Largest Clinical Trials of Artificial Pancreas to Begin This Year

The largest long-term clinical trials involving a so-called “artificial pancreas” to regulate blood sugar levels of persons with type 1 diabetes will take place this year in the United States in Europe, involving 240 patients and 9 different sites, according to a report from Harvard, which is one of the partners.

Funded by the National Institutes of Health (NIH), the undertaking involves teams at Harvard’s Paulson School of Engineering and Applied Science and the University of Virginia School of Medicine, which has been working on a system now licensed to TypeZero Technologies.

Technology that would allow persons with type 1 diabetes to be freed from the need to constantly monitor and adjust insulin delivery via pumps they wear under clothing has been in the works for years. While there have been steady improvements, patients do not quite see the "holy grail" of limited involvement that a true artificial pancreas would bring. There remain fears of hypoglycemic epidsodes during sleep and limitations during some high-intensity sports.

The UVA team will conduct the first trial with 240 patients, testing the safety and effectiveness of its control-to-range system compared with a standard insulin pump on 2 key measures: does the artificial pancreas do a better job of controlling blood sugar, and is the risk of hypoglycemia reduced? This trial will last 6 months.

“To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patient’s natural environment,” Boris Kovatchev, director of the UVA Center for Diabetes Technology, told the Harvard Gazette.

Kovatchev has offered updates on UVA’s progress toward the artificial pancreas at annual meetings of the American Diabetes Association, and said that at some point trials would have to progress beyond the controlled environs of UVA’s “diabetes house” to real-world settings.

Then, 180 of these patients will spend another 6 months completing a trial involving the adaptive control algorithm developed at Harvard by Frank Doyle, dean of the Paulson School. This is based on a strategy Doyle developed that allows for the uncertainty in the human body and regulates the body to stay within a blood sugar range, rather than a fixed point.

Researchers hope that gathering months’ worth of data will allow them to see patterns develop that will allow them to improve the algorithm to allow for different levels of stress, hormonal changes, and periods of anxiety that are all part of life.

The UVA/Harvard award, worth $12.7 million, is the biggest piece of a $20 million program that NIH announced in 2014 to speed development of an artificial pancreas system. The purpose of the program is to advance technology that can pass muster with FDA and other international regulatory agencies. Boston University/Massachusetts General Hospital has also received funding for its project.

The fact that so many competing projects are in the pipeline is considered good news for advocates for persons with diabetes, because it is believed that competing technologies will give patients choices and hold prices in check. A lingering question, however, is whether insurers will cover artificial pancreas technology once it achieves FDA approval. CMS will not cover continuous glucose monitoring that is considered standard care and covered by most commercial insurers.