Voice of the Diabetic

Voice of the Diabetic

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GLUCOWATCH APPROVED

On March 22, 2001, The

U.S. Food and Drug Administration (FDA) announced that it had completed the

approval process for the Glucowatch Biographer continuous glucose monitor. It's

passed; it's here; it will now come to market. Worn like a big wristwatch, the

Glucowatch is the first working alternative to "lancet and test-strip" blood

glucose monitors to reach "approval" status.

Can I buy a Glucowatch?

Not yet, but soon. Cygnus, with help from marketing partner LifeScan, will no

doubt be getting them out to pharmacy shelves as fast as they can.

Will I need a prescription?

Yes. The FDA knows this is a new and different piece of machinery, and, as with

Humalog insulin, extra supervision will be necessary, at least at this time.

Will it replace my finger-stick

meter? No. The Glucowatch works, and it does some neat things, and will help

some people, but it does not replace traditional blood- glucose monitoring.

In fact, every time the user changes the replaceable Autosensor (the Glucowatch's

"test strip"), a finger-stick blood test is necessary to properly calibrate

the meter. That means two sticks a day.

What's the Glucowatch

for, then? The Glucowatch is a continuous glucose monitor. Where traditional

monitors take "snapshot" readings, and cannot tell you whether your blood sugars

are stable, going up, or going down, the Glucowatch tracks patterns. It automatically

tests every 20 minutes, allowing you and your doctor an excellent opportunity

to fine-tune your blood glucose self management. And, the Glucowatch incorporates

a programmable low blood sugar alarm, that can be set to "sound off" if your

sugars are diving into hypoglycemia territory.

Cygnus, the manufacturer,

states the meter is not intended as a replacement for traditional finger-stick

metering, but to provide more complete and on-going information about blood

glucose levels. They point out many diabetics now test only a few times a day,

possibly missing important information about their glucose levels at other times,

such as after meals or while they sleep. The Glucowatch solves this problem,

without requiring radical changes in testing habits. Good diabetes management

requires the most possible information, and the Glucowatch provides its user

more information than has been available before and it does it without a lot

of poking and bleeding.

What about cost? While

some experimental "no needles" glucose monitors have needed a van to tote them

about, and a bankloan to finance them (and never made it to "FDA approved" status)

the Glucowatch will cost several hundred dollars, and its "test strip," the

Autosensor, should cost $3 or $4 each a lot compared to a traditional test strip,

but not compared to the 36 test strips it would replace in a 12-hour period.

Note: Final prices are not set, and will probably vary between retailers.

Can a blind person use

the Glucowatch? The current model does not incorporate speech compatibility,

but Cygnus VP Dr. Russell Potts told the VOICE : "We have every intention of

expanding its use, including use by people who are sight-impaired." He stated

Cygnus had to launch the basic product first, and intended to provide adaptive

products "in the not too distant future."

For more information, contact

Cygnus, Inc., telephone: 1-866-459-2824; website: www.glucowatch.com

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