FDA approves Medtronics’ ‘artificial pancreas’ for Type 1 diabetes

SILVER SPRING, Md. — The Food and Drug Administration this week approved a new device that can automatically monitor glucose levels and provide doses of basal insulin for patients 14 years and older with Type 1 diabetes. Medtronic’s MiniMed 670G hybrid closed loop system is often called an ‘artificial pancreas’ because of its ability to adjust insulin levels with little user input. 

 

"The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin." 

 

The device measures glucose levels every five minutes, automatically administering or withholding insulin. IT includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the patient’s body and an infusion patch connected to the pump with a catheter that delivers insulin. Though it automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption. 

 

"As part of our commitment to improving diabetes care, the FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with type 1 diabetes as quickly as possible," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA's evaluation and subsequent approval of novel devices that can make a difference for patients."

 

The FDA said it’s currently evaluating the device for use in patients aged 7 to 13 years through clinical trials.