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FDA Alternate Site Clearance Offers BD Blood Glucose Meter Users More Convenience
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- Palm testing for BD products deemed equivalent to finger testing - BD blood glucose monitoring products now offer combination of more convenience and more comfort
Contact: Michael Marinello BD Public Relations (201) 847-7437 Franklin Lakes, NJ (November 04, 2004) -- BD (Becton, Dickinson and Company) (NYSE: BDX) today announced that it recently received clearance from the U.S. Food and Drug Administration (FDA) that will allow people using the BD Logic™ and Paradigm Link® blood glucose meters to use alternate site testing (off-finger) when checking their blood glucose levels.
"This is great news for people with diabetes," said Bill Marshall, President, Diabetes Care, BD Medical, "Coupled with the BD Ultra-Fine™ 33 gauge Lancets - the thinnest lancet on the market - this clearance by the FDA equating palm testing with fingertip testing for users of the BD Logic™ and Paradigm Link® provides people a more convenient and comfortable 'best in class' approach to checking their blood glucose levels."
The scope of the FDA 510(k) clearance for BD includes palm and forearm testing for the BD Logic™ and Paradigm Link® blood glucose meters. While other meters on the market have been cleared for alternate site testing, this specific clearance makes palm testing the equivalent to fingertip testing for our specific blood glucose-monitoring systems. BD is now one of a very small group of companies that may claim that palm testing is equivalent to fingertip testing for blood glucose monitoring systems.
According to Dr. Barry Ginsberg, MD, PhD and Vice President of Medical Affairs for Diabetes Care, BD Medical, "This clearance means that patients can now test on their palm when using BD Logic™ and Paradigm Link® meters and know that the values are accurate. The values will tell the patient what is happening now, not 10-30 minutes ago, as often found with arm testing. Patients can now safely test on the palm even after eating, exercising, taking insulin or when their blood glucose is low."
"Before I started using BD Logic™, I did not check my blood sugar regularly--it was painful and difficult. The BD meter is easy to use and requires a small amount of blood. And the BD Lancets are very thin, so they do not hurt at all. Now, I am checking my blood sugar at least four times a day; my diabetes is in much better control and I feel good," says Carlos Lasiloo, a participant in the BD Diabetes Makeover, a registered nurse and an administrator in the Indian Health Service. "I also like the fact that the BD Logic™ meter now lets me test from alternate sites, like my palm, which I cannot do with (all) other meters."
About BD Logic™ and Paradigm Link®:
The BD Logic™ Blood Glucose Monitor produces accurate results in just 5 seconds, requires one of the smallest blood volumes (0.3ul), and uses the thinnest lancet available—BD Ultra-Fine™ 33 Lancets (33 gauge) —for 50% less pain.
Paradigm® insulin pumps (model 512, 515, 712 and 715) and the Paradigm Link® Blood Glucose Monitor are the only pumps and meters that communicate automatically using wireless technology that both saves time and effort, as well as reduces potential errors associated with manually entering meter values into an insulin pump. Manufactured by BD specifically for use with Paradigm® insulin pumps (model 512, 515, 712 and 715), the Paradigm Link® Blood Glucose Monitor provides fast results in just 5 seconds, requires one of the smallest blood volumes (0.3ul), and uses the thinnest lancet available—BD Ultra-Fine™ 33 Lancets (33 gauge)—for 50% less pain.
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