Abbott (NYSE: ABT) today announced it's developing a new biowearable that will continuously monitor glucose and ketone levels in one sensor. The system has secured breakthrough device designation from the U.S. Food and Drug Administration, which is designed to expedite the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
"Abbott revolutionized diabetes care with FreeStyle Libre® technology, which is the number one continuous glucose monitor used by four million people around the world," said Jared Watkin, senior vice president of Abbott's diabetes care business.
The glucose-ketone sensor will be the same size as Abbott's FreeStyle Libre 3 sensor, the world's smallest and thinnest continuous glucose monitoring (CGM) sensor, and will connect to Abbott's digital ecosystem, including personal and caregiver mobile apps and cloud-based data management software for remote monitoring by healthcare professionals.
A continuous glucose-ketone monitor is especially important for people with diabetes who may be at higher risk of developing diabetic ketoacidosis (DKA), a potentially life-threatening condition when ketone levels rise to dangerous levels in the blood.
DKA is a growing concern globally. This morning’s news release said, “in the U.S. alone, there are hundreds of thousands of emergency room visits and hospitalization for DKA each year. Yet today, few people with diabetes are regularly monitoring their ketones because the current methods of testing – typically through blood or urine – are costly and burdensome. Adding continuous ketone monitoring to a continuous glucose monitoring system eliminates the need for a separate ketone test.”
ABT shares faltered 42 cents to $117.09.
