Artificial pancreas approved for use in patients 14 years and older

The FDA recently approved a device that automatically monitors glucose and provides appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. This is the first FDA-approved device of its kind.

Medtronic’s 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. Glucose levels are monitored every five minutes and insulin is automatically administered or withheld.

With this device, a sensor attaches under the skin to measure glucose levels and an insulin pump is strapped onto the body. An infusion patch connected to the pump delivers insulin via a catheter. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption.

“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 Jeffrey Shuren, MD, JD, 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.”

According to the CDC, approximately 5% of people with diabetes have type 1, which is typically diagnosed in children and young adults. Since the pancreas does not make insulin in those with type 1 diabetes, patients must consistently monitor their glucose levels throughout the day. Insulin therapy is typically administered via injection, insulin pen, or insulin pump. In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity.

“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, PhD, 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.”

As part of the approval process, the FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 123 participants with type 1 diabetes. The clinical trial involved an initial two-week period where the system’s hybrid closed loop was not used, followed by a three-month study during which trial participants used the system’s hybrid closed loop feature as frequently as possible.

Results showed the device is safe for use in people 14 years of age and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA), or severe hypoglycemia (low glucose levels) were reported during the study.

Risks associated with use of the system include hypoglycemia and hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is not intended for use in children 6 years of age or younger or in patients who require less than eight units of insulin per day.

As part of this approval, the FDA requires a post-market study to better understand how the device performs in real-world settings. Medtronic is also currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7 to 13 years old.

The MiniMed 670G hybrid closed looped system is manufactured by Medtronic, headquartered in Dublin, Ireland.