The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, marking the first wearable device in the United States that continuously monitors ketone levels and the first globally to monitor both ketones and blood sugar simultaneously in a single device.
The device is approved for people aged 2 years and older living with diabetes. According to the CDC, an estimated 40.1 million Americans have diabetes, while approximately 2.1 million have type 1 diabetes, a population particularly at risk for ketone-related complications.
When the body uses fat instead of glucose for energy, it produces ketones. Elevated ketone levels can lead to diabetic ketoacidosis, or DKA, a serious complication that can develop rapidly and become life-threatening without treatment. Previously, people needing to monitor ketones had to use separate tests that provided only single-point-in-time measurements, offering no indication of whether ketone levels were rising or falling.
The Libre Duo 10 Day addresses this gap by continuously measuring both ketone and glucose levels in the fluid beneath the skin every minute, around the clock. Readings are transmitted wirelessly to a compatible smartphone, allowing users to see current levels and whether they are trending up or down. The device can send automatic alerts when ketone levels reach concerning thresholds, potentially helping patients and caregivers recognize rising ketones before DKA becomes a medical emergency.
FDA authorization was based on comprehensive clinical and performance data. The clinical program included six studies enrolling more than 600 participants aged 2 and older. Results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels over its 10-day wear period and identified elevated ketone levels before diabetic ketoacidosis onset.
According to Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health, real-time ketone information “can be the difference between early intervention and a life-threatening emergency.”
The FDA previously granted the device Breakthrough Device designation to expedite development and review. Abbott Diabetes Care received marketing authorization through the De Novo premarket review pathway, a regulatory process for low- to moderate-risk devices of new types. The authorization also established special controls defining requirements related to labeling and performance testing.
Key facts
- The Libre Duo 10 Day is the first wearable device in the U.S. to continuously monitor ketone levels
- It is the first device globally to monitor both ketones and glucose together in one device
- The device measures levels every minute and sends readings wirelessly to a smartphone
- An estimated 2.1 million Americans have type 1 diabetes, for whom ketone monitoring is particularly important
- Clinical trials included over 600 participants and demonstrated the device’s accuracy in tracking ketone levels and identifying elevated ketones before diabetic ketoacidosis onset