US-based medical device company Abbott is developing a new bio-wearable intended to continuously monitor glucose and ketone levels using a single sensor.

The system has received a breakthrough device designation from the US Food and Drug Administration.

The company’s glucose-ketone sensor will be the same size as its FreeStyle Libre 3 sensor, which is said to be the world’s smallest and thinnest continuous glucose monitoring (CGM) sensor.

It will enable remote monitoring by connecting to its digital ecosystem, including personal and caregiver mobile apps and cloud-based data management software, said the company.

Abbott diabetes care business senior vice president Jared Watkin said: “Abbott revolutionised diabetes care with FreeStyle Libre technology, which is the number one continuous glucose monitor used by 4 million people around the world.

“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.”

According to Abbott, the continuous glucose-ketone monitor is crucial for diabetes patients at high risk of developing diabetic ketoacidosis (DKA), a serious condition where ketone levels rise to dangerous levels.

Only a few people with diabetes are regularly monitoring their ketones due to limitations in the current methods of testing, through blood or urine, which are expensive and tiring, said the company.

Abbott claimed that adding a continuous ketone monitoring feature to a continuous glucose monitoring system will eliminate the need for a separate ketone test.

According to recent studies, continuous ketone monitoring (CKM) enables early detection of rising ketone levels and prevents diabetes patients from developing DKA.

Abbott is already conducting clinical studies on the glucose-ketone monitoring system, with plans to conduct clinical trials in the next year, and regulatory submissions thereafter.

In a separate development, Abbott has reportedly reopened its infant formula production facility in Sturgis, Michigan, which is expected to address the nationwide shortage.