Cygnus GlucoWatch
This article was originally published in The Gray Sheet
Executive Summary
Non-invasive glucose monitoring system indication for use by diabetics ages 7-17 is sought in a PMA supplement submission, announced Sept. 24. The device was approved for adults 18 and older on March 22 (1"The Gray Sheet" March 26, 2001, p. 13). About 100,000 children and 16 mil. adults have diabetes in the U.S. While the wristwatch-like device is currently available under a pilot marketing program, Cygnus is preparing for a full-scale launch and reports to be "in advanced discussions with multiple companies for a potential sales alliance in the U.S."
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ADA Meeting In Brief
Cygnus GlucoWatch Biographer: Alarms on wristwatch-like device increase hypoglycemia detection, particularly at night, according to study results presented June 15 at the American Diabetes Association Annual Scientific Sessions in San Francisco. Data from 40 Type 1 patients age 7-17 show that HbA1c (glycated hemoglobin) levels were significantly lower (p<0.05) in the Biographer treatment group over a nine-month period. The data may further enhance a pending PMA supplement for use in children and adolescents (1"The Gray Sheet" Oct. 1, 2001, In Brief)...
ADA Meeting In Brief
Cygnus GlucoWatch Biographer: Alarms on wristwatch-like device increase hypoglycemia detection, particularly at night, according to study results presented June 15 at the American Diabetes Association Annual Scientific Sessions in San Francisco. Data from 40 Type 1 patients age 7-17 show that HbA1c (glycated hemoglobin) levels were significantly lower (p<0.05) in the Biographer treatment group over a nine-month period. The data may further enhance a pending PMA supplement for use in children and adolescents (1"The Gray Sheet" Oct. 1, 2001, In Brief)...
Cygnus GlucoWatch
Expedited review status is granted for a September PMA supplement submission for use of the non-invasive glucose monitoring system by diabetics ages 7-17 (1"The Gray Sheet" Oct. 1, 2001, In Brief)...