USA – Abbott has 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 US 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 device is intended for people aged four years and older with either Type 1 or Type 2 diabetes. It uses a sensor that sticks to the back of the arm for up to two weeks at a time and automatically sends glucose readings to a Bluetooth-connected smartphone every minute.

The glucose-ketone sensor will be the same size as Abbott’s FreeStyle Libre 3 sensor, a 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.

The FreeStyle Libre 3 system isn’t yet eligible for Medicare reimbursement, but Abbott said it’s aiming to price the monitor at the same rate as previous iterations of the system so it can be widely accessible to more people with diabetes.

Sensor-based CGM systems like Abbott’s are designed to provide blood sugar readings without requiring users to perform regular fingersticks.

According to Abbott, the FreeStyle Libre 3 boasts an overall mean absolute relative difference, or MARD—a measure of the rate of errors in a device’s readings—of 7.9%, making it the first to claim a sub-8% error rate.

The sensor’s Bluetooth signal stretches up to 33 feet, which Abbott claims is 50% further than the ranges of other CGM sensors on the market, including the Dexcom G6 and Medtronic Guardian Connect devices.

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 US 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.

Availability and interoperability

Abbott is already conducting clinical studies on the glucose-ketone monitoring system. Trials will take place in 2023 with regulatory submissions to follow thereafter.

Abbott plans to partner with 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.

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