US clears Cygnus blood sugar monitor for diabetes

[Guest guest]

(UPDATE: New throughout)

By Richwine

WASHINGTON, March 22 (Reuters) - A device similar to a wristwatch that

measures diabetics' blood sugar won approval Thursday from U.S.

officials, who said it marked a first step toward eliminating painful

finger-prick tests for millions of Americans.

But for now the GlucoWatch Biographer by Cygnus Inc.

(NasdaqNM:[15]CYGN - [16]news) should be used in combination with, and

not a substitute for, finger tests to monitor glucose, the Food and

Drug Administration (FDA) said in a statement.

Shares of Redwood City, Calif.-based Cygnus leaped more than 40

percent after the announcement. In late morning trading, Cygnus was up

$1-27/32 at $6-1/4.

Closely watching blood sugar can help diabetics better manage their

disease and avoid complications such as heart and kidney disease,

vision loss or limb amputations. More than 16 million Americans have

diabetes, according to estimates.

The prescription GlucoWatch works by sending tiny electric currents to

extract fluid from the skin. The device can measure glucose in the

fluids every 20 minutes for up to 12 hours at a time and sounds an

alarm if blood sugar reaches dangerous levels.

``The GlucoWatch is one of the first steps in developing new products

that may one day completely eliminate the need for daily finger-prick

tests,'' said Bernard Schwetz, the FDA's acting principal deputy

commissioner.

The FDA said blood drawn from finger-prick tests was needed to verify

readings from the GlucoWatch.

In clinical studies, results between the GlucoWatch and finger testing

differed by more than 30 percent up to a quarter of the time, the FDA

said. It was less effective at detecting very low glucose levels and

did not read at all when a person's arm was too sweaty.

More than half of patients in trials said the watch caused mild to

moderate skin irritation.

The device was not tested in children and was approved only for

adults.

Diabetes affects the body's ability to produce or respond to insulin,

which can cause wide fluctuations in blood sugar levels.

[Guest guest]

Naturally, they are not making a talking version. Again, the blind are left out

in the cold. The know very well that many diabetics are blind, and simply

ignore that segment of the market.

Dan Graham