FDA授权Abbott Libre Duo 10 Day成为美国首个连续酮体与血糖双监测可穿戴设备

FDA News Release
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
New device can help people with diabetes detect warning signs of a dangerous complication before it becomes a medical emergency
- For Immediate Release:
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.
“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., 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."
According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.
Early detection of rising ketone levels is critical. Until now, people who needed to monitor ketones had to do so separately, using tests that could only provide a single measurement at one point in time which could not tell users if ketones were rising or falling. The Libre Duo 10 Day addresses that gap by continuously measuring both ketone and glucose levels in the fluid just beneath the skin, every minute, day and night. Readings are sent wirelessly to a compatible smartphone, where users can see their current ketone and glucose levels and whether they are trending up or down. The device can send automatic alerts if ketone levels reach a concerning threshold, which may help patients and caregivers recognize rising ketones before DKA becomes a medical emergency. Ketone information should always be interpreted in the context of glucose readings and symptoms.
The FDA’s authorization is based on a comprehensive review of clinical and performance data submitted by the device sponsor. The clinical program included data from six clinical studies that together enrolled more than 600 participants aged 2 years and older to evaluate the accuracy of the device’s ketone and glucose monitoring functionality across a range of ketone and glucose levels. The results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketone levels before the onset of diabetic ketoacidosis.
This authorization is also aligned with the FDA’s Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home.
Prior to authorization, the FDA granted Breakthrough Device designation for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System. A breakthrough designation is meant 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.
The FDA granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define requirements including those related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness.
###
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.