The US Food and Drug Administration authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, according to an agency press release. The wearable is the first device in the US to continuously monitor ketone and glucose in a single device. 

The device continuously measures glucose and ketone levels in fluid beneath the skin at 1-minute intervals, aiming to address a gap in detection. A compatible smartphone receives the measurements wirelessly and displays current glucose and ketone concentrations along with trends. Users can receive automated notifications when ketone measurements reach a level of concern.

Excessive ketone production can lead to diabetic ketoacidosis, a serious complication that can develop rapidly and become life-threatening if untreated, noted the US Food and Drug Administration (FDA).  Previously available methods required separate ketone testing and provided point-in-time measurements rather than information about changes in ketone levels over time. The FDA advised interpreting ketone measurements alongside glucose readings and clinical symptoms.

The authorization was based on clinical and performance data submitted by the device sponsor. Across 6 clinical studies, more than 600 participants aged 2 years and older were evaluated to assess the system's glucose and ketone measurement accuracy over a range of concentrations.

According to the FDA, clinical testing showed that the system accurately tracked clinically meaningful differences in ketone levels over 10 days of wear and identified elevated levels prior to diabetic ketoacidosis onset.

The Libre Duo 10 Day previously received Breakthrough Device designation from the FDA. The designation is intended to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Abbott Diabetes Care received marketing authorization for the device through the FDA's De Novo premarket review pathway for new types of low- to moderate-risk devices. The agency also established special controls defining requirements related to labeling and performance testing. According to the FDA, when combined with general controls, these special controls provide reasonable assurance of safety and effectiveness in combination with general controls.

Source: US Food and Drug Administration