Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels.
The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter.
Abbott Park, Illinois-based Abbott said in a news release that the glucose-ketone sensor will be the same size as the recently FDA-cleared next-generation FreeStyle Libre 3 continuous glucose monitoring (CGM) sensor, and it will connect to Abbott’s digital ecosystem that includes personal and caregiver mobile apps along with cloud-based data management software for remote monitoring by healthcare professionals.
The company also plans to partner with leading insulin pump manufacturers to make the new biowearable sensor interoperable with insulin delivery systems.
“Abbott revolutionized diabetes care with FreeStyle Libre technology, which is the number one continuous glucose monitor used by 4 million people around the world,” SVP of Abbott’s diabetes care business Jared Watkin said in the release. “We’re designing our glucose-ketone monitoring system with superior sensing technology that will pair with industry-leading insulin pumps to create a best-in-class solution. We’re optimistic that this will be the next big advancement in diabetes tech and a breakthrough for people with diabetes, especially those who are at risk of developing diabetic ketoacidosis (DKA).”
The company said a continuous glucose-ketone monitor represents an important tool for people with diabetes who may be at higher risk of developing DKA, a potentially life-threatening condition when ketone levels rise to dangerous heights in the blood. The combination sensor would eliminate the need for a separate ketone test to accompany CGM.
“In my practice, I’ve seen numerous cases of DKA in teens and children, which could have been prevented with continuous ketone monitoring,” Midwest Pediatric Specialists (Overland Park, Kansas) Medical Director and pediatric endocrinologist Dr. Kurt Midyett said. “Bringing people with diabetes the ability to continuously monitor both glucose and ketones in a single, intuitive device is an important step forward in diabetes care, as it will allow patients to detect rising ketone levels and intervene before full-blown DKA develops.”