The arrival of a New Year always brings thoughts about all the diabetes tech 'spectations we'd like to see realized in the coming year.
Of course we've been listening to the earnings calls, talking with company execs and industry insiders about what's on the horizon, and reading the D-news tea leaves, so to speak. A lot that's coming down the pike won't come as much of a surprise, but more like a culmination of many high hopes and expectations we've had in this community for a long time.
Here's a roundup of what we expect to see on the D-Tech scene in 2015, with some insights and obs ervations sprinkled in from our end:
Meter Accuracy: Many eyes will be on the accuracy of glucose monitoring systems, with the FDA releasing new draft rules a year ago that have been a hot topic for patient advocates, industry and the diabetes world since. We're hoping that before long (and despite industry pushback), the FDA will release new final guidelines that tighten the rules in a reasonable way. At the same time, we're looking forward to the Diabetes Technology Society's further work on its Post-Market Surveillance Program that's been in development for several months. Word from the group's Steering Committee is that they expect testing of available meters to begin this year, and we can't wait to see what that process looks like.
Tandem: We are all anxiously awaiting news about the Tandem Diabetes new integrated t:slim G4, which combines their popular touchscreen insulin pump with the Dexcom G4 continuous glucose monitor. Now that the Animas Vibe's been approved as the first such combo device, and is being shipped out starting this month, we're hoping it won't be long before we have access to a second G4-integrated device. Tandem filed with FDA in late July, and given that the company has a history of responsive and proactive discussions with regulators, we expect approval won't take too much longer. Of course, there is one catch: Way back when Dexcom agreed to partner up with JnJ Animas, the two agreed on a six-month exclusivity clause, meaning the Vibe would be on the market for six months before any other Dexcom-combined device could be sold as competition. Who would've thought that it would take Animas so long to get its act together, file with the FDA and finally get the Vibe approved? So with that agreement in mind, we don't expect to see the Tandem t:slim G4 on the market before mid-year, say June 2015. Additionally, we should see Tandem's new larger, 480-unit t:flex pump sometime in the coming months, after the company filed that with the FDA in November.
OmniPod: We also expect to see some exciting news from Boston-based Insulet that makes the OmniPod patch pump. Two new developments are apparently in the works for the Personal Diabetes Managers (PDM) device that controls the Pods. First, they'll be switching from Abbott Freestyle test strips used in the system since its launch in 2008 to newer Lifescan Verio glucose strips. The company filed a 510(k) request early in 2014, and in mid-November the regulators approved the updated device that it considers "substantially equivalent" to the PDMs already available. We contacted Insulet, but they declined to offer patients any idea of when the Lifescan-compatable PDMs will be available for sale. So, we wait, but hopefully not for long. The second change is that Insulet is also developing a next-gen PDM that will be more modern and likely include a number of different features. There's also no timeline being shared as to when that might be available or even filed with FDA for review. But we are hearing that Insulet will display a prototype during the American Diabetes Association's Scientific Sessions this June, which will be held in its own backyard in Boston -- perfect time for an announcement, right? And looking at the device market, it doesn't seem unlikely that this next-gen PDM will be Bluetooth connected and also possibly a realization of the planned Dexcom G5 integration announced in Summer 2014. If that's indeed the plan, then we'll hopefully see this head into the hands of the FDA for regulatory review by hopefully by the end of 2015.
And while we're speaking of the Dexcom pipeline...
Dexcom: Lots to expect this year, probably sooner rather than later! Yes, the most-anticipated development we hope to hear about soon is the company's filing of the next-gen G5 sensor, which will bypass the need for a receiver and talk directly to a smartphone (ideally both iPhone and Android). Dexcom has stated that its plan is to file this next iteration by March 2015, following of course on last year's approval of both the Dexcom SHARE mobile platform and Advanced AP Algorithm. But there's something else, too -- a bridge between what has just been OK'd by regulators and the G5. Say hello to the Dexcom G4 SHARE receiver with built-in Bluetooth, allowing the receiver itself to connect directly to a smartphone and send CGM data to the cloud. Yes, Dexcom filed documents with the Federal Communications Commission (thanks to the mHealth aspect) on Nov. 24, spelling out some of the details on how this intermediate unit will work for those who may not want to use a wall plug-in docking station but want a more portable option (similar to what Nightscout is offering!).
Timing? If I was putting money on Dexcom's steps for the next year, I'd bet that we'll see an FDA filing for this Dexcom G4 with SHARE in the coming month, followed by the G5 filing within the next few months.
I'd also bet the FDA will move quickly on this, given a number of factors: 1) They've already approved the Dexcom SHARE as the first mhealth tech of its kind, 2) The G4 sensor and advanced algorithm are both approved, 3) The FDA has crafted its mHealth guidance, and is indicating they're looking to move forward with this kind of tech, and 4) Dexcom has a stellar reputation in working with the FDA, unlike some other companies that traditionally haven't had a two-way dialogue or been receptive to FDA feedback. And remember, the new G5 tech will be using the already-approved G4 AP algorithm, and Dexcom says it's planning to start pursuing a "dosing claim" so that its CGM could be approved as equivalent in accuracy to conventional fingersticks and therefore good enough to support insulin dosing decisions. Yes, we'll probably see the G5 in 2015, but approval on that dosing designation may not be something that comes this calendar year.
Medtronic: The next generation of Medtronic's Minimed devices may not be too far off, at least for those in overseas D-Communities. The company is ready to launch its predictive Minimed 640G in Australia and Europe this month, followed by other international spots this year. And in the past few months, we've scored some exciting views on this next-gen device that will, for the first time in more than a decade, sport a different look than we've come to expect from Med-T. Yes, the pump-CGM combo appears to be designed differently, looking more like a modern Deltec Cozmo that's vertically oriented rather than horizontally. There's also been talk in the past months about the Guardian 2 (next-gen CGM) and closed loop software the company plans to release along with this device. Yes, overseas at first like most devices; we don't expect to see any FDA filing for this device in 2015, and that means we're probably talking at least 2016 or 2017 before the predictive combo device is available for us here in the States. Still, it's exciting to see the launch happening somewhere in the world... you have to start somewhere, right?
Just for Kids: We would hope the two CGM companies -- Dexcom and Medtronic -- would move toward pediatric indications on their respective devices, the G4 with AP algorithm and the Minimed 530G approved in September 2013. Both have achieved initial approval from FDA, but only for adult use so far. More studies are required before the regulatory agency will sign off on this tech for kids. Dexcom has said it plans to file a request for that pediatric indication soon, so hopefully we'll see that come about this calendar year. Unfortunately, Med-T only began its pediatric clinical study this Fall (close to a full year after FDA approval of the adult version!), and the trial shows a Spring 2016 end-date. So official kid-use for the 530G isn't likely anytime soon; if parents want their kids using it now, they'l have to go off-label.
Snapping It Up: We've seen the Asante Snap insulin pump making an impression during the past year, and most recently saw the personalized MySnap appear as an option. These click-together pumps have all been using the pre-filled Humalog cartridges to date, but word is Asante will soon be filing with the FDA an update for the pre-filled Novolog cartridges. Hopefully, that won't take regulators long to review so both Humalog and Novo users will be able to choose this pump, without needing to change insulins if they don't want to!
Data Sharing: We know the doors that will open with direct-to-smartphone sharing, and Dexcom's G5 is a big deal, not only in the CGM transmitter world but because G5 approval by the FDA will likely prompt pretty quick turnaround on other data-integrated devices like the OmniPod, Asante Snap pump, and others that will connect directly with phones and/or the next-gen CGM. And big things are in store of course for the non-profit Tidepool that's been a huge catalyst on the data-sharing front. With backing and funding from the JDRF, it is now developing a Universal Device Uploader that will allow us patients to upload and share our data from any device, and share and view it as we like! (Their Blip app in development is the visualization aid.) According to JDRF stipulations, the Universal Device Uploader is supposed to be developed within a year of funding, so by September 2015!
Inhaled Insulin: We saw the big approval earlier in 2014 of MannKind's long-awaited inhaled insulin Afrezza, and then Sanofi announced it was partnering with Mannkind Corp on the new product and would take up sales on the drug once it was ready for market. That should be sometime in 2015... assuming Sanofi doesn't decide to nix that deal based on second thoughts from senior leadership. We shall see what this year brings! Our wish for the year: Sanofi goes ahead with the deal and gets Afrezza into the hands of people with diabetes, so we can see how it performs in the real world helping PWDs with meal-time insulin dosing. Sure, it probably won't be the blockbuster some have predicted, but at least it will be another tool to aid with glucose control.
Research: Among the great D-Tech and treatment research happening in our community across the globe are the Bionic Pancreas trials and other closed loop research happening here in the States and abroad. It's exciting stuff and we expect to see more headlines on all that this year. We're also closely watching the research by Denise Faustman in Massachusetts, as she's getting close to more clinical studies in 2015 (though those likely won't be finished before the calendar year ends). Other treatments under study everything from next-gen glucagon to new ultra-fast-acting insulins, long-acting basal insulins, and Merck's smart insulin (that can react to glucose levels in the blood) expected to soon start initial clinical trials. Not to mention the exciting encapsulation work by ViaCyte that's already undergoing human trials. What we'll see on all these fronts is TBD, but we're expecting to hear much more on all the progress as 2015 rolls out.
New CGM Makers? Will we see any new CGM players come on the scene in 2015? We have our eyes on both the still-mysterious Insulet partner that is apparently working with the company to create a single-site device that weaves together insulin infusion and glucose monitoring. That partner is a glucose monitoring manufacturer, Insulet has maintained, but maybe not be one of the existing CGM makers...? There's also speculation that Abbott Diabetes Care could bring its Freestyle Libre Flash Glucose Monitoring (FGM) system to the States in 2015, after this past year's release overeas. But there's no official word on that yet.
Patch Pumps -- Yeah, no one here is holding their breath for a new patch pump in 2015. Seriously, we've all but given up hope these will see the light of day in the U.S. anytime soon: the Solo pump that Roche bought years ago, the Jewel Pump from Debiotech that also remains elusive, and Cellnovo, with their patch pump that was launched in Europe during 2014. Will OmniPod finally get some competition? We have no expectations for that. Go ahead, device makers: Prove us wrong!
All-in-one Meters: Excuse us, while we take a quick yawn... Sorry, but this device concept has been pretty much in the "hype" category for far too long. Every year at the big diabetes conferences, we see booths showing off various all-inclusive meters but there's always some reason why they aren't yet available on the market for us here in the States. Maybe the Dario meter will be able to climb that regulatory wall in the near future and get launched in 2015 as it hopes, considering the Israel-based Labstyle Innovations filed its documents with FDA back in January 2014. Still, we aren't expecting to see any game-changing news when it comes to these devices, whether they connect to the cloud or not.
So, those are our observations and tech 'spectations for 2015 so far. Of course, there will without a doubt be unexpected news, too -- here's wishing it's all good and exciting for our D-Community. Happy New Year, Friends!