Abbott announced it's develong a new biowewearable 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. The glucose-ketone sensor will be the same size as the company's FreeStyle Libre 3 sensor, the world's smallest and thinnest continuous glucose monitoring (CGM) sensor, and will connect to the company's digital ecosystem, including personal and caregiver mobile apps and cloud-based data management software for remote monitoring by healthcare professionals.

Need for Continuous Glucose-Ketone Monitoring 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. In the U.S. alone, there are hundreds of thousands of emergency room visits and hospitalization for DKA each year.

Yet, 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. Recent studies show continuous ketone monitoring (CKM) could help prevent DKA.

With continuous monitoring, rising ketone levels can be detected early, as a warning of impending ketoacidosis, and inform care so that DKA does not develop. Leading diabetes experts have called for expansion of ketone monitoring, including its integration with CGM technology in a single sensor. Unchecked ketone levels can pose serious risks for people with diabetes, especially children and young adults with type 1 diabetes.