FDA Clears Additional Body Testing Sites for Freestyle, a Virtually Pain-Free Blood Glucose Monitor
New blood glucose test alternative may encourage better diabetes disease management
ALAMEDA, Calif., December 13, 2000 - The Food and Drug Administration (FDA) today cleared expanded use of FreeStyle*, a breakthrough product that provides a virtually pain-free blood glucose monitoring system to the nearly 16 million Americans with diabetes. Developed by TheraSense (Alameda, Calif.), FreeStyle allows people with diabetes to obtain a blood sample from places other than fingertips. This new clearance permits the use of FreeStyle on the upper arm, thigh, calf, and anywhere on the hand, in addition to the previously cleared forearm testing site, providing multiple alternatives to painful finger sticks.
"Our purpose in developing FreeStyle was to significantly improve diabetes management by reducing one of the biggest barriers to testing-pain," said Mark Lortz, president and CEO of TheraSense. "FreeStyle quickly and accurately provides a blood glucose value using a fraction of the blood sample currently required by other products on the market. This smaller blood sample gives people the freedom to test with virtually no pain on sites other than their fingertips."
Blood glucose monitors have previously used fingertips to get adequate blood for an accurate reading. Because of the sensitive nerve endings in fingertips, repeated testing is painful. "We believe the additional testing sites for FreeStyle will further promote increased blood glucose testing. Now people have many options to test their glucose, making it easier to take better control of their diabetes and enjoy a healthier life," explained Lortz.
Anne Peters, MD, Director of the USC West Side Center for Diabetes and member of the TheraSense Medical advisory board said, "One of the necessities for diabetes management is the measurement of blood glucose levels on a frequent basis, which is a task that until recently was limited to the use of fingertips (which hurt!). As the ability to monitor extends to other sites of the body, less painful areas can be used and testing can be done in a more convenient fashion for the patient, which encourages compliance with necessary monitoring."
Diabetes is a leading cause of death in the United States and a primary cause of amputations, eye, kidney, and heart disease. According to the American Diabetes Association, nearly six percent of the United States population (15.7 million people) has diabetes, and another 798,000 will be diagnosed with the disease this year.
TheraSense, Inc. (Alameda, Calif.) is a privately held medical device manufacturing firm dedicated to caring for people with diabetes through the development of innovative and painless blood glucose monitoring systems. More information can be found at http://www.TheraSense.com.
Posted 13 December 2000
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