The Food and Drug Administration has cleared the first wearable device that continuously measures both glucose and ketones from the same sensor.
Made by Abbott and called the Libre Duo 10 Day, the patch received De Novo authorization on August 25, 2026 for people aged 2 and older who live with type 1 or type 2 diabetes.
The stakes are practical. When insulin runs short, the body starts burning fat and pumps out chemicals called ketones.
If those ketones climb high enough, the blood turns acidic and diabetic ketoacidosis, or DKA, sets in. It can develop within hours and can end in a coma or death if it is not treated.
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Until now, people at risk had to check ketones separately, usually with a fingerstick blood meter or a urine strip, and only when they already suspected something was wrong.
Abbott says hospital admissions for DKA in the United States have risen 55 percent over the past decade, a gap the new sensor is designed to help close.
How the sensor works
The Libre Duo is a small patch worn on the back of the upper arm. It reads glucose and ketone levels in the fluid just under the skin and streams both numbers wirelessly to a compatible smartphone. It is designed for up to 10 days of continuous wear.
Two alerts are built in. An Urgent Low Glucose alarm fires when blood sugar drops below 55 mg/dL, and an Urgent High Ketones alarm sounds when ketones climb above 3.0 mmol/L, according to Abbott. The idea is to catch trouble hours earlier than a person would notice symptoms on their own.
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Why the FDA cleared it
The device took a regulatory route called De Novo, used for genuinely new categories of product.
It is the first system to meet the FDA's existing continuous glucose monitoring benchmark and a newly created standard for integrated continuous glucose and ketone monitoring.
Pediatric endocrinologist Jennifer Sherr of Yale School of Medicine described what changes for patients. "Ketone data is collected in the background, helping provide earlier awareness of rising ketone levels."
Who it is for, and who it is not for
The clearance is narrow. The Libre Duo is authorized for diabetes management, especially for people using insulin or medications like SGLT2 inhibitors that can raise ketone risk.
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It is not marketed as a wellness tool for people following a ketogenic diet, and its alert thresholds are set for medical emergencies, not for tracking nutritional ketosis.
Anyone with diabetes who is considering the device, or who has questions about ketone risk with their current medications, should raise it with their doctor before making changes.
When it will be available
Abbott says it plans to launch the Libre Duo 10 Day in the United States later in 2026.
The company has also announced that integration with automated insulin delivery pumps from Beta Bionics and Sequel Med Tech is expected by the end of 2026, with Insulet, Tandem and MiniMed compatibility set for 2027.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.