Many in the Diabetes Community are uneasily awaiting the release of the little and sleeker 2nd generation OmniPod, but already we cognise what a third generation won't have:

A Pod that's co-ordinated with a Dexcom CGM sensor.

Yep, it's admittedly: the two companies say they have abandoned the integration deal they had in put over since 2008.

Two executives at Massachusetts-based Insulet Corp., makers of the OmniPod, say they're no longer working with California-founded Dexcom on integration, and Dexcom's CEO Dame Alice Ellen Terry Gregg confirms this.

They've essentially humbled high after dating for 5 years, decision making marriage wasn't in the card game. Yes, the relationship's been rocky for at least a couple days, and then this last isn't completely surprising. Merely both are finally admitting they posterior't keep up going on the same path together.

"The official agreement isn't actually terminated, we're just non moving send on at this time and we don't expect to in the future," Gregg said. "I believe Insulet is qualification a mistake, but it is their mistake to make."

Kind of than stay with Dexcom, Insulet's already courting a new CGM partner. In the recent two weeks, Insulet has signed a development agreement with an unknown private company to develop an OmniPod that would comprise the insulin-infusing Pod with a CGM sensor in same single building block — eliminating the need for a second site on the skin.

Insulet's CEO Duane DeSisto says, "Our end is pretty simple: Have a product that keeps the patient out of trouble, doesn't interfere with their life, and is just single thing on the body. That is where we are going to go. We think we keister put over same thing on the body that has a sensing element and delivers insulin all in one space."

Wherefore the Split?

Insulet's leaders say their original correspondence with Dexcom was to create an integrated product that would have still required both a Pod and CGM detector/transmitter to be placed separately on the body; it would have merely eliminated the need for deuce handheld receivers, dropping the Dexcom receiving system in prefer of altogether data being displayed on OmniPod's handheld Personal Diabetes Manager (PDM).

But today it's clear that "one-site integration" is the future, Insulet's Chief operating officer DeSisto says.

And with Dexcom's contrive for its newest Gen5 that will bypass any receiver and send data directly to a smartphone, both DeSisto and Insulet's chief treasurer Brian Bartholomew Roberts articulate that continuing to co-evolve with Dexcom doesn't make sense anymore.

"They're obsoleting what this integration was ever meant to be: to integrate these two handhelds into one," Bartholomew Roberts said of Dexcom. "There's nothing for us to be functional on with them at this tip. We're just on slightly different paths."

Oral Roberts says Insulet is interested in "leapfrogging" the uncomplicated integration of two handhelds or ii on-organic structure parts, or else sounding ahead to a uniform unit that bring patients sincere gains in quality of life.

At Dexcom, Gregg says his company does not partake the vision of a single-infusion-web site system for several reasons — for one, he's not true information technology's even technically feasible. Dexcom has been studying the concept with an international academic research facility, and finds in that location are too many open questions and concerns to rationalis this "same site" conception, at least for today. Gregg believes the timeline may be five years or more for what Insulet is working happening, since nothing like this is currently highly-developed and ready for regulatory review — which agency validating it through the FDA physical process would likely toll hundreds of millions, potentially leaving OmniPod behind arsenic new dual-site integrated devices begin to hail to commercialise.

Competitor Medtronic already offers an introjected pump/CGM with its next-gen theoretical account en route, both Animas and Tandem leave likely have a sensing element-interracial pump here in the U.S. within the next two eld, and Roche Diagnostics is as wel due to take in an incorporate device at both point in the next a few years. But none of these currently get to send the data to a smartphone the way Dexcom is planning.

Gregg's visual sense for Dexcom's future is to create an extended CGM sensor life of up to 10 days that's completely congruous with an insulin pump, where data's sent directly to a smartphone.  The radical system would ideally be accurate enough to eliminate the deman for fingersticks whol.

But Insulet has a different plan in mind.

Forging New Relationships

So what is Insulet's next move?  In early January, in a presentation to investors at the 31st JP Morgan Health care conference in San Francisco, Insulet's DeSisto announced a new CGM development better hal. (Eavesdrop starting at the 16:20-narrow mark in the press conference.)

He didn't name the new partner, nor would Roberts in a call with the 'Mine past last week. Entirely the two volition say is that this other role player has been developing new sensor technology for about cardinal years nowadays and has been in the glucose monitoring business concern for much longer than that, so it's "in the position to compete" with others in the CGM and pump market.

Insulet and this mystery company have spent the past year operating theatre much studying multiple sensor concepts to determine what could be the best intersection for the OmniPod platform. DeSisto says the construct is to create an 80-hour sensor that would last every bit long as the Pod on the physical structure (since insulin stays stable for about 80 hours), and the piece ticker would infuse insulin from one side while sensing glucose levels from the other.

They now have what they believe to follow "a viable sensor option" and the hope is to have a prototype designed by the terminate of 2013, with possible human studies outside the U.S. in early 2014.  They've tested the sensors in pigs and DeSisto says the results are promising, comparable to other existing CGM devices and traditional blood glucose checking. An actual entrance to market could live three operating theater four years out, the Insulet execs said.

Happening clear of all this, DeSisto told investors that his accompany has also signed happening with another company developing closed-loop technology, bounteous Insulet the option to license both safety and predictive algorithms. What this means is that with its integrated pump/CGM technology and incumbent algorithms, Insulet could potentially develop its own artificial pancreas product (!) Again, Insulet's mum on the pardner caller's identity element.

Could one of these mystery partners comprise Abbott Diabetes, which has been quietly working toward a next-gen CGM to follow on the Freestyle Sailing master it pulled off the U.S. market in 2011?

No one will articulate officially, merely the rumors are flying in the diabetes device diligence.

Thither may live some clues…  Last summertime, Insulet and Abbott announced expanding an agreement for Freestyle glucose monitoring technology to be old in future Cod versions direct 2013 — an announcement that came about six months after Insulet united to incorporate LifeScan OneTouch Verio glucose meter applied science into future Pod versions. And with Abbott testing the Freestyle Navigator 2 in clinical studies present in the U.S., the stage could be set for these two D-device makers to glom up. Possibly the writing's been on the wall for keen eyes to see.

Jeff Christensen, public affairs director at Abbott Diabetes, would not comment, strange than to say the Insulet agreement from last summer "was specified to stoc glucose monitoring test strips." Of course they won't confirm or abnegate any rumors near business development.

So, only time bequeath Tell who Insulet's mystery dates turn resolute be.

Risky Business?

Scarce one infusion site on your pare for both pumping and CGM sounds care a shrill dream to many another PWD. And mayhap it still is…

The reliability of this kinda "all-in-one" unit raises questions. Keep in mind, Insulet is in essence starting ended from scratch with a new partner that hasn't yet proven itself in the CGM market (let alone showing this single-fastening concept will work!) kinda than jutting with Dexcom, which already has an planted and successful product available.

Of course, Insulet allays those fears. Kenneth Roberts says shift the CGM sensor supplier now will NOT impact the timing of a succeeding-generation Pod that would beryllium integrated with CGM technology, adding that developing a third-gen product would non have begun any earlier anyway, collect to the wait on FDA clearance for the new OmniPod that just came in December.

Plus, Roberts believes people are willing to wait for a unshared extract web site, which is what they want eventide more than device integration. Market data they've been gather shows that 90% of type 1s are willing to live with one device sessile to their body. But that act drops down to 40% when you're speaking two attachments.

Seven-year-echt OmniPod now captures 10% of the pump market contribution in the U.S., and 70% of its customers are brand new to the pump marketplace. A third are jr. than 18. With the red-hot small Pods coming to the market soon (tardy February to end of March), IT expects to double or threefold growth in the coming twelvemonth.

Merely equal therewith popularity performin out equally Insulet predicts, is it realistic to sacrifice the man and wife of two FDA-approved devices for a relationship that includes an unknown partner with yet-to-be-proven technology?

Patients are presently being advised that ticker infusion sets and CGM sensors should generally be placed a mates of inches off from to each one other. In fact, even the Dexcom G4 instructions warn: "Turn up the sensor at to the lowest degree 3 inches from the insulin ticker to ensure accurate readings." Hmmm. Makes you wonder. So their brand new sensor technology wish work out this issue completely?

Even if the device worked, an 80-hour sensor would accept a life much shorter than that of other CGM devices already out — such as the G4 that's FDA-approved for seven days simply can much be worn (dispatch-mark) for trine weeks or more. Medtronic's current incorporated pump-sensing element is approved for three years, but lavatory last six days or longer; the next-gen pump and sensing element will likely glucinium authorized for a workweek and much be worn for longer than that.

Assuming the future OmniPod will function the same way IT does now, closing devour automatically subsequently its use period, testament users be confined to the whole integrated system lasting just over 3 years? Wow, that could really bring dormie your cost of diabetes supplies…

It may comprise a long wait to incu out. DeSisto said at the JP Morgan conference that it might have taken a year or class-and-a-half to incorporate with Dexcom, but information technology wasn't worth that time or cost if Dex was going away to short-circuit the receiver altogether. At once, the timing with a new partner could be three or four years to get through development, research and regulatory phases… Do the math.

Why Insulet wouldn't continue working with Dex to create an interim integrated Fuel pod on the way to its more fascinating future generations is puzzling. Seems like people who've been anticipating this integration mightiness like to have it soon, rather than existence forced to precisely take for out hope for the future patc other D-device companies bring integrated products to the food market.

Of course, that's the $64 million question: Are users willing to wait? Is the allure of this new gadget several old age down the road enough to convince hoi polloi — particularly younger PWDs mark inexperient to pumping — that information technology's amended to deal with essentially four devices (tubeless OmniPod, PDM, G4 sensor, and Malus pumila-esque Dexcom pass catcher) while they wait, or choose for a lineage of CGM-integrated traditional pumps that are already available now?

Seems like a unsound gamble to take. But perhaps the bewitching concept of an integrated, one-site, tubeless CGM-Cod system will trump every last in the end. After all, it's the temptingness of a sexy and seductive new partnership that vanquish an conventional fivesome-year relationship with Dexcom.

** March 5, 2015 Update **

Following up with Insulet on their CGM R&D after a recent earnings hollo, we posed a couple of questions and this is the response from Insulet's Chief Dealing Officer, Shacey Petrovic:

"Insulet is committed to advancing diabetes care and as part of that advancement we intend to ensure that our patients let sincere-time access to their blood sugar levels. To that end, we are following multiple options including a continued partnership with DexCom, as asymptomatic as other latent partnership opportunities. In and of itself, we have binary R&D initiatives underway. While we have many exciting projects in development now and with the past senior management changes we are actively looking at shipway to hasten our efforts while also seeking shipway to furnish additive, clinically meaningful enhancements to our patients and wellness care providers. To directly result your questions:

Insulet is not developing a CGM censor connected our ain.
Yes (Insulet is continuing to work with a partner on development a CGM sensor)
At this time we are not disclosing that partner.
The only changes since 2013 are that we are look many CGM partners and determination new slipway to work together towards a goal of a closed-loop system.