- On Wednesday, the Food and Drug Administration approved the first automated insulin delivery device for type 1 diabetes.
- Medtronic’s MiniMed 670G hybrid closed-loop system operates as an artificial pancreas, measuring glucose levels every five minutes and adjusting insulin levels up or down as needed.
- Of the more than 29 million people living in the U.S. with diabetes, about 5% have type 1 diabetes.
The FDA based its approval on a three-and-a-half month clinical trial of 123 people with type 1 diabetes. The results showed the system is safe in people ages 14 and older requiring eight or more insulin units per day.
Users will still need to manually request insulin doses to counter sugars consumed during meals. The approval requires Medtronic to perform a postmarket study to assess the system’s use in real-world situations. The company is also evaluating its safety and effectiveness in children seven to 13 years old.
Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said the agency worked closely with Medtronic from the earliest stages to speed evaluation and approval of the MiniMed device. He encouraged other companies to do the same.
Medtronic plans to begin rolling out the device next spring.
The MiniMed joins a growing array of smart medical devices that are revolutionizing the way people with chronic medical conditions live. But with increasing numbers of people attached to devices come concerns about potential hacking and patient safety. The FDA has identified cybersecurity and medical device big data as two of its top regulatory science priorities for 2017.