The FDA has approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System, the first personal continuous glucose monitor that doesn’t require finger stick calibration.
The device, which is the size of two stacked quarters, can be self-applied to the back of the upper arm and provides real-time updates of glucose levels for up to 10 days. A touch-screen reader also gives an eight-hour historical trend and holds up to 90 days of data.
"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, senior vice president of diabetes care at Abbott, said in a Sept. 27 press release. "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."
In June 2016, Abbott announced the results of a six-month trial of 252 adults with type 1 diabetes. Participants with the FreeStyle Libre system spent 38 percent less time in hypoglycemia than those using the traditional method of adding a drop of blood from the finger to a test strip. They also showed a 50 percent reduction in serious hypoglycemia (less than 55 milligrams per deciliter), averaged 15 glucose scans per day and reduced finger sticks by 91 percent.
Previous studies have shown that most diabetics test less than three times per day via the finger stick method.
"This clinical trial has proven that patients will test more often when they have an easier and more convenient way to do so utilizing a device like FreeStyle Libre, leading them to ultimately being healthier, which is our goal for our patients,” lead investigator Jan Bolinder, MD, of Karolinska Institutet in Stockholm, said in a press release announcing the trial results.
According to Abbott, more than 400,000 people worldwide are using their system. Now, it will be available to the approximately 30 million Americans who have diabetes.