[PHNUTR-L] FDA Approves 7-Day Continuous Glucose Monitoring System
fivestar at nutritionucanlivewith.com
Tue Jun 5 17:20:21 PDT 2007
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FDA Approves 7-Day Continuous Glucose Monitoring System
By Neil Osterweil, Senior Associate Editor, MedPage Today
June 04, 2007
ROCKVILLE, Md., June 4 -- A device that measures glucose levels every
five minutes over a seven-day cycle has been approved for marketing, the
The STS-7 System uses a disposable sensor placed subcutaneously in the
abdominal region to measure glucose levels in interstitial fluid.
According to the agency, patients 18 or older can easily place the
sensor themselves with minimal discomfort. The sensors, which must be
replaced weekly, will trigger an alarm if the patient becomes either
hyperglycemic or hypoglycemic as determined by pre-set cutoffs.
The continuous monitoring system will augment but not replace
conventional glucose monitoring, said Daniel Schultz, M.D., director of
the FDA's Center for Devices and Radiological Health.
"The STS-7 System supplements standard fingerstick meters and test
strips, providing diabetics ages 18 and older with a way to see trends
and track patterns," he said. "It can help detect when glucose levels
drop during the overnight hours, show when glucose levels rise between
meals and suggest how exercise and diet might affect glucose levels."
The FDA gave the nod to the STS-7 System following results of a study
conducted by the manufacturer, DexCom, Inc, of San Diego. In 72 patients
with diabetes at five clinical sites in the United States, the device
was found to be safe and effective for detecting trends and tracking
patterns in glucose levels in adults.
A three-day version of the device, the STS Continuous Glucose Monitoring
System, received FDA approval in March 2006.
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
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