What's New in Diabetes Tech from the 2019 ADA Scientific Sessions

Hot Diabetes Tech Seen at #ADA2019

This year’s 100,000+ square-foot Exhibit Hall featured more than 130 booths, from those with plush carpeted seating areas and giant overhead signs, to mini-display tables on the sidelines. Alongside their booth displays, of course many of the tech companies were also presenting new research during the conference. Some of the standouts were:

Tandem Diabetes Care

One of the most highly-anticipated must-sees leading into this conference was Tandem Diabetes Care’s coming-soon Control-IQ closed loop feature. They didn’t disappoint!

Remember, this is the feature planned for the touchscreen t:slim X2 insulin pump that will work with the Dexcom G6 (or any other compatible CGM), predicting and automatically adjusting basal rates to minimize lows but also automating correction boluses to ward off high blood sugars. Tandem is expected to file this with FDA soon and hopes for an approval and launch by year’s end.

New trial data presented on June 9 includes:

Teen and Adult Study: For those 14-71, Time in Range (between 70 mg/dL – 180 mg/dL) went up 2.6 hours overall, or 71% daily compared to 59% for those not using Control-IQ, while overnight that TIR was 76% compared to 59% for non-users. The system was used in active closed loop mode 92% of the time, and most impressively 100% of the 168 people using Control-IQ completed the trial and opted to keep using the system afterward — a positive wave the company hopes will continue in real-world use. (Notably, a smaller Stanford ‘real-world’ observational study on Medtronic’s Minimed 670G showed that as many as 46% of people using that device opted to discontinue use within a year because of the device complexity and perceived burden.) Tandem’s latest NIH-funded study is the first large-scale, 6-month AP study of its kind that included a dedicated control group — increasing the clinical significance of the study results.

Pediatric Study: Know as the Freelife Kid AP study, this one took place in France and included 120 T1D kids ages 6-12 years. Their TIR was just as impressive as the other study, showing time in the 70-180 mg/dL range increasing from 60% to 72% during the day overall and to 83% overnight. No severe hypos were reported, either. The Control-IQ active closed loop mode was used on average 87% of the time.

What makes the new Tandem data — and the Control-IQ concept overall — most exciting is that it brings us competition and choice of commercially available closed loop technology. This device is expected to roll out in the next half-year, and if so will leapfrog what Medtronic offers with its 670G system — and depending on real world use, its functionality could even surpass Medtronic’s planned next-gen 780G Advanced Closed Loop.

With both Tandem and Medtronic presenting positive clinical data on closed loop systems, the insurance companies may be forced to take notice in their coverage decisions.

Meanwhile, Tandem also has some other cool stuff in the works.

t:sport Patch Pump: The company is also working on its t:sport tubeless patch pump that we’ve seen in prototype-form in past years. This is a “hybrid” patch pump that also has a short infusion set connection, is 50% smaller than the existing t:slim pump, and will hold 200 units of insulin. That’s expected sometime after 2020, and in the meantime we’re also looking forward to Tandem’s mobile app that will allow for more insulin pump functionality and data display.

Mobile App: Yep, this is coming soon! We’ve been hearing about the Tandem t:connect mobile app for a couple years now, set to bring us wireless pump uploads, secondary pump data display, decision-support and integration with sleep, diet and fitness data. Tandem’s planning a launch by end of August.

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Medtronic Diabetes

With a wave of press releases this past week, Medtronic certainly snagged its share of attention. As we reported Monday, Medtronic made the huge surprise announcement at our #DData ExChange event that it will be working with open-source data non-profit Tidepool to develop a future Bluetooth-enabled device that will be interoperable with the in-development Tidepool Loop app for automated insulin delivery.

In its giant exhibit booth, the company was touting new trial data on its first-in-class Hybrid Closed Loop 670G system — despite lukewarm patient reviews and rumors that a growing number of endos have stopped prescribing it specifically because of the lack of user-friendliness.

As you walked up to the huge spread with comfy chairs and interactive screens, you were also greeted by a huge picture of the future Medtronic pipeline, including:

• Minimed 780G: Announced on June 8, their next-gen “Advanced Hybrid Closed Loop (ACHL) system” will have the basic form factor of the company’s 6-series models with a vertical “modern” look, compared to the older models with a horizontal design that resembled 1980s pagers. The 780G will use a new algorithm the company says is more accurate and reliable. It will provide automatic correction bolusing, will automatically adjust for missed meals, and allow an adjustable target down to 100 mg/dL (compared to the 670G’s set 120 mg/dL target). It also aims to achieve 80% user Time in Range compared to the existing 71% TIR shown in data on the 670G. Importantly, this BLE-enabled pump will allow for remote software updating — as offered by Tandem’s t:slim X2 — so users won’t be required to buy a whole new device every time new software features are launched. Clinical trials are now ongoing (see here and here) and should wrap by mid-2020.

• Personalized Closed Loop: Medtronic’s already investigating this future version of its own closed loop system that would allow for even more customized control via smartphone interface — with auto-settings optimization, optional auto carb coverage, and AI that lets it adapt to patient behavior. All with a Time in Range goal of 85%. The company says it hopes to submit that to the FDA by Fall 2020, something that may be feasible considering the FDA’s breakthrough designation granted for this investigational device in 2018.

• Interoperability Pathway: As part of all this future tech, Medtronic is ramping up for pivotal trials needed to get an “iCGM” classification — the designation created last year by FDA in approving the Dexcom G6 that refers to CGMs approved to work with related interoperable versions of insulin pumps, and control algorithms/apps. So far, Dexcom is the only CGM approved in this category, though competitors Abbott Libre and Eversense implantable CGM are pursuing this designation as well.

• Dosing Claim (and Medicare): Medtronic also tells us they’re prepping to soon submit an FDA “dosing claim,” aka “non-adjunctive designation” — meaning no fingerstick tests required to double-check CGM accuracy. They hope to submit the claim to FDA for their current Guardian 3 sensor by the end of July. That’s a crucial step in getting Medicare coverage, which Dexcom CGM and Libre Flash currently have but Medtronic does not.

• Future Smart CGM Sensors: We also got a peek at Medtronic’s planned future sensors: one called the “Zeus Sensor” that will still have the same seashell design requiring overtape, and their “Synergy Sensor” all-in-one sensor/transmitter that will be fully disposal and have a new look. The Synergy will be a flatter, square form factor 50% smaller than the current model, will not require any overtape to keep it on, and have a simpler three-step insertion process that would take just 10 seconds. Interestingly, Medtronic is planning for both to require a fingerstick calibration on the first day only (a departure from how Dexcom and Libre work without any needed calibrations). As of now, Medtronic forecasts filing the Zeus in mid-2020 and the Synergy in roughly 2021.

• Sugar.IQ Machine-Learning: In what it dubs as the fist app to use machine-learning to detect glucose patterns and offer “advanced notification” of Highs and Lows, MedT highlighted real-world data from its IBM Watson developed mobile app that works with its stand-alone Guardian Connect CGM. More than 3,100 PWDs using the Sugar.IQ app stayed within range 4.1% more often than those using the CGM without the app. And when using the Nutrino-powered Glycemic Assist feature, that TIR jumped another 4%.

We have to hand it to Medtronic. In spite of a legacy of unpopular business practices that have seemingly strong-armed many into ordering their devices, they’re now taking well-publicized steps toward supporting interoperability and patient choice.

Dexcom CGM

Over in the Dexcom booth, the company didn’t have as much on display as last year (when they were prepping for the newly-approved G6 launch). One big question on everyone’s mind seemed to when patients on Medicare can expect coverage for the G6? Overheard in the booth was a rep saying they would get on that “as soon as we can handle the inventory,” as they are still busy switching many patients from the older G5 model to G6. Of course, they don’t want to exacerbate customer service issues that have surfaced since they began an overhaul of their call center operations overseas, creating language barriers and other concerns.

Upcoming G6 Updates: There were no further updates on the coaching and decision support services the company had originally planned for a late-2019 launch. But we hear they will definitely start manufacturing the promised lower-cost G6 transmitter in the latter part of the year, with hopes to start selling them by year’s end. It will be roughly 50% less expensive than the current G6 transmitter, as well as having new electronics to expand Bluetooth range and offering new memory processing. Dexcom’s CEO Kevin Sayer also says they’re working to make that newer G6 transmitter capable of supporting the long-awaited direct-to-Apple Watch functionality.

G6 Professional Version: In a product demonstration on Saturday, Dexcom’s Chief Technology Officer Jake Leach mentioned that its G6 Professional CGM with both blinded and real-time data options is being delayed until early 2020. That’s not too surprising but still disappointing for clinicians and T2s who’d like to have this professional CGM option sooner rather than latter. It will connect to the existing G6 mobile app for data-viewing and sharing, and will be the first professional version since the G4 Pro. It will also put Dexcom’s clinical-focused version more on par with the Abbott FreeStyle Libre Pro product. Notably, Dexcom’s Pro version will also have a disposal transmitter which will pave the way for lowering device costs.

Next-Gen G7 Updates: As to the future, Leach said their next-gen G7 product being developed with Verily will have a faster warm-up time than the current G6 two-hour startup window. Other cool new features will include extended wear time of 14-15 days (!), a fully-disposable combined all-in-one sensor-transmitter that has a smaller on-body footprint, a dramatic cost reduction, more accuracy and reliability that comes with its iCGM interoperability designation, and direct Bluetooth-to-smartphone communication. Dexcom’s still slating this for later 2020 with a limited launch at first, before rolling it out more broadly across the U.S. and internationally in 2021.

Eversense Implantable CGM

Making itself known, Senseonics captured some of the earliest headlines on the day before the conference began with news that it had snagged the FDA’s OK for a “dosing claim” — meaning regulators think the company’s Eversense 90-day implantable CGM is accurate enough for insulin dosing and treatment decisions, without requiring fingerstick calibrations to double-check accuracy. Senseonics joins Dexcom in having this “non-adjunctive” status, though unlike Dexcom’s current G6 (and also the Abbott FreeStyle Libre Flash) that require no calibrations at all, the Eversense does require two fingerstick calibrations daily. Still, this is huge news, as the dosing claim paves the way for Medicare coverage for Eversense.

We’re also eager to see what comes next as to the 180-day-wear version, which is available overseas but not yet approved here in the USA. And we’re encouraged to hear that Senseonics is planning to pursue the “iCGM” interoperability designation, which would allow it to be used as a “plug n play” style device for compatible pumps and systems.

Along with a traditional booth, the company also had its big mobile Eversense truck-trailor parked at one end of the Exhibit Hall, plastered with a huge images of medical professionals who vouch for the company, including respected Drs. Bruce Bode and David Ahn! Conference attendees were filtering through the truck to get a look at the Eversense insertion procedure.

Abbott and the FreeStyle Libre Flash

No Libre 2.0 (Yet): Many were anticipating a near-conference announcement from Abbott Diabetes Care about FDA approval of its Libre 2.0 for the U.S. launch, but that didn’t happen just yet. Still, Libre was one of the most popular “Product Theater” presentations and was getting significant attention throughout the conference.

The Libre 2, which is approved overseas and currently before the FDA, will bring the Flash Glucose Monitoring system closer to being an actual CGM, where “continuous” means something… With the existing 14-day Libre, users must scan the round sensor every time they want to see a glucose reading. But it doesn’t offer any alerts for high or low blood sugars, a key difference from full-featured CGMs. The Libre 2.0 will offer optional real-time alerts via Bluetooth; it will alarm if sensor connection is lost or if it predicts a Low or High and prompt the user to scan the sensor for a real-time result. The Low range is 60-100, while the Highs are 120-400.

Short of U.S. regulatory approval, Abbott had new data to share that generated excitement: The first-real world study on Libre for those with type 2 diabetes doing Multiple Daily Injections (MDI) shows lower A1Cs — nearly a whole percentage point down from 8.9% to 8.0% after three months of use. That’s great to hear!

We’re also glad to see that the Libre data app is now compatible with Android smartphones, meaning non-iPhone users can make use of this technology!

Insulet Omnipod

Makers of the OmniPod tubeless pump were showcasing their latest DASH platform in their booth, even as the bigger news focused on new positive study results in children using their future Horizon hybrid closed loop system that’s expected to hit market in the second half of 2020.

They were also talking about pursuing approval for use of highly concentrated U-500 insulin in a new OP version aimed at people with type 2 diabetes, which they’re hoping will happen early next year. Additionally, they’re working on another version designed specifically to work with Humalog U200 insulin in a partnership with Eli Lilly.

Not surprisingly, they’re very active fighting for expanded access at the moment. “We’re seeking more coverage for DASH, through the Medicare appeal process internally and also via Medicaid. We’re doing advocacy for families that can’t afford the pump and really want it,” company leaders told us in the booth. “We’d like to see broader access for the type 2 population, and more uptake there.”

One big stride is getting Omnipod covered through payers’ “Pharmacy channel” as opposed to classifying Omnipod as DME (Durable Medical Equipment). This eases the process in that, for example, patients seeking the Omnipod would no longer be required to take a c-peptide test (specific to type 1 diabetes). Currently, no other insulin pumps are covered in the Pharmacy channel, and on the CGM front, only Abbott Freestyle Libre qualifies.

They’re also looking at changing the delivery and payment model for the Omnipod system, doing away with the four-year insurance lock-in required with most insulin pumps. They plan to offer the PDM (controller unit) for no-cost up front, and the first 30 days of supplies would be pay-as-you-go, to allow people to try out the system before they commit to long-term use.

For the DASH and future versions, they’re working on remote upgrades like Tandem offers, that allow users to get the latest features without having to swap out hardware.

Finally, Insulet folk told us they’re considering a marketing push to call their offering “pod therapy” versus “pump therapy” — to really differentiate the user experience.

Companion Medical’s InPen

Besides closed loop players, Companion Medical’s new InPen was something of a belle of the ball this year.

This small San Diego-based company has been working on its “smart” data-connected insulin pen for a good decade, and finally received FDA clearance in 2016. They began product rollout in 2017, and now are really coming of age, it seems.

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InPen is a Bluetooth-enabled ½ unit refillable insulin pen with a companion smart phone app. Except for the Bluetooth capability, the pen is pretty much a traditional metal insulin pen that accepts either Humalog or Novolog penfill cartridges. The insulin calculator and other “smart” features all reside in the app. See our full product review of the InPen here.

What’s exciting now is two new interoperability agreements announced just before this year’s ADA conference:

• A partnership with Glooko that will let InPen users easily integrate their data into Glooko’s D-data management system and mobile app.

• A collaboration with Dexcom
  that will enable two-way data-sharing between the InPen smart pen and
  the Dexcom CGM and its CLARITY software platform. The InPen/CLARITY
  report integration was being showcased in InPen booth at ADA, which was quite well-visited despite being one of the smaller, sideline booths.

“Now patients on injection therapy can also get the dose calculation and tracking capabilities of insulin pumps. We’re bringing pump features to MDI, finally!” says Sean Saint, Companion Medical’s President and CEO who lives with T1D himself. “The InPen is also great for ‘pump vacations’ and you can also do a seamless back-and-forth if you like.”

BD’s Ergonomic Needles

BD was showing off their educational diabetes app and new Nano 2nd Gen pen needle that’s been “redesigned from an ergonomic perspective.” Essentially, they’ve recreated the needle base to account for “injection force variability,” or the different amount of force people use when poking themselves with a pen needle or infusion set. With 4mm needles people can often go too deep — especially leaner people — but this second-gen design by BD concentrates and distributes the force to allow better depth for insulin absorption and less pain.

With modern small needles, it is recommend to inject at a 90-degree angle to be sure to reach the subcutaneous layer rather than just skin-deep, we’re told.

The Nano 2 should be available for purchase in July.

A few fun facts we learned about injections and needles:

• In the UK, PWDs who inject too vigorously are called “jammers”
• It is no longer recommended to pinch up your skin for a pen injection, as compressing tissue can lead to
  hypos
• 2000 research shows that all people have uniform skin thickness despite
  the weight or body type of the person

Xeris Pharmaceuticals

This is the company working on stable liquid glucagon. The planned FDA decision date has been pushed back from June to Sept. 10 for its Epipen-style glucagon rescue pen called Gvoke. Once approved, this will constitute a revolution in emergency glucagon treatment, saving us all from the inconvenient and downright frightening mix kits we’ve been forced to rely on for decades.

The Xeris booth at ADA was somewhat incognito, with a tagline that didn’t even mention the word “glucagon.” But we understand they’ve just released positive study results from two adult trials and one pediatric trial.

There was also a research poster on display in that hall about a study they did with Insulet of a dual-chamber automated insulin delivery (closed loop) system that delivers both insulin to lower glucose and liquid glucagon to raise BG when needed.

We’re all anxiously awaiting their Gvoke rescue pen, which we’re told will be priced “comparable to current kits.”

Coming later from Xeris: mini-dose liquid glucagon for exercise, and more “continuous delivery in dual chamber pumps” such as the iLet “Bionic Pancreas” out of Boston, which is also testing Xeris glucagon in its system.

One Touch

Seeing One Touch on the Exhibit Hall floor was notable on its own, as a lot has changed since last summer’s conference. Since then, JnJ sold off the LifeScan/One Touch brand to a private equity firm — and of course there was J&J’s unfortunate shutdown of the Animas insulin pump unit that took away one device option. Anyhow, One Touch was present, reassuring all that it’s still a leader in fingerstick glucose meters.

They were showcasing their popular Verio Flex meter and Reveal app, with signs boasting that the Reveal app is currently the No. 1 downloaded diabetes app in the United States with over one million downloads. No kidding! We were surprised, too. The Reveal app got an upgrade at the end of last year to include automatic detection of repeat high or low trends, personal goal-setting, and a feature to compare your 90-day BG average to your logged lab A1C result to dig into fluctuations over the past three months.

Oh, and they’re getting ready to launch a new Delica lancing device! Yep, a new, improved version of their Delica lancet is on tap for this August. The new model is white and lime green, and apparently reduces friction for even more comfortable use. It includes 13 depth settings to choose from, up from the previous 10. (Wow, more choices there than most PWDs would need, we’d assume). The good news for Delica users is that the new version will be compatible with existing proprietary Delica lancet needles.

Diabetes Data Companies, and Patch Pumps

Three of the leading companies in the diabetes data world had smaller, humbler booths on the sidelines but were getting plenty of attention nonetheless.

Tidepool — people were flocking by to congratulate CEO Howard Look and team on the announcement that they’ll be formally working with both Dexcom and Medtronic on the new Tidepool Loop system, quite possibly the most-anticipated thing in the DIY community to date.

Glooko — this company apparently now has over 2.2M patients on its award-winning diabetes data management platform, and was getting a lot of attention for partnering with… seemingly just about everyone these days. The company now has partnerships in place with Dexcom, Dreamed, Companion Medical (InPen), Insulet (Omnipod), Novo Nordisk, Senseonics (Eversense) and a whole host of clinics. Kudos to them!

One Drop — not to be outdone, this sexy meter+app+coaching provider made a major announcement on Saturday, June 8: they are launching 8-hour blood glucose forecasts for people with type 2 diabetes on insulin. This builds on the company’s expansion of their AI-powered Predictive Insights technology, and makes One Drop now the only provider of BG forecasts for people with T2D. The company says their machine learning algorithms “are powered by more than 2.2 billion data points, collected from over 1.2 million One Drop users.”

Valeritas V-Go: Meanwhile, we were somewhat surprised to see such a big booth display from Valeritas, with their V-Go patch pump for people with T2D. Remember, the V-Go was originally FDA approved back in 2010 and didn’t seem to be gaining much traction over the years. It’s a small one-day-wear patch that comes in three different sizes for varying basal rates. What’s given the company a boost is that Medicare now covers the V-Go under Part D, and that “disposable patch-like devices” were recently added to the ADA Standards of Care for type 2 diabetes. Could this mean a jump in competition in this space? Of course, we’re all still waiting for the long-promised Cequr / Calibra patch pump originally developed by J&J.

Valeritas is also still using a “Coming Soon” marketing mesage for the V-Go SIM (Simple Insulin Management) technology, a snap-on durable accessory for the V-Go pump that will provide one-way Bluetooth streaming of insulin dosing data to a smartphone. This is in partnership with Glooko, as announced in April 2018.

That’s what caught our eye on the Exhibit Hall floor, and that’s not even getting into all the research presented in sessions… So much to take in!

Stay tuned for our upcoming report on the more sciency-parts of the Sci Sessions.