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Strategies & Market Trends : Cents and Sensibility - Kimberly and Friends' Consortium -- Ignore unavailable to you. Want to Upgrade?

To: KevinMark who wrote (39373)	12/6/1999 7:17:00 PM
From: EtTuBrute	Respond to of 108040

CYGN: Here is full AP story: Monday December 6 6:44 PM ET Panel OKs Wrist Glucose Monitor By LAURAN NEERGAARD AP Medical Writer GAITHERSBURG, Md. (AP) - Diabetics may soon get their first painless way to measure blood sugar, as government advisers recommended approval Monday of a wristwatch-like device to supplement - but not completely replace - the painful finger-prick blood tests patients now endure. The GlucoWatch checks glucose levels every 20 minutes by sending tiny electric currents through the skin. It sounds an alarm if patients' blood sugar hits dangerous levels, even while they sleep. Advisers to the Food and Drug Administration voted unanimously that the GlucoWatch should be approved for adult diabetics, saying it could offer a tremendous benefit by measuring glucose far more often than blood tests can today. But the advisers stressed the GlucoWatch is not perfect: It sometimes gives erroneous readings, won't measure when the patient perspires too much, and is less effective at detecting life-threateningly low blood sugar than at spotting dangerous high glucose levels. Indeed patients should never decide to use insulin based on a GlucoWatch measurement without first doing a finger-stick test to doublecheck, FDA advisers and manufacturer Cygnus Inc (NasdaqNM:CYGN - news). agreed. And the FDA panel demanded that Cygnus offer a stringent education program to teach patients and doctors how to use the GlucoWatch. Still, ''this is quite a device, a huge undertaking,'' said FDA adviser Dr. Stephen Clement of Georgetown University Medical Center. The FDA is not bound by its advisers' recommendations but typically follows them. Some 16 million Americans have diabetes, meaning their bodies cannot properly regulate blood sugar, or glucose. Frequently checking their glucose levels by pricking a finger and placing a drop of blood on reactive strips helps patients make diet and medication choices to better control diabetes, dramatically lowering their chances of debilitating complications such as blindness, kidney disease and nerve damage. But these fingerstick tests are painful and inconvenient, leading the average patient to test only twice a day, said Dr. Steven Edelman of the University of California, San Diego, who has diabetes himself. Even regular blood testing cannot helps if glucose soars or drops between tests or while patients sleep. Indeed, one of diabetics' greatest fears is sliding into a coma during sleep from plummeting glucose. So diabetics, and parents of diabetic children, pleaded with the FDA on Monday to quickly allow the GlucoWatch to sell. ''The alarm function would be an absolute godsend, a lifeline for Michael,'' said Vivien Skinner of Dallas, whose 9-year-old son frequently experiences hypoglycemia during the night. Mrs. Skinner and her husband set alarm clocks to wake them every two hours every night, so they can prick Michael's finger while he sleeps and check his blood sugar. ''It's been four years in our house since we've had a full night's sleep,'' she said. ''If I have the watch, my whole life will be easier,'' 11-year-old Ryan Harvey of Holliston, Mass., told the FDA panel. But to parents' distress, California-based Cygnus has not yet tested the GlucoWatch on any children, so if the FDA approves its sale, it initially will be only for adults. The GlucoWatch, which would require a prescription, looks like a wristwatch. Patients slide a thin plastic sensor onto the watch's back each time they strap it on. Small electric currents extract a tiny portion of glucose from fluid in skin cells to measure it every 20 minutes for 12 hours. Cygnus said studies found the GlucoWatch as accurate as standard blood tests, which themselves sometimes are erroneous. But FDA officials warned that 25 percent of the time, GlucoWatch readings can differ from blood tests by about 30 percent - meaning if the GlucoWatch reads a glucose level of 150, it might really be anywhere from 135 to 165. Experts said that was mainly a concern in detecting hypoglycemia, blood sugar that drops below a measure of 70. But patients can program the GlucoWatch to sound an alarm well before glucose drops that low, giving them time to do a finger-prick blood test to verify their real level, the company said. The only other safety concern: Most patients experienced mild to moderate skin irritation, but it cleared up when the watch was removed. FDA advisers urged studying the irritation question in children, who have more sensitive skin. Research thousands of health terms, drugs, and diseases