FDA Approves the First Hybrid Artificial Pancreas
The U.S. Food and Drug Administration (FDA) yesterday approved the first so-called “artificial pancreas” – a device that monitors blood sugar and automatically delivers personalized insulin doses to people with type 1 diabetes.1 The breakthrough will “make a difference for people with diabetes—though they should be aware that it’s not a fully automatic system,” says endocrinologist Grazia Aleppo, MD, FACE, FACP, an EndocrineWeb editorial board member and associate chief for clinical affairs in the division of endocrinology, metabolism, and molecular medicine at Northwestern University in Chicago.2
The MiniMed 670G, developed by Medtronic,3 is a little larger than a pager and can be worn on a belt. It checks glucose levels every five minutes via a sensor attached to the skin and delivers insulin through a pump and infusion patch. The dose is customized to a user’s personal needs – and can shut off if glucose levels fall too low, reducing risk for potentially life-threatening hypoglycemia at night.4
Technically, the MiniMed 670G “isn’t an artificial pancreas,” says Robert Gabbay, MD, PhD, chief medical officer at the Joslin Diabetes Center in Boston.5 “You can’t just set it up and stop thinking about your glucose levels,” Dr. Gabbay says. “Future systems may do that. This one is a breakthrough because it brings us closer to that.” Called the world’s first “hybrid closed loop system,” it automatically delivers tiny insulin doses around the clock that are, for the most part, preset by a user and his or her doctor. At meals, however, a user must enter information about the carbohydrate count of the food they’re about to eat, approve an insulin dose and push a button for delivery.
The device was approved on September 28 by the FDA for teens and adults age 14 and older with type 1 diabetes; Medtronic is now studying it in younger kids. The company expects to begin selling it in the spring of 2017. One hint at price: Medtronic is making it available to users of an earlier version, the MiniMed 630G, for $799 minus a $500 trade-in of the older model.6
A trial presented at the American Diabetes Association’s scientific sessions in June suggests the MiniMed 670G can improve blood sugar control with fewer highs and lows. When 123 teens and adults with type 1 diabetes wore the artificial pancreas for three months, their blood sugar went high (over 180 mg/dl) 24.5% of the time versus 27.4% of the time with their previous systems. Episodes of low blood sugar were shorter and less frequent during the day and at night, reported lead researcher Richard Bergenstal, MD, executive director and a research clinician at the International Diabetes Center at Park Nicollet Methodist Hospital, in St Louis Park, Minnesota.7 No diabetic ketoacidosis, severe hypoglycemia, or serious device-related adverse events occurred and 99 study participants opted to keep using the device after the trial ended.
“Everyone wants less hyperglycemia, which raises risk for diabetic complications, and fewer episodes of hypoglycemia, especially overnight when they can be very dangerous,” Dr. Aleppo says. “Systems like this appear to help.”
One participant in that study was Les Hazelton,8 60, of Minnetonka, MN. The creative director for an advertising agency and an avid bicyclist, Hazelton says the MiniMed 670G has helped him keep his blood sugar inside a healthy range more often despite work stress and the often tough-to-control effects of exercise on glucose levels. “I can track my glucose levels closely, make connections with what’s happening in my life, and see how the continuous mini-boluses of insulin help,” he says. “It was mind-blowing.”
Dr. Aleppo notes that the FDA’s relatively quick OK —six months earlier than expected—is also very encouraging. “We’re happy that the FDA is embracing new technology for diabetes control in a faster fashion than perhaps the agency did in the past,” she told EndocrineWeb. “There are several closed-loop systems in development right now that are fully automated and can provide bolus doses of insulin for meals as well as basal insulin around the clock. It’s good to see the FDA moving toward acceptance of cutting-edge tools that can make a big difference in people’s lives.”
The FDA called the pump system a breakthrough. “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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.9
In addition to entering data about their next meal, users will have some housekeeping to do. This includes changing the sensors as directed. “Patients will also need to perform finger-stick glucose checks for calibration of the device,” notes the American Diabetes Association in a statement released to EndocrineWeb on September 28. 10
"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, in a statement to the press.11 "We appreciate the unprecedented speed by which the agency approved our PMA [premarket approval application] submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy."