The US Food and Drug Administration (FDA) on Wednesday approved Medtronic’s artificial pancreas, known as the MiniMed 670G hybrid closed looped system, which is the first device approved in the US to automatically monitor glucose and provide appropriate basal insulin doses in people 14 and older with type 1 diabetes.
The system is intended to adjust insulin levels with little or no input from the user, and works by measuring glucose levels every five minutes and automatically administering or withholding insulin.
The device 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 (meal) consumption, FDA said.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, added: “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 US Centers for Disease Control and Prevention, approximately 5% of people with diabetes have type 1 diabetes. Because those with type 1 diabetes have a pancreas that does not make insulin, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels).
“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 CDRH. “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 involving 123 participants with type 1 diabetes, which included 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. This clinical trial showed that the device is safe for use in people 14 years of age and older with type 1 diabetes and 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 may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.
Medtronic has said that it will launch the new device in April 2017.
As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings. Medtronic is also performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7-13 years old.