Yesterday marks "a milestone" in the development of new technology to help automate the care and treatment of type 1 diabetes, according to JDRF!
The U.S. Food and Drug Administration unveiled its eagerly awaited Draft Guidance document for research and development of the Artificial Pancreas system, and initial reaction from JDRF — in a press conference held yesterday afternoon — was a mix of jubilation and a more measured response that they remain "guardedly optimistic" about the details until they've had time to review the 60-page document more thoroughly.
JDRF has been aggressively pursuing the AP since 2006. They've invested over $50 million and created a consortium of research sites around the world, working with leading device manufacturers and scientists to create the necessary algorithms.
"We feel the technology is ready for prime time. It's ready to transfer to patients, and FDA guidance is a critical component in being able to take this technology from a clinical setting to studies in the real world," said Aaron Kowalski, head of the JDRF's Artificial Pancreas Project. "It's a milestone event, that the FDA has gone on record with a point of view... that allows us to test and deliver these systems in a reasonable amount of time."
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Of course, the actual timeline for the first commercial Artificial Pancreas to be available for sale is anybody's guess. But JDRF is "initially very encouraged" that the new guidelines "will allow a quick transition to the real world," said JDRF CEO Jeffrey Brewer, who's also been a huge personal advocate for improved diabetes devices.
Jeffrey and Aaron both emphasized that they'd only had the document in their hands a few hours, but on first glance, what looks encouraging to them is:
- FDA seems to have made "strong moves to listen to researchers' concerns"
- "There's a good deal of flexibility embedded in the document," for example on the types of patients who could participate in trials, and on "study endpoints" such as not using A1C results as the only indication of results (it's about less hypo and hyperglycemia in the daily lives of patients, after all!)
- Allowing for the use of CGM data to gauge study results — as opposed to requiring patients in home-based studies to wake up repeatedly overnight to perform fingerstick tests, or wear some sort of IV all night (ugh!)
- Flexibility also seems to be built in around how the various components will interact. For example, if researchers have to swap out a meter model, ideally they wouldn't have to scrap the current study and begin all over again.
These provisions represent "a big step forward in (making) these studies realistic to conduct in the real world," Aaron said.
Some interesting questions that surfaced in the press conference:
How does this FDA guidance differ from similar AP-related guidance issued earlier this year?
"That first guidance was on the low glucose suspend (LGS) function only, whereas this new one is a roadmap to the first-ever systems that will automatically dose insulin. This is more forward-looking...
"Low glucose suspend is already available around the world, used by thousands of people. In the U.S., the FDA was not requesting the right clinical trials."
Aaron added that JDRF continues to lobby the FDA, and that guidance is not finalized yet. "I think we will have access soon to this life-saving technology," he said.
How might the FDA deal with the issue of "mix and match components" in an AP system?
"Clearly, more flexibility is good for patients," Aaron said, simply adding that JDRF hopes FDA will "be reasonable" on this consideration.
This guidance seems to be aimed at the adult population. When might FDA allow patients under the age of 18 to participate in clinical trials?
Of course, the JDRF guys couldn't answer that, but emphasized how anxious they are to make this life-saving technology available to their young constituents!
"In the last month, the first outpatient trials of closed loop systems in Europe have been completed. The data shows significantly better outcomes for patients — less high blood glucose and less low blood glucose... the potential is very big, and this is an important step to provide this system to patients," Aaron said.
"This is an opportunity to get the U.S. back in line with the rest of the world."