Many in the Diabetes Community are anxiously awaiting the release of the smaller and sleeker 2nd generation OmniPod, but already we know what a third generation won’t have:

A Pod that’s integrated with a Dexcom CGM sensor.

Yep, it’s true: the two companies say they have abandoned the integration deal they had in place since 2008.

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

They’ve essentially broken up after dating for five years, deciding marriage wasn’t in the cards. Yes, the relationship’s been rocky for at least a couple years, and so this parting isn’t completely surprising. But both are finally admitting they can’t keep going on the same path together.

“The official agreement isn’t actually terminated, we’re just not moving forward at this time and we don’t expect to in the future,” Gregg said. “I believe Insulet is making a mistake, but it is their mistake to make.”

Rather than stay with Dexcom, Insulet’s already courting a new CGM partner. In the past two weeks, Insulet has signed a development agreement with an unnamed private company to develop an OmniPod that would incorporate the insulin-infusing Pod with a CGM sensor in one single unit — eliminating the need for a second site on the skin.

Insulet’s CEO Duane DeSisto says, “Our goal is pretty simple: Have a product that keeps the patient out of trouble, doesn’t interfere with their life, and is just one thing on the body. That is where we are going to go. We think we can put one thing on the body that has a sensor and delivers insulin all in one space.”

Why the Split?

Insulet’s leaders say their original agreement with Dexcom was to create an integrated product that would have still required both a Pod and CGM sensor/transmitter to be placed separately on the body; it would have only eliminated the need for two handheld receivers, dropping the Dexcom receiver in favor of all data being displayed on OmniPod’s handheld Personal Diabetes Manager (PDM).

But now it’s clear that “one-site integration” is the future, Insulet’s CEO DeSisto says.

And with Dexcom’s plan for its newest Gen5 that will bypass any receiver and send data directly to a smartphone, both DeSisto and Insulet’s chief financial officer Brian Roberts say that continuing to co-develop with Dexcom doesn’t make sense anymore.

“They’re obsoleting what this integration was always meant to be: to integrate these two handhelds into one,” Roberts said of Dexcom. “There’s nothing for us to be working on with them at this point. We’re just on slightly different paths.”

Roberts says Insulet is interested in “leapfrogging” the simple integration of two handhelds or two on-body parts, instead looking ahead to a single unit that bring patients real gains in quality of life.

At Dexcom, Gregg says his company does not share the vision of a single-infusion-site system for several reasons — for one, he’s not sure it’s even technically feasible. Dexcom has been studying the concept with an international academic research center, and finds there are too many open questions and concerns to justify this “same site” concept, at least for now. Gregg believes the timeline may be five years or more for what Insulet is working on, since nothing like this is currently developed and ready for regulatory review — which means validating it through the FDA process would likely cost hundreds of millions, potentially leaving OmniPod behind as new dual-site integrated devices begin to come to market.

Competitor Medtronic already offers an integrated pump/CGM with its next-gen model on the way, both Animas and Tandem will likely have a sensor-integrated pump here in the U.S. within the next two years, and Roche Diagnostics is also expected to have an integrated device at some point in the next few years. But none of these currently aim to send the data to a smartphone the way Dexcom is planning.

Gregg’s vision for Dexcom’s future is to create an extended CGM sensor life of up to 10 days that’s completely compatible with an insulin pump, where data’s sent directly to a smartphone.  The new system would ideally be accurate enough to eliminate the need for fingersticks altogether.

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 Healthcare conference in San Francisco, Insulet’s DeSisto announced a new CGM development partner. (Listen in starting at the 16:20-minute mark in the news conference.)

He didn’t name the new partner, nor would Roberts in a call with the ‘Mine late last week. All the two will say is that this other player has been developing new sensor technology for about eight years now and has been in the glucose monitoring business 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 or more studying multiple sensor concepts to determine what could be the best product for the OmniPod platform. DeSisto says the concept is to create an 80-hour sensor that would last as long as the Pod on the body (since insulin stays stable for about 80 hours), and the patch pump would infuse insulin from one side while sensing glucose levels from the other.

They now have what they believe to be “a viable sensor option” and the hope is to have a prototype designed by the end 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 sugar checking. An actual entrance to market could be three or four years out, the Insulet execs said.

On top of all this, DeSisto told investors that his company has also signed on with another company developing closed-loop technology, giving Insulet the option to license both safety and predictive algorithms. What this means is that with its integrated pump/CGM technology and necessary algorithms, Insulet could potentially develop its own artificial pancreas product (!) Again, Insulet’s mum on the partner company’s identity.

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

No one will say officially, but the rumors are flying in the diabetes device industry.

There may be some clues…  Last summer, Insulet and Abbott announced expanding an agreement for Freestyle glucose monitoring technology to be used in future Pod versions through 2013 — an announcement that came about six months after Insulet agreed to incorporate LifeScan OneTouch Verio glucose meter technology into future Pod versions. And with Abbott testing the Freestyle Navigator 2 in clinical studies here in the U.S., the stage could be set for these two D-device makers to hook up. Maybe the writing’s been on the wall for keen eyes to see.

Jeff Christensen, public affairs director at Abbott Diabetes, would not comment, other than to say the Insulet agreement from last summer “was specific to blood glucose monitoring test strips.” Of course they won’t confirm or deny any rumors about business development. 

So, only time will tell who Insulet’s mystery dates turn out to be.

Risky Business?

Just one infusion site on your skin for both pumping and CGM sounds like a pipe dream to many a PWD. And maybe it still is…

The reliability of this kind of “all-in-one” unit raises questions. Keep in mind, Insulet is basically starting over from scratch with a new partner that hasn’t yet proven itself in the CGM market (let alone showing this single-attachment concept will work!) rather than sticking with Dexcom, which already has an established and successful product available.

Naturally, Insulet allays those fears. Roberts says switching the CGM sensor supplier now will NOT impact the timing of a next-generation Pod that would be integrated with CGM technology, adding that developing a third-gen product would not have begun any earlier anyhow, due 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 single infusion site, which is what they want even more than device integration. Market data they’ve been gathering shows that 90% of type 1s are willing to live with one device attached to their body. But that number drops down to 40% when you’re talking two attachments.

Seven-year-old OmniPod now captures 10% of the pump market share in the U.S., and 70% of its customers are brand new to the pump market. A third are younger than 18. With the new smaller Pods coming to the market soon (late February to end of March), it expects to double or triple growth in the coming year.

But even with that popularity playing out as Insulet predicts, is it realistic to sacrifice the marriage of two FDA-approved devices for a relationship that includes an unknown partner with yet-to-be-proven technology?

Patients are currently being advised that pump infusion sets and CGM sensors should generally be placed a couple of inches away from each other. In fact, even the Dexcom G4 instructions warn: “Locate the sensor at least 3 inches from the insulin pump to ensure accurate readings.” Hmmm. Makes you wonder. So their brand new sensor technology will solve this issue completely?

Even if the device worked, an 80-hour sensor would have a life much shorter than that of other CGM devices already out — such as the G4 that’s FDA-approved for seven days but can often be worn (off-label) for three weeks or more. Medtronic’s current integrated pump-sensor is approved for three days, but can last six days or longer; the next-gen pump and sensor will likely be approved for a week and practically be worn for longer than that.  

Assuming the future OmniPod will function the same way it does now, shutting down automatically after its use period, will users be confined to the whole integrated system lasting just over three days? Wow, that could really bring up your cost of diabetes supplies…

It may be a long wait to find out. DeSisto said at the JP Morgan conference that it might have taken a year or year-and-a-half to integrate with Dexcom, but it wasn’t worth that time or cost if Dex was going to bypass the receiver altogether. Now, 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 Pod on the way to its more fascinating future generations is puzzling. Seems like people who’ve been anticipating this integration might like to have it soon, rather than being forced to just hold out hope for the future while other D-device companies bring integrated products to the market.

Of course, that’s the $64 million question: Are users willing to wait? Is the allure of this new gadget several years down the road enough to convince people — especially younger PWDs brand new to pumping — that it’s better to deal with essentially four devices (tubeless OmniPod, PDM, G4 sensor, and Apple-esque Dexcom receiver) while they wait, or opt for a line of CGM-integrated traditional pumps that are already available now?

Seems like a risky gamble to take. But maybe the captivating concept of an integrated, one-site, tubeless CGM-Pod system will trump all in the end. After all, it’s the allure of a sexy and seductive new partnership that beat out an established five-year relationship with Dexcom.


** March 5, 2015 Update **

Following up with Insulet on their CGM R&D after a recent earnings call, we posed a few questions and this is the response from Insulet’s Chief Commercial Officer, Shacey Petrovic: 

“Insulet is committed to advancing diabetes care and as part of that advancement we intend to ensure that our patients have real-time access to their blood glucose levels. To that end, we are pursuing multiple options including a continued partnership with DexCom, as well as other potential partnership opportunities. As such, we have multiple R&D initiatives underway. While we have many exciting projects in development now and with the recent senior management changes we are actively looking at ways to expedite our efforts while also seeking ways to provide additional, clinically meaningful enhancements to our patients and health care providers. To directly answer your questions:

Insulet is not developing a CGM censor on our own.
Yes (Insulet is continuing to work with a partner on developing a CGM sensor)
At this time we are not disclosing that partner.
The only changes since 2013 are that we are looking at more CGM partners and finding new ways to work together towards a goal of a closed-loop system.