We're now well into the second half of the year, and with many diabetes companies holding their quarterly earnings calls to update investors, many of us are wondering: What's next in diabetes technology, before this year ends?
Short answer: Quite a bit, if you know what you're looking for.
We've been listening in to many of these D-industry conference calls for updates on what's in development and what's in the hands of regulators.
Just yesterday, we learned that the global tech standards body IEEE adopted a new standard for open communication and interoperability between glucose meters. This is great news, as our Diabetes Community has been pushing for this for years. The hope is that device manufacturers will immediately start weaving this set of requirements into their product design.
Here's a look at what else is now on our radar for the latter months of 2015 and moving into 2016:
Tandem Diabetes Care
Big news came recently with a development agreement between Tandem Diabetes and CGM-maker Dexcom, announcing that the two San Diego companies would be working toward future integration of the next-gen t:slim insulin pump and Dexcom G5 and G6 sensors, which will eliminate the need for a seperate CGM receiver.
That announcement came on July 30, just hours before Tandem Diabetes held its second quarter earnings call reporting on its most recent finances and also talked more about its future tech plans. What we learned on that call -- and in follow-up questions posed to Tandem execs -- is that the next-gen integrated device is going to take a while to materialize.
This is mainly because the current (original) t:slim tech doesn't contain the necessary Bluetooth chip to communicate with the G5 and G6 sensors. So Tandem will have to introduce an entirely new design.
Tandem is tying this in with its so-called Project Odyssey, it seems -- their internal name for the web-based program that will allow customers to access incremental updates to t:slim software and eventually will also serve as a channel for ordering hardware updates as well.
The company plans to submit the initial components of Project Odyssey to the FDA by the end of 2015. Tandem is also working to develop protocols and clinical study parameters for its next-gen tech, and will be talking more with regulators by year's end about how that investigatory process should play out.
Of course, we're still waiting for the integrated CGM-pump known as the t:slim G4 that the company filed with FDA in July 2014. Approval could come any time now, and Tandem says it can begin shipping the combo device within 60 days of getting the agency's green light.
Yet, we do have to wonder about this young company's ability to survive for the long haul. Via Diabetic Investor there are rumors circulating that Medtronic may have interest in acquiring this touchscreen pump company, but of course neither company will comment on that speculation.
Rumors aside, Tandem has a lot going on at the moment and is exciting to watch.
Many are eager to enter the next generation of CGM with Dexcom, after the company filed at the start of the year for its direct-to-smartphone G5 that will eliminate the need for a separate receiver.
That FDA approval could very well happen by the end of 2015, according to Dexcom's CEO Kevin Sayer's remarks during the company's second-quarter earnings call on Wednesday.
A G5 mock-up shown at the Consumer Electronics Show in January 2015
Dexcom says it plans to have that G5 available for both kids and adults at the same time -- different from previous generations, where pediatric designation came later. Nice!
Dexcom leaders also say they're moving quickly on the next-gen G6 sensor, which will allow for extended wear of likely 10 days and have more interference blocking for increased accuracy, and less calibration needed! Dexcom is planning the pilot pre-pivotal study on that before the end of 2015, with an expected FDA filing sometime in early 2016. That could mean a launch by 2017. Wow!
In the realm of data-sharing, Dexcom made headlines at the start of the year with its SHARE Direct solution. Of course, the company had acquired the cloud-based SweetSpot platform in 2012, and yesterday their execs said we can finally expect to see that updated software platform launched by the end of 2015 (pretty much timed with the G5 kickoff, we assume).
Currently, their solutions allow users to share and follow CGM data on iOS devices, and as of June, also follow other people's CGM data on Android devices, but you aren't able to share that data with an Apple device. The company tells us they're holding off with full Droid access now since G5 is so close to being approved, which will bring changes anyway.
During yesterday's call, we also heard Dexcom say its advanced R&D pipeline continues work on a new insertion device, improved receiver, and better transmitters, as well as work on the dosing claim that would show CGM data from the G4 is good enough to replace fingersticks. That would open the door for expanded access and coverage, especially from Medicare, and Dexcom's leadership expects that dosing claim to happen in 2016.
You can also listen to the Dexcom earnings call, and check out our live-tweeting from @DiabetesMine on Twitter. Or for more insight, see our March interview with Dexcom leaders, current CEO Kevin Sayer and past CEO Terry Gregg.
Lots to look forward to from Dexcom yet this year, and into 2016!
The first half of 2015 has been big for Medtronic, with giant leaps forward on data-sharing and a partnership with Samsung that will yield some exciting new tech down the road.
Medtronic's proprietary mobile data-sharing solution is called Minimed Connect, and it will be available this Fall. You can sign up now to pre-order this tool -- an uploader that you can easily carry in your pocket or on a keychain, which then transmits data via Bluetooth into the cloud where it connects with MedT's proprietary CareLink software and will link up with Glooko, thanks to the partnership announced in June.
The hardware system costs $199 and the app is free (iOS only for now, but Android is in the works).
We're still awaiting on word (long overdue) about Medtronic's 530G pump-CGM combo system getting approved for kids, which doesn't seem to be moving very quickly... which is a little curious. The 530G launched in the U.S. in late 2013, with the much-anticipated "Threshold Suspend" feature that automatically suspends insulin if the users blood sugar dips too low. It has been available overseas for several years.
We're excited to hear more about the next-gen Minimed 640G, a system that would not only suspend insulin but use the future Enlite 3 CGM sensor to predict when you're going Low and cut off insulin before you reach that point. But Medtronic seems overly optimistic about submitting that by year's end and even getting approval by mid-2016; we'll see how quickly that all moves along, especially since the clinical trial on that is still ongoing.
Exciting news came this week about Animas (owned by JnJ Diabetes) partnering with non-profit Tidepool, which is creating an open platform for diabetes data. Animas becomes the 6th major device manufacturer to open up its data for that purpose.
Other than that, the JnJ diabetes division appears to holding still at the moment, following the Animas Vibe launch early this year.
But looking ahead, we hear there may finally be some movement on the Calibra Finesse patch that JnJ acquired a few years ago, at which time it already had FDA approval! But the device has been hidden behind the scenes at JnJ since then.
The Finesse is a slim plastic "patch pump" worn on the skin for up to 3 days, holding as much as 200 units of fast-acting insulin for bolus-use only (in 2-unit increments). Users can just push buttons on the patch itself without any handheld controller or separate devices needed to control it.
This is similar to the Valeritas V-Go pump aimed at type 2 users, and those needing basal insulin will still have to use an insulin pen or needles for that purpose.
At the big ADA meeting in June, we got a first glimpse of the next-gen OmniPod PDM (personal diabetes manager) that Insulet is developing. As reported, the design is iPhone-ish, and the big updates are:
- color touchscreen with super-easy swipe navigation
- a home screen that is “action-oriented” with just three main command bars
- IOB (insulin on board) displayed on the lock screen
- contains the carb database from Calorie King, with tons of info on common packaged and restaurant foods
- allows 0% temp basal periods (which they say is big for pediatric use)
- there’s even an illustration of a body on the PDM with markings to help you track your infusion sites, for good rotation
- it’s Bluetooth LE-enabled, allowing data sharing with the Dexcom and software and app partners
Word has it that Insulet hopes to submit this to regulators by the end of this year, but that remains to be seen. The management at Insulet has been undergoing many changes, and now there may even be questions about the company's finances after the originally-scheduled July 30 earnings call was postponed to a TBD date. Insulet is now 10 years old and rumors have long been circulating that the company is looking for a buyer, but that too remains TBD.
Abbott Diabetes Care
We're hoping to hear official confirmation before long from Abbott Diabetes Care about what many of us already believe: That the FreeStyle Libre Flash Glucose Monitoring (FGM) system will be coming to the United States some time soon.
This is an entirely new breed of glucose monitor, as the user wears a quarter-sized patch and just scans a handheld device over that sensor to get an "in the moment" blood sugar reading. Users can do the scan as often or as little as they want -- with no need for a fingerstick test to confirm the result. The Libre has been on the market overseas already for the past year.
Key clues that it's coming here are the clinical trial that finished up in March 2015, and a more recent FDA filing of the professional version of the Libre. Hopefully, we'll see Abbott move on FDA filing of the patient-facing system by year's end.
(see also: some great coverage and real-world photos of the Libre from our friends at diaTribe)
Roche and More
There's also the Roche Diabetes Care intro of Accu-Chek Connect that we covered earlier in the year, but beyond that we're not aware of anything immediate coming from Roche. We're not holding our breaths for news of the Accu-Chek Insight pump already available overseas or the notorious Solo patch pump bought by Roche in 2010 but never materializing into anything.
Meanwhile, there's a LOT more going on in the diabetes tech and data world, moslty among smaller innovating players -- from new apps, glucose meters, future devices and smarter closed-loop generations that will change the game in D-care. Innovation is on a roll at the moment, it seems.
Know of anything big that we missed? Or that you're particularly looking forward to? Please share...