Hybrid Closed Loop Insulin Delivery System approved for marketing
Recently, the innovative product Hybrid Closed Loop Insulin Delivery System ( MiniMed 670G BLE) of Medtronic MiniMed is approved by China NMPA.
The MiniMed670G BLE consists of insulin pump kit, transmitter kit and glucose sensor. It possesses two core technologies: one is the hybrid closed-loop algorithm used in auto mode; the other is the electrochemical impedance spectroscopy technology used to check the state of the sensor, which can ensure that the glucose sensor has sufficient accuracy.
The product continuously monitors the trend of glucose concentration in subcutaneous interstitial fluid through the glucose sensor worn by the patients. According to the received dynamic glucose monitoring results, the hybrid closed loop insulin pump can continuously deliver basal insulin (rates selectable by user) and boluses (amounts selectable by user) for the management of type 1 diabetes mellitus in patients 14 years of age and older. Through the SmartGuard technology, the basal insulin delivery can be automatically adjusted according to the continuous glucose monitoring results, ensuring round-the-clock blood glucose control and facilitating the life of patients with diabetes.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.