Abbott receives FDA authorization for dual glucose-ketone sensor

Abbott Laboratories has received FDA authorization for its Libre Duo 10 Day system, a dual glucose-ketone sensor designed to monitor both glucose and ketone levels for individuals with diabetes. The system, which is intended for people with Type 1 or Type 2 diabetes who use insulin or other glucose-lowering medications, received De Novo authorization after securing breakthrough device designation from the FDA.

The Libre Duo 10 Day system is the first to meet the FDA’s integrated continuous glucose monitoring standard and the new integrated continuous glucose and ketone monitoring standard. Hospital admissions for diabetic ketoacidosis, a serious complication that can develop when the body does not have enough insulin and begins breaking down fat for energy, have increased 55% over the past decade.

Abbott plans to launch the device in the United States later this year, with plans to enable automated insulin delivery systems to connect with the sensors in collaboration with pump manufacturers.

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