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.
This past week, three earnings calls revealed some very news-worthy tidbits -- from Insulet, Tandem Diabetes Care and Dexcom. Here's what we learned about each on the business and new-product front:
Business Front: Insulet appears to be doing well on the business side these days. New patient starts were up 20% this past year, while new pediatric patients were up a full 30% over the previous year. So more patients are starting the OmniPod than ever before, it seems. Insulet CEO Pat Sullivan says the company now has a total 85,000 OmniPod users, as of the end of 2015.
Insulet sold its Neighborhood Diabetes Business (the mail order medical supply company it acquired a few years ago) to Liberty Medical early this month, meaning those OmniPod customers who used Neighborhood Diabetes as a durable medical equipment provider will now be switched to Liberty.
Higher Concentrated-Insulin Pods: Insulet’s excited about its partnership with Eli Lilly for developing OmniPod devices that will have both the concentrated U-200 and U-500 insulins inside. They're queuing up a clinical study the U-500 version now, and already have a third of the required patients signed up. Insulet expects both of these new Pods to be available in the next 2 or 3 years, offering more choice for PWDs who may need more insulin.
Mobile-Friendly OmniPod: Apparently, the company spent much of the past year doing market research to learn more about what patients want, don’t want, and how they can improve their offerings going forward.
By mid-year, Insulet plans to launch a mobile app that has basic functions like allowing customers to order supplies, find training resources, and generally “enhance the customer user experience.” We’re told the company isn’t ready to unveil the app’s name yet, but the initial launch will be iPhone compatible, followed by Android compatibility to be released towards the end of the year.
This combines with the recently announced Insulet Provided Glooko system, which is a fancy name for OmniPod data being merged into the Glooko data-viewing platform. That began in January and gives customers a way to use Glooko's mobile apps to display to track their diabetes data from the OmniPod and combine that with data from other devices.
All of this mobile-friendliness is a part of the new “Digital Insulet" campaign, aimed at shifting the focus to a digital platform and move the OmniPod controller functionality from the existing PDM to an app – eventually making way for a smaller and less complicated handheld device (that will likely only serve as a backup, if it follows the Dexcom smart CGM tech pathway).
Based on early discussions with regulators, Insulet is not yet sure what all can be put onto the first-generation mobile app, especially as it relates to insulin dosing functions. But the company wants to move as quickly as possible from the PDM to the mobile phone app, cutting down the size of its PDM so it only serves as a backup device – as that’s what their recent market research has told Insulet customers want the most.
New PDM: Yes, Insulet still plans to upgrade its OmniPod PDM but that is gradually going to be phased out as customers are shifted to a more mobile, smartphone app based system in the coming years. Insulet’s new chief commercial officer Shacey Petrovic says they’ll file a 510k application with regulators later this year, for a new touchscreen Bluetooth-enabled PDM that will be integrated with the Dexcom G5 system.
Hold up, Insulet’s planning to have Dexcom CGM tech weaved into its OmniPod system?
What about those plans Insulet had back in 2013 about developing its own CGM and working with an unnamed partner on that? Last we heard, that tech was in animal trials and they were seeing promising results. Of course, that was before the Insulet management team totally turned over, so whatever happened to that?
“We are no longer pursuing the specific program,” said Insulet's VP of Marketing Christopher Gilbert. “We do continue to explore other potential partnerships and development opportunities with CGM companies, but we do not have any public comments to share at this point."
OmniPod Artificial Pancreas: Big news came on this the morning of the Insulet earnings call, with an announcement that the OmniPod maker was partnered with Palo Alto startup Mode AGC (Automated Glucose Control) to develop its own OmniPod Artificial Pancreas system. We introduced Mode AGC last summer when talking with co-founder Dr. Jennifer Schneider, and it’s exciting to see this closed-loop algorithm being put into practice.
The algorithm will reside partly in the OmniPod itself, and the rest will be in the Cloud analyzing a person’s D-Data. Human on-body trials are planned to start later this year, with a pivotal trial in later 2017.
On the earnings call, Insulet execs said they want to offer predictive low glucose suspend, and eventually the capability for the system to automatically adjust insulin-dosing based on CGM readings.
We asked Insulet’s Gilbert for more detail on what that means, and he tells us this:
“Mode AGC uses a model that approximates an individual’s type 1 diabetes. It uses information from the past and present to predict the future. This information includes the patient’s total daily dose of insulin, correction factor, insulin-to-carbohydrate ratio, current glucose, rate of change of glucose, meals, etc. Once it makes the prediction it makes a decision on what to do with the insulin delivery dosage and then recalculates the dose over and over again.
"The best analogy is that of playing chess. One uses past and current info to forecast or predict what your opponent will do, then you make a move and re-forecast and make another move. In this way, the Mode AGC algorithm will use past and current data to forecast future blood glucose levels and make the necessary corrections on a regular basis (e.g. 5-minute intervals) to insulin delivery to optimize glycemic control while minimizing adverse events (i.e. hypoglycemia and hyperglycemia)."
In terms of design, the system won't look particularly unique, we’re told. It will use the existing Pod platform to expedite the program and to maintain the competitive advantage of this tubeless patch pump system.
Tandem Touchscreen Tech
Business Front: During the earnings call on Wednesday covering the Fourth Quarter and Full Year 2015, Tandem Diabetes reported that it has 33,000 customers now using all three of its touchscreen pumps -- the original t:slim, the larger 480-unit t:flex, and the t:slim G4 combo. More than 15,400 pumps were sent out during 2015, which is an increase of 43% over the previous year.
Tandem Tubeless Wearable Patch Pump: We first heard some company chatter about this t:sport back in early 2014 during earnings calls, and then it went off the radar until Summer 2015 when we heard Tandem Diabetes execs talking more about this during the Friends For Life conference.
This is what we know at this point about Tandem's plan for a sleek, OmniPod-like tubeless pump that it describes as a "hybrid" device:
- The t:sport will utilize the same t:slim technology to create a smaller, tubeless, waterproof patch pump
- It's designed for people who want greater discretion and flexibility, no tubing, the ability to deliver insulin without touching the pump
- Tandem anticipates it will include a wireless, touchscreen controller, and a small, waterproof reservoir unit attachable to the skin (like the Pod)
- It will be half the size of the t:slim, with a shorter cannula (of course)
- The reservoir will also be smaller, likely holding 200 units (compared to the 300 in original t:slims and 480 units in the t:flex); Tandem believes this will be popular, given the success Animas had with its smaller 180-unit reservoir size
- It will be controlled through either mobile app or a separate handheld device
- Development is underway and clinical trials are planned for 2016, with an FDA submission expected in 2017
Despite that last point, company execs say the t:sport is still in the early conceptual phase, therefore no images are publicly available yet of the prototypes being developed.
Remote Updating: You may remember that last year, Tandem was talking about introducing something called "Project Odyssey," a new way to upgrade our devices through software updates remotely from home, much like we do now with smartphones. This plan is now referred to more simply as "Tandem Device Updater."
The first iteration of this program will offer software enhancements for early t:slim users, giving them the ability to get the latest upgrades released in the past couple years that new t:slims now have built-in. Tandem plans to submit a 510k filing for this upgrade program with the FDA by July with a beta roll-out shortly after that.
They tell us the first iteration won't allow the Bluetooth chip to be turned on in t:slim pumps, but that's the eventual goal for Tandem. Turning on the BT would allow for the pump to be compatible with the Dexcom G5 and future BT-enabled CGM generations. Unfortunately, the newest t:slim G4 combo product will quickly become obsolete because it doesn't have the BT chip inside.
Tandem Artificial Pancreas: Tandem's first generation AP will use a predictive hypoglycemia algorithm that the company is developing internally. Tandem filed a pre-investigative submission last year and hs been talking to the FDA about plans to start a pivotal clinical trial by the end of 2016, and ideally a commercial launch by the end of 2017.
The second generation AP from Tandem would likely automatically increase or decrease insulin based on the predictive algorithm of CGM data. So it seems Tandem's AP pipeline resembles what Medtronic has going with its 640G predictive device as well as its 670G hybrid closed loop. Of course, Tandem uses the Dexcom CGM tech and says its system will be more desirable for patients because of the touchscreen design of Tandem pumps.
Pediatric and Provider Focus: Tandem plans to soon file a 510k filing with the FDA to get its t:slim tech approved for kids as young as age 6; it's currently approved only for those 12 and older. The company is also getting ready to launch its so-called t:connect HCP, a version of its software for healthcare providers that will allow them to better manage patient data as well as establish a separate account for all of their t:slim users. A beta launch will happen in the coming weeks, with a broader HCP launch in mid-2016.
Dexcom's was actually the first call we tuned into last week -- after which we posted a brief news alert about a Customer Notification that Dexcom Receivers may not sound audible alerts like they're supposed to for High and Low blood sugars. Meanwhile, they offered other pipeline R&D updates:
Receiver: Dexcom remains confident that it will have a newly-designed receiver by the end of the year, as we reported most recently in our D-Tech 'Spectations 2016 post. Dexcom's new receiver will sport a touchscreen and possibly an added feature with the G5 Mobile app that will display Insulin On Board (IOB) info fed from partner pumps like Animas Vibe, Tandem t:slim, and Insulet OmniPod. Very cool!
Inserter: The company is also excited about its new insertion system that will launch toward the end of the year, which will provide us CGM'ers with a smaller handheld applicator that you just stick on the skin, and push a button to insert (no more plunger!). Dexcom CEO Kevin Sayer says this will be the first new inserter the company has had since launching the CGM 11 years ago, and will be the biggest operational and manufacturing change the company has endured to date.
G6: Plans also remain for Dexcom to file its next-generation G6 model later this year, with that hopefully gaining FDA approval and coming to market by the end of 2016 or early 2017. That next-gen sensor will offer improved accuracy with a different algorithm, likely only one calibration needed daily, and probably a 10-day wear (instead of the current FDA-approved 7 days).
So D-peeps: What do you think of all the D-Tech that's coming down the pipeline in the near future? Anything to add?