News | March 23, 2001

FDA approves new glucose test for adult diabetics

The Food and Drug Administration recently 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 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 Schwetz, DVM, PhD. "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 in children.

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.

Source: Food and Drug Administration

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