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| |  FDA Clears First Glycated Protein Self-Test For Diabetes SAN DIEGO, June 19, 1997 -- The first ever self-test for glycated protein for use by patients with diabetes has received pre-market clearance from the Food and Drug Administration (FDA). The clearance allows over-the-counter sale and use of the test without requiring a prescription from a physician. The new test system is a home version of the fructosamine test which has previously been available only in laboratories, allowing people with diabetes to regularly monitor their overall glucose control with just a fingerstick blood sample and a simple test procedure. The announcement coincides with a presentation on the clinical validity of the innovative test at the 57th Scientific Sessions of the American Diabetes Association in Boston. The research was performed by William Cefalu, M.D., associate professor of medicine at the Bowman Gray School of Medicine of Wake Forest University, and a recognized expert on protein glycation in diabetes. "This system for rapid fingerstick fructosamine testing provides a reliable assessment of antecedent glucose control comparable to the laboratory assessment of fructosamine," Dr. Cefalu noted. Maintaining control of blood glucose at near normal levels has been shown to significantly reduce the risk and progression of the major complications of diabetes, including eye disease, kidney disease, cardiovascular disease, and nerve disease which can lead to amputations. Currently, two different glycated protein tests are used to monitor patients' overall glucose control. One is the glycated hemoglobin (HbA1c) test which indicates a patient's glucose control over the previous two to three months. The other test is fructosamine which indicates glucose control over the previous two to three weeks. "Because fructosamine is more sensitive to recent changes in glucose control than HbA1c, regular home monitoring can help patients and their physicians make earlier and more precise changes in diet, activity levels and medication in order to improve their overall diabetes control," said Cefalu. Cefalu's research found that short-term changes in glucose control were accurately monitored in persons with Type II diabetes who performed the test weekly. Subjects' self-test results were shown to correlate significantly to laboratory tests of both fructosamine and glycated hemoglobin. "The weekly fructosamine home test will complement patients' recommended regimen of daily blood glucose testing and quarterly or semi-annual HbAlc testing," Cefalu observed. "The test will be particularly valuable for the majority of persons with Type II diabetes who we know to be infrequent users of these other two test methods. Because this new home-test will be both convenient and cost-effective to perform on a weekly basis, it will be a truly practical way for most people with diabetes to monitor and improve their glucose control." The new test has been developed by LXN Corporation of San Diego, Calif., and will be marketed by the company under the Gluco-Protein(TM) brand name. LXN Corp. is a privately held company formed in January 1994 to develop innovative diabetes test products. It has previously received 510(k) clearances for a laboratory fructosamine test and for a rapid self-test for blood glucose.
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