FDA Approves First Hybrid Artificial Pancreas
A brand-new “artificial pancreas” that automatically checks glucose levels and delivers customized insulin doses to people with type 1 diabetes has won approval from the U.S. Food and Drug Administration (FDA). Device manufacturer Medtronic says the MiniMed 670G should be on the market by the spring of 2017. Diabetic Lifestyle editorial advisory board member Grazia Aleppo, MD, FACE, FACP, says it can help protect against dangerous blood-sugar highs and lows—but she notes that the device isn’t fully automatic.1
“It’s a breakthrough that will make a difference, but people with diabetes should know that this is a hybrid system,” explains Dr. Aleppo, associate professor of medicine and associate chief for clinical affairs at the division of endocrinology, metabolism, and molecular medicine at Northwestern University in Chicago. “It delivers insulin doses throughout the day and can make adjustments, such as if glucose levels drop. But at meals, a user has to input information about carbohydrates. The pump recommends an insulin dose and the user pushes a button on the insulin pump to deliver the pre meal bolus dose.”
The FDA approved the MiniMed 670G on September 28 for teens and adults age 14 and older with type 1 diabetes.2 (The company is now studying it in younger children.) Just a little bigger than a pager, the device can be worn on a belt. It checks glucose levels every five minutes via a sensor attached to the skin and delivers insulin doses via an infusion patch. A constant dose is customized to a user’s personal needs. Technically, the MiniMed 670G is called a “hybrid closed loop system” that takes care of background insulin levels, but users have to step in for mealtime doses.
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.3
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. One study participant, Les Hazelton of Minnetonka, MN, told Diabetic Lifestyle using the pump has been “mind-blowing.” 4 “I can track my glucose levels throughout the day and have much better control,” he told DiabeticLifestyle. “One benefit has been that my wife and my two children don’t have to worry about me as much. I’ve always taken good care of my blood sugar, but it would trend high and low overnight. Lows can be very dangerous. Since I’ve started using this pump, I’ve had just two lows in the past year.”
In the study, 124 teens and adults with type 1 diabetes wore the artificial pancreas for three months. The result? Their blood sugar went high (over 180 mg/dl) less often —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 overnight, 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. No diabetic ketoacidosis, severe hypoglycemia, or serious device-related adverse events occurred, and 99 study participants (including Hazelton) opted to keep using the device after the trial ended.5 “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.”
Hazelton, 60, the creative director for an advertising agency, says the system has made controlling stress-related glucose surges easier. “I can see my glucose levels rising on the display screen. It also tells me how fast it’s rising. That way I can do something about it if I have to, but the continuous insulin doses help keep things in better control.” Hazelton, an avid bicyclist who logs 20-40 miles over the weekend, can also program customized insulin doses into the pump to keep his glucose steadier during exercise.
An advocate for young people with diabetes, Hazelton adds that the device is the leading edge for new technology that will do more to monitor glucose and adjust insulin doses automatically – acting more like a human pancreas. (In type 1 diabetes, the immune system attacks and disables the pancreas.) “If this system is helping me, think of what it could do for a child or teen with diabetes – and for the peace of mind of their families,” he says. “To grow up in good control for good health, and without as much stress about overnight lows if blood sugar falls too much will be a real blessing. I’m happy to be a guinea pig to help make that happen.”
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. 6
Dr. Aleppo notes that the FDA’s relatively fast approval is 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 DiabeticLifestyle. “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.”
In addition to entering data about their next meal, users will have some maintenance to do on a regular basis, such as changing the sensors and infusion sets as directed. But, the FDA’s approval signals its interest in new devices for people with diabetes, according to Robert Gabbay, MD, PhD, Chief Medical Officer at the Joslin Diabetes Center in Boston. “You can’t just set it up and this one isn’t technically an artificial pancreas – the Holy Grail will be a system that takes care of all your blood glucose needs on its own. This device is exciting because it’s the first and because it will help people.”
"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. "We appreciate the unprecedented speed by which the agency approved our PMA [premarket approval] 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."