The U.S. Food and Drug Administration has authorized the first wearable device capable of continuously monitoring both glucose and ketone levels in people with diabetes, a dual-sensing biowearable that Abbott Laboratories says can catch the warning signs of a dangerous complication before it turns into a medical emergency. The device, called Libre Duo 10 Day, is worn for 10 days and is designed for anyone two years and older living with diabetes.
The FDA said it authorized the sensor through its De Novo premarket review pathway, a regulatory route reserved for novel low- to moderate-risk devices that have no existing predicate on the market, according to the FDA. The agency had previously granted the system Breakthrough Device designation to speed its development. As reported by Reuters, the device brings glucose and ketone readings together in a single dashboard, giving patients what Abbott describes as a more complete picture for making informed decisions about their care.
Alongside the authorization, the FDA established special controls for continuous ketone monitoring, meaning Libre Duo is the first product to meet both existing continuous glucose monitoring standards and newly created continuous glucose-ketone criteria, according to Investing.com. Those special controls dictate mandatory labeling and performance testing meant to ensure the sensor works as claimed. The authorization was backed by six clinical studies involving more than 600 participants, evaluating how accurately the sensor measures interstitial fluid glucose and ketone concentrations every minute, per HCPLive.
How the Sensor Works and Why Ketones Matter
Diabetic ketoacidosis, or DKA, occurs when severe insulin deficiency forces the body to break down fat for energy, producing toxic ketone acids, the outlet notes. Reuters describes DKA as a serious health complication for people with diabetes, and Chris Scoggins offered a simple way to think about the two readings the device tracks: “Glucose is the speedometer and ketones are like the check engine light,” he said, according to Reuters. Libre Duo 10 Day sends automatic alerts when ketones begin rising, which Abbott says may help patients and caregivers intervene before the situation becomes a medical emergency.
Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said real-time, 24/7 ketone tracking can mark the difference between early medical intervention and a life-threatening emergency for diabetes patients, according to the agency. Unlike a one-time fingerstick or urine strip, continuous monitoring provides directional trend arrows rather than isolated static readings, giving users a clearer sense of where their levels are headed rather than just where they stand at a single moment.
A Gap in Everyday Diabetes Care
Dr. Jennifer Sherr, a pediatric endocrinologist at Yale School of Medicine, said diabetic ketoacidosis can develop rapidly and that opportunities to catch early warning signs are frequently missed during routine care, per StreetInsider. That risk is especially acute for younger patients, who face heightened vulnerability to rapid ketone escalation tied to higher metabolic rates and pump dislodgement, the outlet notes.
The scale of the problem is significant. Hospital admissions for diabetic ketoacidosis in the U.S. have climbed 55% over the past decade, and the condition now accounts for roughly 30% of all hospital admissions among people with Type 1 diabetes, according to Investing.com. Those hospitalizations carry a steep price tag too: William Blair estimates the annual economic burden at $6.8 billion nationwide, with individual stays lasting three to four days and costing between $21,215 and $36,600 per admission.
Much of that burden appears tied to a basic testing gap. An estimated 64% of Type 1 diabetes patients don't test for ketones at all, and nearly half report not knowing the primary causes or early symptoms of DKA, per William Blair's research. Traditional fingerstick blood meters and urine test strips require patients to deliberately test during acute illness, a step that's easy to skip when someone doesn't feel imminently sick.
International Rollout and What Comes Next
Abbott isn't new to dual-sensing technology overseas. The company secured European CE Mark clearance for the Libre Duo platform in May, covering both a 10-day pediatric sensor and a 15-day sensor for adults, according to HCPLive. U.S. commercial launch of the Libre Duo 10 Day is planned for later this year, and the device integrates with Abbott's existing Libre app.
On the pump-integration front, Abbott said it is working with leading pump companies to enable automated insulin delivery systems to connect with the sensors. Compatibility with Beta Bionics' iLet and Sequel Med Tech's twiist systems is expected in late 2026, followed by Medtronic's MiniMed in 2027, per StreetInsider. Reuters reports the device is also expected to work with devices from Insulet and Tandem in 2027, rounding out connections to the industry's larger automated insulin delivery players.
Endocrinologists caution that the leap forward shouldn't be mistaken for a standalone diagnostic tool. Ketone trend data is meant to be paired with glucose readings and clinical symptoms, not relied upon in isolation, to avoid unnecessary panic or improper insulin dosing. That guidance will matter as more patients and pump makers begin building the device into daily diabetes management routines over the next two years.
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