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FDA Clears Becton Dickinson Diabetes Measurement Kit For Marketing


Franklin Lakes, NJ (September 11, 1997) -- Becton Dickinson and Company announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing a new kit for measuring long-term blood glucose levels, an important health indicator for people with diabetes. The B-D EASY A1C™ kit -- the first of its kind -- will enable patients to draw samples at home for mail-in laboratory measurement, offering greater convenience than current testing methods that can require a separate visit to a laboratory or medical professional's office.

Using the B-D EASY A1C kit, patients will be able to determine their levels of glycated hemoglobin, a blood component long recognized as an accurate, valuable indicator of long-term levels of glucose, or sugar, in the blood. Unlike the monitoring of day-to-day glucose levels -- a necessary activity for many people with diabetes -- measuring HbA1c levels provides a long-range perspective on how glucose levels are being controlled.

Convenience and Long-term Information
Users of the B-D EASY A1C kit will, with a simple fingerstick procedure, draw two drops of blood and place them on a specially treated test strip, which they then send to a laboratory in a prepaid mailer. Within seven to ten days, both patients and their doctors will receive test results. Once enrolled in the B-D EASY A1C program, patients can receive a new test kit via mail every three months. Over time, the B-D EASY A1C program will provide information on prior B-D EASY A1C test results along with new results, so users can identify trends in the course of their long-term blood glucose levels.

The American Diabetes Association recommends that people with diabetes test their HbA1c levels regularly. Studies have shown that long-term reductions in HbA1c are associated with a dramatically reduced risk of major diabetes complications, including amputations, loss of vision and kidney failure.

"Controlling blood glucose levels is one of the most important steps a person can take to minimize the complications of diabetes," said Ken Weisshaar, senior vice president, Worldwide Consumer Products/Diabetes Care. "The B-D EASY A1C test kit offers people with diabetes a way to get an accurate, big-picture view of their glucose levels wherever and whenever it's most convenient."

 

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