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