The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people ages 2 and older living with diabetes.

The device is the first wearable in the United States to continuously monitor ketones and the first in the world to continuously measure both glucose (blood sugar) and ketones with one device. It takes readings every minute and sends them to a compatible smartphone. It can also alert users when ketone levels reach a concerning threshold.

Why Ketones Matter

Ketones are acids the body makes when it breaks down fat for energy instead of using glucose. When ketones rise too high, they can contribute to diabetic ketoacidosis (DKA) — a serious complication that can develop quickly and requires prompt medical care.

🗳️ Has your healthcare team recommended that you track your ketones?

Yes, and I track them regularly.

Yes, but I only track them in certain situations.

No, but I track them on my own.

No, and I don’t track my ketones.

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DKA is more common in type 1 diabetes than in type 2, but health experts agree people with type 2 diabetes should be aware of the risks.

What Did the FDA’s Review Show?

The authorization was based on clinical and performance data from six studies involving more than 600 participants ages 2 and older. The studies evaluated the accuracy of the system’s glucose and ketone monitoring across a range of levels.

According to the FDA, the device accurately tracked clinically meaningful differences in ketone levels during its 10-day wear period. The studies also showed that the system could identify elevated ketone levels before the onset of DKA.

That doesn’t mean the device has been shown to prevent DKA. The FDA said ketone readings should be considered together with glucose readings and symptoms. The device also doesn’t replace the steps in a person’s diabetes care or sick-day plan.

Why Does This Authorization Matter for People With Type 2 Diabetes?

Not everyone with type 2 diabetes needs to monitor ketones. DKA is much more common in type 1 diabetes, but it can also occur in some people with type 2 diabetes, particularly when the body isn’t producing enough insulin. The risk can also be higher in people taking sodium-glucose cotransporter 2 (SGLT2) inhibitors, a class of diabetes medications.

For people whose healthcare team recommends ketone testing, tracking glucose and ketones together could provide more information than checking glucose alone. Continuous monitoring may also make it easier to see whether ketone levels are rising or falling over time rather than relying only on separate blood or urine checks.

Who Should Consider Ketone Monitoring?

The device won’t be the right fit for everyone, and FDA authorization does not mean everyone with type 2 diabetes should start monitoring ketones. Decisions about ketone monitoring or diabetes treatment should be made with a healthcare provider.

If you’re living with type 2 diabetes, ask your healthcare provider whether ketone monitoring should be part of your care plan, when you should check ketones, and what results should prompt you to take action.