FDA Approves Freestyle Libre CGM With 14-Day Sensor
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
“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.
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.
Related Articles
- Rural-Urban Disparities in Colorectal Cancer Screening Persist
September 21st 2025
- AML Survival After 3 Years in Remission Comparable With General Population
September 20th 2025
- AHA Launches New Initiative to Help Patients With Heart Failure
September 20th 2025
- CSU More Burdensome in Female Patients, Especially in Midlife
September 20th 2025
- Pirtobrutinib Shows Clinically Meaningful PFS Improvement in Frontline CLL
September 19th 2025