In a milestone for Americans with diabetes, the Food and Drug Administration (FDA) has cleared the first-ever continuous blood sugar monitoring device that doesn’t require patients to take potentially painful and invasive blood tests that require pricking their fingertips to collect samples. The approval was granted to Abbott Diabetes Care Inc.
The device, Abbott’s FreeStyle Libre Flash Glucose Monitoring System, is approved for adult diabetes patients 18 years of age and older, and the approval sent Abbott stock up 3.5% in Thursday trading. It slashes the need for the so-called fingerstick tests that people with diabetes regularly endure to figure out whether their blood sugar levels are too high or too low, and to monitor general fluctuation in blood glucose so they can adjust their diets or medication. The device itself uses an under-the-skin sensor wire which keeps tabs on sugar levels. In order to get a gauge on where those glucose levels are at, users simply have to wave an accompanying, specialized mobile reader device over the sensor like a wand.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said the FDA’s Donald St. Pierre in a statement. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”
Medical device and tech companies alike have shown growing interest in diabetes management and monitoring devices. Last year, the FDA approved an artificial pancreas from device giant Medtronic to treat people with type 1 diabetes with a largely automated glucose monitoring and insulin dose-adjusting system. And then there’s Apple, which made waves over the spring when reports emerged that it had hired a team of biomedical engineers to work on a blood sugar sensor of its own, possibly integrated into an AppleWatch-type device.