Yale researchers are partnering with colleagues across the United States and around the world to test devices known as the “artificial pancreas,” the last step before requesting regulatory approval for permanent use. “A successful artificial pancreas would be a life-changing advance for many people with type 1 diabetes,” the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) said in a press release issued last week.
The artificial pancreas is an integrated system that monitors blood glucose levels automatically and provides insulin or a combination of insulin and a second hormone. The closed-loop system replaces reliance on testing by fingerstick or continuous glucose monitoring systems and separate, non-integrated delivery of insulin by shots or a pump. Four separate trials are underway, and Yale is participating in two of them.
The artificial pancreas has been in development for more than 10 years and in 2015 it was tested on a group of teenagers in a trial at Yale led by Stuart A, Weinzimer, M.D., professor of pediatrics. Five teens wore the device over four days, the first test outside a hospital. It was also tested at Stanford University and the Barbara Davis Center for Childhood Diabetes in Denver. Weinzimer will lead two trials at Yale that are part of the international project.
The device tested at Yale in 2015 consists of a sensor worn under clothing that transmits blood glucose readings every five minutes to a smartphone. The phone, in turn, tells an insulin pump, also worn under clothing, when and how much insulin to deliver.
“These devices, which consist of an insulin pump, a continuous glucose sensor, and a control algorithm, enable a person with type 1 diabetes to have better control of his/her blood sugars, because the systems will automatically adjust the delivery of insulin all the time, with minimal user intervention,” Weinzimer said. “We hope to include up to 50 volunteers between these two studies over the next 1-2 years to show that these devices are safe, well-tolerated, and effective in improving blood sugar levels in children with type 1 diabetes.”
In 2016, the U.S. Food and Drug Administration approved a hybrid model of an artificial pancreas, an automated system that requires users to adjust insulin intake at mealtimes. A fully automated system will sense rising glucose levels, including at mealtimes, and adjust insulin automatically.
In addition to easing the burden of management for people with type 1 diabetes or their caregivers, in shorter studies, the devices brought glucose levels closer to normal than traditional management. NIH research has found that early, tight control of blood glucose helps reduce diabetes complications including nerve, eye and kidney diseases.
The four research projects beginning in 2017-2018 will be conducted in larger groups over longer periods of time and in largely unrestricted conditions. The participants will live at home and monitor themselves, going about their normal lives, with remote monitoring by study staff. The studies will take place at various sites in the United States, and in France, Germany, Holland, Israel, Italy, Slovenia, and the United Kingdom.
The studies will look at safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. The Jaeb Center for Health Research in Tampa, Florida, will serve as coordinating center. The trials are:
- The International Diabetes Closed-Loop trial, at the University of Virginia in Charlottesville, will test an automated insulin delivery system called inControl. The trial, which uses smartphones, will follow 240 people age 14 and up with type 1 diabetes for six months.
- A full-year trial of an artificial pancreas for youth aged 6-18 will begin this year at the University of Cambridge in England. The study seeks to enroll 130 youth for a full year of use of an artificial pancreas system that uses a smartphone as one component.
- Starting in late 2017, the International Diabetes Center, Minneapolis, and Moshe Phillip of Schneider Children's Medical Center, Petah Tikva, Israel, will compare the FDA-approved hybrid artificial pancreas to a next-generation system, programmed to further improve glucose control, particularly around mealtime.
- In mid-2018, a study at the Massachusetts General Hospital in Boston and Boston University will test a bihormonal “bionic pancreas” system, with a dual-chamber pump to deliver both insulin and its counteracting hormone, glucagon, using tested algorithms for automated dual-hormone delivery.