The start of a new year always brings curiosity about what's on tap in new diabetes technology, and we're excited to take an inside look, especially with the big JP Morgan Healthcare and Consumer Electronics Show events underway this month.
Of course, these days Amazon and Google generate quite the med-tech buzz, not to mention wearable smartwatches and Apple talk and the very many mobile health apps being developed. Some of the recent buzz includes FitBit investing $6M to develop a continuous glucose sensor, and rumors that Apple's developing its own super-secret continuous monitor built directly into its Apple Watch.
On the flip side, you can't talk about innovation or D-tech these days without the lockstep concerns of access and affordability. It's encouraging to see reimbursement being more of a focus at the R&D stage of new products, and the latest news of Medicare coverage for the tubeless OmniPod pump and new Abbott FreeStyle Libre flash glucose monitor are big moves forward.
We've reached out to many leading diabetes vendors and combed through public reports from investor earnings calls and other news announcements to compile this (not exhaustive) look at what's ahead in D-tech for this coming year.
Closed Loop Tech
You might refer to this as Artificial Pancreas systems, but whatever the name it's about "closing the loop" in glucose-monitoring and insulin dosing. While we won't see any fully closed loops (requiring no user intervention) on the market during 2018, we'll certainly see progress from numerous players.
Beta Bionics: This B-Corp startup in Boston now has its fourth-generation prototype of its iLet4 system, a dual-hormone glucagon and insulin closed loop device. We expect to see some news this year on clinical trial work, especially as it relates to a stable glucagon formula needed for this tech. Usually during the CWD Friends For Life conference in July, Beta Bionics presents its latest and greatest -- whether it's a new prototype or research. So we can look forward to that!
Bigfoot Biomedical: While they won't bring any products to market this year, Bigfoot plans to submit an investigatory study request with regulators and start its pivotal trial for the "Bigfoot Loop," its investigational infusion-pump based automated insulin delivery (AID) system. Bigfoot's also planning for a feasibility study for "Bigfoot Inject," the investigational auto-titrating connected insulin pen system its developing thanks to its recent acquisition of Timesulin.
Tandem: This provider of the t:slim touchscreen pump says it plans to submit its closed loop tech for FDA review in the first quarter of 2018 (by the end of March) and hopes for a launch by the end of summer. This first iteration will be a Predictive Low Glucose Suspend (PLGS) device that Tandem's named Basal IQ would automatically decrease and suspend insulin when lower glucose levels are predicted 30 minutes in advance based on Dexcom CGM data. Early clinical trial data's expected to be released in February. Then, their second-gen system would be a "hybrid closed loop" using Dexcom G6 data and TypeZero Technologies algorithms; they've already completed a first pilot study on this combo, and the second expected this year. The launch goal for that is mid-2019. (see more below, under the Tandem heading...)
Abbott Diabetes Care
LibreLink mobile app for the USA? Just launched at the end of this past year, the Abbott Freestyle Libre flash glucose monitor has been quite the newsmaker recently. This first-gen system isn't technically continuous, as you must wave a handheld reader over a round sensor to actually get your BG data, but we hear that movement is happening internally on a second-gen version that will eliminate the need for the receiver and simply stream data automatically to an app. Of course, overseas where the Libre's been available for years, a supplementary app called LibreLink offers data-display and sharing with up to 20 people via the Libre LinkUp, and we hope to see that come to the USA sometime soon in 2018.
It's also TBD whether Abbott will move forward this year on the possibility of label/designation changes for extended wear time (maybe 14 days as allowed outside the US, compared to our 10-day wear) or the 12-hour sensor warmup period compared to the two-hour window internationally.
We pressed to find out details on what's next, but Abbott spokes-folk kept it vague: "We will have new data, including at the European ATTD meeting (happening in February in Vienna), and updates to our digital platform -- both internationally in and in the US."
It is possible that the US could finally see another patch-style pump, to compete with the Insulet OmniPod that's been the first and only device of its kind since 2005. OK, the internationally-available Cellnovo is actually not 100% the same as it's a sort of 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 a year, and so it's certainly possible that '18 could be their launch year. Keep in mind the future potential here too, as Cellnovo's partnered with closed loop startup TypeZero Technologies as well as Diabeloop, and has invested heavily developing a future AP system that this past year.
Next-Gen G6 Sensor: As we've reported previously, the G6 will be a true leap forward in CGM tech, with 10 days of wear instead of the current 7 days. The transmitter will be 30% thinner with improved accuracy and reliability, will have new predictive alerts, and acetaminophen (Tylenol) will no longer interfere with CGM readings. Dexcom submitted the G6 for FDA review at the end of the third quarter of 2017. But what happens next is TBD. Dexcom filed a single-calibration G6 (meaning you'd have to do one fingerstick calibration per day), but with the Libre's recent approval for no-fingersticks it's possible the FDA might be willing to speed up a no-calibration G6 version. Depending on that, the CGM maker says it plans to have a G6 launched "some time in 2018." Importantly, the recently-released touchscreen receiver will be able to work with the G6.
One-button Inserter: Dexcom will also be getting a new insertion system for sensors, a single-button-push device. That launch had originally been planned for pre-G6, but with all the timing changes it's now planned to come with the next-gen sensor.
Verily Collaboration: Dexcom's development partnership with Verily (formerly Google Life Sciences) announced in 2015 will lead to a much-anticipated milestone: a miniaturized, disposable CGM sensor that is flatter than the current transmitter, will possibly last 14 days and require no calibrations. Later, a second-generation Verily product will be a disposable device that's even smaller, possibly the size of an M&M candy, available at lower cost -- the two companies' projected home-run product expected in roughly 2020/21.
Smartwatch Connectivity: The CGM maker announced a partnership with Fitbit last year, to develop products for diabetes management. Their first project is displaying Dexcom G5 data directly onto the new Fitbit Ionic smartwatch, which is based on Fitbit's acquisition of Pebble. That will be for Android and iOS devices. If that works the way it has with Apple Watches via HealthKit, then it's likely CGM data will first be relayed through Dexcom's G5 smartphone app, with direct transmitter-to-smartwatch beaming coming later. Of course, there's already talk of direct Dexcom-to-Apple Watch data coming in 2018, so we'll just have to wait and see.
Clarity Software and App Updates: Dexcom does periodic updates to its online mobile app platform at times without much fanfare, but it's nice to see those happening every so often. Most recently, some new features came in late 2017 and we'd expect to see more during the course of this year. And yes, we're aso crossing our fingers that Dexcom CGM users on Medicare get word this year that they'll be allowed to use the smartphone app to share data, something that hasn't been allowed as a covered benefit to date.
Eversense Implantable CGM (Senseonics)
Made by Maryland-based Senseonics, this implantable Eversense CGM sensor would be the first of its kind: a small, pill-like sensor about the thickness of a Tylenol tab is implanted completely under the skin during a five-minute surgical procedure. It can last 90-180 days before needing replacement. You wear a thin black box transmitter device adhered to the skin over the implanted sensor that sends data to a smartphone app, and this transmitter can be removed and re-attached to start sharing data again. This system still requires two fingerstick calibrations per day.
The Eversense CGM is available in 13 countries, but not yet the U.S. In September, Senseonics received European approval for the Eversense XL that lasts 180 days. A 90-day sensor version has been pending before the FDA for the past year, and Senseonics’ CEO has said he expects an FDA advisory panel will be exploring the safety of the implantable sensor in early 2018; with possible regulatory approval to follow.
Interestingly, if that gets approved here, it could move some more D-tech forward from other companies -- such as TypeZero Technologies and Roche Diabetes Care on the closed loop front (more on that below).
One of the biggest stories of the past 18 months has been the Minimed 670G, the world's first hybrid closed loop that is an early generation, pre-Artificial Pancreas system. The limited and gradual launch began in Spring 2017 and took most of last year, though it was plagued by manufacturing delays of its newest Guardian 3 CGM sensor -- partially due to the hurricanes devastating its Puerto Rico plant in the Fall. While the company says the PR facility is now "fully operational" with existing customers being prioritized, many in the D-Community continue to wait impatiently.
Stand-Alone Guardian Connect CGM: For years, MedT has pushed its diabetes tech as a "system" -- not a separate pump and CGM product but a combo. Yet the company's had its eye on a stand-alone system like it once had a decade ago. That's where the Guardian Connect comes in, sending CGM data directly to a smartphone app.
In the US, Medtronic would tie this to the newest Guardian 3 sensor that's part of the 670G system, unlike outside the US where it's currently being sold with the older Enlite CGM sensor. It was filed with the FDA in 2017 and the company tells us they expect to bring that to the US market in '18; investor presentations have it slated for launch in the first half of the year, though that's all dependent on regulatory approval.
iPro3 (Blinded, Provider-CGM): This is on tap for outside the US sometime between May 2018 and April 2019, coinciding with Medtronic's fiscal year. A slide presented at #JPM18 showed the technology, noting that this professional blinded CGM iteration would connect to the Guardian 3 sensor.
Sugar.IQ with IBM Watson App: This was launched to a small beta-testing group in Fall 2017. But this year, Medtronic plans to bring it to a "more broad market." The app uses IBM Watson analytics to find patterns in diabetes data and offers real-time, actionable and personalized insights. Results from its 250-person limited preview program at the ADA Scientific Sessions in 2017 showed 60% were using the app more than once a day, with time in range increasing 2.6% on average and fewer hypos as a result of the mobile app use. What the company learned from that beta test will help inform the commercial launch and future development of the app, we're told.
Smartwatch Capability? Nothing is finalized, particularly as it relates to the big 2016 news that Medtronic was partnering with Samsung to bring a smartwatch data-display component to its D-tech. A Medtronic spokesperson tells us, "No updates on the Samsung watch project right now. We are still exploring options to make glucose information easily available on digital watches."
BD Flow-Smart Infusion Sets: This will be a re-launch of new infusion set tech that came out in September 2016 but ran into issues with users experiencing occlusion errors (tube blockage). The company pulled the product, went back to further review and redesign, and now are planning a re-launch at some point probably in the second half of 2018.
Next-Gen 690G and Harmony 1 CGM Sensor: Not much detail has been released yet on the next-gen Medtronic system or its future CGM, but we got a glimpse of the so-called Harmony CGM sensor at the ADA Scientific Sessions in 2016. Conceptual research on this redesigned CGM sensor showed a 10-day wear time with single calibration, using a proprietary "Fusion" algorithm allowing for better accuracy. It also was said to have improved adhesive-backing to keep the sensor on more securely and built-in Bluetooth Low Energy for smartphone communication. In December 2017, a clinical study began for the Harmony 1 sensor at eight sites across the country that's slated to run through December 2018. So while we won't see a launch this year, hopefully we'll get more glimpses of what's ahead.
And just as a refresher, Medtronic reiterated what it has told us in the past about data-sharing and connectivity not being added to the existing 640G or 670G devices, but something that will be weaved into future genrations. Until then, only the MM Connect via 530G device and the stand-alone Guardian 3 CGM will allow for data-sharing like its competitor Dexcom has.
OmniPod's Next-Gen Platform
DASH PDM: Insulet CEO Pat Sullivan confirmed on Jan. 9 at #JPM18 that the new OmniPod DASH system was filed with FDA at the start of 2018, leading to a possible launch by end of the year. The tubeless Pod will retain the same form factor, but will have Bluetooth Low Energy wireless capability built in to allow for communication with the new color touchscreen PDM (controller unit). This will also allow for communication with any BT-enabled fingerstick glucose meter, but that means the next-gen OmniPod DASH won't have a built-in FreeStyle glucose meter like the current system has. The DASH will actually ship packaged with a Contour meter from Ascensia Diabetes, and that company also happens to be adding more smart data analytics to its own mobile app (not yet available in the US).
Insulet's BT-enabled Pod and PDM will be able to talk directly with a smartphone app so users can track features like Insulin on Board (IOB), dosing records, BGs, and CGM data both on the new PDM and on their smartphone screens. The new PDM sports an improved food database for logging carbs, and you can manually enter BG and other data using a nifty touchscreen wheel. The new touchscreen will be what Insulet calls a "locked down Android" device, one that's secured so other cellular data won't interfere.
Future Pipeline: When the DASH launches, it will be the first since the Eros-generation of Pod came to market in 2013 and Insulet's planning a limited launch at first. This BT-enabled DASH will also serve as the platform for new generations of OmniPod tech, including the closed loop Horizon device it's working on and the higher-concentration insulin Pods being developed with Eli Lilly. Working timelines for that are roughly 2019 for the U-500 version, and the following year for the U-200 product.
Horizon Closed Loop: While it's not expected to hit the market before 2020, Insulet's OmniPod Horizon system would bring an AP component to the tubeless patch pump. Investigational work is happening now, including a five-day clinical trial the company just finished, and more data on that will materialize throughout the year.
Global Expansion: Also notable for those outside the US, Insulet will take on direct sales and marketing of its OmniPod starting July 1, 2018, after deciding last year to not renew its third-party distributor contract; that means more direct interaction with the company itself.
Roche Diabetes Care (+ mySugr)
Though we're sad the Switzerland-based company (with US HQ in Indianapolis) decided to stop selling insulin pumps in the USA, the door isn't completely shut. Spokes-folk have told us they may bring future D-tech back to the States, which is something that certainly seems possible with eventual closed loop technology -- Roche has partnered with Senseonics to use the Eversense implantable CGM. If Eversense gets approved soon enough this year, it's feasible some good progress could happen in 2018 for Roche.
On the data side, the big news from last year was Roche acquiring mySugr and bringing the popular diabetes data logging app in-house to become a foundation for their next-gen digital platform. The mySugr app is now bundled with the Accu-Chek Connect meter, so we do expect to see more from Roche-mySugr over the course of '18.
Tandem Diabetes Care
First off, Tandem remains alive and despite what naysayers and "investor experts" claim, the company's hiring and building new facilities and completing valuable R&D; they recently moved into a new San Diego facility and are expanding manufacturing. If the company's in danger, it sure isn't showing signs of slowing down.
We're told: "Tandem is committed to free software updates for all t:slim X2 Pumps for features approved in 2018."
So any new features or updates the California pump company releases this year will be available to t:slim X2 users for remote-updating from home.
"Basal IQ" Predictive Low Glucose Suspend (PLGS) System: Tandem says it plans to submit it's "Basal IQ" product in the first quarter of 2018 (by the end of March) and hopes for a launch by the end of summer. This device would be the first-gen automated insulin delivery system, designed to automatically decrease or suspend insulin when blood sugars are predicted to o below 80 mg/dL based on the Dexcom G5 CGM sensor values:
Hybrid Closed Loop: As mentioned above, the second-generation system is a hybrid that would function similarly to the Minimed 670G, except Tandem's tech would use Dexcom CGM and the TypeZero algorithms. Tandem just completed its first pivotal trial and expects to do more later in the year, with a possible launch in the first half of 2019.
Autosoft XC Infusion Set (t:lock version of Animas Inset): Last year, Tandem announced it would be offering its own infusion sets instead of going through different manufacturers. The Animas Inset was a popular luer lock set for Tandem users, and now Tandem will sell those directly starting in the first quarter of 2018.
Mobile App: Tandem’s goal is to have an initial version of its mHealth app that displays current pump information on a smartphone and provides wireless uploads of pump data to a user’s t:connect account sometime in 2018.
International Expansion: Yes, Tandem's going global. The company plans to start selling the t:slim X2 outside the US in 2018, and has prioritized efforts in Canada first. They've not yet disclosed which additional countries are up next, but we'll stay tuned for that international gameplan.
Becton Dickenson's new Flow-Smart infusion set is on tap to make strides in 2018, as mentioned. Also, last year we reported on BD's analyst day when it announced two new innovations it has in the works:
Patch Pump for Type 2: This will be a fully disposable, three-day wear pump offering both basal and bolus dosing. Few details are available yet, but the original timeline of 2017 has come and gone and so we're hoping to see that in '18.
Smart Pen Needle Technology: They're also talking about Bluetooth-enabled pen needles that allow for dosing data to be shared, as BD works to bring more interconnected diabetes management into its product portfolio. These smart needles will work with all types of insulin pens, BD says. We haven't heard any timeline for that launch either.
Insulin Makers & Onduo
We now know that Eli Lilly is quite interested in developing its own connected diabetes devices, from a hybrid patch-tubed pump with CGM-connectivity to a smart insulin pen that could automatically dose and track insulin. These offerings are likely still years out, but it'll be interesting to see what more Lilly says about this in the year ahead.
The other two major insulin manufacturers, Novo and Sanofi, have their eyes on this space as well. Sanofi specifically has a joint-venture spinoff with Alphabet-owned Verily known as Onduo, and we've heard they'll be working with Blue Cross Blue Shield in a pilot program during 2018 to provide a wireless Band-aid style wearable device that goes on the stomach to monitor glucose levels and communicates with Onduo a mobile app. This well help healthcare providers be able to better guide PWDs with T2.
It's also worth mentioning that Glytec announced late last year it was integrating its Glucommander outpatient insulin titration product with the new "Onduo Virtual Diabetes Clinic" to provide a virtual health platform to help T2s better manage. Pilot programs are expected in 2018 with select US providers and clinics.
No doubt, aside from the official regulatory-cleared D-tech, we’ll see a ton of progress in homemade DIY items that have made huge strides over the past several years -- data-sharing apps, #OpenAPS and further closed loop tech.
Also exciting are the possibilities for patient innovators to collaborate with industry thanks to initiatives like Tidepool’s Big Data Donation Project, Dexcom's Open API/developer platform effort and the JDRF Call for Open Protocols launched in late 2017. These have HUUUGE potential to bring us better, more powerful and usable tools faster than ever before. Viva la Tech'spectations!
What about you, D-Community? Any diabetes tech / tools that you're particuarly excited or concerned about for this year? Let us know by emailing us at email@example.com!