BOULDER, CO - FEBRUARY 08, 2001 - Children With Diabetes Foundation (CWDF), a non-profit volunteer organization dedicated to supporting children, families and adults with diabetes, has announced that it will fund a new clinical study that will evaluate the effectiveness of the Cygnus GlucoWatch® Biographer in monitoring glucose levels of children and adolescents with Type I diabetes. The Children With Diabetes Foundation is affiliated with www.childrenwithdiabetes.com, which is the most widely-visited diabetes-related Web site, with millions of hits per month, according to Yahoo.
The study, funded by CWDF, which pursues research and care opportunities that have the potential to make immediate improvements in the lives of families living with diabetes, will attempt to determine whether ongoing information provided by the GlucoWatch Biographer can lead to improved control of glucose levels and better detection of hypoglycemia (low blood sugar). The study calls for the testing of the GlucoWatch Biographer with children and teenagers from 7 to 17-years-old. For this study, the enrollment phase has already been completed.
The lead investigator of the study, which recently started, is Dr. H. Peter Chase, Clinical Director of the Barbara Davis Center in Denver, Colorado. Dr. Chase has been a leader in the study and management of pediatric diabetes for over thirty years. "We are pleased to be supporting work in this important area of research," noted Harriet Austin, Ph.D., Vice President of Research at CWDF, in announcing the study. "Oftentimes, the pain and inconvenience of finger-stick blood glucose testing results in too few tests and potentially insufficient information for optimal control. Additional information may lead to better control, and we know that better control can lead to vastly improved long term outcomes."
The GlucoWatch Biographer, which is currently under FDA review for use by adults with diabetes, is a frequent, automatic, and non-invasive monitoring device intended to help detect trends and track patterns in glucose levels. It measures glucose through the wearer's skin, not from blood, as conventional glucose meters do.
Measurements are made as frequently as every 20 minutes, for up to 12 hours, through the ease and convenience of a device worn like a wristwatch. Every reading is displayed to the wearer and stored in memory. The GlucoWatch Biographer also has the capability to alert users when glucose levels are too high or too low, or are rapidly declining.
According to the American Diabetes Association, 30,000 Americans are diagnosed with Type I diabetes every year. Approximately 13,000 of these new cases are children or adolescents. This means that Type I diabetes affects nearly one out of every 600 children in this country. Diabetes is a leading cause of death in the U.S. and costs the U.S. an estimated $98 billion annually.
Cygnus, Inc., headquartered in Redwood City, California, develops and manufactures non-invasive diagnostic medical devices, utilizing proprietary biosensor technologies to satisfy unmet medical needs cost-effectively. The company's current efforts are focused on a frequent, automatic, and non-invasive glucose monitoring device (the GlucoWatch Biographer) and enhancements thereto.
The Children With Diabetes Foundation is managed strictly by volunteers who have children with diabetes themselves, and it is funded by donations. Because there are no paid staff and most expenses are donated, each dollar can be targeted at research and care opportunities. The majority of the donations are from families affected by this devastating illness.