ADA: Abbott plans new wearable sensor for catching diabetic ketoacidosis

Fresh off the FDA’s clearance for its latest continuous glucose monitor, the FreeStyle Libre 3, Abbott is already attempting to one-up itself.

On the first day of the American Diabetes Association’s annual scientific sessions, the devicemaker laid out plans for a new sensor that’ll use its CGM technology as a jumping-off point to add in ketone tracking, aiming to help people with diabetes at an elevated risk for diabetic ketoacidosis.

Known as DKA, the condition occurs when a shortage of insulin causes the body to begin breaking down fat, rather than glucose, to use as energy. In the process, acids called ketones build up in the bloodstream. If left untreated, that buildup can lead to DKA, which may cause nausea, pain, confusion, fatigue and even death in severe cases.

Currently, DKA typically requires either a blood or urine test to diagnose. But according to a 2020 study cited by Abbott, continuous ketone monitoring can help prevent the condition without requiring a separate test, which may be costly or painful.

Abbott’s proposed new biowearable would continuously track both glucose and ketone levels in a single sensor, helping users catch rising ketones as early as possible, well before it develops into diabetic ketoacidosis.

The sensor—still in development—will be the same size as the FreeStyle Libre 3 device, which boasts a small and thin form factor measuring in with a width of just two stacked pennies.

Also like its glucose-only predecessor, the new sensor will connect to Abbott’s existing slate of digital tools, allowing users to track their continuous readings through a mobile app and giving their caregivers and healthcare providers remote access to those readings through online portals of their own.

Patients will also be able to link the sensor to their insulin pumps to help manage dosages, according to Jared Watkin, senior VP of Abbott’s diabetes care business.

Abbott said it has already received the FDA’s breakthrough device designation for the technology. That label paves a somewhat clearer pathway to full regulatory clearance by prioritizing their assessment and review at the agency.

In preparation for that regulatory submission, the company has begun clinical studies of the new sensor, with pivotal trials on track to begin next year—meaning that broad availability of the device likely won’t arrive for at least a few years.