There's always a fair amount of buzz and excitement whenever a "next-generation" diabetes device is announced, or talked about for the first time. They often get big play in the mainstream press despite still being a long ways from available on the market for patients to access and use.
But hey, we're always excited about what's on the horizon.
Sometimes though, plans change. Perhaps the R&D doesn't pan out, or business decisions are just made to go a different way, and/or the manufacturers decide to keep their pipeline plans under wraps.
So we in the D-Community are left wondering -- what happened to that rumored new product?
This has come up recently with two much-anticipated D-devices from Insulet and Tandem. Today, we're happy to share everything we know about where their next-gen products stand:
Insulet's Next-Gen OmniPod PDM
About a year ago, we learned that Insulet was working on its future PDM (Personal Diabetes Manager) controller for the OmniPod tubeless pump. This would be a huge design shift, even bigger than the most recent second-gen PDM unveiled not long ago with a sleeker profile and new color screen. Many of us had heard that OmniPod would be switching to Lifescan OneTouch Verio glucose monitoring technology inside, instead of the Abbott Freestyle glucose monitioring system that it had been paired up with since the beginning. After all, Insulet had announced a global agreement with Lifescan in 2012. And in November 2014, the FDA approved the Lifescan-integrated PDM model. So it seemed like only a matter of time... right?
Wrong, apparently. Just this past week, we learned Insulet and Lifescan would not be teaming up as planned. Instead, Insulet has opted to stick with Abbott for the foreseeable future, signing an expanded agreement to continue their long-established relationship.
Although many OmniPod users were nervous about the change in test strips, others were looking forward to this new integration. And it seems so strange -- why go through the rigorous FDA approval process for new paired device, and then pull it at what seems like the last minute after it's already been cleared by regulators?
Then again, maybe it shouldn't be such a surprise given that Insulet has been playing musical development partners in recent years. In early 2013, the company scrapped its original plans to integrate with Dexcom CGM (continuous glucose monitoring) technology as it had been promising for 5+ years. Even though the patch pump company and CGM company eventually rekindled a partnership to bring their respective data worlds together, this new agreement is far short of the fully integrated product that had been promised years before.
We were unable to get any specifics from Insulet about their decision to stick with Abbott, and Lifescan's Communications Director David Detmers provided offered only a prepared general statement about ending their relationship:
"Both parties mutually agreed not to pursue the agreement or commercialize the product. We remain committed to exploring other opportunities to work together to provide patients across the widest range of diabetes management and insulin delivery systems on a global basis. No further details about the agreement will be disclosed."
So, what can we expect with the next-gen PDM?
It actually sounds pretty cool. The new PDM will have a "totally new chassis and design" with color touchscreen and a new user interface. It will be thinner and have a rechargeable lithium battery (thanks to the color touchscreen), so you will have to plug it in to recharge and they expect most users to do that overnight. Insulet is shooting for 4-7 days of battery life, although that could change.
Using a standard micro USB cable, this next-gen device will be a bluetooth-enabled handheld PDM, allowing you to send data out directly to an iPhone or other iDevice. Apps will be offered by one or more third-parties.
Insulet tells us they currently have a "functional prototype" of the new PDM that will be showed off at the ADA Scientific Sessions this June in Boston. And after a planned FDA submission by end of Q1 2016 at the latest, they are planning for a mid-year launch.
We've also learned that Insulet has some very cool new ad campaigns coming out with this next-gen PDM, that focus on living your best life; they feature real people with diabetes, surfing and swimming and doing other physical activities, with moving imagery. The company hopes this approach will help more people who've been hesitant to warm up to the idea of adopting pump therapy, they tell us.
A Dual-Chamber Pump?
You may also remember the news from two years ago about a dual-chambered pump, one that could be a critical step toward a closed-loop system as it would allow users to infuse both insulin and another hormone like glucagon in a single device. Exciting news of this so-called t:dual device being co-developed by Tandem Diabetes Care and the JDRF came in January 2013. The announcement said JDRF would be funding $3 million for this during the subsequent 24 months, with "performance-based milestones" scattered throughout that two-year period.
Well, here we are 24 months later... and there are no updates, Tandem and JDRF tell us.
Apparently the project is still alive, but neither party will say anything publicly about how the R&D has been moving along, what they've discovered to date, or what we might expect in the future.
The California-based makers of the t:slim pump are fairly vague:
"Tandem continues to be excited about the potential of a dual-hormone pump, although insulin is currently the only hormone approved for use in treating diabetes with pump therapy," spokesperson Steve Sabicer says. "At this time, we do not have a further update on the project, but the company does provide R&D updates on quarterly earnings calls."
We listen closely to earnings calls, but have not heard a word about this dual-chambered pump since the initial announcement two years ago. Their next earnings call is coming at the end of this month, we're told, so hopefully something more will be shared then.
Meanwhile, the JDRF says that corporate R&D confidentiality prohibits them from sharing specifics about the t:dual project. All they can say is that the two orgs continue working on a design for the first study to test this dual-chamber pump, and that researchers are making "significant progress."
The JDRF press office didn't answer our questions about how much money has been provided to this Tandem t:dual project in the past 24 months, or what kind of funding might go toward that in the future -- something that donors like me find disappointing, since I've given money specifically to the org as a result of this device development. I wish I knew what my money was paying for and whether it will be something that might actually come to market someday.
But JDRF's chief mission officer and VP of research Aaron Kowalski (also a fellow T1) was able to tell us that larger conversations around this issue are happening based on how much has changed in just the past two years. Significant progress on stable glucagon, faster-acting insulin, and closed-loop tech since early 2013 have changed the larger thinking about this kind of device, Kowalski says.
And with Medtronic recently announcing a planned 2017 launch for its next-gen "hybrid closed loop" 670G system that uses insulin only to raise glucose levels back up, everyone must re-think whether the benefits of a new dual-chambered pump are worth the cost of development if it's not first to market, he says. From a user's perspective, you also have to think about the extra reservoir/cartridge, glucagon and even another infusion set that would have to be purchased and managed.
"How do we think about diabetes technology, and how do we judge whether an investment in these systems is a good idea?" Kowalski asked rhetorically. "Those are conversations we're having with Tandem and the entire industry."
He tells us that JDRF and the Helmsley Trust are busy surveying the Diabetes Community about the kinds of D-tech we want to see pursued, and they want to hear what we all think about which next-gen device projects worth investing in.
"We don't have unlimited funds, so where do we go now that we know that insulin-combo systems are coming?" he asked. "They are literally getting slotted in at FDA, so that means they'll come to market first. So, what do we want next?"
Respecting Confidentiality vs. Public Accountability
In the case of the dual-chamber project, we understand the nature of R&D agreements requires some confidentiality. But at what point does that meet public accountability, in this new era of ultimate transparency?
This is an important issue, in our opinion, given that so many diabetes device projects are so heavily-touted in press releases and media coverage. If you are able to make such a splash at launch, then you should be responsible for following through and sharing some details not too far down the road.
And if you're going to promote something -- especially a project that may have prompted us patients to donate money to your org -- it only makes sense that you'll be prepared to update us from time to time, no matter the results, good or bad.
In short, we're excited about new R&D, but cautious about getting people's bopes up until there's a reason to do so.