THE GLUCOWATCH SYSTEM IS ALMOST HERE

Self-monitoring of blood glucose has been an integral part of diabetes self-management for decades now, but almost as soon as lancets and test strips became standard equipment, folks have dreamed of ways to monitor without puncturing yourself and bleeding. Today's equipment, while reliable and accurate, is not much fun.

Many companies and inventors have tried to make a needle-free glucose monitor. Some found the technical problems and the expenses of research insurmountable. Others have built prototypes, but had them tested and refused by the Food and Drug Administration (FDA), which believes the needle-free machines must be as accurate as the traditional monitors they would replace.

For a number of years, Cygnus, Inc., of Redwood City, California, has been working to develop a practical and reliable "no-bleed" glucose monitor. They called their wrist-mounted prototype the "Glucowatch." They stayed with it. After some 3000 variations, It appears they have perfected it.

The Glucowatch System ("Glucowatch Monitor" and the disposable "Autosensor" worn beneath it) offers, after one traditional finger-stick test each morning, to calibrate, a more or less continuous glucose readout, 12 hours of data, plus user-definable alarms for too high or too low. The Glucowatch provides more blood glucose information than any regime of discrete finger-stick tests. Painless and automatic, "the Glucowatch is no Rolex, not tiny and discreet, but more discreet than what you're doing right now!" says Cygnus.

On March 27, 1999, at the "Day of Hope," the Desert Diabetes Club's annual gathering in Palm Springs, California, Russell Potts, PhD, Cygnus' Vice President for Research, spoke about his company's progress in bringing the Glucowatch to market. He was upbeat. He said his company had already delivered a substantial portion of the evaluative data to the FDA, and that "their response is really benign."

Dr. Potts noted that in most cases, the FDA rules on the suitability of new products some three to six months after all materials are delivered for their evaluation, but that in the case of his product (where all data are scheduled to be in FDA hands before July 1, 1999), he expects the process to take a bit longer than six months, because the product type is so new, and comparative standards do not yet exist.

"Control is the process of taking measurements and then acting appropriately," says Dr. Potts, who points out that with the greater volume of information provided by the Glucowatch system, diabetics, whether insulin-using or taking oral medications, can expect improved outcomes.

"With a little luck, and some good will, I'll be standing here next year with some Glucowatches you can buy."

The pricing strategy has not yet been finalized. One possible scenario, at the retail level, is to price the hardware (watch) at $225-250, and the consumable Autosensor at $3.75-$4.00. The watch should last about three to five years and the Autosensor is designed to provide measurements for approximately 12 hours. To learn more about the Glucowatch, visit Cygnus' website: http://www.cygn.com