The US Food and Drug Administration (FDA) has approved Abbott ’s FreeStyle Libre Flash Glucose Monitoring System for adults with diabetes.
The new personal continuous glucose monitor (CGM) is intended as a replacement for blood glucose monitoring (BGM) and does not require the standard finger sticks or their calibration.
The system is designed to read the glucose levels through a long-lasting personal glucose sensor that can be self-applied on the back of the upper arm for up to ten days.
Abbott Diabetes Care senior vice-president Jared Watkin said: “Today, we are celebrating a breakthrough moment for people with diabetes in the US – 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.”
FreeStyle Libre allows patients to capture real-time readings even through clothing by scanning a small hand-held reader over the water-resistant sensor.
The data obtained from the system delivers a visual snapshot of a person’s glucose fluctuations called an Ambulatory Glucose Profile (AGP) that provides information on glucose level trends.
Patients and their doctors can also review the glucose history, allowing them to make better diabetes management decisions.
Findings from clinical trials and real-world studies in a total of more than 50,000 patients revealed that FreeStyle Libre enables more frequent testing.
Image: FreeStyle Libre is now approved for adults with diabetes in the US. Photo: courtesy of PRNewsfoto/Abbott.