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[IP] RE: insulin-pumpers-digest V3 #733


The GlucoWatch monitor measures blood sugar through a device worn like a

Panel backs diabetic wrist monitor

FDA advisors recommend
approval for GlucoWatch


GAITHERSBURG, Md., Dec. 6 —  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

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. 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

Some 16 million Americans have diabetes, meaning their bodies cannot properly
regulate blood sugar, or glucose. \


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.

 MSNBC's coverage of diabetes

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.

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