FDA Approves World’s First Wearable That Simultaneously Measures Glucose and Ketones; Abbott Plans U.S. Launch This Year — BigGo Finance

The U.S. Food and Drug Administration (FDA) on August 25, 2026 approved the wearable device “Libre Duo 10 Day” developed by Abbott Laboratories (ABT). It is the first approval in the United States and the first in the world for a system capable of simultaneously and continuously measuring glucose and ketone levels in diabetes patients using a single device.

The device is indicated for diabetes patients aged 2 and older. It can be worn continuously for up to 10 days, measuring glucose and ketone levels in interstitial fluid just beneath the skin every minute around the clock, and wirelessly transmitting data to a smartphone. It features an automatic alert function that activates when ketones reach a specified threshold, enabling continuous monitoring as an alternative to traditional one-off urine or blood tests.

The FDA granted approval through the De Novo pathway for novel low- to moderate-risk medical devices. The agency conducted a comprehensive review of six clinical trials involving more than 600 participants and confirmed that the device can accurately track clinically significant ketone fluctuations.

Chris Scoggins, Executive Vice President of Abbott’s diabetes care business, said, “If glucose is the speedometer, ketones are like the engine warning light. Libre Duo 10 Day brings both levels together on a single dashboard, providing more comprehensive information so people with diabetes can make more informed decisions.”

Addressing Diabetic Ketoacidosis

According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 40.1 million Americans have diabetes. In type 1 diabetes, which accounts for approximately 5% of all cases, autoimmune issues destroy insulin-producing cells, leaving the body unable to produce insulin.

For these patients, diabetic ketoacidosis is a serious acute complication. When glucose cannot be used as an energy source due to insulin deficiency, the body breaks down fat as an alternative energy source. When ketones produced in this process accumulate excessively, the blood becomes acidic, causing symptoms such as intense thirst, frequent urination, vomiting, and fatigue. If left untreated, it can lead to loss of consciousness or even death.

Jennifer Sherr, a pediatric endocrinologist at Yale School of Medicine, said, “As a physician, I have witnessed how rapidly diabetic ketoacidosis can progress and how often early warning signs and opportunities for ketone measurement are missed. This system, which collects ketone data in the background, is significant in that it enables earlier detection of rising ketone levels.”

Insulin Pump Integration Plans

Abbott is working with major insulin pump manufacturers to integrate Libre Duo 10 Day with future automated insulin delivery (AID) systems. Synchronization with Beta Bionics’ (BBNX) “iLet” and Sequel Med Tech’s “twiist” is expected by the end of 2026.

In 2027, integration with systems from Insulet (PODD) and Tandem Diabetes Care (TNDM) is also planned. Additionally, the company is collaborating with MiniMed Group (MMED) on an exclusive integration for a smart dosing system in the same year.

William Blair analyst Brandon Vazquez noted, “Our initial impression of the U.S. approval of Libre Duo 10 Day is that this sensor is likely to be most competitive in the pediatric patient population if integrated with AID pumps over the coming year.” He also suggested that the approval could create a new competitive landscape, potentially leaving a lasting impact on the stock price of rival DexCom (DXCM).

Abbott plans to launch Libre Duo 10 Day in the United States within 2026.