The FDA cleared the first wearable that tracks ketones and blood sugar together to catch a diabetic emergency early

On August 25, 2026, the FDA authorized Abbott’s Libre Duo 10 Day, the first wearable that continuously tracks ketones and blood sugar in a single sensor, giving people with diabetes a way to see a diabetic emergency building rather than discovering it after symptoms start. The device is cleared for anyone aged 2 and older living with diabetes, and it reads both markers every minute from fluid just beneath the skin.

More than a month later it is still not on sale in the United States, and Abbott has named no price.

What one sensor measures instead of two

Ketones are acids the liver makes when the body burns fat for fuel because it lacks the insulin to use sugar. In the FDA’s announcement, the agency said the Libre Duo 10 Day “continuously measures ketone and glucose in fluid beneath the skin every minute” and sends the readings wirelessly to a compatible smartphone, which shows current levels and the direction they are heading. The phone app sends automatic alerts when ketone levels reach concerning thresholds.

Until now ketones were checked in bursts: a finger-stick blood meter or a urine strip used when a person felt unwell or when glucose ran high. Each check is a single moment with no trend attached. A sensor that logs a reading every minute for 10 days turns the question from “what is it now” into “which way is it moving,” and that trend is the piece that a strip cannot give.

The emergency it is built to catch

The Centers for Disease Control and Prevention describes diabetic ketoacidosis, or DKA, as the result of very high blood sugar combined with too little insulin, which leaves ketones accumulating to dangerous levels. Its most common causes are illness and missed insulin doses or pump malfunctions, and it is most common in type 1 diabetes though type 2 patients can develop it. Early signs are thirst and frequent urination; later ones include fast, deep breathing, dry skin and mouth, a flushed face and fruity-smelling breath. The agency says elevated ketones are a sign of DKA and a medical emergency.

Michelle Tarver, the director of the FDA’s Center for Devices and Radiological Health, put the value of the new device this way: “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.”

Abbott’s own executives and its clinical partners talk about the device as a background layer. Dr. Jennifer Sherr of Yale School of Medicine said in the company’s release that the dual system “is meaningful because ketone data is collected in the background, helping provide earlier awareness of rising ketone levels.” Alisa Schiffman, an Abbott senior medical director, told MedTech Dive the aim is to “reduce hospital admissions and prevent people from going into DKA.”

The limits of a De Novo authorization

The FDA used its De Novo pathway, which the agency’s own page describes as a marketing route for novel devices of low to moderate risk with no legally marketed predicate. That is why the announcement’s word is “authorizes,” not “clears,” and why later ketone-and-glucose sensors from other makers can point back to this one as a reference. The device had earlier received a Breakthrough Device designation, according to HCPLive.

The evidence behind the decision was six clinical studies enrolling more than 600 participants aged 2 and older. The FDA said the results showed the sensor tracking clinically meaningful ketone differences across the 10-day wear period and identifying elevated ketones before diabetic ketoacidosis began. The agency added a caution that ketone information should always be read alongside glucose readings and symptoms, which means the sensor is an early-warning layer for a decision that still involves the person and their clinician, and the alert does not replace the CDC’s advice to call 911 for blood sugar at 300 mg/dL or higher, or for fruity-smelling breath, vomiting or trouble breathing.

The gaps are practical ones. Abbott says only that it will launch in the United States later in 2026, and TechRepublic reports no release date or price, and no statement on whether a prescription is needed. Abbott says it is working with pump makers so the sensor can feed automated insulin delivery systems: Beta Bionics’ iLet and Sequel Med Tech’s twiist by the end of 2026, and Insulet and Tandem devices in 2027, with MiniMed to produce its own exclusive version. The sensor had already received a CE mark in Europe in May 2026, the same outlet reports, so U.S. patients are following a European launch path rather than leading one. Insurance coverage is unanswered: MedTech Dive reports that pricing and coverage remain unannounced and that Abbott has committed only to working with payers on access.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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