As we've noted before, one of the best ways to find out what's new and hot in diabetes technology is to follow the quarterly "earnings calls" that D-companies hold to update investors on product pipelines and near-term business projections. They're essentially sneak peeks into what we patients can expect to see soon.
What? You say you don't have time to join all these mid-day calls yourself? No worries, we're on it for you!
Amazingly, we're already winding down 2016, and wow, what a fascinating time in technology it is. Headlines have touted recent news of the first FDA-approved commercial closed loop system (pre-Artificial Pancreas), which Medtronic plans to start shipping in Spring 2017. Naturally, that milestone has dominated the discussion over much of the past few months.
Here's a rundown of what we learned about several of the leading diabetes device manufacturers from their recent earnings calls:
The most exciting thing we heard in the Nov. 1 earnings call by California CGM maker Dexcom was that the company has made four big filings with the FDA in the past quarter. Now waiting on regulatory approval:
G5 for Android: A premarket approval (PMA) supplement for the G5 Mobile app to work with Android phones. This is long-awaited, as the app's worked with the iPhone since the G5 launch in summer of 2015. We understand it's much more complicated getting 'Droid approval, as makers have to get the FDA's approval for each version of the phone (compared to iOS, which gets a blanket OK for all models).
Next-Generation Receiver: No one has seem images or specific details, but we've heard rumor that the next update to the existing G5 receiver will include a touchscreen. (The current receiver has not changed much since the original 2012-launched G4 model.) It's said that the new interface will resemble the G5
mobile app, and the FDA will continue to officially require that patients are provided a receiver even if they choose to not use it and just keep it handy as backup to the smartphone app.
New Inserter: This is a new push-button insertion system that Dexcom has been working on for some time now (no more plunger!). While it looks a bit different, this system appears to work similarly to Medtronic's one-button push inserter.
Smaller Transmitter: As we've reported before, Dexcom is also prepping its updated G5 transmitter, which we hear will be about 50% smaller. No official word on whether the battery life will be extended past three months, but it's likely that won't change since it's a hard-wired issue.
Hopefully, all of the above is coming sooner rather than later.
And what else?
Next-Gen G6: Dexcom is also moving forward on its next generation G6 sensor, which will accommodate 10-day wear and require a just single calibration per day, along with reducing data noise and outliers for better accuracy. Dexcom has already started its pivotal trial and enrolled about 40-50% of the total 300 adults and kids who will test the system in a clinic for three days -- making it the largest pivotal trial Dexcom has ever done. They're shooting for a possible commercial launch in 2017. Dexcom says it plans to present detailed data from the pre-pivotal studies at this week's Diabetes Technology Society meeting in Washington D.C. (we'll be attending and covering!).
Dosing Claim: Dexcom also continues working with the FDA on a non-adjunctive "dosing" claim for its G5 system, allowing this CGM generation and beyond to be labeled for use instead of fingersticks. An advisory panel approved this over the summer, and now the full FDA is considering this change. It's widely seen as a way to not only make CGM more available to PWDs who might want to use it in place of fingersticks, but also to ensure more CGM coverage for those on Medicare. As it stands, the Centers for Medicare and Medicaid Services (CMS) does not currently cover CGM, but this policy on a dosing designation could help persuade the center to change its policy.
Google Tech: Remember too that Dexcom's collaborating with Verily (formerly Google Life Sciences) on next generation diabetes technology. What we've been told is that this will be a miniature size CGM sensor as small as a bandage or dime! That Dr development continues, with an early generation launch planned for second half of 2018 and a 2nd gen planned for roughly 2020.
Towards an Artificial Pancreas: Of course, there's tons of chatter about launching commercial AP systems, and the landmark Medtronic Minimed 670G came up in both prepared remarks and questions during the Dexcom call.
Dexcom's Executive VP of Strategy and Corporate Development Steve Pacelli pointed out how the 2013-launched Minimed 530G was supposed to "put Dexcom out of business" based on all the hype surrounding that product, but obviously that didn't happen. So for now, the company says that until the new 670G is available to patients in Spring, they can't speculate about how it might influence Dexcom's business.
"We’re fighting a ghost for the next six to nine months, and we won’t really know what we’re up against until we actually have physical product,” Pacelli said on the call.
No doubt, the t:slim X2 is the most news-making item Tandem Diabetes Care has going at the moment. Approved over the summer, this X2 began shipping in mid-October and is the California pump company's future platform that will allow users to update features from home -- without needing to obtain a different hardware device each time, as has been traditionally required. It's approved for ages 6 and older, and offers two-way Bluetooth for communicating with more than one external device at a time.
Dexcom G5 Integration: During the earnings call, Tandem CEO Kim Blickenstaff said the company plans to file its G5 submission to the FDA by year's end, and with any luck a six-month review period could bring launch by mid-2017 of a Dexcom G5-enabled t:slim X2. This would mean that if you bought a t:slim X2 now, once this approval happens, you'd be able to update the pump from home remotely to include G5 CGM functionality for no extra charge.
Presumably, this would also pave the way for quicker FDA review of the next-gen Dexcom G6 update n the coming months (see details above).
Closed Loop: Tandem also plans in the coming year to move forward on its Automated Insulin Delivery (AID) system, which will rely on data from the Dexcom G5, which Tandem emphasizes is the most accurate sensor on the market. Tandem's first generation automated system will include Predictive Low Glucose Suspend (PGLS), meaning insulin delivery will be automatically suspended when a serious hypo is predicted, similar to what Medtronic has introduced. Tandem finished its feasibility trial in August and plans to conduct its pivotal trial in early 2017 -- meaning a mid-year FDA filing is likely, with a possible launch by the end of next year. That means it may be only a handful of months later than the expected Minimed 670G launch planned for Spring, and it would offer many of the same features as that system but with the more-popular Dexcom CGM and the unique t:slim pump look (!)
A second-generation Tandem system using both the Dexcom G6 and the TypeZero Technologies algorithm is expected to be launched at some point in 2018 as well, Blickenstaff said.
Despite all it has in the pipeline, Tandem says it is seeing an impact on ordering during this final leg of the year thanks to the Minimed 670G, as many customers appear to be holding off on buying a new pump until they get a closer look at that new "hybrid closed loop" system. Indeed, there is a lot of uncertainty right now, as the market waits to see how the 670G product actually performs once released.
Insulet and the OmniPod
Next-Gen Mobile Pod: Plan to see this debuted at the 2017 American Diabetes Association Scientific Sessions in San Diego, CA. This new “truly differentiated and connected system" will be a Bluetooth-enabled PDM and mobile app, with Bluetooth capabilities built into the insulin-containing Pod. It will give users the ability to view key data like IOB (insulin on board), last bolus, and even Dexcom G5 data on the smartphone app.
During Insulet's first Investor Day on Nov. 16, it announced more detail about this next-gen OmniPod that will be dubbed the "DASH" platform (short for mobile dashboard, at your fingertips).
This will be the same Pod form factor with Blue Tooth Low Energy built in, to communicate with a new color touchscreen PDM, any BT-enabled meter, and allowing for data-sharing with others.Yes, that means you'll have to carry a separate meter -- different from what's needed now, with the built-in FreeStyle glucose meter on the PDM. For this DASH platform, the Pod will have two-way BLE and will display data on the PDM as well as a smartphone, so you'll be able to see info like insulin on board, dosing, BGs, and CGM data. Insulet plans to submit to FDA in mid-2017, with an anticipated launch late next year. This will be Insulet's future tech platform to eventually use for the U-500/U-200 Pods being developed with Eli Lilly, as well as its first-generation closed loop technology.
Closed Loop Functionality: First up in closed loop product pipeline for Insulet will be the so-called Omnipod Horizon Automated Glucose Control System. The company’s kept much of the details of its AP plans under wraps, but it teases that this will go beyond just Predictive Glucose Suspend -- meaning it will offer more sophisticated functionality than the Medtronic 670G hybrid closed loop and what Tandem’s said publicly about its first-generation system in development.
Insulet has just completed its first investigational study on the algorithm in September and will soon be starting the second phase to evaluate how it performs for kids and teens. Unfortunately, Insulet has this on tap for a 2019 launch -- a full two years past when other systems are expected to hit the market, putting the OmniPod signiciantly behind competitors in the closed loop space. It retains the unique differentiator of being the only system with a patch pump at this time, but that's still a long way off by comparison.
Horizon hybrid closed loop system planned for late 2018, or sometime in 2019.
For U-500 OmniPod: Work continues with Eli Lilly on developing the Humalog U-500 and U-200 (higher concentrated insulin) Pods, which would allow for wider use among T2s and others who need higher doses of insulin. For the U-500 Pod specifically, Lilly has finished study enrollment, so most of 2017 will include that clinical trial work. Insulet's projecting this to be a late 2018-early 2019 market entry.
New Manufacturing: In September, Insulet announced plans to establish an automated manufacturing operation in the U.S. by 2019. That's meant to help meet the expected higher demand in the coming years, especially as the Boston area company releases new product platforms and eventually its closed loop system in the coming years.
Next-Gen Animas Vibe with Dexcom G5: The recent Johnson & Johnson Diabetes investor call didn't actually mention its pump brand Animas specifically, but we know that its next generation pump-CGM combo, the G5-enabled Animas Vibe, is currently under FDA review after being filed on June 4, 2016.
No one's talking specifics on the design or mobile app plans for his newer Vibe, but when it's approved, it will certainly be a biz boost for both Animas and Dexcom. Of course, we're crossing our fingers for a sooner-rather-than-later approval, yet not overlap too much with the much-anticipated Dexcom G6 launch.
BD Insulin Delivery Tech
During its Analyst Day on Nov. 17, Becton Dickenson announced two new innovations it has in the works:
Patch Pump for Type 2: A new Type 2 Patch Pump that will be fully disposable, three-day wear, with both basal and bolus dosing. Few details are available, as the company's quick to limit product specifics for "confidentiality" reasons, but expect to see this at some point in Fiscal Year 2017.
Smart Pen Needle Technology: This will be Bluetooth-enabled and allow for dosing data to be shared, as BD works to bring more interconnected diabetes management into its product portfolio. These in-development pen needles will work with all types of insulin pens, BD says.
These are just some snippets from the many exciting things happening in D-Tech progress -- all good!
What do y'all think?