Want a sneak peek of new and future diabetes tech tools? One great way is to listen in to the quarterly "earnings calls" medtech companies hold to update investors on their product pipelines and business projections.
What? You say you don't have time to join all these mid-day calls yourself? No worries, we're on it for you! Here's a rundown of what we learned about several of the leading diabetes device manufacturers from their recent earnings calls for Spring 2019, as they recapped the first few months of the year.
Omnipod and the New DASH Platform
Maker of the popular Omnipod tubeless patch pump, Insulet Corp., held their first-quarter earnings call on May 2, on the heels of announcing the full commercial launch of their new connected Omnipod DASH system. That system was FDA approved in June 2018, and had been in initial limited launch mode since late last year. The details are as follows:
Touchscreen PDM: With the DASH system comes a new touchscreen PDM (Personal Diabetes Manager) controller unit that's actually a "locked down" Android phone, i.e. doesn't allow for other apps or cellular phone use to interfere. It has Wi-Fi connectivity, allowing the software to be remotely updated. It's pretty much the same size as the previous PDM (1 cm thick and weighing 6.17 ounces) but has a four-inch touchscreen for entering data. It also allows for duplicating and copying basal rate patterns and setting 0-unit basal rates as needed. The new PDM also sports an improved food database for logging carbs that includes as many as 80,000 items from Calorie King, and you can manually enter BG and other data as well as personalizing meal entries for quick access. Another change is that the new PDM uses lithium ion batteries that require recharging, compared to the older version that took replaceable AAA batteries.
New Bluetooth Pods: Existing Omnipod users will need to purchase new Pods, as the current Pods aren't compatible with the new Bluetooth-enabled PDM (Personal Diabetes Manager) controller. The new Pods will have the same form factor -- 1.53'' wide by 2.05'' long and .57'' high, weighing 30 grams without insulin -- but of course have Bluetooth Low Energy wireless capability built in, to allow for communication with a new color touchscreen PDM. The Pod still holds 200 units and is designed for 72-hour wear.
Find Your PDM Feature: This is a huge plus for the many users who've ever left PDMs behind by accident. Insulet has added a "Find My PDM" feature (as part of one of two new apps) allowing users to track its whereabouts. We do recall that at the big ADA conference a few years ago, a number of pediatric clinicians told Insulet reps how so many of their young patients lose or forget their PDMs, and that a "lost keys" alert was needed. Great to see the Omnipod DASH designers were listening!
No CGM Data: While there isn't any direct integration of CGM data with the new DASH, Insulet has told us previously that this is going to happen -- it's only a matter of time.
New Mobile Data Apps: Meanwhile, the company is releasing two new mobile apps and a widget tool to make the DASH system as smartphone-friendly as possible.
These apps are only iOS-compatible for now, but Android versions are under development:
- OmniPod DISPLAY app: allows users to discreetly monitor their system data -- BG results, insulin dosing records, Insulin on Board (IOB), etc. -- directly on their smartphones, with no need to pull out the PDM. This app also includes the "Find My PDM" feature.
- OmniPod VIEW app: allows parents and caregivers (up to 12 people) to easily monitor their loved ones’ BG levels on a continuous basis.
- The iOS Today View widget: allows users and their care teams to see their own data or a loved one's shared data from both the PDM and their CGM on a smartphone with just one screen swipe.
Omnipod Horizon Closed Loop: The DASH will serve as the platform for new generations of Omnipod tech, including the closed loop OmniPod Horizon system in the works. During this latest investor call, Insulet execs said they'll be starting a pivotal study soon that's been granted the new fast-track "breakthrough designation" by the FDA. The hope is for the Horizon to be ready for market by late 2020.
U-500 Pods: You may also recall that Insulet's been working for several years now on an Omnipod model that will use higher-concentration insulin, specifically Eli Lily's U-500. This would make the tubeless pump a real option for patients who need large amounts of insulin, which is the case for many people with type 2 diabetes. During the call, execs confirmed that final clinical studies of this model are now complete, and the company plans to submit the U-500 Pod to the FDA for review pretty much immediately -- so hopefully we'll see that approved and ready to launch by year's end!
Abbott Freestyle Libre 2 with (Optional) Alarms
We also learned that Abbott Diabetes Care has filed with regulators its next-gen version of the FreeStyle Libre 2 Flash Glucose Monitoring (FGM) system, which is already CE Mark approved outside the USA as of Fall 2018. That's the system that includes a little round disk-sized sensor worn on the arm, and a scanning device that patients wave over the disk to pick up glucose readings as frequently as they want, but to date the system didn't include any alerts that would sound to mark high or low blood sugar readings.
The new Libre 2 version will solve that problem, offering optional alarms that would sound if you scan the sensor and are experiencing an out-of-range high or low blood sugar.
Abbott says it has followed the protocols to get an 'iCGM" designation, which the
Keep in mind that while adding alarms helps the Libre to be a more "fully functional" CGM closer to what Dexcom, Medtronic or the implantable Eversense CGM offers, it still doesn't provide true continuous data, because it only picks up reading when the user does a scan.
But Abbott says they're developing a future version of the Libre with Bluetooth that would provide a continuous stream of data without any sensor-scanning required. That's what automated insulin delivery startup Bigfoot Biomedical has signed on to use in their future closed loop system. However, Abbott did not provide any hint as to timeline when that continuous Libre version might hit market.
"Smart" Insulin Pens and Glucagon, Too
Connected Insulin Pens: There's been anticipation around insulin pens that will be able to track dosing data and share that with other apps and devices. In Eli Lilly's recent earnings update the company confirmed it has submitted its first connected pen product -- referred to as a "Connected Care prefilled insulin pen" -- to the FDA during the first few months of 2019. Interestingly, word on this is that it's disposable, but we don't know much more than that. We assume that would be a prefilled version of the Lily Kwikpen with Humalog inside. Competitors Sanofi and Novo Nordisk are also working on connected pen technology, by the way, and early this year, Novo announced a partnership with Abbott to connect its pens specifically with the Libre Flash Monitor.
Glucagon: Meanwhile, we're anxiously awaiting updates on new forms of easy-to-administer glucagon to offset hypoglycemia. The Xeris rescue-pen version is before the FDA now, and expected to be decided upon in June. And Lilly's nasal mist glucagon is also before regulators, but word is that FDA has slowed that review process. We remain eager to see those get to market ASAP.
Tandem's Control-IQ System
Tandem Diabetes Care, which made a remarkable comeback in 2017 after almost going bankrupt, now has us on the edge of our seats awaiting their next-gen automated delivery system called Control-IQ.
In their recent April 30 earnings call, the company confirmed they plan to file that with FDA in July. From there, the hope is for a quick turnaround by regulators and possible launch by year's end.
As a reminder: this is the tech that would use the Dexcom G6 sensor (and theoretically, any other compatible CGM) to automatically predict glucose level changes in advance and adjust basal insulin to keep users in range.
We expect to see more data on Control-IQ at the ADA Scientific Sessions conference in June, and of course a launch by the end of 2019 would put this company ahead of the game on new commercial Automated Insulin Delivery (AID) systems -- even ahead of Medtronic Diabetes Care with its much-hyped Minimed 670G system.
Dexcom CGM Future Products
Problems Solved? San Diego-based CGM leader Dexcom made headlines earlier this year with corporate restructuring and customer service woes that frustrated many of us. While that's all being addressed, as discussed with CEO Kevin Sayer recently, none of it got much mention in their May 1 earnings call. Still, Dexcom talked about its business models and said that an expanding push to get its Dexcom G6 into pharmacy channels is a priority for this year.
Lower-cost Transmitter: While details are scarce, Dexcom did mention that it's planning a lower-cost G6 transmitter and other mobile app updates later in 2019. We've not yet been able to obtain any details on the form factor of that new transmitter, like how much smaller it might be, or other revisions it could bring to the CGM experience, beyond improved affordability.
Next-gen G7 product: The next-gen Dexcom sensor, expected in late 2020 or early 2021, will apparently be the product that Dexcom has been quietly developing with Verily (formerly Google Life Sciences division) for the past several years, It promises to be a mini-sized CGM device that's easy to use, available at a low cost. Both companies are betting that this will be a big win among the larger market of people with T2 diabetes.
These are just some snippets from the rapid progress in diabetes technology at the moment -- which is exciting, but somewhat dampened by access and affordability challenges.
Our hope is to see these innovations improve the lives of as many people with diabetes as humanly possible.