FDA Authorizes First Wearable Device to Continuously Monitor Glucose, Ketones

The US Food and Drug Administration has authorized Abbott Diabetes Care’s Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for persons aged 2 years and older living with diabetes, according to an FDA announcement.¹

The Libre Duo 10 Day is the first wearable device in the US to continuously monitor ketone levels and the first device globally to continuously monitor ketones and blood glucose together in a single system, the FDA stated.¹

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “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.”¹

What does the Libre Duo 10 Day monitor?

The Libre Duo 10 Day continuously measures both glucose and ketone levels in the fluid just beneath the skin every minute, day and night. Readings are transmitted wirelessly to a compatible smartphone, where users can view current glucose and ketone levels and whether those values are trending up or down.¹

The device also can send automatic alerts if ketone levels reach a concerning threshold. The FDA noted that ketone information should be interpreted in the context of glucose readings and symptoms.¹

Why does continuous ketone monitoring matter?

Ketones are produced when the body uses fat instead of glucose for energy. When ketone levels rise too high, patients with diabetes can develop diabetic ketoacidosis (DKA), a serious complication that can progress quickly and become life-threatening without prompt treatment.¹

Until now, patients who needed ketone monitoring had to test separately using methods that provided a single measurement at one point in time. Those tests could not show whether ketone levels were rising or falling.¹

For patients with diabetes—particularly those at higher risk for DKA—continuous glucose and ketone monitoring may provide earlier warning of metabolic deterioration and support timelier sick-day management, hydration, insulin adjustment, and escalation of care when clinically appropriate.

What data supported FDA authorization?

The FDA’s authorization was based on a review of clinical and performance data submitted by Abbott Diabetes Care. The clinical program included 6 studies enrolling more than 600 participants aged 2 years and older. The studies evaluated the accuracy of the device’s ketone and glucose monitoring functions across a range of ketone and glucose levels.¹

According to the FDA, results showed that the device accurately tracked clinically meaningful differences in ketone levels across the 10-day wear period, including identification of elevated ketone levels before the onset of DKA.¹

Before authorization, the FDA granted the Libre Duo 10 Day Breakthrough Device designation. The designation is intended to expedite development and review of devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.¹

Why is this relevant to primary care?

The authorization is relevant for primary care clinicians because diabetes technology is increasingly used across both specialty and frontline care settings. An estimated 40.1 million individuals in the US are living with diabetes, including approximately 2.1 million persons with type 1 diabetes, according to the US Centers for Disease Control and Prevention.²

For clinicians caring for patients with diabetes, the device introduces a new monitoring category: continuous dual glucose-ketone monitoring. Practical counseling will likely need to emphasize what rising ketone alerts mean, when patients should follow sick-day protocols, when to contact the care team, and when symptoms warrant urgent evaluation.

The device may be particularly relevant for patients and caregivers who need clearer real-time information during illness, prolonged hyperglycemia, insulin delivery interruption, or other situations in which DKA risk may increase. However, clinicians should reinforce that ketone data are not interpreted in isolation and should be considered alongside glucose trends, symptoms, insulin use, hydration status, and the patient’s individualized diabetes management plan.

Reference

1. US Food and Drug Administration. FDA authorizes first wearable device that continuously monitors both ketone levels and blood sugar. News release. Published August 25, 2026. Accessed August 25, 2026. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-wearable-device-continuously-monitors-both-ketone-levels-and-blood-sugar?utm_medium=email&utm_source=govdelivery
2. US Centers for Disease Control and Prevention. National Diabetes Statistics Report. Published January 21, 2026. Accessed August 25, 2026. https://www.cdc.gov/diabetes/php/data-research/index.html