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Next-Gen Product, Safety Concerns and an Exploding Pod

What an interesting time it’s been recently for the tubeless insulin pump OmniPod and its parent company Insulet.

From new product updates released at its first-ever Investor Day on Nov. 16, to claims about safety concerns circulating in social media, to one family’s story about… well, an « exploding pod » on their 12-year-old son at school.

Yep, there’s a lot going on.

Just this week, Insulet announced it had reached the milestone of 100,000 Podders, with a majority of those customers being young children and teens. Insulet’s own research reflects they now command 21% of the insulin pump market in the United States, sandwiched between Medtronic’s whopping 41% and competitors Animas and Tandem, each at 18%. This a big moment for the Boston-area company, which has been around since 2005 and, amazingly, remains the sole full-featured patch pump company here in the US.

Now, Insulet’s prepping for the launch of its next-generation product, that will bring the OmniPod into the mobile, data-sharing age. Here’s a look at those developments announced recently, and also a report on the cloud of safety concerns.

 

New OmniPod DASH Platform – But No More Built-In Meter

During the company’s inaugural Investor Day on Nov. 16, they revealed some detail about their upcoming « DASH » platform (short for mobile dashboard, at your fingertips).

The tubeless pod will retain the same form factor, but will have Bluetooth Low Energy wireless capability built in to allow for communication with a new color touchscreen PDM. This will also allow for communication with any BT-enabled fingerstick meter, but that means the next-gen OmniPod DASH won’t have a built-in FreeStyle glucose meter like the current Pods have — which may be a big downside for many users who love this combo device.

With this new BT-enabled Pod and PDM, the system will be able to talk with a smartphone app to see features like Insulin on Board (IOB), dosing records, BGs, and CGM data right on the new PDM and smartphone screen.

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The new PDM sports an improved food database for logging carbs, and you can manually enter BG and other data using a nifty touchscreen wheel. The new touchscreen will be what Insulet describes as a locked down Android device, one that doesn’t allow for other apps or cellular phone use to interfere.

At this time, Insulet is actually not sure whether a PDM will be required at all — or if they’ll be able to allow insulin dosing directly from the smartphone. That’s up to the FDA to decide.

Also, the company is banking on the FDA to soon approve use of CGM for diabetes therapy without the requirement for backup fingerstick tests — which would mean it’s no longer critical for CGM users at least to carry around a traditional meter along with their pump.

« We anticipate the use of CGM/Flash technologies to increase as the ‘adjunctive dosing’ claim becomes a reality for these technologies. Given that, we are working/plan to work closely with Dexcom and Abbott Libre on integrating those readings…

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