FDA approved glucose monitor doesn't require finger prick

In a move that’s sure to please adults with diabetes in the US, the FDA has approved a glucose monitoring device that doesn’t require the user to prick themselves for a blood sample. 

The FreeStyle Libre Flash Glucose Monitoring System is developed by Abbott and is intended as a replacement to traditional blood glucose monitoring devices in the US. Users attach a sensor to the back of their arm which captures real-time glucose readings. To get the information they scan a small hand-held reader over the sensor which can be detected through clothing and can be worn in the shower or when swimming.  

The sensor can be worn on the back of the arm for up to 10 days, negating the need for routine finger sticks which some people have to do up to 12 times per day.

The sensor captures data across a user’s entire day giving them information into their hypoglycaemic and hyperglycaemic trends. The real-time data means that healthcare professionals can make treatment decisions based on a person’s blood glucose fluctuations throughout the day, helping them better manage their condition.

Jared Watkin, senior vice president, Diabetes Care, Abbott, said: “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. 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 for the FreeStyle Libre show that people using the system test their glucose levels an average of 15 times per day. The studies show that people testing their levels more frequently spend less time in hypoglycaemia or hyperglycaemia and manage their glucose levels better.

Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said: “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. 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.”