No Kidding Around!
FDA Grants GlucoWatch Approval for Youngsters With Diabetes
Parents who wanted to see GlucoWatch Biographers on the wrists of their children with diabetes received good news on August 28, 2002, with the announcement that the U.S. Food and Drug Administration had approved the GlucoWatch for use with children ages 7 to 17. The device received ear-lier FDA approval for adults with diabetes in April 2002.
“A comprehensive clinical research program conducted at the Barbara Davis Center for Childhood Diabetes, University of Colorado, has shown that use of the GlucoWatch Biographer in younger patients results in significant, sustained improvement in glucose control,” said H. Peter Chase, MD, clinical director emeritus of the center. “The most valuable feature is that it helps in the detection of hypoglycemia before a severe episode happens such as a seizure or a critically low glucose level.”
The GlucoWatch consists of two main parts: the watch-like Biographer that is worn on a person’s wrist, and the disposable AutoSensor (attached to the back of the device) that allows glucose monitoring for up to 13 hours.
Additional information about the GlucoWatch Biographer can be obtained by calling the toll-free number (866) 459-2824 or by logging on to www.glucowatch.com.