The U.S. Food and Drug Administration announced approval Wednesday of the first device to automatically monitor blood sugar levels and provide appropriate insulin doses. The Medtronics MiniMed 670G artificial pancreas is approved for people 14 years of age and older with type 1 diabetes.
The FDA is the first regulatory agency in the world to approve the device, manufactured by the Dublin company Medtronics. The Juvenile Diabetes Research Foundation (JDRF), which has invested more than $116 million in the past decade toward development of such a device, hailed the FDA action.
“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,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
The device is described as a hybrid closed-looped system that will adjust insulin levels with little or no input from users. It measures glucose levels every five minutes and provides insulin if needed. The system includes a sensor attached to the body, an insulin pump and an infusion patch with a catheter.
“While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate [meal] consumption,” the FDA said.
Approximately 5-10 percent of diabetes sufferers have the type 1 version of the disease, which typically is diagnosed in children and young adults, the Centers for Disease Control and Prevention has said. In all, some 29.1 million Americans have been diagnosed with both type 1 and type 2 diabetes, and an additional 8.1 million people may have the condition but have yet to be diagnosed.
The device was approved following the evaluation of clinical trial data involving 123 participants, who were able to keep their blood sugar levels within range 72 percent of the time compared to 67 percent without the system. At night, the device enabled participants to stay in range 75 percent of the time. HbA1c levels, which measures a type of hemoglobin that can provide a three-month average of glucose concentration, also improved, going from 7.4 percent to 6.9 percent by the end of the study.
No serious adverse events were recorded. Side effects included hypo- and hyperglycemia, and skin irritation or redness around the infusion patch. The device was found unsafe for children less than 6 years of age and in patients who take less than eight units of insulin a day.
“This is a fantastic step forward, but we are not done. JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology,” said Dr. Stuart Weinzimer of Yale University, a leading artificial pancreas researcher.
Dr. Aaron J. Kowalski, JDRF’s chief mission officer, said several other technologies are in the pipeline.
Follow-up real-world use studies have been ordered for the Medtronics unit. Clinical trials currently are underway for children 7-13.