Medtronic

October FDA Update – Approval of Medtronic’s New Insulin Delivery System

William Salage

On September 28, 2016 the U.S. Food and Drug Administration (FDA) approved Medtronic’s new insulin delivery system for people with Type 1 diabetes, the MiniMed 670G hybrid closed looped system (MiniMed 670G). The MiniMed 670G consists of two major parts: (1) an insulin pump, and (2) a continuous glucose monitor. These two components were already approved by the FDA separately and are already on the market. The MiniMed 670G however combines these two components together with a new part, a program which communicates between the two devices. The MiniMed 670G is therefore the first device to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. Specifically, the MiniMed 670G predicts when a person’s blood sugar is dropping and prevents the low in the first place, and also corrects high blood sugars. However, users still need to manually request insulin doses to counter carbohydrate (meal) consumption

The implication of Medtronic’s new system is enormous for those with Type 1 diabetes. The new capabilities mean they can both sleep through the night without worrying about their blood sugars dropping too low and can go through their day without having to think about their diabetes all the time, according to Aaron Kowalski, chief mission officer for the JDRF, the organization that funds much of the “artificial pancreas” research.