Abbott's Freestyle Libre Pro System Gains FDA Approval

The Abbott system allows physicians to gather up to 14 days' worth of glucose data without the patient having to interact with any device, or even calibrate it.

Earlier this week, FDA approved the Abbott FreeStyle Libre Pro continuous glucose monitoring (CGM) system, which allows physicians to remotely monitor their patients with diabetes. The system allows physicians to collect reliable blood glucose without relying on the patient to interact with system, or even be trained to calibrate it.

The system is applied to patients in a clinic setting, where a sensor is attached to a patient’s arm with adhesive that lasts for up to 14 days. No finger sticks to calibrate the sensor are required. The system records glucose levels every 15 minutes, giving the physician a glycemic profile that includes up to 1340 separate results. After 14 days, the patients come back to the office, where the doctor scans the sensor to download 14 days’ worth of results in just a few seconds.

Medtronic and Dexcom have competing devices that are designed for professional use, but both have shorter periods of data capture and require finger stick calibration, according to information from Abbott.

In a statement, Eugene E. Wright, Jr, MD, of Duke Southern Regional Area Health Education Center in Fayetteville, North Carolina, said without adequate information, treatment decisions are difficult. “My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels.”

“This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data,” said Jared Watkin, senior vice president of Diabetes Care at Abbott.

More than 29 million Americans, or 9% of the population, has diabetes, with the vast majority having been diagnosed with type 2 diabetes (T2D). Because T2D develops over time and symptoms might not always be present, more of these patients are inconsistent about monitoring blood sugar levels. A survey by the International Diabetes Federation found that T2D who fail to take blood tests do so because they forget (26%), they dislike finger sticks (29%), or due to the expense of test strips (31%).

Separately, Abbott is seeking approval on a FreesStyle CGM system that could be used directly by patients, which is already on the market in Europe.