FDA approves first glucose sensing tech that doesn’t require routine finger sticks

Abbott (NYSE:ABT) said yesterday that the FDA approved its FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes.

The company’s technology doesn’t require finger stick calibration and eliminates the need for users to routinely stick their fingers for samples.

The blood glucose monitor replacement indication means that people with diabetes can make treatment decisions based on information from the FreeStyle Libre device, according to Abbott.

The system includes a sensor the size of two stacked quarters that’s placed on the back of the upper arm. Users can capture real-time glucose readings using a hand-held reader that picks up signals from the sensor. Users can also review eight hours of glucose history and keep an eye out for glucose level trends, monitoring fluctuations throughout the day.

“Today, we are celebrating a breakthrough moment for people with diabetes in the U.S.—an end to the worry and hassles associated with routine finger sticks which have been the standard of glucose testing for more than 40 years,” Jared Watkin, SVP of Abbott’s diabetes care business, said in prepared remarks.

“At Abbott, we believe that FreeStyle Libre will transform diabetes management and we’re proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives.”

Clinical trials and real-world evidence from 50,000 FreeStyle Libre users have shown that people who use Abbott’s system test their glucose levels, on average, 15 times each day. Previous work demonstrated that people who scan more frequently spend less time in hypoglycemia or hyperglycemia, while maintaining improved average glucose levels.

“Diabetes management requires active participation by the patient. Regular monitoring of glucose levels is especially crucial among patients being treated with insulin,” Dr. Maria Tulpan, from Lenox Hill Hospital in New York, N.Y., added. 

“What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.”