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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.
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