FDA Approves Libre DUO, the First CGM to Track Glucose + Ketones

Today marks a big breakthrough in ketone monitoring history: The Food and Drug Administration (FDA) approved the Libre DUO 10 Day system, the world’s first continuous glucose and ketone monitor (iCGK) that tracks both glucose and ketone levels in a single sensor. 

This is the first system to meet the FDA’s approval standard for a newly integrated continuous glucose and ketone monitoring. This historic approval also expands access to millions of more patients, as it builds on earlier approvals in the European Union this year.  

Why this approval matters

A dual glucose-ketone sensor is critical to the health and safety of people living with diabetes, especially when they are insulin-dependent. Diabetic ketoacidosis (DKA), which is a serious and potentially fatal complication, is caused by rising ketone levels due to a lack of insulin in people with diabetes. Although DKA is a leading cause of death for people living with type 1 diabetes (T1D), the signs and symptoms of DKA are often missed and mistaken for illnesses like the flu. 

DKA is the most common hyperglycemic emergency in people with diabetes, but:

• DKA hospitalizations have increased 55% over the last decade. 
• Monitoring ketone levels is a big part of preventing DKA, but only 18% of people report having a blood ketone meter at home.
• Nearly one-third report having no ketone testing supplies at all. 

Until now, ketones as markers of DKA could only be checked at a single point of time, much like a single blood sugar check. Someone could easily miss rising ketone levels over a longer period of time.

The new Libre DUO 10 Day system’s continuous sensor will be the first device to track ketone levels in real-time. You’ll be able to see trends in glucose and ketone levels to monitor them more closely. The system will alert users when it senses glucose and/or ketone levels rising at an alarming rate. 

What this means for people with diabetes

DKA can develop quickly, especially in people on insulin, on insulin pumps and automated insulin delivery (AID) systems. Despite guidance to check for ketones regularly and early, monitoring for and diagnosing DKA before it becomes dangerous remains a barrier for many people living with diabetes.

The Libre DUO 10 Day system gives you continuous visibility into both glucose and ketones to support day-to-day diabetes management and earlier awareness of DKA risk. This can help prevent DKA emergencies, avoid unnecessary hospital visits and admissions, and improve the lives of people living with diabetes.

How the Libre DUO 10 Day system works

“If glucose is the speedometer, ketones are like the check engine light, providing an alert that something may need attention,” said Chris Scoggins, executive vice president of Abbott’s diabetes care business. “Libre DUO 10 Day brings both glucose and ketone levels together in a single dashboard, providing a more complete picture to help people with diabetes make more informed decisions.”

The Libre DUO’s FDA approval is for people with type 1 diabetes or type 2 diabetes, ages two and older, who use insulin or other glucose-lowering medications, such as sodium-glucose cotransporter 2 inhibitors (SGLT2).

Looking ahead

Having integrated glucose and ketone monitoring technology available for millions of more people living with diabetes will improve and ultimately save lives. Abbott is working with insulin pump companies to enable automated insulin delivery (AID) systems to connect with the new sensors. The company expects Libre DUO 10 Day to work with Beta Bionics’ iLet and Sequel Med Tech’s twiist AID systems by the end of 2026, and with devices from Insulet (Omnipod systems) and Tandem (T:slim x2, Mobi) in 2027.

Abbott and MiniMed are collaborating on an integration between the dual glucose-ketone sensors and MiniMed smart dosing systems, which is expected in 2027.