The FreeStyle Flash Glucose Monitoring System has been approved by the U.S. Food and Drug Administration, making it the first sanctioned device to monitor blood sugar in adult diabetics without the need for a finger prick.
"This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health.
The system uses a small sensor implanted below the skin and a mobile reader to continuously monitor blood sugar, the agency said in a news release.
People with diabetes must monitor their blood glucose levels frequently, often multiple times per day. Typically, they use a fingerstick sample to decide whether to administer the pancreatic hormone insulin. The new system eliminates the need to take this blood sample, which may be painful, the agency said.
More than 29 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention. People with type 2 cannot use insulin properly, triggering a buildup of blood sugar. This can lead to heart disease, stroke, blindness, kidney failure and amputation of the legs, feet or toes, the FDA said.
The new device does not produce any type of alarm or alert if blood sugar levels are inappropriate, the agency noted.
The system is produced by Abbott Diabetes Care, based in Alameda, Calif.
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