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Re: [IP] GlucoWatchApproved by FDA

In a message dated 12/7/99 8:15:36 AM US Eastern Standard Time, 
email @ redacted writes:

<< NON-INVASIVE glucose testing is finally here!!!!!!!. >>

Yes, but it won't replace finger-sticks, some news reports say:

FDA Panel OKs Wrist Glucose Monitor

.c The Associated Press

GAITHERSBURG, Md. (AP) - Diabetics tired of those painful finger-prick blood 
tests required to check their blood sugar may soon wear a 
science-fiction-like wristwatch to do the job. 

Cygnus Inc.'s GlucoWatch is poised to become the first painless glucose 
monitor. Advisers to the Food and Drug Administration voted unanimously 
Monday that it should be approved for use by adult diabetics. 

The GlucoWatch works by sending tiny electric currents through the skin to 
measure glucose levels every 20 minutes - even while patients are sleeping. 
It sounds an alarm if patients' blood sugar hits dangerous levels. 

Some 16 million Americans have diabetes, meaning their bodies cannot properly 
regulate blood sugar, or glucose. They check their levels by pricking a 
finger and placing a drop of blood on reactive strips. 

Doctors urge those tests be done frequently, four to eight times a day, 
because they can help patients better control diabetes and thus lower 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 if patients frequently do the tests, they cannot know if glucose soars 
or drops between testing or while they sleep. Indeed, one of diabetics' 
greatest fears is that their glucose will plummet to life-threatening levels 
during sleep. 

``To sleep through the night at our house is to court disaster,'' Vivien 
Skinner of Dallas told the FDA panel in describing how often her 9-year-old 
son Michael becomes hypoglycemic at night. 

She and her husband set alarm clocks to wake them every two hours every night 
so they can prick Michael's finger and check his glucose while he sleeps. A 
GlucoWatch could work far better, she said. 

``The alarm function would be an absolute godsend, a lifeline for Michael.'' 

The GlucoWatch would offer patients far more frequent measurements than 
finger-prick testing now affords, and could wake them if their blood sugar 
drops, the FDA's advisers concluded Monday. 

But they stressed it is not perfect: It sometimes gives erroneous readings, 
won't measure if the patient's arm becomes too sweaty and is less effective 
at detecting very low glucose than very high levels. 

Indeed, because of the potential for error, patients never should decide to 
use insulin based on a GlucoWatch measurement without first double-checking 
with a fingerstick test, FDA advisers and Cygnus agreed. 

And for Mrs. Skinner and four other mothers who traveled hundreds of miles to 
plead for the GlucoWatch, there was distressing news: Cygnus has not studied 
it on any children to know if it works on them. So if the FDA approves the 
device, it initially would be for adults. 

Still, ``this is quite a device,'' said FDA panelist Dr. Stephen Clement of 
Georgetown University Medical Center. 

The FDA is not bound by its advisers' recommendations but typically follows 

To use the prescription-only GlucoWatch, patients would 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 instead 
of blood, measuring 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 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. 

Before selling, Cygnus must develop a stringent education program to teach 
patients and doctors how to safely use the GlucoWatch, the FDA panel 

AP-NY-12-07-99 0128EDT

Diabetic blood sugar monitor wins FDA panel support

By Lisa Richwine

GAITHERSBURG, Md., Dec 6 (Reuters) - A watch-like device designed to closely 
track diabetics' blood sugar and help control the disease won support on 
Monday from a U.S. government advisory panel. 

The GlucoWatch painlessly measures blood sugar, or glucose, levels every 20 
minutes for up to 12 hours at a time, according to maker Cygnus Inc.<<A 
HREF="aol://4785:CYGN">CYGN.O</A>>. The hope is that patients can use the 
information, along with traditional glucose measures, to spot trends and 
decide when to adjust treatment. 

A Food and Drug Administration advisory committee voted to recommend U.S. 
approval for the GlucoWatch, which would be available only by prescription. 
Members stressed that the device should not be a substitute for traditional 
glucose tests done by pricking a finger to draw blood. 

"Certainly it's very useful, mainly for detecting trends and giving 
information for better managing glucose," said panel member Nader Rifai of 
Children's Hospital in Boston, but "it's not to replace (other) glucose 

The FDA usually follows its panels' advice, and the agency is expected to 
make a decision in the coming months. 

If perfected, frequent glucose monitoring could revolutionize the treatment 
of diabetes, which affects nearly 16 million Americans, experts have said. 
Many companies are trying to develop products aimed at providing accurate, 
non-invasive, continuous glucose measures that could help prevent serious 
complications such as blindness and kidney damage. 

Panel members recommended that the FDA, if it approves the GlucoWatch, 
require studies after the product hits the market to further evaluate its 
usefulness, particularly at identifying dangerously low blood sugar. 

The panel's endorsement was vital to Redwood City, Calif.-based Cygnus, which 
is planning to sell most assets from its drug delivery business and focus on 
the product, industry analysts said. 

"This is the pivotal event in this company's history," said Amerindo 
Investment Advisors analyst William Slattery, who predicted GlucoWatch sales 
would hit $200 million in about three years. 

People with the diabetes either cannot produce or cannot properly use 
insulin, the hormone needed to convert sugar, starch and other foods into 
energy. Patients use insulin injections, medications and/or diet and exercise 
to try and keep blood sugar at safe levels. 

Now, many diabetics must monitor glucose rises and falls several times a day. 
Aside from being painful, the so-called fingerstick tests are inconvenient, 
and many patients do not perform them as often as recommended, experts said. 

The GlucoWatch uses tiny electrical currents to draw fluid from just beneath 
the skin into the watch and measure glucose. Readings show up on a digital 
display, and an alarm sounds if glucose levels are too high or low. 

In clinical studies, GlucoWatch readings did not always match results from 
fingerstick tests. Panel members, however, noted that fingerstick tests also 
can be inaccurate. 

Some users reported mild to moderate skin irritation from using the watch, 
which includes sensors that must be discarded and replaced after 12 hours. 
The device also requires a three-hour warm-up period and occasionally shut 
off or skipped readings. 

Cygnus has said the watch itself may cost between $225 and $250, and the 
sensors would cost $4 apiece. Sales of the sensors are expected to eventually 
comprise most revenue. 

Several possible competitors also are working on glucose monitoring system 
for patients, including MiniMed Inc. <<A HREF="aol://4785:MNMD">MNMD.O</A>>, 
which has an implantable monitor on the market that must be read by doctors. 

20:57 12-06-99

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