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.

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

🗳️ When do you typically check your ketones?

I check them regularly.

I check them only in certain situations, such as when I’m sick or my glucose is high.

I check them only when my healthcare team recommends it.

I don’t check my ketones.

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Why Ketone Monitoring Matters in Type 1 Diabetes

DKA most often affects people with type 1 diabetes. Because people with type 1 produce little or no insulin, ketone monitoring may be an important part of a diabetes care plan in certain situations. For example, a healthcare team may recommend checking ketones during illness, when glucose levels remain high or when symptoms of DKA develop.

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.