Medtronic has started enrolling US patients for Enlite Sensor investigational device exemption (IDE) study for Continuous Glucose Monitoring (CGM).
The multi-center, prospective, randomized study is designed to assess the performance of the Enlite Sensor in patients with diabetes during a calibration and wear period totaling 146 hours (six days).
The primary endpoint will be sensor accuracy with the minimum calibration requirements (every 12 hours after the second calibration).
Medtronic Diabetes business Global Clinical Affairs CMO and vice president Francine Kaufman said the Enlite sensor is designed to provide improved hypoglycemia detection and better overall system accuracy.
"The study will demonstrate whether these improvements, combined with our system’s ability to predict when hypoglycemic events will occur through predictive alerts, can help people with diabetes achieve better glucose control," Kaufman said.