The FDA has authorized the first wearable device that continuously monitors both glucose and ketone levels at the same time, offering people with diabetes a new way to catch dangerous metabolic emergencies before they develop. Abbott's Libre Duo 10 Day measures both glucose and ketones in the fluid under the skin every minute, sending readings to a smartphone and issuing automatic alerts when ketones reach concerning levels.

Why Does Tracking Ketones Matter for People with Diabetes?

Diabetic ketoacidosis (DKA) is a serious condition that develops when the body lacks enough insulin and begins breaking down fat for energy, causing ketone levels to rise to dangerous levels. The American Diabetes Association warns that DKA can progress within hours and, left untreated, can lead to coma or death. Hospital admissions for DKA have risen 55% over the past decade, making it the most common hyperglycemic emergency in diabetes.

Until now, people could only check their ketone levels with blood or urine tests that provide a single point-in-time reading. These tests cannot show whether ketones are climbing or falling, leaving patients and families without critical information about whether a dangerous trend is developing. The new device changes that by providing continuous, real-time ketone trends alongside glucose readings.

"DKA accounts for nearly 75% of pediatric hospitalizations for people with type 1 diabetes, so monitoring ketones for that group is important. The Libre Duo 10 Day system will provide alerts when ketones are rising, so families can make informed decisions when they need to," explained Eden Miller, DO, a board-certified family practitioner and diabetologist.

Eden Miller, DO, Board-Certified Family Practitioner and Diabetologist

Who Should Use This Device?

The device is approved for people with diabetes ages 2 and older, with particular focus on those at higher risk of elevated ketones. This includes people with type 1 or type 2 diabetes who use insulin or other glucose-lowering medications such as SGLT2 inhibitors (sodium-glucose cotransporter 2 inhibitors). This last group deserves special attention: SGLT2 inhibitors can trigger DKA even when glucose readings appear normal, a scenario that traditional continuous glucose monitoring alone cannot detect.

Abbott notes that most people do not have a blood ketone meter at home, and early signs of rising ketones are frequently mistaken for common infections, delaying critical treatment. The continuous monitoring approach addresses this equity gap by making ketone tracking accessible and automatic.

How to Prepare for Using a Continuous Ketone Monitor

• Talk with your healthcare provider: Determine whether continuous ketone monitoring is right for your specific diabetes management plan and risk factors.
• Understand sensor wear time: Plan for realistic wear duration; Abbott's studies found that 84.1% of sensors in adults lasted the full 10 days, while 68.8% in children did, meaning some sensors may need earlier replacement.
• Learn to interpret readings alongside symptoms: Ketone output should be interpreted together with glucose readings and physical symptoms, not in isolation, to guide treatment decisions.
• Set up smartphone alerts: Ensure your compatible smartphone is ready to receive automatic alerts when ketones reach concerning thresholds.

What Does the Clinical Evidence Show?

The FDA authorization is based on six clinical studies involving more than 600 participants ages 2 and older, evaluating the accuracy of both the ketone and glucose functions across a range of levels. According to the FDA, the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketones before the onset of DKA.

The device received breakthrough device designation from the FDA and was cleared through the De Novo pathway, which is used for novel low- to moderate-risk devices that don't have a direct predicate on the market. Abbott says it is the first system to meet both the integrated continuous glucose monitoring standard and a new integrated continuous glucose-ketone monitoring standard.

One important safety note belongs in every conversation with a healthcare provider: the Urgent High Ketones alarm may not catch all instances of ketones above 3.0 mmol/L, so readings and symptoms should guide treatment decisions together rather than relying on the device alone.

When Will This Device Be Available?

Abbott plans a US launch later in 2026 and expects the device to be compatible with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery systems by the end of this year. Integrations with Insulet and Tandem systems are expected in 2027.

For people with diabetes at risk of DKA, particularly those using SGLT2 inhibitors or managing type 1 diabetes in children, this represents a significant advance in real-time health monitoring. The ability to catch dangerous ketone trends before they become emergencies could reduce hospitalizations and improve outcomes for a vulnerable population.