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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