FDA approves MiniMed 670G system - the first Hybrid Closed Loop insulin delivery system to treat type 1 diabetes.-Medtronic

Medtronic plc announced it has received FDA approval of its MiniMed 670G system - the first Hybrid Closed Loop insulin delivery system approved anywhere in the world. Featuring the company's most advanced algorithm - SmartGuard HCL - the system is the latest innovation in Medtronic's phased approach toward developing a fully automated, closed loop system.

"With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes - particularly for minimizing glucose variability and maximizing time in the target range," said Richard M. Bergenstal, M.D., principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis.

The MiniMed 670G system features the Guardian Sensor, Medtronic's newest and most advanced glucose sensor with enhanced accuracy and performance, and a longer 7-day life. The Guardian Sensor, the first and only sensor approved by the FDA to control a hybrid closed loop system, incorporates diagnostic technology that continuously monitors sensor health. Driven by the SmartGuard HCL, the system delivers a variable rate of insulin 24 hours a day based on the personalized needs of the patient, maximizing the time glucose levels are within the target range. It is designed to learn what an individual's insulin needs are and to take action to minimize both high and low glucose levels. As a result, the system requires minimal input - patients only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 123 participants with type 1 diabetes. The clinical trial included an initial two-week period where the system�s hybrid closed loop was not used followed by a three-month study during which trial participants used the system�s hybrid closed loop feature as frequently as possible. This clinical trial showed that the device is safe for use in people 14 years of age and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia (low glucose levels) were reported during the study.