Continuous readings and trend alerts are sent wirelessly to a smartphone app
The FDA approved the Libre Duo on Tuesday for diabetes monitoring in people ages 2 and older. The agency said the device is the first wearable approved in the United States to monitor ketones and the first to combine continuous ketone and blood-sugar monitoring.
Before the approval, the FDA said, people had to monitor ketone levels with separate tests that provided only one measurement at a point in time. The new system combines blood sugar and ketone tests and monitors both continuously.
The system sends readings to a smartphone app through a wireless connection. The app also receives alerts when the readings show dangerous trends, according to the FDA.
Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, called the authorization a safety advance. “Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” Tarver said. “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.”
The body creates ketones when a lack of insulin causes it to use fat instead of glucose for energy. Too much ketone can cause diabetic ketoacidosis, which UPI described as a dangerous complication of diabetes.
The U.S. Centers for Disease Control and Prevention estimates that 40.1 million Americans live with diabetes. About 2.1 million have type 1 diabetes, making the monitoring of ketone levels important, UPI reported.
The FDA separately stated the safety rationale more succinctly: “Early detection of rising ketone levels is critical.”
The system previously received “breakthrough device” status from the FDA. The designation is meant to expedite the device’s development and review.