FDA approves world’s first dual-sensor CGM in diabetes 'breakthrough' — new Libre Duo sensor tracks ketones and blood sugar in real-time

The US Food and Drug Administration (FDA) has given approval to the Libre Duo 10 Day CGM, a wearable device that can simultaneously track both ketone and blood sugar levels. This marks a significant breakthrough for the safety of those living with diabetes, both children and adults. The device, developed by Abbott Diabetes Care, is a small wearable sensor worn on the arm as a continuous glucose monitor (CGM).

It provides real-time glucose updates to a smartphone and also monitors ketone levels, sending an alert if they exceed a certain threshold.

The Libre Duo 10 Day is designed for use by individuals aged two or older who have diabetes. It takes the form of a small wearable sensor that measures glucose and ketone levels within the fluids under the skin. One of the primary benefits of this device is its ability to track ketone levels in real time, offering a trend over time rather than a single snapshot like standalone test kits.

This feature helps users monitor their risk of diabetic ketoacidosis (DKA), a condition that can become life-threatening if left untreated.

The FDA's approval of the Libre Duo 10 Day is aimed at preventing DKA. By providing continuous monitoring of ketone levels, the device helps users stay informed about changes in their risk of DKA, allowing for timely intervention. The combination of ketone monitoring with blood sugar analysis means that users do not need two separate devices to manage their diabetes, simplifying the process.

However, the exact release date of the Libre Duo 10 Day remains unknown, and its availability is expected to simplify ketone and blood sugar monitoring for the 2.1 million Americans with type 1 diabetes, who face a significant risk of DKA.