Investor Updates: Diabetes Technology Tidbits Mid-2016

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One of the best ways to find out what"s new and hot in diabetes technology is to follow the industry"s "earnings calls." These quarterly webcast sessions are designed to update investors on product pipelines and how business is expected to go in the coming months -- so essentially they"re sneak peeks into what we patients can expect down the road.

Here we are, at the mid-point of 2016 -- and oh boy, there"s quite a lot of news coming out of these investor calls held in the past few weeks by Dexcom, Insulet, Tandem Diabetes Care, and MannKind Corp. (makers of Afrezza inhaled insulin). In case you"re wondering why we don"t include Medtronic Diabetes in these updates, it"s because the company structures its business differently and is already in the first quarter of Fiscal Year 2017, with the next investor update in late Auust.

Here"s a rundown of what we learned about each on the business and new-product front in the recent earnings calls:

Tandem Diabetes Care

Making the biggest splash in earnings calls this quarter was San Diego-based Tandem Diabetes Care, which announced the plan for its next-gen technology platform and a new, remote upgrade program. We covered this pretty extensively in a NewsFlash post, but here"s an at-a-glance look at what the company has in the works:

• New t:slim X2 Platform: Pronounced just how it looks (t:slim ex2), this new pump will keep the original aspects of the t:slim color touchscreen, first launched in Summer 2012 and updated with new features in April 2015. It will have a new anodized housing with more of a satin finish. The X2 will have two-way Bluetooth, and will start shipping between October and December 2016. This is the platform that all future t:slim devices will be built on, eventually using the newly FDA-approved Remote Device Updater (see below) to allow CGM-integration and closed loop functionality.

• Closed Loop Tech: Tandem has a two-pronged pathway in mind -- first, it plans to launch a Predictive Low Glucose Suspend (PLGS) feature that would automatically shut off your insulin when a hypo is predicted based on the Dexcom CGM. Tandem hopes for launch of this by the end of 2017. Then for the next generation, Tandem plans a commercial launch of its "Treat-to-Target" system in 2018 that will use Dexcom CGM data to adjust insulin doses to keep users continually aiming for a particular blood sugar number.
• Upgrade Program: The Remote Device Updater is Tandem"s new program allowing quick and easy software upgrades directly from home. It"s PC and Mac compatible, and you can read more details on the program here.

But Tandem offered more than product updatees on its July 28 investor call. The company also addressed the current community advocacy push dubbed #DiabetesAccessMatters.

As a refresher, Tandem was the first to sound the bell on the controversial United Health Care decision in early May to offer an exclusive deal for new Medtronic insulin pumps, meaning that any covered patient wanting a new pump not made by Medtronic is up for fight. That policy went into effect July 1 and the D-Community is pushing hard to tackle this topic and related access issues.

And so is Tandem, it seems. During their July 28 earnings call, CEO Kim Blickenstaff said he met in June with UHC’s executive management team, responsible for making the decision to partner with MedT. While he didn’t elaborate with specifics, Blickenstaff said he “appreciated their willingness to meet and the meeting was a constructive and candid conversation.”

Blickenstaff says his team "walked away with a better understanding of what went into their decision-making," and that will allow Tandem to gather evidence and information that could possibly convince UHC to change the policy. Tandem shared clinical data illustrating why the company believes t:slim is a compelling pump choice and leads to better health outcomes. “At a higher level, I can say that we do not anticipate a near-term reversal of the UnitedHealthcare decision, but the door is open for future conversations and we look forward to continuing these discussions.”

Dexcom CGM

Dexcom held its quarterly earnings call on Aug. 2. The California CGM company had an impressive quarter, particularly with the landmark July 21 meeting in which an FDA advisory panel agreed that the G5 is accurate and safe enough to be used for treatment decisions.

That decision was a highlight of the call and Dexcom says it’s working with the FDA to finalize possible label changes, as well as post-market safety studies, that might be required to go along with its Dosing Claim that is currently under review by the full agency.

Dexcom CEO Kevin Sayer also said the company managed to snag 2% of the T1D population in the U.S. as customers during this past quarter. Wow, that’s a huge amount in just three months, considering there are 1.3-1.5 million PWDs in the United States!

Sayer went over the following technology updates as well:

• New Receiver: Dexcom has filed its touchscreen receiver, which would be an update to the existing G5 receiver that is for the most part the same in look and style as its predecessors going back to the 2012-launched G4 model. The interface will resemble the G5 mobile app.
• Updated G5 Mobile App: Dexcom filed firmware updates to its iOS-compatible G5 app, which may include new features such as Insulin on Board (IOB) information as well as other retrospective data analysis reports.
• New Smaller Transmitter + Insertion Device: Dexcom is also prepping its updated G5 transmitter, which we hear will be about 50% smaller. This goes along with a new push-button insertion system planned for launch by year’s end. The company plans to file both with the FDA by the Fall (delayed some due to the FDA panel meeting on dosing the company was prepping for).

• Android App: Dexcom plans to file with the FDA its Android compatible app before the end of September, meaning we could see a launch by year’s end or early 2017 (dependent on the FDA’s decision-making for the Transmitter firmware update). Dexcom’s also working to make Android compatibility happen internationally within the coming weeks.
• G6 Pivotal Trial: The pivotal study on their next-gen 10-day wear sensor should begin shortly. It will be more accurate in reading glucose data and require just one calibration per day, the company says. The pivotal trial will include a total of 300 adults and kids in a clinic for three days, making it the largest pivotal trial Dexcom has ever done -- with a possible commercial launch in 2017. This G6 is also being integrated into the work many Artificial Pancreas developers are using in their research.
  

• Sensor Auto Shutoff? Dexcom’s CEO says an auto-shutoff to protect from blood sugar lows is something the company has mulled over internally as far as electronics and software, but they aren’t sure what the FDA may ultimately require. As of now, the regulatory agency has not mandated an auto-shutoff for CGM sensors, even in light of the potential new Dosing Claim. If the sensor length plays into accuracy, then it’s possible the FDA might have concerns about people stretching the approved wear-time (10 days, for the G6). If for example a user doses insulin based on CGM data when they"re on Day 15 or 20 of a sensor, there"s a risk they"re seeing an inaccurate result. So who would be at fault, Dexcom or the patient? Of course, Sayer said that as we approach a two-week-wear sensor, there is less and less incentive for users to try to extend the wear. He confirmed that while Dexcom"s been hesitant to develop an auto-shutoff for sensors so far, they plan to explore that with FDA going forward.

• Verily (formerly Google Life Sciences) Partnership: Dexcom believes the first product developed (no details provided) will be ready for market in 2018, and that a smaller bandage-like sensor could be available by 2020. The first feasibility study for the latter will take place this Fall.

Next-Gen Animas Vibe with Dexcom G5: While it"s not specifically Dexcom-dictated and wasn"t mentioned on this earnings call, we have to remember the update from Animas earlier in the summer about its filing the G5-enabled Animas Vibe that it filed with the FDA on June 4, 2016. No way to know when that may get the green light from regulators, and until then no one"s talking specifics on what this newer Vibe will feature as to design, mobile app, etc. But when it"s approved, this latest Vibe will certainly be a boost for biz for both Animas and Dexcom as the G5 CGM sensor will be a great new product.

Insulet"s OmniPod

We’ve noticed during the past few earnings calls that Insulet’s management team seems to be the most excited bunch of folks we’ve heard talk about their own company and product lineup.

Here are some of the updates they provided during their Aug. 3 call:

• New Executive: Insulet has hired a new senior VP of Research & Development, Aimen Abdel-Malek. He’s largely responsible for the innovation behind what’s dubbed "Digital Insulet," their effort to develop next-gen mobile apps, data analytics, algorithms and user experience.
• OmniPod Mobile Apps: Launched in May 2016, the company"s new patient app offers training videos, tips and a direct link to customer care is available on both iOS and Android devices. It"s had more than 4,000 downloads as of the call, and Insulet says they’re seeing a steady increase in use and supply reorders through the app. Their new educational app for kids was also launched at the Children With Diabetes Friends For Life conference in early July. This virtual storybook called Toby"s T1D Tale features the Pod mascot Toby the Turtle and teaches young children about type 1 and D-management.

• Next-Gen OmniPod System: 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, and the insulin-containing Pod will have Bluetooth built in. It will give users the ability to view key PDM data like IOB, last bolus, and even Dexcom G5 data on their smartphone app.
• International Pods: Insulet’s excited about growth in Canada and Europe, particularly higher-than-expected demand in France where doctors are telling them there’s been a pent-up demand for Pods leading up to the launch in July.
• Higher Concentrated Insulin Pods: Works continues with Eli Lilly on developing the Humalog U500 and U200 Pods, which would allow for wider use among T2s and others who need higher doses of insulin. Insulet reports it’s more than 50% done with U500 clinical trials and the U200 work is also making progress.
  
• Artificial Pancreas Development: Insulet is working with the FDA to finalize its clinical trial protocols, and expects to start its on-body clinical trials later in Fall 2016. 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 Medtornic 670G hybrid closed loop expected next year, and what Tandem’s said publicly about its first-generation AP in development.

MannKind Corp.

Any regular readers here will know that we"re more focused on following device companies than medications themselves (read: we don"t follow investor calls on most insulins or oral drugs). But MannKind Corp., with its inhaled insulin Afrezza, is an exception because it"s both a medicaton and a unique inhaler delivery device.

During the most recent Q2 earnings call held Aug. 8, MannKind offered a snapshot of how it is currently re-launching Afrezza after Pharma giant Sanofi dropped their marketing and distribution agreement at the start of the year. The company"s been focusing on better pricing and access, including offering new samples packs and working toward label changes for easier and more effective dosing.

We found it interesting that MannKind execs pointed to the recent Dexcom CGM regulatory panel meeting and stated that should boost Afrezza marketing. The idea is that because CGM use is becoming more widespread and standard, and PWDs are used to seeing their diabetes data in real-time, they"re more likely to turn to a super-fast-acting insulin like Afrezza where they can more quickly treat Highs and Lows.

Interesting take, showing just how much the D-tech industry itself is inter-connected.

While we continue to be nervous about the company"s cash flow and overall ability to remain sustainable, we are cautiously optmistic about MannKind and certainly hope it remains an option for those who want to use it!

So D-peeps, any thoughts to share on all this new stuff coming down the pipeline? Or anything to add?

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

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