Leading experts from industry, academia, and government came together in early April in Bethesda, MD, to discuss innovation in the development of an artificial pancreas at a workshop hosted by the National Institutes of Health, the Food and Drug Administration (FDA), and JDRF. Artificial pancreas systems will automate insulin delivery and likely other hormones in the future. These systems will reduce high and low blood-sugar levels while simultaneously lessening the burden of managing type 1 diabetes (T1D).
The workshop took a comprehensive approach to developing an artificial pancreas system and bringing it to market—research scientists presented their latest findings from laboratory work and clinical trials, industry investigators highlighted state-of-the-art advancements in technology, and government officials laid out the opportunities and challenges of commercialization. Topics included everything from new device designs and approaches to optimize artificial pancreas systems, to improving insulin hormone replacement and ways to accelerate device production.
Leading the Way
Bruce Buckingham, M.D., a JDRF-funded professor of pediatrics at Stanford School of Medicine, presented his study of reducing overnight incidences of hypoglycemia using a system that suspends insulin delivery when it senses falling blood-glucose levels. Nocturnal hypoglycemia is a serious issue for people with T1D because if left untreated, it can cause convulsions, coma, or even death.
Dr. Buckingham has tested this low glucose suspend system in people with T1D in an outpatient setting and has more than 1,400 nights of data. “This is a way to prevent people from getting low overnight or at least from having a sustained low that is going to result in a bad event. It’s a safety feature that is easy to implement and has very little downside. The system is used without remote monitoring, without a nurse at your bedside, and it’s preventing lows,” Buckingham said. “It’s allowing [people with T1D and their families] to sleep at night. Everyone wants to use it because they are getting a decent night’s sleep.”
Roman Hovorka, Ph.D., director of research in the department of pediatrics at the University of Cambridge, who is also supported by JDRF funding, shared successful results from a recent outpatient clinical trial of the artificial pancreas system that was used in children and adolescents overnight. Using unsupervised home studies that lasted an average of one week, Dr. Hovorka found that blood-glucose levels remained in healthy targeted ranges and that participants found the technology easy to use. “The whole field is moving toward testing these closed-loop systems at home and getting closer to [commercialization of] products,” Hovorka said.
Edward Damiano, Ph.D., assistant professor of biomedical engineering at Boston University, shared his lab’s success with a bihormonal artificial pancreas system that automatically makes a new decision about insulin and glucagon dosing every five minutes, and addressed the timeline of bringing an artificial pancreas to market. “We are moving very quickly. We have a device that needs to be tested, and we are very encouraged by the results,” Damiano said. “The technology we have is going to be transformative, but to do that we need to test it in a sufficient number of people and circumstances. We want to move as quickly as we can, but not so quickly that we compromise what gets out there—the entire initiative could be at stake.”
The Regulatory Perspective
Arleen Pinkos, scientific reviewer at the FDA, addressed the regulatory challenges of making the artificial pancreas commercially available. Pinkos emphasized that the challenge lies in labeling the device—it has to be easy to understand, with concise yet comprehensive directions. “If the user thoroughly understands the limits of the system, that helps mitigate risk and tips the balance in a favorable direction [for approval],” Pinkos said. “We want data. We want perspective from the patients and from the clinicians.”
Cynthia Rice, JDRF’s senior vice president of advocacy and policy, commented, “The Artificial Pancreas Project is a tremendous example of how JDRF has the unique ability to drive therapies from the early stage of research through the development process to people with type 1 diabetes.”
Other key presenters included Boris Kovatchev, Ph.D., director of the University of Virginia Center for Diabetes Technology, who spoke about the mobile platform of artificial pancreas systems and how it operates; Kenneth Ward, M.D., director of diabetes research at Legacy Research Institute, who shared with participants the development of an “intelligent” catheter that combines hormone delivery with glucose sensing; and Steve Prestrelski, Ph.D., CEO and chief scientific officer at Xeris Pharmaceuticals, who shed light on novel glucagon formulations being developed for possible use in artificial pancreas systems.
In total, more than 40 presenters shared key findings in their field with the 175-person-strong audience. “There is a pressing unmet medical need for better ways to manage type 1 diabetes and ultimately reduce the burden. But incredible progress has been made on developing an artificial pancreas system—we have a tool that could potentially transform diabetes,” said Aaron Kowalski, Ph.D., vice president of treat therapies at JDRF. “The ultimate goal is to get these devices into the hands of people with type 1 diabetes to ease the burden of living with this disease.”