Big news for the Diabetes Community, as the next generation of the OmniPod tubeless insulin pump is finally FDA approved and ready to hit the market in the United States!
Dubbed the "DASH," this is the first new OmniPod patch pump model in five years, since the second-generation "Eros" device was released. Most notably, the newest Bluetooth-enabled pump will serve as the platform for all future tech from Massachusetts-based manufacturer Insulet, including their OmniPod Horizon closed loop system expected in the next couple of years.
The FDA cleared this next-gen Pod in less than six months, granting 510(k) clearance on June 1, 2018 after it was submitted on Jan. 8. Insulet announced this approval via press release on Monday, June 4.
Some may be wondering what took so long, since the company had been talking of a new "smartphone-compatible" system since early 2014, but those plans hit a two-year delay due to corporate restructuring and focus group research findings. Insulet unveiled the OmniPod DASH at its first-ever investor day in November 2016, and finally submitted it at the start of this year.
And now, at a time when Insulet has more than a million "Podders" globally, we're all ready to embrace its next generation...
OmniPod DASH: At a Glance
Here's what we know so far about the new tubeless DASH system:
New Pods: Users will need to purchase new Pods, as the current Pods won't be compatible with the new PDM (Personal Diabetes Manager) controller. The Pod retains the same form factor -- (1.53'' wide by 2.05'' long and .57'' high, weighing 30 grams without insulin) -- but has Bluetooth Low Energy wireless capability built in, to allow for communication with a new color touchscreen PDM. It holds 200 units and is designed for 72-hour use (same as before).
Touchscreen PDM: DASH comes with a new touchscreen PDM that's a "locked down" Android device, i.e. doesn't allow for other apps or cellular phone use to interfere. It has Wi-Fi connectivity and software can be remotely updated over the air. It's pretty much the same size (1 cm thick and weighing 6.17 ounces) as the previous PDM 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 and including as many as 80,000 items from FoodKing, and you can manually enter BG and other data as well as personalizing meal entries for quick access. Note that the old Pods will not work with this new PDM.
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 hearing, a few years ago at the big ADA conference, a number of pediatric clinicians telling Insulet reps how so many patients lose or forget their PDMs, and that a "lost keys" alert was needed. Great to see the OmniPod DASH designers were listening!
No Built-in Meter: In what may be a big downside for many users who love this combo device, the new DASH will no longer have a built-in FreeStyle fingerstick glucose meter like the current system does. Instead, it will use the BLE communication to talk directly with the Contour Next ONE meter from Ascensia Diabetes, with one of these meters being packaged with the system. While some may be disappointed to have to carry an extra meter around, the BT-communication is a big step forward in setting the stage for more data-streaming in the future. The DASH will store up to 800 readings/ 90 days of data. And don't forget that Insulet has partnered with Glooko to allow BG results and other D-data from the OmniPod system to be beamed to that data platform.
New Rechargeable Battery: This change may also be a downside for those who appreciated the use of ubiquitous AAA batteries in the old PDM. The new system will take lithium ion batteries that require recharging, and may be more difficult to find in stories when in quick need of replacements.
No Phone Insulin Dosing: As far as we can tell, it doesn't appear the FDA is allowing mobile app dosing from a smartphone. The PDM is the only way to dose insulin from the OmniPod, and similar to past versions of the device, there are no buttons on the Pod itself to allow for insulin dosing if you don't have the PDM.
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. Meanwhile, the company is releasing new mobile apps and a widget tool to help users view their Dexcom CGM data alongside their DASH data on their smartphone.
New Mobile Data Apps: Specifically, with this new system, Insulet is launching two new smartphone apps for easy iOS-based monitoring of BG results, dosing records, Insulin on Board (IOB), etc., along with a widget for viewing CGM data right on the smartphone alongside your OmniPod data. While Android is a work in progress, these apps will only be iOS-compatible for now:
- OmniPod DISPLAY app: allows users to discreetly monitor their system data 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.
Yes to Kids: The new DASH system is approved for all ages, kids and adults alike!
Waterproof? Opinions may vary on what this means, but yes you can (still) wear the OmniPod in the shower or during a bath. The Pod can be submerged in up to 25 feet of water for as long as an hour, but the PDM is not waterproof.
Insulet has also published a comprehensive FAQ on the new OmniPod DASH system, which has even more data that the D-Community may be interested in.
Availability and Cost
We asked for details, but Insulet's not ready to disclose that info just yet... Still, we are happy to see Insulet has established a 24/7 phone line for people to call to navigate access issues. Here's what we know:
Launch Plans: Insulet says a limited launch for the first six months will begin in July, releasing the DASH to a pre-selected number of endocrinologists across the country through an OmniPod DASH AHEAD program. A full commercial launch is planned for "early 2019." There's no waiting list yet, Folks. Insulet is directing people who want more info to call their Customer Care line at 800-591-3455.
Pricing: Props to Insulet for providing the new OmniPod DASH PDM for free (!) with the purchase of new Pods -- although they have not yet released the cost of those. That will likely be disclosed as the limited launch rolls out.
Insurance and Medicare: Like most things in diabetes, Your Insurance Coverage May Vary. OmniPod's had pretty decent coverage from private insurers, and the company says that will likely remain the case for the new DASH platform. It's also notable that as of early 2018, Medicare Part D has allowed coverage for OmniPod. We hope to see Medicare coverage extended to this new platform ASAP, too!
Prior System Still Available? Yes! Insulet tells us they have no plans to discontinue the existing generation of the OmniPod at this time.
International Availability: As of now, Insulet hasn't announced any plans for international distribution anywhere outside of the U.S. We do know that Insulet plans to take over direct sales and marketing of the OmniPod overseas as of July 1, 2018, instead of relying on third-party suppliers, so we'll likely hear more specific plans later this year.
Future OmniPod Pipeline: The DASH will serve as the platform for new generations of OmniPod tech, including the closed loop OmniPod Horizon system it's working on and the higher-concentration insulin Pods being developed with Eli Lilly. Working timelines for the latter are roughly 2019 for the U-500 version, and the following year for the U-200 product. While its closed loop system is not expected to hit the market before 2020, investigational work is happening now, including a five-day clinical trial the company just completed in late 2017.
All very exciting to hear!
We're looking forward to getting our hands on this new OmniPod DASH, and are eager to see how it's received in the diabetes Podding community!