FDA Wants Artificial Pancreas Approval

An artificial pancreas, as commonly reported, is a medical device that is worn and attached to a person.  It autonomously changes the insulin administered to a person with diabetes in response to glucose measurements, which are measured automatically.

The system has a few basic components that include a continuous glucose monitor (CGM), a continuous subcutaneous insulin pump and a control system that determines the rate of insulin infusion given the measured glucose through time.  An artificial pancreas will also include a display, communication system, overrides, alarms, fail safes, and controls for user input (i.e., for indicating meals, exercise, etc).  However, the fundamental components are the three I mentioned.

Despite decades of research, the three basic components as a whole may not be ready for complete autonomous application.  Insulin pumps are quite reliable and control algorithms have reportedly been developed that effectively achieve a target range while avoiding hypoglycemia.  However, continuous measurement of blood glucose through current subcutaneous sensing technology has proven to be quite challenging .

That said, researchers are now entering what appears to be the final stretch to bring an artificial pancreas (or a system that at least reduces insulin in response to low glucose) to the FDA…. And, we want it:

Teenaged delegates from the Juvenile Diabetes Research Foundation testified on Capitol Hill, urging Congress to accelerate research and review of artificial pancreas systems for managing insulin for patients with type 1 diabetes.

“After participating in clinical research since I was three years old, I can honestly say the closed loop artificial pancreas trial was the most amazing experience of my entire life and holds so much promise for people living with this disease,” said Kerry Morgan, a 17-year-old JDRF Children’s Congress delegate from Glen Allen, Va., who testified before the Senate Committee on Homeland Security and Government Affairs this week.

Would you be surprised to learn that the FDA wants it too:

FDA WANTS APPROVAL, TOO

Charles “Chip” Zimliki, chairman of the U.S. Food and Drug Administration’s Artificial Pancreas Critical Path Initiative, which was created in 2006 to accelerate the availability of an artificial pancreas system, says he is eager to have a system approved.

“The FDA wants the artificial pancreas on the market as much as anyone else does. We just have to operate within U.S. laws to make sure it is safe and effective,” Zimliki said.

Last week, the agency released guidance for how to develop a low glucose suspend system, an automatic shut-off mechanism used with an insulin pump. Medtronic already sells pumps with this the feature in Europe. It safeguards against a dangerous drop in glucose levels by temporarily halting glucose delivery.

By year-end, FDA plans to release detailed guidance on more complicated closed-loop systems, Zimliki said.

“We think of this system, the artificial pancreas, as one unit. There is going to have to be agreement among various companies to determine who is the reporting party for submitting it,” he said.

“That is a relatively new idea with respect to these systems.”

Zimliki, who is a type 1 diabetic, thinks the first approved devices will be ones that deliver insulin only, but he is very encouraged by the system being developed by the team at Boston University and Massachusetts General.

“They have what I call the Cadillac of closed-loop systems,” he said. In addition to delivering insulin, the device also delivers an infusion of glucagon, a hormone released by the pancreas to raise blood sugar levels.

“They are showing some very promising results,” he said.

See the JDRF more more information on this project and the latest FDA guidance.

Diabetes Mine has an interesting post and interview with the principle investigators from Boston University and Massachusetts General Hospital (see the youtube video).