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    Diabetes Demands a Triad of Treatments

    Blood Glucose Monitoring Devices

    For millions of Americans with diabetes, regular home testing of blood glucose levels is critical in controlling their disease.

    "The most near-normal glucose patterns you can get will have a terrific long-term impact on how well people with diabetes do," says Steven Gutman, M.D., director of the division of clinical laboratory devices in FDA's Office of Device Evaluation. But he adds, "Tight control isn't easy because it requires multiple glucose measurements."

    For many years, diabetics relied on home urine glucose testing to monitor blood sugar levels. But the method was not without drawbacks. Monitoring glucose levels via the urine is problematic for several reasons: First, blood glucose concentrations above which glucose appears in the urine vary widely among individuals, so the tests are not very reliable. Second, factors such as fluid or vitamin C intakes can influence test results. And third, negative tests can't distinguish between normal, low, and moderately high blood sugar levels.

    By the late 1960s, manufacturers began introducing home blood glucose monitoring kits. These kits allowed diabetics to detect blood sugar levels by looking at color changes on a chemical test strip using a single drop of blood from a pricked finger. Portable meters that could electronically read the strip and provide immediate results came along in the late 1970s.

    Although today's monitors are small, easier to use than early ones, and reasonably priced at between $50 and $100, they all require users to prick their fingers to provide a blood sample for testing. So diabetics were understandably enthusiastic when a noninvasive glucose sensor monitoring device was developed. It doesn't require a finger prick but instead uses infrared technology to measure blood glucose. But after reviewing data from the device's manufacturer, the Clinical Chemistry and Clinical Toxicology Devices Advisory Panel of FDA's Medical Devices Advisory Committee decided more data were needed to ensure the device's safety and effectiveness.

    "The idea of being able to test yourself without a painful prick is very attractive. It would probably increase compliance because some patients simply don't want to prick their fingers," Gutman says. "It's a very promising technology. But you have to balance technology against performance."

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