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FDA approves seven-day glucose monitoring system
Device measures glucose levels every five minutes in a seven-day cycle.
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Patients with diabetes now have the option to use a continuous glucose monitoring system that measures glucose levels for up to seven days.
Other continuous glucose monitoring devices on the market are approved for no more than three consecutive days when using a single sensor.
The FDA has approved the STS-7 System (DexCom), indicated for patients with diabetes aged 18 years and older.
The system uses a disposable sensor, which is placed subcutaneously in the abdomen and measures interstitial glucose levels. Patients can replace the sensors themselves.
“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics aged 18 and older with a way to see trends and track patterns,” Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “It can help detect when glucose levels drop during overnight hours, show when glucose levels rise between meals and suggest how exercise and diet may affect glucose levels.”
A three-day version of the device was approved in 2006.
The FDA approved the device based on study results of 72 patients at five clinical sites that demonstrated that the system was safe and effective for use in adults with diabetes.
This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
The STS-7 prescription device is used with fingerstick measurements and is intended for us by patients with diabetes at home and in health care facilities. It should be used to complement, but not replace, data from standard home glucose monitoring devices.
It can help detect episodes of hyperglycemia and hypoglycemia. Patients can adjust their therapy to minimize these episodes.
More than 20 million people in the United States have diabetes, or about 7% of the population. Previous study data demonstrate that patients who regularly monitor and regulate their blood glucose levels have lower incidences of diabetes complications, such as retinopathy, kidney disease, amputations, stroke and heart disease.
Patients with both type 1 and type 2 diabetes can use the STS-7 to aid in tracking fluctuations in blood glucose levels. It presents the opportunity to keep track of blood glucose levels more closely than ever before.
For more information:
- Visit www.dexcom.com for additional information regarding the STS-7 System.