June 3, 2022 – Abbott announced it is 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.
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. 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.
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.
Abbott is already conducting clinical studies on the glucose-ketone monitoring system. Pivotal trials will take place in 2023 with regulatory submissions to follow thereafter.
Abbott plans to partner with leading insulin pump manufacturers to make the dual monitoring system interoperable with insulin delivery systems.
Abbott currently has the world’s most widely used CGM. Abbott’s FreeStyle Libre portfolio has already changed the lives of approximately 4 million people across 60 countries by providing breakthrough technology that is accessible and affordable.