FDA Approves First Wearable That Continuously Tracks Blood Sugar and Ketones

A new wearable health sensor could make it easier for people with diabetes to detect rising ketone levels before they develop into a serious medical emergency.

The U.S. Food and Drug Administration has authorized a new device from Abbott that continuously measures both glucose and ketones. According to the FDA, it is the first wearable sensor authorized to monitor these two important health measurements at the same time.

The device, called Libre Duo 10 Day, is designed to provide information around the clock. It attaches to the skin and measures glucose and ketones in the fluid beneath the skin every minute. The readings are then sent wirelessly to a smartphone application, where users can see their current measurements and whether their levels are increasing or decreasing.

The technology could be particularly important for people who are at increased risk of developing diabetic ketoacidosis, commonly known as DKA.

Why ketones matter in diabetes

Ketones are chemicals produced when the body begins using fat for energy instead of glucose. This can happen when the body does not have enough insulin to allow glucose to enter cells and be used as fuel.

A small amount of ketones can occur under certain circumstances, including fasting or illness. However, significantly elevated ketone levels can be dangerous, particularly in people with diabetes.

When ketones build up excessively, the blood can become acidic. This condition is known as diabetic ketoacidosis. DKA can become severe within a relatively short period and may result in hospitalization, coma or death if it is not treated promptly.

Early symptoms can include nausea, vomiting, abdominal pain, excessive thirst, frequent urination, weakness and unusual fatigue. Because these symptoms can resemble a stomach virus or other common illnesses, DKA may not always be recognized immediately.

Having access to continuous ketone information could provide another opportunity to identify a developing problem.

"Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency," said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.

A different approach to ketone monitoring

Before this authorization, people generally had to test ketones separately using blood or urine testing methods.

Those traditional tests can provide useful information, but they offer a snapshot rather than continuous monitoring. A person might have a normal reading at one point and then experience a significant increase later.

The new wearable is intended to provide a more complete picture by tracking changes continuously.

According to Abbott, the sensor can alert users when ketone levels reach a concerning range. The accompanying smartphone application can also display whether measurements are moving upward or downward.

That trend information may be especially useful because the direction of a measurement can provide additional context. A ketone level that is increasing may warrant closer attention than a similar level that is stable, although users should always interpret the readings in conjunction with their glucose levels and symptoms.

Dr. Jennifer Sherr, a pediatric endocrinologist at Yale School of Medicine, said that the ability to identify changes earlier could be valuable because DKA can develop quickly.

"As a physician, I see how quickly DKA can develop," Sherr said, adding that opportunities to measure ketones can sometimes be missed.

Who could benefit?

The FDA authorization covers people with diabetes who are age 2 and older.

Abbott says the technology is intended for people who may have a higher risk of elevated ketones. This includes some individuals who use insulin or glucose-lowering medications.

The potential benefit may be particularly relevant during periods when ketone levels can rise, such as illness or other situations in which insulin requirements and glucose control can change.

Still, continuous monitoring does not mean that other aspects of diabetes management become unnecessary. The FDA emphasizes that ketone readings should be considered together with glucose measurements and a person's symptoms.

The device also should not be viewed as a replacement for medical care when someone is experiencing signs of DKA.

Evidence behind the FDA decision

The FDA said its authorization was supported by six studies involving more than 600 participants.

According to the agency, the studies showed that the sensor could accurately identify meaningful changes in ketone levels throughout its 10-day wear period. The device was also able to identify elevated ketones before DKA developed.

These findings were important because a continuous monitoring system needs to provide reliable information over the entire period that a person wears the sensor, rather than simply producing accurate results at isolated points.

The FDA's authorization represents a significant step in bringing continuous ketone monitoring into diabetes care, although real-world use will provide additional information about how the technology affects everyday diabetes management and emergency prevention.

What happens next?

Abbott said it plans to introduce the Libre Duo 10 Day in the United States later in 2026.

The company is also developing ways to integrate the sensor with automated insulin delivery systems. Such connections could eventually allow ketone information to become part of broader diabetes-management technologies.

That possibility could be significant as diabetes devices increasingly work together. Continuous glucose monitors, insulin pumps and automated insulin systems have already changed how many people manage their condition. Adding continuous ketone measurements could provide another layer of information, particularly for people vulnerable to DKA.

However, patients and caregivers should not wait for a wearable alert if serious symptoms occur. Symptoms such as persistent vomiting, severe abdominal pain, difficulty breathing, confusion or extreme weakness can require urgent medical attention.

A potential new layer of protection

Diabetes management often involves monitoring glucose, taking medications, adjusting insulin, responding to illness and watching for symptoms that could signal complications. Ketones have traditionally been more difficult to monitor continuously.

The new FDA-authorized wearable aims to change that by making ketone monitoring more frequent and automatic.

For people at elevated risk of DKA, having information about ketone levels throughout the day and night could potentially help identify concerning changes sooner. Earlier awareness may give patients and healthcare professionals more time to respond before a dangerous complication becomes severe.

The device is not a guarantee against DKA, and it does not replace medical advice or established diabetes-management practices. However, continuous access to both glucose and ketone information could represent an important development in wearable diabetes technology.

As the sensor becomes available, healthcare professionals and patients will have an opportunity to determine how best to incorporate continuous ketone monitoring into individualized diabetes care.

Sources

• U.S. Food and Drug Administration, Aug. 25, 2026
• Abbott, company announcement, Aug. 25, 2026
• U.S. Centers for Disease Control and Prevention, diabetes information
• American Diabetes Association, information on diabetic ketoacidosis

Medical Disclaimer

This article is intended for general informational and educational purposes only. It does not provide medical advice, diagnosis or treatment. Information about medical devices, diabetes, ketones and diabetic ketoacidosis should not be used as a substitute for advice from a qualified healthcare professional. Individual circumstances can vary significantly. If you have diabetes and experience symptoms that may indicate diabetic ketoacidosis or another medical emergency, seek appropriate medical care promptly. Always consult your doctor or diabetes care team before making changes to your treatment or monitoring routine.