美国FDA授权首款监测酮体与血糖水平的可穿戴设备上市

美国食品药品监督管理局（FDA）已正式授权Abbott Diabetes Care研发的Libre Duo 10 Day连续双葡萄糖酮体监测系统上市 1。该设备不仅是美国首个可连续监测酮体水平的可穿戴设备，也是全球首款能在同一设备中同时连续监测酮体与血糖的产品 1。

Libre Duo 10 Day系统面向2岁及以上的糖尿病患者 1。该设备能够每分钟测量皮下液体中的酮体和血糖水平，并将数据无线传输至兼容的智能手机 1。当酮体水平达到警戒阈值时，系统会自动发送警报，有助于早期发现糖尿病酮症酸中毒风险 1。美国约有4010万人患有糖尿病，其中约210万人患有1型糖尿病 1。FDA的授权基于6项临床研究，共纳入600多名2岁及以上的参与者 1。此前，FDA已授予该设备突破性设备认定，并通过De Novo上市前审查路径授予Abbott Diabetes Care营销授权 1。

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System 1. This product marks the first wearable device in the United States capable of continuously monitoring ketone levels, as well as the first globally to simultaneously and continuously track both ketones and glucose within a single device 1. Designed for diabetic patients aged 2 and older, the system measures ketone and glucose levels in interstitial fluid every minute and wirelessly transmits the data to a compatible smartphone 1. Furthermore, it automatically sends alerts when ketone levels reach a warning threshold, which aids in the early detection of diabetic ketoacidosis risks 1.

The FDA's authorization was supported by six clinical studies that included more than 600 participants aged 2 and above 1. Prior to this approval, the agency had already granted the device a Breakthrough Device Designation and ultimately cleared it for marketing through the De Novo premarket review pathway 1. Approximately 40.1 million people in the United States have diabetes, with about 2.1 million of those cases being type 1 diabetes 1.