What an absorbing time it's been recently for the tubeless tire insulin pump OmniPod and its parent company Insulet.

From freshly merchandise updates released at its basic-ever Investor Day on November. 16, to claims about safety concerns circulating in social media, to i family's history about… well, an "exploding pod" on their 12-yr-old boy 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 girlish children and teens. Insulet's own research reflects they now command 21% of the insulin ticker market in the Conjunctive States, sandwiched between Medtronic's whopping 41% and competitors Animas and Tandem bicycle, all at 18%. This a big minute for the Boston-area company, which has been around since 2005 and, amazingly, remains the sole well-lined-faced temporary hookup pump company Hera in the US.

Now, Insulet's prepping for the launch of its next-generation product, that will impart the OmniPod into the mobile, information-sharing old age. Here's a look at those developments announced of late, and likewise a report on the cloud of rubber concerns.

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

The tubeless fuel pod will retain the same form constituent, but will have Bluetooth Low Vitality radio receiver capability built in to allow for communication with a recent color touchscreen PDM. This volition also leave communication with whatsoever BT-enabled fingerstick beat, but that means the adjacent-gen OmniPod DASH won't have a well-stacked-in FreeStyle glucose beat suchlike the rife Pods have — which may be a big downside for many users World Health Organization love this combo device.

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

The freshly PDM sports an built food database for logging carbs, and you can manually participate BG and other data using a nifty touch screen wheel. The new touchscreen will be what Insulet describes as a locked pull down Android twist, unity that doesn't take into account for other apps surgery cellular phone practice to interfere.

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

Too, the fellowship is banking on the FDA to soon approve use of CGM for diabetes therapy without the necessary for backup fingerstick tests — which would mean it's no longer critical for CGM users at least to comport around a traditional metre along with their pump.

"We counter the use of CGM/Flash technologies to gain as the 'adjunctive dosing' claim becomes a reality for these technologies. Given that, we are operative/plan to work closely with Dexcom and Abbott Libre on integrating those readings via mobile app integration or along the PDM, depending on where our Podders desire 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 usableness perspective. In the meantime, we're focused happening providing a sui generis hand over held device (i.e. protective type that combines the cardinal) that allows for wireless transfer of BG readings from a measure to the refreshing PDM), also as making the same BLE communicating protocol open to all meters so people can opt their favorite meter as recovered."

Present's the brief video shown to investors on Nov. 16:

Insulet plans to submit this new system to Food and Drug Administration in middle-2017, with an anticipated set in motion late next twelvemonth. This will be Insulet's future tech platform to eventually use for the U-500/U-200 Pods beingness mature with Eli Lilly, as well every bit its first-generation closed loop technology.

First up in Insulets' closed-loop system product pipeline will be the questionable Omnipod Horizon Automated Glucose Control Organisation. The party's unbroken more of the inside information of its AP plans covert, but IT teases that this will go beyond evenhanded Predictive Glucose Suspend — significant IT will offer more sophisticated functionality than the Medtronic 670G intercrossed closed loop and what Tandem's said publicly about its first off-generation system in growth.

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Insulet has just completed its first investigational study on the algorithmic program in Sept and will soon be starting the second phase to evaluate how it performs for kids and teens. Unfortunately, Insulet has this available for a late 2018 Beaver State 2019 launch — about two long time past when other systems are predicted to hit the market, putt the OmniPod importantly behind competitors in the closed loop space. Information technology retains the unique discriminator of existence the only system with a spot pump at this time, merely that's still a long way off by comparison.

IT's glamourous to see what Insulet has along tap — flush if some of us believe these changes are long due and OmniPod's a bite late to the party.

Meanwhile, just a day in front Insulet's Investor Day, a report began current the Web claiming that OmniPods were "causative to childrens' deaths."

Given that the source is unidentified and inside information are meager, 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 forbidden there, and has garnered attention from some patients and HCPs. So for the saki of intelligence coverage, here's that SkyTide clause.

Insulet's Chief executive officer Shacey Petrovic described IT as "unbelievably frustrating" and told us she hopes that the Diabetes Community can experience through this scare tactic. Insulet also responded with a full statement, via email from spokeswoman Alissa Heizler-Mendoza:

"We are sensitive of a paper being circulated by a chunky seller spreading unsupported rumors about the prophylactic & efficacy of the Omnipod system. It's obvious that this individual has malicious intent to spread rumors about our product to drive the lineage damage down for the benefit of himself operating theater the clients atomic number 2 serves."

"The sources of information this individual is using to support his erroneous claims appear to glucinium from a number of publicly available sources, including the FDA MAUDE website. These data, some of which date from A further as 2008, come along to take been taken out of context to fork up a unreal conclusion. Whol manufactures including Insulet are needed by Food and Drug Administration regulations to routinely report cartesian product events that occur during commercial use. To utilize these data out of context demonstrates the venomed intent of this short seller."

Insulet says IT ISN't aware of a various death caused by the OmniPod and it's "completely confident" that the Pod system is safe and effective. The company also points down that it routinely monitors altogether safety reports receive and uses those in product carrying into action reviews, to assure they comply with FDA regulations.

That organism aforesaid, Insulet — like any device maker — has from time to tim run into issues with faulty products…

Through the DOC, we detected more or less a family who recently had a scare with the OmniPod patch ticker.

The D-Mom mutual along a large Facebook group that her 12-year-previous Word was at school when apparently his OmniPod exploded while motionless organism worn on his arm — yikes! The pictures we saw online seem to confirm this.

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Whoa!

We were unable to gather more inside information nigh the explosion itself, but this D-Mamma did share that when she alerted Insulet, the company told the mob nothing care this never had of all time happen before. The company sent replacement Pods, but didn't whir any explanation every bit to what may have gone wrong. She also shared that she was hesitant to send the imperfect Pod rearmost to Insulet, because she would no longer have proof of the malfunction.

Insulet notes that the boy affected remains along the Pod, contempt this fatal consideration. And the company offered this statement by email about the "increasing Cod" report:

"We are sensible of a product complaint circulating on social media. We take all complaints very seriously and make believe all effort latent to follow-adequate to sympathise all related details. We induce made initial link with this Podder's mother to better understand their charge and too call back the product for examination. We have notwithstandin to receive the returned product for testing, after a number of attempts from customer care, our clinical team and the topical anesthetic sales manager to contact the mother. It's important for United States to receive the product in question precondition we have no knowledge of whatever similar complaints in over 10 years on market which equates to roughly 60M+ pods. So we are impotent 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 quandary — we patients want to protect ourselves and not cease what could cost important evidence, just on the other bridge player, it's most-valuable for the company to have access to any inaccurate technology in order to investigate and determine what the problem is, and whether information technology could be a widespread issue.

This is surely an exciting clock for diabetes devices with all the new smart technology coming out. Concurrently, it's important to keep altogether our eyes on product safety — without whipping up superfluous fear either. Perhaps we may offering half-dozen words of wisdom for makers of new diabetes technical school:

Keep innovating. Be bold. Be ethical.