Timothy S. Bailey, MD, FACE, FACP, CPI
The artificial pancreas is coming! Medical device makers have been making that promise for 30 years, but this time it appears certain.
“The road to the artificial pancreas started in the early 1990s and, finally, early products are available with others poised to enter the marketplace,” said Timothy S. Bailey, MD, FACE, FACP, CPI, President and CEO of Advance Metabolic Care and Research, a clinical trial site in Escondido, CA, with long-term experience testing diabetes technology.
There’s also new data on artificial pancreas systems in new populations and new settings.
“What I’m really excited about are some of the recently published trials in pregnancy and in hospitalized patients,” said Jennifer B. Green, MD, MPH, Professor of Medicine, Endocrinology, Metabolism, and Nutrition at the Duke University School of Medicine. “We also have new advances in system components (sensors, pumps, and algorithms) and new data about bihormonal therapy, insulin plus glucagon, delivered through an artificial pancreas system.”
Jennifer B. Green, MD, MPH
Dr. Bailey and Dr. Green will examine the rapidly evolving landscape of artificial pancreas systems during the Sunday symposium On the Road to Automated Insulin Delivery (AID), which will begin at 4:30 p.m. in N-Hall E (North, Exhibition Level).
One of the key developments was the acceptance of collaborative devices by manufacturers, patients, and regulators at the U.S. Food and Drug Administration (FDA). The traditional model involves a single manufacturer producing all three components of an artificial pancreas system. A more sophisticated model is needed to combine the best available components from different manufacturers into a single artificial pancreas device, Dr. Bailey said.
“The FDA is very supportive of this collaborative framework, so things are moving forward,” he said. “Now if you want to change out the continuous glucose monitor (CGM), all you have to do is demonstrate that the new CGM is of the same caliber or better than the old component. We now have elements of standardization that allow different components to play together in a single device.”
This altered approach has been driven in part by the very public success of the Loop Community, a loose coalition of do-it-yourself developers who have created functional, but unapproved, artificial pancreas systems. Another driver is the growing body of clinical trial evidence supporting the development and use of artificial pancreas systems.
“We now have published meta-analyses providing a big picture view of the benefits of artificial pancreas therapy compared to more traditional therapies for type 1 diabetes,” Dr. Green said. “And we have data on user acceptance, which is critically important for successful treatment.”
Some of the most useful artificial pancreas data may be yet to come from four projects sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
“One challenge in the artificial pancreas space is that outcomes measures are fairly heterogeneous from one study to the next,” Dr. Green said. “The NIDDK initiative is geared to introduce some consistency in the way trials are conducted and the ways the benefits of artificial pancreas treatment are reported, which makes it easier to compare outcomes across trials.”
Regulatory authorities are bringing similar consistency to the device approval process. The FDA is looking to performance standards in areas such as accuracy, reliability, and security.
“To change the FDA, persistent collaboration and education is needed,” Dr. Bailey said. “Pushing the envelope requires a lot of data to be generated and to prove both safety and efficacy.”
The reality is that artificial pancreas systems are here and they work, he added. And they have the potential to improve the quality of glycemic control and reduce burden in people with diabetes.
“To move forward, we have to continue to improve system performance and safety,” Dr. Bailey said.
