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The U.S. Food and Drug Administration unveiled its eagerly awaited Draft Guidance document for research and development of the Artificial Pancreas system, and initial reaction from JDRF — in a press conference held yesterday afternoon — was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.”
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.”
YAY!!!
It’s important for parents of kids with type 1 diabetes to realize that trials on children with diabetes aren’t a huge deal, as assuming the AP is approved for adults, any doctor can prescribe it legally to children with diabetes. Getting a formal approval in kids with diabetes is more of a formality unless your endo/primary care doctor doesn’t prescribe anything off-label.
This is a yawner… We are already using the technology and equipment we have to act as an artificial pancreas. Come on everyone, we need a cure not a moneymaking device that we can wear and “forget” about. This is a conglomeration of treatment devices that will earn manufacturers big $. JDRF should spend time and money working to cure, not treat diabetes. But, a cure is not a money maker, so don’t hold your breath.
Speak for your self! My cousins sin has type1 and ehlie they along with the rest of my family want nothing more then a cure for this disease but we also realize how important this is and how much closer this is to a cure
@Scott S, while endo’s can prescribe off label and CWDs can use getting insurance to cover is a whole other and equally critical issue. FDA approval those under 18 is a must for those of us who are fighting for the AP to work for kids!
@Steve, JDRF and many others are working on the cure. The AP and the cure are not mutually exclusive. We should make the most of technology until the cure comes.
To follow-up… This device is not one bit closer to a cure. JDRF knows a cure is the end of the JDRF. That’s why they concentrate on Treatments $$$ not a Cure. Wake up!
@Steve I’m sure every board member and employee of the JDRF has a personal connection to a person with T1. To suggest they are working for purely monetary gains is offensive.
As a T1 for 26 years, I’m hopeful for every step forward, whether that’s smart insulin, an artificial pancreas or a possible vaccine that could slow the immune system enough to allow beta cell regeneration, I’ll continue to support the JDRF.
The JDRF lost me when they decided to get into the device business with Animas. Ever since that date, they have done nothing but steer the FDA toward an easier path for their JDRF/Animas device. Pay attention to the wording they want changed in the FDA’s draft guidance. It applies to “subsequent” systems and making the path easier for approval. Basically, they know that Medtronic is YEARS closer to the AP. The JDRF wants the FDA to allow their product a less stringent criteria based on the fact that they only need to prove they are comparable to the MDT product. It’s all about the almighty dollar on this one. Don’t believe me? What about the fact that when Medtronic announced the approval of the in-home clinical trials, the JDRF barely acknowledged this milestone. Instead, they took the opportunity to spin it to their agenda citing that this innovation is what the FDA was preventing. Preventing? How is the FDA preventing innovation when they approved the Medtronic trial. If JDRF truly believed in the innovation of the first product as much as their own vested interest product, they would have made a big deal about the trials. Instead, they promoted their own agenda….their own product….because they want the revenue from it. Sad but true.
[...] when trials get underway, but they’re ”cautiously optimistic.” Joshua Levy and Amy Tendrich have great [...]
Does a Batman utility belt also come with this contraption?
The JDRF is a joke and have lost my family as donors years ago. They (JDRF) have shifted their mission from a cure to maintenance so this AP is a disgrace. If you look at the illustration above how can you tell anyone this is a breakthrough and improve quality of life? I guess if you play sports you will need 30 minutes just to unplug!
Brewer is somehow convinced this AP would have prevented the incident with his own son and that’s why he is such a personal advocate… It must be nice to spend money donated for a ‘cure’ on your own personal mission.
The JDRF is like a NFP art museum, they brag about everything they have ‘hanging on the walls’ and you can look, but don’t touch because none of it is useful to the onlooker.
But, if the JDRF can’t brag about the AP what else do they have? SmartInsulin is seemingly dead or moving slower than a snail. Encapsulation, same! ESC’s and transplantation of beta cells is a joke, as I can’t find one clinical trial using anything that could be commercialized.
So, at the end ot the day, the ‘transformative research’ train is nothing more than savvy marketing to dupe donors.
And please, stop saying this is close to a ‘cure’! If you don’t know what a cure means, go read a dictionary.