FDA Authorizes First Continuous Dual Glucose-Ketone Monitor

The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System (Abbott Diabetes Care) for people with diabetes aged 2 years and older. The agency described it as the first wearable device authorized in the US to continuously monitor ketones and the first worldwide to monitor ketones and glucose together in one device.

The device measures ketone and glucose levels in fluid beneath the skin every minute throughout its 10-day wear period. Readings are transmitted wirelessly to a compatible smartphone, showing current values and whether they are rising or falling. Automatic alerts can signal when ketones reach a concerning threshold.

The authorization was supported by clinical and performance data that included six studies enrolling more than 600 participants aged 2 years and older. According to the FDA, results showed that the system accurately tracked clinically meaningful differences in ketone levels across the wear period and identified elevated levels before the onset of diabetic ketoacidosis (DKA).

The agency noted that excess ketone production can lead to DKA, which may develop rapidly and become life-threatening without treatment. Previously, separate ketone tests provided a single measurement without showing whether levels were increasing or decreasing. The FDA cautioned that ketone information from the new system should be interpreted alongside glucose readings and symptoms.

The FDA granted marketing authorization through the De Novo premarket review pathway for new types of low- to moderate-risk devices. It is also establishing special controls covering requirements such as labeling and performance testing. The system previously received Breakthrough Device designation, a status intended to expedite development and review of devices that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.

Source: US Food and Drug Administration. FDA authorizes first wearable device that continuously monitors both ketone levels and blood sugar. News release. US Food and Drug Administration; August 25, 2026. Accessed August 26, 2026.