What’s Happening?

The U.S. Food and Drug Administration (FDA) approved Abbott’s Libre Duo 10 Day, the world’s first two-in-one sensor that monitors both glucose and ketones. People with diabetes ages two and up will soon be able to access this technology in the U.S. This follows from its recent approval in Europe earlier this year.

Why Ketone Monitoring is Important

The primary benefit of ketone monitoring is simple: it can prevent diabetic ketoacidosis (DKA), a potentially life-threatening condition and one of the most common complications of type 1 diabetes (T1D).

Diabetic Ketoacidosis (DKA)

DKA occurs when the body doesn’t have enough insulin, which means that sugar can’t be used for energy. In this scenario, the body breaks down fat for energy, leading to the buildup of ketones in the blood. Rising ketone levels increase the risk for DKA—and very high levels of ketones require immediate emergency medical care.

DKA can develop quickly. Symptoms include nausea, vomiting, and abdominal pain that can be mistaken for common illnesses. While DKA is relatively common in people with T1D, a survey found that:

32%

have no ketone testing supplies at home

50%

never or rarely check ketone levels

38%

never check ketones when nauseated or vomiting

Abbott’s dual glucose-ketone sensing technology has the potential to change these numbers. Its approval is a major milestone in better ketone monitoring and management for the T1D community. Individuals now have a seamless way to monitor ketones before levels get too high or symptoms develop, without needing an additional device. Ultimately, this device will empower people with T1D to act earlier and prevent a trip to the hospital because of DKA.

Integration with Diabetes Devices

Abbott’s Libre Duo 10 Day offers up to 10 days of wear and is compatible with the current app and Libre ecosystem. This technology is expected to integrate with multiple systems and devices. This includes Beta Bionics’ iLet and Sequel Med Tech’s twiist automated insulin delivery (AID) systems by the end of 2026, with Insulet and Tandem Devices in 2027, and with MiniMed smart dosing systems through an exclusive integration in 2027.

This means that people with T1D interested in monitoring their glucose and ketone levels will have more than one option for integrating Abbott’s technology into devices they may already be using.

Breakthrough T1D Advocates for Ketone Monitoring

This milestone reflects years of Breakthrough T1D investment. We have funded research to help make continuous ketone monitoring (CKM) devices a reality. We are currently supporting several studies exploring how CKM can further improve outcomes for the T1D community, including reducing the risks associated with certain adjunctive therapies, like SGLT2 inhibitors.

Breakthrough T1D also spearheaded the first international expert recommendations for use of CKM, published in The Lancet Diabetes & Endocrinology earlier this year. This publication establishes guidance for integration of CKM into clinical care and outlines practical recommendations for use of CKM to reduce the risk of DKA.

We will continue to advocate for broad, equitable access to this technology for people all over the world. DKA is preventable—and the approval of Abbott’s dual glucose-ketone sensing technology is a big step forward in reducing this complication in the T1D community.