The Food and Drug Administration today approved a wristwatch-like
device that provides adult diabetics with more information for managing their
disease. It is intended for use along with, not as a replacement for, finger-prick
blood tests to monitor glucose.
The GlucoWatch Biographer, made by Cygnus Inc., of Redwood City,
Calif., extracts fluid through the skin by sending out tiny electric currents.
Glucose levels are measured using this fluid every 20 minutes for 12 hours-even
during sleep. The device sounds an alarm if patient’s glucose reaches dangerous
levels, thus helping patients manage a potential problem.
The FDA approved the GlucoWatch, which is available only by prescription,
to detect trends and track patterns in glucose levels in adults age 18 and older.
“Today’s action heralds the advent of new technologies that promise
dramatic improvements in the quality of life for the millions of Americans who
have diabetes," said Secretary of Health and Human Services Tommy G. Thompson.
“New technology for monitoring glucose levels in diabetics is
moving ahead rapidly, and the FDA has been working with a number of companies
to help bring it to market,” said Acting Principal Deputy Commissioner of Food
and Drugs Bernard A. Schwetz, D.V.M., Ph.D. “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."
Currently the GlucoWatch measurements must be used along with
finger pricks to ensure accurate results.
Clinical studies conducted by the manufacturer showed that GlucoWatch
measurements generally were consistent with the results from traditional finger-prick
blood tests. However, up to 25 percent of the time, the results differed by
more than 30 percent. The GlucoWatch sometimes gave erroneous readings, was
less effective at detecting very low glucose levels than very high levels, and
would not measure it at all if a patient’s arm was too sweaty. The GlucoWatch
also caused mild to moderate skin irritation in at least 50 percent of patients.
Because of the potential for error, physicians and patients should
never use an individual GlucoWatch reading alone to make changes in insulin
doses. Instead, the GlucoWatch results should be interpreted with several sequential
readings over time and then confirmed with a finger prick test.
The device was studied in adults 18 and older in both clinical
and home settings. The studies generated 19,000 glucose readings from 1,400
devices over 25,000 hours of use. Some 129 patients participated in the home
study, which most closely reflected real-life use. The device was not tested
Diabetes is a chronic disease that affects the body’s ability
to produce or respond to insulin. This can cause wide fluctuations in blood
sugar levels, from extremely high to extremely low.
More than an estimated 16 million people in the United States
have diabetes. While there is no known cure, studies have shown that patients
who regularly monitor and regulate their blood glucose levels have lower incidences
of complication such as heart disease, stroke, vision loss, leg amputation,
and kidney disease.