Pivotal Trials Launch for 4 NIH-Funded Artificial Pancreas Projects

Four key projects to bring an “artificial pancreas” to those with type 1 diabetes (T1D) have reached the point of recruiting patients for pivotal trials, according to the National Institutes of Health (NIH), which is funding the efforts.

Projects at the University of Virginia, Charlottesville; Massachusetts General Hospital (MGH) in Boston; the International Diabetes Center in Minneapolis; and the University of Cambridge, England, are seeking patients. All but the MGH study will include teenagers, a group historically at risk for hypoglycemia as parents become less involved in self-care.

A true “artificial pancreas,” which would automatically monitor blood glucose levels and administer insulin without patient involvement, could be transformative for those who live with T1D. Today, these patients must constantly monitor blood glucose and adjust insulin doses and carbohydrate intake, to keep levels from rising too high or falling too low. Failure to do so can result in an event that lands a person with diabetes in the hospital.

Thus, this next round of studies, said Guillermo Arreaza-Rubin, MD, in the statement, “could change and save lives.” Arreaza-Rubin is the director of the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), the division of NIH funding the studies.

The 4 trials will test next-generation artificial pancreas designs with larger groups of patients over long periods of time, and in settings closer to real-world conditions. Early studies, which have shown the new devices do more to control blood glucose levels than traditional management, have taken place during summer camps or asked patients to live in hotels for a few weeks. Test-driving the new technology in unrestricted settings will likely be key to getting payers to cover new devices.

In September 2016, FDA approved Medtronic’s MiniMed 670G, the world’s first closed-loop hybrid insulin delivery system. While the 670G is a major advance, it still requires patients to adjust insulin doses at mealtimes. According to NIH, the goal of the next round of trials is to achieve a fully automated closed loop system, which “will sense rising glucose levels, including at mealtimes, and adjust insulin accordingly.”

According to NIH, the 4 projects reaching critical stages are:

• University of Virginia. Boris Kovatchev, PhD, and Stacey Anderson, MD, are now recruiting people with T1D to test the inControl system, which uses smartphone technology. Researchers will follow 240 people ages 14 and older for 6 months. Participants will come from 7 states and 3 foreign countries. After the first 6 months, 180 participants will continue with an evaluation of an alternate algorithm to manage insulin flow.
• Massachusetts General Hospital. Steven Russell of MGH and Ed Damiano of Boston University will enroll 312 people age 18 and older to test a “bionic pancreas” for 6 months. This device delivers both insulin and glucagon, using algorithms to deliver both. Participants will come from 8 sites across the United States.
• University of Cambridge. In early 2017, recruitment will start for 130 youth ages 6 to 18 for a full-year trial of an artificial pancreas system, which also uses a smartphone. Participants will be studied from sites in 4 US states and 2 sites in the United Kingdom.
• International Diabetes Center. Centers in Minneapolis and Schneider Children’s Center in Israel will compare the Medtronic MiniMed 670G to a next-generation system; 100 youth will test each system for 3 months, at 5 US sites and 3 sites in Israel, Germany, and Slovenia.

Advocates for people with T1D have long pointed to the diversity of competing “artificial pancreas” projects as a good sign for patients, who arguably will have choices and price competition if multiple systems gain FDA approval. However, there are other trends in managed care—including UnitedHealthcare’s 2016 decision to direct most adults with T1D to Medtronic technology—that are seen as limiting choice and innovation.

“For many people with type 1 diabetes, the realization of a successful, fully automated artificial pancreas is a dearly held dream. It signifies a life freer from nightly wake-up calls to check blood glucose or deliver insulin, a life freer from dangerous swings of blood glucose,” said NIDDK Director Griffin P. Rogers, MD, in a statement. “Nearly 100 years since the discovery of insulin, a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”