June 5, 2007 -- The FDA has approved a device that measures blood sugar (glucose) levels continuously for up to seven days in people with diabetes.
The device is called the STS-7 Continuous Glucose Monitoring System (STS-7 System).
While a standard fingerstick test records a person's glucose level as a snapshot in time, the STS-7 System measures glucose levels every five minutes throughout a seven-day period.
However, people with diabetes must still rely on the fingerstick test to decide whether additional insulin is needed.
"The STS-7 System supplements standard fingerstick measures and test strips, providing [people with diabetes] age 18 and older with a way to see trends and track patterns," says Daniel Schultz, MD, in an FDA news release.
Schultz directs the FDA's Center for Devices and Radiological Health.
The new device "can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals, and suggest how diet and exercise might affect glucose levels," says Schultz.
The STS-7 System, made by DexCom Inc. of San Diego, uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid of the body's tissues (interstitial fluid).
According to the FDA, sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient's glucose level reaches preset lows or preset highs.
The FDA approved the STS-7 System based on results of a study conducted by DexCom of 72 diabetes patients at five sites across the U.S. The study showed that the STS-7 System was safe and effective for detecting trends and tracking patterns in adults' glucose levels.
The FDA approved the STS-7 System last week. In March 2006, the FDA approved the STS Continuous Glucose Monitoring System, a three-day version of the device.