Four major research projects to test and fine-tune several fully automated artificial pancreas systems are getting underway. The trials, which are being funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), are intended to be the potential last steps between evaluating the devices and requesting regulatory approval from the U.S. Food and Drug Administration (FDA).
In a person without diabetes, the pancreas releases insulin to keep blood sugar levels under control. In those with Type 1 diabetes, the insulin-producing beta cells of the pancreas have been destroyed by an autoimmune reaction and no longer produce insulin. The artificial pancreas is designed to automatically monitor blood sugar levels and release insulin or a combination of insulin and glucagon, a hormone that raises blood sugar levels, to keep the user in their target range.
Previous studies have evaluated artificial pancreas devices in short-term trials with varying levels of supervision, such as in children at a diabetes summer camp or in participants accompanied by a nurse staying within a few miles of the study site. The studies found that the devices kept blood sugar at levels closer to target than traditional diabetes management and additionally helped reduce the management burden for people with Type 1 diabetes and their caregivers.
In 2016, the FDA approved a hybrid closed-loop artificial pancreas system, which automatically monitors blood sugar levels and provides the appropriate background doses of insulin with little or no input from the user. The fully automated systems under review would additionally be able to adjust mealtime blood sugar levels.
The four trials getting underway in 2017–2018 would evaluate factors such as safety, effectiveness, user-friendliness, and cost of the devices. They will be conducted in larger groups and over longer periods of time than previous studies, and will be in generally unrestricted conditions, with participants being monitored remotely by researchers but otherwise going about their normal daily lives.
The four studies are as follows:
• The International Diabetes Closed-Loop trial, which is currently recruiting participants, will use smartphones and will evaluate 240 people with Type 1 diabetes ages 14 and up for six months. Another six-month trial will look at 180 participants from the first trial to test a different artificial pancreas algorithm. The initial study has sites in California, Colorado, Florida, Massachusetts, Minnesota, New York, and Virginia, as well as in France, Holland, and Italy. More information can be found on Clinicaltrials.gov at NCT02844517 and NCT02985866.
• Early in 2017, a trial will begin enrolling 130 youth ages 6–18 for a yearlong trial that uses a smartphone as one component of the artificial pancreas system. The study has sites in California, Colorado, Connecticut, Minnesota, and two locations in the United Kingdom. More information can be found on Clinicaltrials.gov at NCT02925299.
• In late 2017, a trial will begin recruiting 100 young adults with Type 1 diabetes ages 14–29 to compare the FDA-approved hybrid artificial pancreas system to a next-generation system that has been programmed to further improve blood sugar control, especially around mealtime. The study will be conducted in sites in California, Connecticut, Florida, Massachusetts, and Minnesota, as well as in Germany, Israel, and Slovenia. More information is available on Clinicaltrials.gov at NCT03040414.
• In mid-2018, a six-month trial will enroll 312 people with Type 1 diabetes ages 18 and older to evaluate a two-hormone “bionic pancreas” that will deliver both insulin and glucagon. The trial will take place in two sites in California as well as in Massachusetts, Michigan, Missouri, North Carolina, Ohio, and Washington. More information can be found at www.bionicpancreas.org.
“These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it,” notes Dr. Guillermo Arreaza-Rubín, director of NIDDK’s Diabetes Technology Program. “Results from these studies could change and save lives.”
For more information, see the NIH press release “Four pivotal NIH-funded artificial pancreas research efforts begin.” And to learn more about the iLet, one of the devices being evaluated in these trials, watch our interview with co-developer Steven J. Russell, MD, PhD.
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