HURDLES TO AN ARTIFICIAL PANCREAS

As with the development of any new medical technology, the process by which an artificial pancreas system ultimately arrives in the marketplace is a long, arduous one.

To say it’s a challenge to duplicate the complex, glucose-regulating function of the pancreas is an understatement. And the effort is further complicated by the many biologic and behavioral factors that affect diabetes management, as well as present-day limitations of devices that are components of the systems being developed.

Still, the potential of automated blood glucose control has bioengineers, doctors, and scientists across the globe racing to develop a viable system. Here are some of the hurdles that need to be overcome to reach the finish line:

Insulin and glucagon formulas
The insulin that is currently being used in artificial pancreas delivery systems takes hours to completely absorb, plus absorption rates can vary among patients as well as for the same patient throughout the day. Consequently, when the artificial pancreas system calculates insulin doses from sensor readings, these readings lag behind the actual fluctuations in blood glucose. Creating a mathematical model (control algorithm) that allows the system’s CGM to take these factors into account is difficult. Therefore, the development of a faster-acting insulin would help mitigate these variables.

Also, outside of research studies, currently there is no FDA-approved synthetic glucagon formula that can be used in prototype artificial pancreas systems; glucagon is the hormone whose purpose is to counteract low blood sugar (hypoglycemia) episodes. The current man-made glucagon is in powdered form and must be dissolved in water before being injected or infused. And, once dissolved, it cannot be kept for long periods in a portable pump. Thus, there is a need for a glucagon formulation that is stable over several days and can be delivered by an infusion pump.

Device integration
A number of different manufacturers create the medical devices that make up the artificial pancreas systems under development, each with their own proprietary device programming and data communications protocols. In order for the artificial pancreas systems to work across multiple manufacturer and device platforms, leaders in the field agree that communications standards must be developed and adopted to ensure integration and functionality amongst varied devices.

Regulatory hurdles
Like any other new medical technology, the artificial pancreas is subject to the U.S. Food and Drug Administration’s (FDA) exhaustive review and approval process. And while estimates suggest that delivery of an artificial pancreas is anywhere from five to 10 years away, it is a testament to the potential value of the technology that the FDA has actively advanced the process, prioritizing its review of artificial pancreas research protocol studies, providing clear guidelines to help advance projects through each stage of approval, setting performance and safety standards, and facilitating interactions between government and private researchers to expedite research and development efforts.

Costly...or not?
One of the biggest question marks surrounding the artificial pancreas is what the system’s cost will be once it is commercially available...and whether or not it will be covered by health insurance. For most patients, the costs of continuous glucose monitors alone can be prohibitive, and not all insurance plans cover the device, including Medicare. Some argue that while it’s expected to cost thousands of dollars, the artificial pancreas could prevent costly complications. Others suggest a large part of technology’s value is how it can ease the burden and fear experienced by patients faced with managing their diabetes hour by hour, day by day, every day.

Whatever the hurdles, there’s no denying that those with type 1 diabetes are awaiting the availability with great anticipation...and hope.