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 inuagral 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.
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 an Android platform, that's locked down so other cellular data won't 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 via mobile app integration or on the PDM, depending on where our Podders want it, and the technical and regulatory requirements," says Insulet VP of Marketing Chris Gilbert.
"We feel that this will be a big improvement from a usability perspective. In the meantime, we're focused on providing a single hand held device (i.e. protective case that combines the two) that allows for wireless transfer of BG readings from a meter to the new PDM), as well as making the same BLE communication protocol open to all meters so people can choose their favorite meter as well."
Here's the brief video shown to investors on Nov. 16:
Insulet plans to submit this new system to FDA in mid-2017, with an anticipated launch late next year. This will be Insulet's future tech platform to eventually use for the U-500/U-200 Pods being developed with Eli Lilly, as well as its first-generation closed loop technology.
OmniPod Horizon Hybrid Closed Loop
First up in Insulets' closed loop product pipeline will be the so-called Omnipod Horizon Automated Glucose Control System. The company’s kept much of the details of its AP plans under wraps, but it teases that this will go beyond just Predictive Glucose Suspend -- meaning it will offer more sophisticated functionality than the Medtronic 670G hybrid closed loop and what Tandem’s said publicly about its first-generation system in development.
Insulet has just completed its first investigational study on the algorithm in September and will soon be starting the second phase to evaluate how it performs for kids and teens. Unfortunately, Insulet has this on tap for a late 2018 or 2019 launch -- about two years past when other systems are expected to hit the market, putting the OmniPod significantly behind competitors in the closed loop space. It retains the unique differentiator of being the only system with a patch pump at this time, but that's still a long way off by comparison.
It's exciting to see what Insulet has on tap -- even if some of us believe these changes are long overdue and OmniPod's a bit late to the party.
Investor Concerns over Safety
Meanwhile, just a day before Insulet's Investor Day, a report began circulating the Web claiming that OmniPods were "contributing to childrens' deaths."
Given that the source is unnamed and details are scarce, it seems pretty clear that this report is suspect -- likely originating with short-selling investors (folks who make money when the stock tanks). Therefore we hesitate to even share the link, but the fact is that it's already out there, and has garnered attention from both patients and HCPs. So for the sake of news coverage, here's that SkyTide article.
Insulet's Chief Operating Officer Shacey Petrovic described it as "unbelievably frustrating" and told us she hopes that the Diabetes Community can see through this scare tactic. Insulet also responded with a full statement, via email from spokeswoman Alissa Heizler-Mendoza:
“We are aware of a report being circulated by a short seller spreading unsupported rumors about the safety & efficacy of the Omnipod system. It's obvious that this individual has malicious intent to spread rumors about our product to drive the stock price down for the benefit of himself or the clients he serves."
"The sources of information this individual is using to support his erroneous claims appear to be from a number of publicly available sources, including the FDA MAUDE website. These data, some of which date back as far as 2008, appear to have been taken out of context to deliver a false conclusion. All manufactures including Insulet are required by FDA regulations to routinely report product events that occur during commercial use. To utilize these data out of context demonstrates the malicious intent of this short seller."
Insulet says it isn't aware of a single death caused by the OmniPod and it's "completely confident" that the Pod system is safe and effective. The company also points out that it routinely monitors all safety reports receive and uses those in product performance reviews, to assure they comply with FDA regulations.
That being said, Insulet -- like any device manufacturer -- has occasionally run into issues with faulty products...
Mystery of the Exploding Pod
Through the DOC, we heard about a family who recently had a scare with the OmniPod patch pump.
The D-Mom shared on a large Facebook group that her 12-year-old son was at school when apparently his OmniPod exploded while still being worn on his arm -- yikes! The pictures we saw online seem to confirm this.
We were unable to gather more details about the explosion itself, but this D-Mom did share that when she alerted Insulet, the company told the family nothing like this never had ever happen before. The company sent replacement Pods, but didn't offer any explanation as to what may have gone wrong. She also shared that she was hesitant to send the faulty Pod back to Insulet, because she would no longer have proof of the malfunction.
Insulet notes that the boy affected remains on the Pod, despite this unfortunate circumstance. And the company offered this statement by email about the "exploding Pod" report:
"We are aware of a product complaint circulating on social media. We take all complaints very seriously and make every effort possible to follow-up to understand all related details. We have made initial contact with this Podder’s mother to better understand their complaint and also retrieve the product for testing. We have yet to receive the returned product for testing, after a number of attempts from customer care, our clinical team and the local sales manager to contact the mother. It’s important for us to receive the product in question given we have no knowledge of any similar complaints in over 10 years on market which equates to roughly 60M+ pods. So we are unable to speculate as to the cause of this particular issue and, therefore, cannot confirm that the alleged situation took place."
We certainly understand that these situations present a dilemma, as noted in our recent series on FDA Recalls: we patients want to protect ourselves and not give up what could be important evidence, but on the other hand, it's important for the company to have access to any faulty technology in order to investigate and determine what the problem is, and whether it could be a widespread issue.
This is surely an exciting time for diabetes devices with all the new smart technology coming out. At the same time, it's important to keep all our eyes on product safety -- without whipping up unnecessary fear either. Perhaps we may offer six words of wisdom for makers of new diabetes tech:
Keep innovating. Be bold. Be ethical.