Medtronic, based in Dublin, Ireland, says it received U.S. Food and Drug Administration (FDA) approval for its MiniMed 670G hybrid closed-loop insulin delivery system. Dubbed one of the first artificial pancreas, the device automatically monitors blood glucose and administers appropriate basal insulin doses, for patients aged 14 years and older with type 1 diabetes.

The device both monitors and administers insulin. Image source: MedtronicThe MiniMed 670G responds to both low and high blood glucose levels. The system comprises a subcutaneously worn continuous glucose monitor that measures glucose levels every 5 minutes, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin. Users enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor; the device adjusts insulin levels.

The FDA evaluated data from a clinical trial 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 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, or severe hypoglycemia (low glucose levels) were reported during the study, the company says.