FDA Authorizes First Continuous Glucose and Ketone Monitor

The FDA authorized the Libre Duo 10 Day continuous glucose and ketone monitor on August 25, 2026, giving people aged 2 and older with diabetes a new way to track two important metabolic signals together. The device can provide alerts when ketones reach a concerning threshold, potentially helping patients and caregivers recognize rising ketones before diabetic ketoacidosis (DKA) becomes a medical emergency.

What is different about this diabetes wearable?

Continuous glucose monitors are already familiar to many people managing diabetes. Ketone testing has generally required a separate test that captures a measurement at one point in time.

The new device combines both measurements. FDA says Libre Duo measures glucose and ketone concentrations in fluid beneath the skin every minute, day and night during its 10-day wear period. Results are transmitted to a compatible smartphone, showing current readings and whether they are trending up or down.

That trend information matters because excessive ketone production can lead to DKA, a potentially life-threatening diabetes complication.

What did FDA review?

FDA says the clinical program included six studies with more than 600 participants aged 2 and older. The agency reported that the device accurately tracked clinically meaningful differences in ketone levels during its 10-day wear period, including detecting elevated ketones before DKA onset.

The agency authorized it through the De Novo pathway, used for novel low- to moderate-risk medical devices.

What should patients do?

This authorization is not a recommendation that everyone with diabetes switch devices. FDA specifically says ketone information should be interpreted alongside glucose readings and symptoms.

People interested in continuous ketone monitoring should discuss whether the technology fits their diabetes-management plan with their healthcare professional. Seek urgent medical care for symptoms or circumstances that your care team has told you could indicate DKA rather than relying solely on a wearable alert.