FDA approves first wearable device to monitor blood sugar, ketone levels

Aug. 25 (UPI) — On Tuesday, the U.S. Food and Drug Administration approved a device designed to continuously monitor both blood sugar levels and ketone levels in people with diabetes.

The Libre Duo 10-Day Continuous Dual Glucose Ketone Monitoring System is the first of its kind to be approved in the United States — both the first wearable device to monitor ketone levels and the first to combine monitoring of ketone and blood sugar levels, the FDA said. It’s approved for those ages 2 and older.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “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 U.S. Centers for Disease Control and Prevention estimates that 40.1 million Americans live with diabetes. About 2.1 million of them have type 1 diabetes, which also makes it important to monitor the levels of ketone, an acid. The body creates this substance when, due to a lack of insulin, it uses fat instead of glucose to produce energy. Too much ketone can cause diabetic ketoacidosis, a dangerous complication.

“Early detection of rising ketone levels is critical,” the FDA said.

Until now, the agency said, people had to monitor ketone levels with separate tests that only provided a single measurement at one point in time. The new system combines blood sugar and ketone tests and monitors them continuously. Readings — and alerts in case of dangerous trends — are sent wirelessly to a smartphone app.

The FDA previously granted “breakthrough device” status to the system, which is meant to expedite the device’s development and review.