glucowatch
ASSOCIATED PRESS
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
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. agreed. And the FDA panel demanded
that Cygnus offer a stringent education program to teach patients and doctors
how to use the GlucoWatch.
QUITE A DEVICE
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.
GEARED TOWARD ADULTS
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.