[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]

[IP] Glucowatch update

Looks like the FDA is getting closer to approving the GlucoWatch for use in the USA.  
The latest is in an AP news release which follows:

Panel OKs Wrist Glucose Monitor  
 GAITHERSBURG, MD. - The Associated Press via NewsEdge Corporation : 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.  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. 	

for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
send a DONATION http://www.Insulin-Pumpers.org/donate.shtml