Federal regulators have approved the first continuous device that will bypass the finger prick tests, according to the Food and Drug Administration. Current models require users to test a drop of blood twice a day.
Abbott's new FreeStyle Libre Flash Glucose Monitoring System, approved Wednesday by the FDA, uses a small sensor attached to the upper arm. Patients wave a reader device over it to see the current blood sugar level and changes over the past eight hours.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” 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. “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 — with a wave of the mobile reader.”
Most of the 30 million Americans with diabetes use standard glucose meters, which require multiple finger pricks each day and only show current sugar level. More-accurate continuous glucose monitoring devices are used by about 345,000 Americans.
Abbott's device was approved for adults with Type 1 or Type 2 diabetes and should be available in pharmacies within months, according to The Associated Press. The company, based near Chicago, did not disclose the price of the reader or the sensors.