The hidden value of the artificial pancreas

The hidden value of the artificial pancreas

Recently the FDA issued draft guidance for the artificial pancreas, according to the FDA’s web site “The FDA is helping advance the development of an artificial pancreas system — an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with type 1 diabetes.

FDA’s efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, provide the most flexible recommendations to guide Sponsors in designing and testing these devices that are consistent with the least burdensome principle to provide options while assuring that testing is adequate to support marketing approval, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten and streamline study and review time.”

As regular readers of Diabetic Investor know we have not always been a strong advocate of this project questioning  the many technological hurdles this system faces and wondering who will pay for what surly be a very expensive system.  Several well respected insulin pump researchers have also questioned the validity of this quest, while others in the diabetes community see this as one huge waste of time and money.

While Diabetic Investor remains skeptical on the project this does not mean the quest to develop an artificial pancreas will not yield several ancillary benefits that will help a greater percentage of the overall diabetes population. The first two most obvious benefits will come from the key components of the system, insulin pumps and continuous glucose monitors. While we have seen great advancements in both technologies the harsh reality is that as far as these systems have come over the years they still have several notable flaws.  The simple fact is these systems must get better if the artificial pancreas has any chance at all at becoming more than a dream. It should go without saying that insulin pump patients and patients who use a CGM will benefit from these improvements.

Yet, better and more reliable insulin pumps and CGMs won’t be the only beneficiaries of this quest. Given the volume of research surrounding the artificial pancreas and what these researchers are learning it’s also likely we could see better short-acting insulin’s, we’ll understand better the role glycemic variability plays in managing diabetes and most importantly we’ll learn more effective insulin dosing regimens. Truth be told while the artificial pancreas is really nothing more than a collection of devices working together the key isn’t just the devices that make up this system, the real key is gaining a deeper understanding of how insulin works.

Some may remember that many questioned America’s quest to go to the moon, why the country was spending all this money. Back then critics of the space program believed that even if the program was successful the average person would see no real benefit. Many of these critics believed America was spending billions for a program that was really nothing more than nationalistic pride campaign. That America was somehow inferior to Russia who had beat America into space and by being the first country to put a man on the moon we would once again feel good about ourselves. Basically these critics believed this race to the moon was nothing more than a very expensive propaganda program.

As it turned out this race to the moon yielded numerous innovations and advancements that we now take for granted.  Microwave technology and cellular communication systems are just two of the many technologies that came from the space program that have become commonplace in today’s society.

Considering that diabetes is growing at epidemic rates around the world and that diabetes is not just a healthcare but an economic crisis combined with the fact that we are still years more likely decades away from a cure, it is possible that the quest to develop an artificial pancreas will provide many notable side benefits that we’re not envisioned when this program first began.  The simple fact is with all the advancements that have been made with diabetes management over the years one fact has remained constant in that nearly two-thirds of all patients are not properly controlling their diabetes and this fact has devastating consequences.

Although Diabetic Investor remains somewhat skeptical that we will see a true artificial pancreas in our lifetime, we do believe that we will see much advancement in diabetes care that will come from this quest.  Better and more reliable insulin pumps and CGM systems are just the beginning. The simple fact is the more we know about insulin and how it works the better we can help the millions of patients following insulin therapy.

So while everyone gets all caught up in the technological aspect of this quest, it’s important to remember that this quest isn’t just about technology and is in reality a quest for more effective diabetes management and how could you argue with that?