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The US Food and Drug Administration (FDA) has granted
marketing approval to Cygnus' GlucoWatch
Biographer, a non-invasive blood sugar monitoring device designed
to be worn like a wristwatch by diabetic patients aged 18 and older.
The device, which works by extracting
fluid through the skin using tiny electric currents, is "one
of the first steps" on the road to technology that could eventually
replace the traditional finger-stick method of monitoring blood sugar,
or glucose.
For now, the GlucoWatch is
intended for use only in combination with finger-stick blood testing
because of the device's "potential
for error." The FDA noted that the GlucoWatch results
differed by more than 30% from those yielded by finger-stick tests up
to 25% of the time.
Moreover, the wristwatch device is
less reliable at detecting
very low blood sugar levels than very high levels and will
not work at all if the user's arm is "too sweaty," the agency
cautioned.
For these reasons, physicians and patients should
never base changes in insulin doses on a single GlucoWatch reading, the
FDA advised. "Instead, the GlucoWatch results
should be interpreted with several sequential readings over time and then
confirmed with a finger-prick test."
High blood sugar levels -- a complication of diabetes -- can
lead to nerve damage, kidney disease and blindness. But regular monitoring
and regulating of blood sugar levels with insulin injections and other
treatments can lower these risks.
The agency noted that the wristwatch device caused
mild to moderate skin irritation
in about half of patients tested and has not been studied in children.
The GlucoWatch measures blood sugar levels in the
blood every 20 minutes for 12 hours "even during sleep," the
FDA said. An alarm is triggered if the patient's blood sugar levels exceed
acceptable levels.
Washington, D.C, FDA Report
March 22, 2001
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