FDA www.fda.gov has approved Medtronic’s MiniMed 670G hybrid closed looped system. This is the first FDA approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses to people 14 years old or older with type 1 diabetes.
The MiniMed 670G hybrid closed looped system often referred to as an artificial pancreas, is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administers or withholds insulin.
The system includes a sensor that attaches to the body to measure 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. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption.
FDA worked interactively with Medtronic www.medtronicdiabetes.com headquartered in Dublin Ireland to make this technology available to people as quickly as possible,” said Alberto Gutierrez PhD, Director of the Office of In-Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.
FDA evaluated data from a clinical trial of the device 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 where the 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 or older with type 1 diabetes. No serious adverse events such as diabetic ketoacidosis or severe hypoglycemia were reported during the study.
As part of this approval, FDA is requiring a post market study to better understand how the device performs in real-world settings. While the device is being approved for people 14 and older, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7 to 13 years old.