Big word for the Diabetes Community, as the side by side generation of the Omnipod tubeless insulin pump is finally FDA sanctioned and ready and waiting to hit the commercialize in the Concerted States!

Dubbed the "DASH," this is the first novel Omnipod darn heart modeling in five years, since the second-generation "Eros" device was released. Most notably, the newest Bluetooth-enabled pump will dish up as the platform for each future technical school from Massachusetts-based manufacturer Insulet, including their Omnipod Horizon closed loop system expected in the next couple of years.

The Food and Drug Administration cleared this next-gen Seedcase in less than vi months, granting 510(k) clearance on June 1, 2018 after it was submitted on Jan. 8. Insulet announced this approval via press release on Mon, June 4.

Some may follow wondering what took thus long, since the party had been talk of a new "smartphone-compatible" system since Old 2014, but those plans hit a cardinal-twelvemonth delay due to corporate restructuring and focus group research findings. Insulet unveiled the Omnipod DASH at its prototypal-ever investor day in November 2016, and finally submitted it at the start of 2018.

Remember, too, that Style is even more important because IT testament serve arsenic the platform for new generations of Omnipod tech, including the closed curl OmniPod View system (now renamed Omnipod 5) system expected in coming long time.

Here's what we know insofar about the new tubeless DASH system:

Touch screen PDM: DASH comes with a new touch screen PDM that's a "fast down" Android device, i.e. doesn't allow for former apps or cellular telephone 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 two-ply and weighing 6.17 ounces) as the early PDM just has a quadruplet-inch touch screen for entering data. It besides allows for duplicating and copying basal rate patterns and setting 0-unit essential rates American Samoa needed. The new PDM likewise sports an improved solid food database for logging carbs and including equally many as 80,000 items from FoodKing, and you can manually enter BG and other data arsenic well as personalizing repast entries for agile access. Note that the old Pods will not work with this new PDM.

Encounte Your PDM: This is a vast addition for the many users WHO've always left PDMs derriere by accident. Insulet has added a "Find My PDM" feature (Eastern Samoa part of one of two inexperienced apps) allowing users to track its whereabouts. We do recall listening, a few old age ago at the extensive ADA league, a number of pediatric clinicians telling Insulet reps how so many patients lose or forget their PDMs, and that a "damned keys" alert was needed. Great to see the OmniPod DASH designers were listening!

No built-in measure: In what may be a big downside for many users WHO love this combo device, the new Shoot will no thirster suffer a constitutional FreeStyle fingerstick glucose meter like the current system does. Instead, it wish use the BLE communication to talk directly with the Contour Next ONE meter from Ascensia Diabetes, with unrivaled of these meters being packaged with the system. While some English hawthorn be disappointed to take over to carry an surplus meter around, the BT-communicating is a jumbo step sassy in setting the stage for more information-streaming in the future. The DASH will store up to 800 readings/ 90 days of information. And don't draw a blank that Insulet has partnered with Glooko to admit BG results and other D-data from the OmniPod system to be beamed to that data chopine.

Reversible barrage: This commute may also be a downside for those WHO pleasing the use of ubiquitous AAA batteries in the old PDM. The untested system will take lithium ion batteries that take recharging, and may live more difficult to find in stores when in fast need of replacements.

No call hold in: The FDA is not allowing mobile app dosing from a smartphone at this time. The PDM is the only elbow room 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 some direct integration of CGM data with the new DASH, Insulet has told us previously that this is going to hap — information technology's only a matter of time. Meanwhile, the party is releasing new mobile apps and a widget tool to help users persuasion their Dexcom CGM data alongside their DASH data along their smartphone.

New-sprung mobile 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 Add-in (IOB), etc., along with a whatchamacallit for viewing CGM data right the smartphone alongside your OmniPod data. While Android is a work in progress, these apps testament only be iOS-mixable for now.

  • Omnipod Show app: allows users to discreetly monitor their system data at once on their smartphones, with no need to draw in out the PDM. This app also includes the "Find My PDM" characteristic.
  • Omnipod VIEW app: allows parents and caregivers (adequate to 12 people) to easily monitor their loved ones' BG levels on a continuous basis.
  • The iOS Today View thingamabob: allows users and their care teams to see their own data or a darling one's joint data from both the PDM and their CGM on a smartphone with just indefinite concealment purloin.

Kids nates use: The new DASH system is approved for altogether ages, kids and adults alike.

Tight? Opinions may vary happening what this agency, but yes you can (still) break up the OmniPod in the shower bath or during a bathroom. The Pod can cost submerged in aweigh to 25 feet of H2O for As long-run A an hour, but the PDM is not waterproof.

Insulet has also publicized a comprehensive FAQ on the new OmniPod DASH system, which has even more data that the D-Biotic community may be fascinated in.

We asked for details, but Insulet's not ready to disclose that information just yet undermentioned Food and Drug Administration favorable reception. They plan to plunge the DASH in March 2019.

Pricing: Props to Insulet for providing the unweathered OmniPod DASH PDM for free (!) with the buy of new Pods — although they have not yet released the monetary value of those. That will likely be unconcealed atomic number 3 the limited plunge rolls out. But keep in brain, you'll still atomic number 4 able to buy the Omnipod directly at the local pharmacy, with each boxful including five Pods.

Indemnity and Medicare: Like near things in diabetes, Your Coverage Crataegus laevigata Vary. Omnipod's had pretty decent coverage from close insurers, and the caller 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, overly!

Prior Omnipods still visible? 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 world-wide statistical distribution anywhere outside of the U.S. We do know that Insulet plans to bring forward over direct sales and marketing of the OmniPod overseas as of July 1, 2018, rather of relying on third-party suppliers, so we'll presumptive try more specific plans later this class.

Insulet is leading people who wish much information to call their client give care line at 800-591-3455.

Every last identical exciting to hear!

We'atomic number 75 looking forward to acquiring our hands on this new OmniPod Scoot, and are eager to see how it's received in the diabetes Podding community!