FDA authorizes first dual glucose-ketone monitor for children as young as 2

The FDA has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable device in the US to continuously track ketone levels and the first in the world to pair continuous ketone and glucose monitoring in a single sensor.¹ The device, made by Abbott, is cleared for patients with diabetes aged 2 years and older.¹

"Today's authorization is a breakthrough for the safety of children and adults living with diabetes," said Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health, in a statement announcing the decision. "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

FDA authorization pathway and clinical data for Libre Duo 10 Day

The FDA granted marketing authorization through the De Novo premarket review pathway, reserved for novel, low- to moderate-risk device types without an existing predicate.¹ Alongside the authorization, the agency established special controls covering labeling and performance testing requirements that, combined with general controls, are intended to provide reasonable assurance of safety and effectiveness.¹ The device previously received Breakthrough Device designation, a status meant to expedite review of technologies addressing life-threatening or irreversibly debilitating conditions.¹

Supporting data came from 6 clinical studies enrolling more than 600 participants aged 2 years and older, evaluating sensor accuracy for ketone and glucose levels.¹ According to the FDA, results showed the device tracked clinically meaningful changes in ketone levels across its 10-day wear period, including identifying elevated ketones before the onset of diabetic ketoacidosis (DKA).¹

Disease burden of diabetes and DKA risk in children

An estimated 40.1 million Americans live with diabetes, and roughly 2.1 million have type 1 diabetes, for whom glucose monitoring alone does not capture the full clinical picture.¹ DKA develops when the body, lacking sufficient insulin, shifts to burning fat for energy and produces excess ketones; the complication can progress quickly and become life-threatening without treatment.¹ Population data from the SEARCH for Diabetes in Youth study found that DKA prevalence at type 1 diabetes diagnosis rose from 35.3% in 2010 to 40.6% in 2016, an upward trend that held even after adjusting for sociodemographic factors.² Younger children are disproportionately affected, with some cohort studies reporting DKA rates exceeding 50% at diagnosis in children younger than 2 years.²

How the device works and what it changes for monitoring

Previously, ketone testing relied on single-point blood or urine measurements that could not show whether levels were rising or falling.¹ The Libre Duo 10 Day instead samples interstitial fluid every minute, sending glucose and ketone readings and trend arrows to a paired smartphone, with alerts when ketones cross a concerning threshold.¹ Abbott has described the technology, which also received a CE mark in Europe earlier this year as Libre Duo and Libre Duo 10 Day, as eliminating the need for separate ketone testing.³ The FDA noted that ketone readings should be interpreted alongside glucose data and clinical symptoms rather than in isolation.¹

Limitations and next steps

The FDA's review centered on sensor accuracy rather than downstream outcomes such as DKA hospitalization or emergency department visits, so it remains unclear how continuous ketone alerts will change real-world DKA rates. Abbott has said it is working with insulin pump manufacturers to eventually connect Libre Duo data to automated insulin delivery systems, but that integration is not yet available.³ The authorization applies specifically to the 10-day, pediatric-eligible version of the device; a longer-wear 15-day version intended for adults has been cleared in Europe but was not addressed in this FDA action.³

References

1. US Food and Drug Administration. FDA authorizes first wearable device that continuously monitors both ketone levels and blood sugar. 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

2. Jensen ET, Stafford JM, Saydah S, et al. Increase in prevalence of diabetic ketoacidosis at diagnosis among youth with type 1 diabetes: the SEARCH for Diabetes in Youth Study. Diabetes Care. 2021;44(7):1573-1578.

3. Reuter E. Abbott receives CE mark for dual glucose-ketone sensor. MedTech Dive. Published May 27, 2026. Accessed August 25, 2026. https://www.medtechdive.com/news/abbott-receives-ce-mark-for-dual-glucose-ketone-sensor/821296/