The FDA has authorized the first wearable device to continuously measure both blood sugar and ketone levels for 24 hours.
What was authorized
On August 25, 2026, the FDA granted marketing authorization to Abbott Diabetes Care's Libre Duo 10 Day Continuous Glucose Ketone Dual Monitoring System.
The target population is individuals with diabetes aged 2 years and older, and the wear time is 10 days.
It is the first wearable in the United States to continuously measure ketones, and the first device worldwide to continuously measure both ketones and blood sugar in a single device.
Why is it important?
Ketones are produced when the body uses fat instead of glucose for energy. If they build up excessively, it can lead to diabetic ketoacidosis (DKA), a condition that progresses rapidly and can be life-threatening if left untreated.
Previously, ketones could only be measured separately from blood sugar, and only as a single value at a given point in time. This meant it was impossible to know whether ketone levels were rising or falling.
How does it work?
It measures ketones and blood sugar from interstitial fluid just below the skin every minute and wirelessly transmits the results to a smartphone.
In addition to current values, it shows trends of increase or decrease, and sends automatic alerts if ketone levels reach dangerous thresholds.
However, ketone levels should always be interpreted in conjunction with blood sugar levels and symptoms.
Rationale and Process
Data from six clinical trials involving over 600 participants (aged 2 years and older) were reviewed. The device was shown to accurately track clinically meaningful ketone changes over a 10-day wear period and detect rising ketones before the onset of DKA.
It received Breakthrough Device designation prior to authorization and was granted through the De Novo pathway, which is intended for novel low-to-moderate risk devices. The FDA also established special controls outlining labeling and performance testing requirements.
This authorization aligns with the FDA's 'Home as a Health Care Hub' initiative.
Statements from Stakeholders
"Today's authorization represents a groundbreaking advancement in the safety of children and adults living with diabetes. Knowing in real time, 24 hours a day, that ketone levels are rising can make all the difference for early intervention and preventing life-threatening emergencies." — Michelle Tarver, Director of the FDA's Center for Devices and Radiological Health (CDRH)
▶ Source: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-wearable-device-continuously-monitors-both-ketone-levels-and-blood-sugar
