WHERE'S THE GLUCOWATCH?

 

 

���� Various companies have been working for years to

provide a viable alternative to fingerstick blood glucose

monitoring.� They're still working.� The problem has been to

develop a reliable alternative to reading the saturated

glucose in blood ‑‑ and then develop practical equipment for

the mass market.

�

���� Many have tried, and most products have been

inaccurate, prohibitively expensive, or both, but Cygnus,

Inc., of Redwood City, California, has jumped to the head of

the pack, with their Glucowatch Biographer blood glucose

monitor.�

 

���� In VOICE Vol. 14, No. 3, Summer 1999, we reviewed the

Glucowatch.� At that time, we quoted Dr. Russell Potts,

Cygnus' VP for Research, as saying in March 1999:� "With a

little luck, and some good will, I'll be standing here next

year with some Glucowatches you can buy."

 

���� They're not here yet, but on December 6, 1999, the U.S.

Food and Drug Administration's Clinical Chemistry and

Clinical Toxicology Devices Panel, part of the FDA's Medical

Devices Advisory Committee, voted to approve the Glucowatch Biographer for marketing in the United States.� The biggest hurdle was passed.

�

���� On May 9, 2000, Cygnus announced receipt of an official

"approval letter" from the FDA.� The company stated:� "An

approval letter means the FDA has reviewed the Company's

pre‑market approval (PMA) petition, as well as its own

Advisory Committee's report and recommendation, and that the FDA believes it will approve the application, pending

specific final conditions."

 

���� Cygnus has also filed for marketing approval with the

European Union, and received a "CE Certificate," granting

such approval, from the EU, on December 2, 1999.

�

���� Assuming final U.S. approval is granted, Cygnus

anticipates "broad product introduction in early 2001."� Of

course, no company is going to tool‑up for large‑scale

manufacture, or seek marketing/distribution partners, until

all regulatory hurdles have been passed.

 

���� Is the Glucowatch "noninvasive?"� Not completely.� The

user will still need to fingerstick, once every 12 hours,

when changing the disposable sensor (the Glucowatch's

equivalent of a test strip).� But ‑‑ that's the last

fingerstick for 12 hours ‑‑ so you can get multiple readings, after a minimal number of fingersticks.

 

���� Is it accurate?� The FDA is satisfied with its accuracy.

 

���� Is it inexpensive?� Final prices have not been set ‑‑

not until marketing agreements are finalized ‑‑ but the

meter should cost several hundred dollars, and each sensor

(disposable pad) should cost $3 to $4 each.� That's not low‑

budget ‑‑ but if you need repeat tests, without repeat

fingersticks, it may be your best choice.

 

���� Another thing:� Because the Glucowatch is continuous,

and it has a programmable low‑blood‑sugar alarm, it should

be good for folks who have hypoglycemia unawareness.� Set it

at the top of the danger zone, and it can warn you to get

yourself a snack ‑‑ before you get into trouble.

 

���� Is the Glucowatch "adaptive?"� No.� It depends on sight

to manipulate it and to read it.� It does not talk, and it

does not incorporate tactile aids.

 

���� From the Editor:� I contacted Cygnus' VP Dr. Russell

Potts, several times, by phone and letter, to urge him to

consider making the Glucowatch speech‑compatible, so blind

diabetics could enjoy its benefits.� I find it disturbing

that neither he nor any other Cygnus representative got back

to me.� And, I would point out that the total mailing of

this Voice issue will be more than 300,000 copies.� Cygnus

should not ignore the many blind diabetics who might benefit

from the Glucowatch.�

 

���� For more information, contact Cygnus, Inc., telephone:

(650) 369‑4300; website: http://www.cygn.com�

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