By January 2015, we could be offered a choice of wearing a dual-chambered infusion pump that distributes both insulin and another medication like fast-acting glucagon or a meal-time infusion of Symlin.
Could be... that's the tentative timeline for a new device being developed as part of a partnership between the JDRF and Tandem Diabetes, maker of the Apple-esque t:slim insulin pump that debuted in 2012. On Tuesday, the two entities announced they've teamed up to create a novel, first-of-its kind dual-chambered pump.
The news release had little detail about the partnership, but did point out this dual hormone pump is aimed at accelerating the development of a fully automated Artificial Pancreas that could use multiple therapies in conjunction with insulin — to essentially "close the loop" and both monitor blood sugars with CGM (continuous glucose monitor) technology while also raising and lowering BGs as needed. A complete AP is system is still years off, but multiple clinical trials and research projects are underway and last year the FDA approved final R&D guidelines for these types of AP projects. This new JDRF-Tandem partnership is set to provide the next piece in that puzzle.
Nothing like this dual-chambered pump is currently on the market, although some researchers have been calling for this type of device for years. Having immediate pumping access to a substance that can actually raise your blood sugar alongside one that lowers it (insulin) seems so intuitively necessary... Double the diabetes management power! (and we all know double is good!)
The closest thing we're aware of in the works is Pancreum (former DiabetesMine Design Challenge winner), a modular three-part "wearable artificial pancreas" prototype that has a chamber for delivering glucagon alongside insulin. Back in 2011, its creator Gil de Paula said that gaining FDA approval for glucagon delivery in a pump was the biggest hurdle because were many unanswered questions -- although JDRF-funded research has made great strides in developing a stable glucagon formula in the last two years.
JDRF will support Tandem with a total of $3 million in "performance-based milestone funding" to develop the dual-chamber pump during the next 24 months, according to Tandem spokesman Steve Sabicer. He wasn't able to provide details on the specific milestones in question, and JDRF spokesman Bill Sorensen (a longtime type 1 himself) tells us that information is considered confidential company R&D info, and therefore isn't disclosed.
Why Tandem? Sorensen says the JDRF's board of directors explored the research field and looked at other potential partners for creating the dual-pump, but Tandem had the most potential and was the "furthest along" to warrant funding.
Not surprisingly, the dual-chambered pump may not be completed at the end of this two-year cycle or be ready for FDA submission, Sorensen said, as additional design time or even more funding may be needed. Progress will be evaluated along the way.
What might this dual-chamber pump look like?
Sabicer says, "We aren't prepared at the moment to discuss the particulars of the kinds of research, product design, or specifications of the hormones to be used in a dual-chamber infusion pump. It's simply too early to speculate on any of these details." He only noted that Tandem would retain all "intellectual property and product rights" from this funded program.
So, we might have to use our imaginations.... Or just ask an expert who has a better idea of what this pump might entail.
That's where D-Dad and Boston University researcher Ed Damiano comes in.
Last August, we told you about the work he and his team are doing to create a bionic pancreas. Well, he's been using a makeshift version of a dual-chambered pump based on today's existing technology — two t:slims that have insulin and pre-mixed glucagon inside, communicating via an iPhone 4 with a now-approved Dexcom G4 CGM sensor.
Since there is still no stable pre-mixed glucagon fully developed and FDA-approved at this time, Damiano has gotten regulatory OK for his investigational study to use Eli Lilly's existing glucagon formula, and just change the reservoir out every 27 hours to keep the glucagon fresh. Damiano's hoping the data from this study will help gain broader FDA approval for use of existing glucagon in a pump going forward, at least until a more stable version is ready.
Damiano's experimental combo device is enclosed in a plastic case and is about as thick as three iPhones, with a screen on both the front and back sides. It even has a slot to carry test strips! A special app calculates the algorithm and communicates wirelessly to the insulin pumps, and then also sends everything to the "iCloud," where all the data can be accessed and managed. Not to worry: for this round of experiments, the cellular and texting function is turned off on the phone, so users only have access to the pancreas app and can't possibly get mixed up with other phone functions.
Damiano says they received FDA-clearance Nov. 30, 2012 to use this new "mobile bionic pancreas platform" as an investigational device in a clinical study, which will begin by the end of this month and conclude in June 2013. This first study with their mobile device will involve 20 adults with type 1, each undergoing five days of closed-loop control. Previously, study participants were required to stay inside Massachusetts General Hospital -- but now they have the OK to allow the PWD participants to sleep in a hotel near the hospital and have access to a three-square mile area in downtown Boston (with an 11 p.m. curfew). In July and August, Damiano is planning to test this two-pump system on 32 kids at Camp Joslin and the Clara Barton Camp.
"This dual-pump system that we've built is a poor man's solution that uses current technology to do what a the dual-chamber pump of the future will do," he said. "You use the latest and greatest technologies now and continue to move the device-development forward, integrating more advanced and better technology as it becomes available."
Damiano says he's known this dual-chambered pump partnership has been in the works for a while, and he's "extremely excited" by this recent news that it's moving forward. He's traveling to California next week to meet with Tandem executives to discuss how to combine the dual-chamber pump with stable glucagon in his "bionic pancreas" system. He's hoping the real dual-chamber pump will be ready to replace his current homemade system by early 2014 (despite the two-year timeline of this JDRF/Tandem partnership), since that would be just in time for the next phase of his study.
Since the t:slim is the smallest traditional pump on the market right now with a 3mL insulin reservoir, he says that even a device that's slightly larger to accommodate a second chamber would likely be smaller than other existing pumps. With higher-concentration glucagon formulations being developed, Damiano thinks even a smaller chamber -- one-half or a third of the current size -- could be used in the dual-chamber pump and make it only a bit larger than the existing t:slim. Wow!
Of course, the physical designs are only one piece, and Damiano is eager to see how newer technology and medications will all come together to help realize the "closed-loop" dream we've all been hearing about for so long.
The three pillars are Dual Chamber Pump design, developing and getting FDA approval for a Stable Glucagon formula, and pulling all the tech together with more clinical study information showing results for PWDs. Huge efforts are now underway in all three arenas, along with improving CGM tech, fine-tuning algorithms and moving closer to faster-acting insulin.
"There are three different football games going on at the same time," Damiano says. "We're just going to keep pushing the ball down all three fields, and hopefully we'll all make it into the end zone together."