women differently and harder," she says. "Also because of our partners—the American Diabetes Association and the National Association of Chain Drug Stores—were willing to help us move this message beyond what we could do alone."
I told Dr. Wood that I had never heard that diabetes struck more women than men. In fact, Women's Health USA 2002, a new report from the U.S. Department of Health and Human Services, confirms that "Among persons aged 64 and younger the prevalence of diabetes is slightly higher among U.S. females than males." But among those over 65 men are more likely to have diabetes.
The two new FDA sites dealing with diabetes are linked together. "We did it on purpose to coordinate an outreach effort especially targeting women along with the background of what the FDA has to offer," Laurie says. "They do fit together!"
The glucose meter section is the most popular part of the FDA Diabetes site, she says. Food and meal planning follows and then insulin.
That surprised Laurie. "I would first click over to the news," she says.
I told her that what surprised me the most was that I couldn't find FDA accuracy standards for approving glucose meters on her glucose meter page. Different people had told me that readings could be off by either 15% or 20%, but I had looked in vain through the entire FDA site for it. She referred me to the director of the FDA's Division of Clinical Laboratory Devices, Steve Gutman, M.D.
His answer surprised me even more. There aren't any such FDA standards—yet.
"Premarket review of glucose meters has traditionally not been standards based," Steve wrote me. "That's because there is not a well-defined single reference to use for establishing performance and because the relative degrees of performance required may vary with the setting."
He went on to state, however, that "total errors in the neighborhood of 20% or less are acceptable for current practice and are being met by virtually all meters," but that "this informal performance target has not been codified anywhere."
The International Organization for Standardization (ISO) will soon adopt a standard that will require a 20% maximum system error, Steve says. "We plan to recognize this standard and believe that the current products probably represent a reasonable balance between performance and cost."
Maybe because of my question, updates to the FDA's diabetes site will include national and international glucose meter accuracy standards. Laurie also plans to expand the site to include more information about complications of diabetes and products for those complications.
"I would also like to include more in-depth information about supplements, alternative treatments, and as much information as we are allowed to release about emerging technologies," Laurie says. "That is our specialty. We know the emerging technologies, and the minute we can talk about them I would like to see it posted."
The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.
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