It's a New Year's tradition here at the 'Mine to look ahead at the new technology and tools we expect to see coming down the pike in the new year. So we've been listening to earnings calls and talking with company execs, industry insiders and PR teams to get a sense of what's on the horizon, compiled in the following report (focused on devices that seem most likely to shake up the coming year).
Diabetes Products to Watch for in 2019
1. New Glucagon Formulations
Definitely watch for two new forms of fast-acting glucagon. One is a puff-up-your-nose version from Eli Lilly, which finally made its way to the FDA in mid-2018 after years of clinical trial work by the pharma giant. If you remember, this is the nasal glucagon created by Canadian company Locemia Solutions and acquired by Lilly in 2015. There was also the Chicago-based Xeris Pharmaceuticals, which submitted its ready-to-use glucagon emergency pen (requiring no mixing or prep) this past year and has an FDA meeting set for June 2019. Hopefully, both will get regulatory approval and launch by year's end -- meaning we could be on the verge of finally seeing the first new types of glucagon in more than six decades!
2. Tandem's New Control Tech
- Control-IQ: Many are waiting for the next iteration of Tandem Diabetes Care's touchscreen insulin pump-CGM combo device, called the Control-IQ Hybrid Closed Loop. This system will add more features to their Basal-IQ system just launched in 2018 that can automatically shut off basal insulin dosing when a Low is predicted by the connected Dexcom G6 CGM; the Control-IQ will add automatic correction boluses to address high blood sugars, too. Users will still have to enter in meal information. Tandem predicts this could hit the U.S. market in summer 2019, adding another hybrid closed loop device to give PWDs real choice.
- Interoperability: Along with that, Tandem has also submitted its foundational t:slim X2 pump to the FDA under a new special designation as an "iPump," meaning the device wouldn't have to go through all the same regulatory processes because it would work with other, already-FDA-cleared devices. This opens up the door to quicker approvals as well as much more interoperability, and potentially more efficient access and coverage decisions by payors. Since the
FDA already granted "iCGM" statusto the Dexcom G6 in 2018, and the t:slim X2 is cleared on a few fronts, it seems logical we'll see this happen before long in 2019.
- Mobile App: Expected very soon in early 2019, Tandem's new mobile app will connect to the t:slim X2 using Bluetooth to display pump status and alerts on a smartphone with no need to pull out the pump itself. It will also offer remote sharing capability, and automatic uploading of D-data to the t:connect web platform. This first-gen app won't allow any pump control or insulin dosing from the phone, but that's a work in progress for future updates once the FDA allows it. Tandem tells us they'll plan for an iPhone launch first (the way it typically works) and eventually will have an Android version.
3. OmniPod with Touchscreen
Hello, DASH: Insulet has been gradually rolling out its new DASH system, just approved in mid-2018, with a broader launch planned for early 2019. This is the first new OmniPod patch pump model in roughly 6 years, since their second-generation "Eros" device was released. Most notably, the newest Bluetooth-enabled pump will serve as the platform for all future tech from Massachusetts-based manufacturer, including their OmniPod Horizon closed loop system expected in 2020. The DASH has a new touchscreen PDM (personal diabetes manager) device that resembles a locked-down Android-style phone, and most recently Insulet announced it's the first device to be cleared within a heightened security protocol system developed by the Diabetes Technology Society.
4. Dexcom Coaching Offerings
In early December, the California CGM company held its first-ever Investor Day where it updated analysts and the general public on all of its planned. Keep in mind, this next year won't have anything like a G6 launch in store for us, but many of the upcoming items will expand the use and functionality of that G6 platform going forward into 2019:
- G6 Glucose Coaching: This mobile app will be a slightly revised version compared to the current G6 app, this one intended for type 2 PWDs and those who are not at high-risk for severe hypos, compared to others who are or have a more intensive management routine. There will be in-app chat with a wellness coach, but no high or low glucose alerts -- addressing the alarm fatigue issue. This may be available by year's end, though Dexcom hasn't officially released a launch timeline.
- Advanced Decision Support: During its investor presentation, Dexcom showed a slide featuring a CGM-based mealtime (bolus) calculator, forward-looking hypo prediction, and sleep and exercise advice -- such as, “For 60 minutes of medium intensity exercise, we recommend eating 38 grams of carbs” or “Before you sleep, we recommend eating 9 grams of carbs.” This would come through the TypeZero Technologies software that Dexcom bought earlier in 2018.
We also expect to see more pharmacy availability of Dexcom G6 sensors and will likely also more data and mobile app updates throughout 2019. The Dexcom and Verily (formerly Google Life Sciences) collaboration for a low-cost, mini CGM is now expected at some point in 2020.
5. Medtronic Diabetes Improvements
Tech Updates: We expect to see incremental improvements and wider availability of the Minimed 670G Hybrid Closed Loop that's faced speed bumps due to CGM sensor manufacturing and bad press on product safety. The company has made the recent decision to stop manufacturing older pumps (523, 723, 530G models) and only make the 6-series, which will force their customers to either upgrade or jump ship to another pump. Medtronic's spokes-people tell us they do plan to launch a Bluetooth-connected 670G at some point, but there's no ETA yet and it may not be until early 2020. We'll probably see more talk on the stand-alone Guardian Connect CGM approved and launched in 2018, as it seems to only get random whispers of mention since the initial press stream. Also, the Sugar.IQ mobile app that functions as a “personal diabetes assistant” to recognize D-Data patterns is going to be more fully launched during 2019 -- with the New Year already bringing the launch of a new predictive feature called IQcast! This mobile app feature announced on Jan. 3 can help PWDs predict potential hypos 1-4 hours in advance.
Working Toward Medicare Coverage: For those wondering why other CGMs like Dexcom and the Abbott FreeStyle Libre are covered by Medicare but Medtronic is not, there may be hope on the horizon. Medtronic is the only traditional CGM that isn't currently designated as a "thereapuetic CGM," meaning deemed accurate enough to use for dosing decisions without backup fingersticks. While other companies have pursued and gotten that FDA clearance (required for Medicare to sign off on coverage), Medtronic opted to not pursue this pathway -- until now. Company spokes-folk tell us they plan to pursue this in 2019.
6. New Patch Pumps
There are at least three new patch pumps in the works that are likely candidates to finally hit market in 2019.
BD's T2 Patch Pump: This will be a fully disposable, three-day wear tubeless pump offering both basal and bolus dosing. It holds 300 units and has a reusable handheld controller with Bluetooth connectivity to a smartphone app. BD has talked about this very simple pump being more comparable to insulin injection therapy for T2s, making it potentially a better option for T2s who may also face payor challenges in getting approved for a traditional insulin pump. The original timeline of '17 and then '18 have come and gone and now BD says it expects to file with FDA in the coming months with a limited launch expected in late '19.
Roche Solo: People had pretty much given up on the Solo patch pump device that Roche acquired way back in 2010. Despite the first-gen device already being FDA-approved, Roche Diagnostics made the corporate decision to not launch it because there wasn't an integrated blood glucose monitor -- a head-shaking decision in hindsight, because nothing ever came to be. Yet, it remained in the company's development pipeline, and in 2018 Roche finally launched the Solo micro-pump in Europe. Will that translate to an FDA filing for the new 2nd-gen device before long? Hopefully, though Roche US isn't saying anything beyond its hope to file with FDA as soon as possible.
Cellnovo Hybrid Patch Pump: We speculated that this system would come to market last year but it didn't happen, so we're hopeful for 2019. The internationally-available Cellnovo is actually not a fully tubeless system like OmniPod but rather a hybrid -- a patch pump that also sports a very short infusion set. Cellnovo submitted this device to the FDA in November 2016 and has been following up with regulators for more than two years now, so it's certainly possible that '19 could be their launch year. ** UPDATE: Unfortunately, in March 2019 this French med-tech company announced it had stopped production and manufacturing of the Cellnovo device and would be discontinuing the product, as it explores strategic moves to sell its product intellectual property.
7. New 'Smart' Insulin Pens
Novo Nordisk: The Pharma Giant is developing the next generation of its insulin pens, in the NovoPen 6 and NovoPen Echo Plus. Both will be reusable connected "smart" pens that will automatically record insulin doses -- a notable feature for pen users who currently need to use other tools to record any insulin doses or other data they'd like to track. This is also especially for anyone who might forget to take a shot or when they last dosed. The data will be displayed on a little screen located on the flat circular end-part of the pen. Novo will initially launch overseas in early 2019, with a gradual rollout to more countries, so we may indeed see this in '19 here in the States (depending on regulatory review).
Novo is also planning to develop and launch an attachment for existing disposable FlexTouch insulin pens that will allow for connectivity and data-sharing to a smartphone app. All of that is part of a trio of agreements that Novo signed -- partnering with data platform Glooko, with Roche's mySugr platform, and with Dexcom to integrate data. With mySugr now a part of Roche, we're told that group is especially eager to move forward on this Novo partnership. mySugr's Head of Product Marlis Schossr says this about data integration in 2019: "We will soon be able to sync insulin data from their connected insulin pen, adding more relevant medical data to our systems.”
Bigfoot Inject: California-based startup Bigfoot Biomedical is of course working on a future closed loop system they call AID (Automated Insulin Delivery). But we're also told that in 2019, they'll be filing for regulatory approval of a connected insulin pen they're calling "Bigfoot Inject." D-peep and Bigfoot PR lead Melissa Lee tells us, "2019 will see Bigfoot initiate our pivotal clinical trial for our AID system, Bigfoot Loop (software), and a PMA submitted for Bigfoot Inject, our connected injection system." We aren't privy to all the details on this, but assume it's related to the Bigfoot acquisition of the Timesulin pen dosing tracker in 2017. Depending on the FDA, it's certainly possible we could see this hit the market in '19. But no matter the timing, it's awesome that this smart pen will eventually fit into their closed loop system, as an option for those who don't want to be connected to an insulin pump!
8. Onduo + Sanofi Pipeline
This year, we're going to see more on the Verily-Sanofi joint venture known as Onduo. After first being announced a few years back, the virtual clinic and coaching service officially launched on a limited basis in early '18 with pilots in southeast states. They're now ready to enter a "full-scale" national launch in 2019. At our DiabetesMine Innovation Summit recently, Onduo talked about data showing significant A1C improvements among its users.
We're told this is also weaved into the pathway forward for Sanofi's collaboration with med-tech company Sensile to develop a connected patch pump system. While we most likely will not see that product come to fruitiion in '19, the Onduo offerings are maturing and apparently paving the way for a customer base.
What Not to Expect in 2019
Obviously, some new technology takes a long time to materialize, launch dates can slip, and sometimes products just get dropped. On that note, here's a quick look at a few items NOT on our 2019 list:
The Closed Loop Boom: Despite all the buzz about these pre-Artificial Pancreas systems, 2019 is not quite the year for product launches by most of the closed loop startups Bigfoot Biomedical, Beta Bionics with its iLet, or even what Lilly and others have in the works. Good things take time. But clearly, we'll see progress on clinical research setting the stage for 2020 and beyond -- especially mid-year when the big ADA Scientific Sessions conference takes place.
#WeAreNotWaiting: Oh, and it wouldn't be right to not mention the #WeAreNotWaiting movement and some of the closed loop tech that's in development. Obviously the open-source, do-it-yourself technology is always evolving. We do expect 2020 to be a pivotal year on progress that front, especially when it comes to Tidepool Loop being developed with the help of the FDA. But an actual launch won't likely happen this year.
BD FlowSmart Infusion Sets: Remember these, developed by BD and co-opted by Medtronic as the so-called "Minimed Pro Sets"? They initially launched in September 2016 but ran into users experiencing occlusion errors (tube blockage). After that BD pulled the product, went back to further review and redesign and planned for an eventual re-launch, but in 2018 the company announced it would be scrapping the infusion sets and discontinuing them.
Abbott LibreLinkUp: The Libre flash glucose monitoring system had a huge year in 2018 with its 14-day sensor being approved and launched, the LibreLink mobile app (allowing for iPhone scanning) getting cleared, and Medicare coverage being allowed for the latest system. That probably means there isn't as much on tap for 2019, but we do hope the internationally-available LibreLinkUp app enabling data-sharing makes its way to the USA soon. We also wonder if the Libre 2 device that recently launched overseas means more updates here in the States, but that's TBD and Abbott remains tight-lipped about its future pipeline.
WaveForm CGM Tech: We also reached out to AgaMatrix and WaveForm Technologies, which announced in 2017 they would be moving forward on a new CGM technology. WaveForm tells us they're anticipating a late 2019 launch in Europe of a new CGM, but clinical trials planned are the extent of what we'll see on this in the USA before a planned submission in December 2019 to the FDA.
So, those are our observations and tech 'spectations for 2019 so far. Clearly, we don't have a crystal ball and anything can happen. Here's wishing it's all good and exciting for our D-Community.
Happy New Year, Friends!