FDA Clears First Dual Glucose-Ketone Monitor

The U.S. Food and Drug Administration has authorized the first wearable device capable of continuously monitoring both ketone and glucose levels, a breakthrough designed to help prevent a dangerous diabetes complication. The agency announced the decision on Tuesday, August 25, 2026, clearing Abbott Laboratories' Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for use in people with diabetes aged 2 years and older.

The device addresses a critical gap in diabetes management by providing real-time, minute-by-minute tracking of ketones alongside blood sugar. Ketones are acids produced when the body burns fat for energy instead of glucose. A dangerous buildup can lead to diabetic ketoacidosis (DKA), a serious complication that can escalate from symptoms like nausea and fatigue to a medical emergency within hours. Until now, monitoring ketones required separate, one-time tests using urine strips or fingersticks, which offered only a snapshot without indicating whether levels were rising or falling.

"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...