The FDA today released a long-awaited draft guidance on the development and approval pathway for an "artificial pancreas" system for Type I diabetes.
The agency hopes to spur progress by providing flexible guidance and a clear path from feasibility studies to an outpatient study for the devices, which combine a continuous glucose monitor and an insulin pump to provide automatic moderation of blood sugar levels.
"We felt like it was a good idea to give academicians and people that aren’t familiar with the regulatory process at least a pathway to develop these systems and allow them to go forward," the FDA’s Artificial Pancreas Working Group & Critical Path Initiative leader Charles "Chip" Zimliki said during a conference call with reporters. "We didn’t want them just to study these things in the hospital – we wanted people to actually move this thing forward."
Zimliki personally emphasized the urgency in getting a safe and effective artificial pancreas system on the market.
"We’re very hopeful that this will happen sooner than later," he said. "As a person with Type I diabetes, I hope it happens tomorrow."
The guidance centers on a three-phase approach to clinical trials for getting devices into an outpatient settings as quickly as possible, while providing some wriggle room on how to get there. Since no device has yet gone through the regulatory process, the guidance leaves the door open for developers to study endpoints and design.
"We needed to have extreme flexibility because these devices systems haven’t been developed even worldwide," Zimliki said. "Because of the novelty of these devices and because of the fact that these device systems are continually being developed and changed and modified, we couldn’t be prescriptive in this guidance document. We really needed to have flexibility in this.
"What we’re trying to say is that we understand that there are probably many ways in which we can get a device approved, here’s our recommendations, but if you have other ways please come talk to us," he added.
Several organizations are already working on the devices, including Medtronic (NYSE:MDT) and the Mayo Clinic.
The FDA last month granted Medtronic’s MiniMed Paradigm system an investigational device exemption for the second phase of the Automation to Simulate Pancreatic Insulin Response trial, which will involve in-home study of its subjects (the trial’s first leg involved in-patient treatment).
The watchdog agency currently has 20 artificial pancreas systems with IDEs for study purposes, Zimliki said.
Researchers at the Mayo Clinic in Rochester, Minn., are also looking for ways to relieve diabetic patients of the need for frequent finger-pricks and insulin dosing. Mayo researchers Dr. Yogish Kudva and Dr. Ananda Basu studied how the mundane movements of everyday life affect blood sugar levels. Among the newest findings is that even basic physical activity after meals has a profound impact on blood sugar levels for people with Type I diabetes.
