FDA Approves First-of-its-Kind Insulin Delivery Device for Type 1 Diabetes
The Food and Drug Administration (FDA) has approved Medtronic's MiniMed 670G hybrid closed looped system, the first device intended to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged ≥14 years with type 1 diabetes.
The MiniMed 670G hybrid closed looped system, referred to as an "artificial pancreas" adjusts insulin levels with little or no interaction from the user. It measures glucose levels every 5 minutes and automatically administers or withholds insulin. The system consists of a sensor attached to the body that measures glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin.
Although the system automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption.
The approval was based on data from a clinical trial (n=123) of patients with type 1 diabetes. The hybrid closed loop system was not used during the initial 2-week period but then was used as frequently as possible during the 3-month study period. The device was shown to be safe for use in patients ≥14 years with type 1 diabetes. In addition, no serious adverse events, diabetic ketoacidosis or severe hypoglycemia were reported during the study.
The FDA is requiring a postmarketing study to evaluate the system's performance in real-world settings. The Company is currently conducting studies to evaluate its safety and efficacy in children with diabetes aged 7–13 years.
For more information call (800) 633-8766 or visit Medtronic.com.