[PHNUTR-L] FDA Approves 7-Day Continuous Glucose Monitoring System

[Kathrynne Holden]

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FDA Approves 7-Day Continuous Glucose Monitoring System
			
   	
By Neil Osterweil, Senior Associate Editor, MedPage Today
June 04, 2007

http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/dh/5847

ROCKVILLE, Md., June 4 -- A device that measures glucose levels every 
five minutes over a seven-day cycle has been approved for marketing, the 
FDA announced.

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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