The system was the first to allow people with diabetes to monitor blood glucose without fingersticks.
Abbott’s 14-day Freestyle Libre continuous glucose monitor (CGM) has been approved by the FDA, giving US patients with diabetes access to technology that has been used in Europe for years.
The company announced the approval Friday in a statement. FDA’s action comes 10 months after it approved the Freestyle device with a 10-day sensor, offering people with diabetes the ability to monitor blood glucose without finger sticks. The Freestyle Libre is factory calibrated.
“At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes," said Jared Watkin, the company’s senior vice president for Diabetes Care. “With the new FreeStyle Libre 14-day system, people with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition.”
The round sensor is placed on the upper arm; a thin filament inserted just under the skin takes blood glucose readings once a minute. For monitoring, users hold a scanner over the sensor to transmit the data.
In its statement, Abbott said the system requires a 1-hour warmup and offers improved accuracy compared with the 10-day sensor approved last year. The 14-day system has a mean absolute relative difference, or MARD, of 9.4, compared with 9.7 for the 10-day system.
The company said the 14-day system will be available “in the coming months” with a prescription at pharmacies and durable medical equipment suppliers.
The 14-day system launched in Europe in 2014 and is available in 30 countries.