In the world of diabetes devices, company execs, PR pros, sales reps and even doctors are often vague about when new products will hit the market and be available for us people with diabetes. They tout new tools "coming soon" without any specificity as to when a product might actually be available. And on message boards frequented by patients, rumors can fly.
After an exciting year of new diabetes product approvals in 2012, we wanted to find out more about the status of these developments and where the vendors stand in terms of getting these new D-products into our hands.
We all know that sometimes looking at diabetes device introductions overseas is kind of like peering into a crystal ball for what's to come Stateside, but it's still tough to nail down a specific timeline for appearance in the U.S.
Fellow D-Blogger Michael Aviad over at ASweetLife recently compiled a list of seven new D-products expected at some point this year. With the clock ticking now that 2013 has begun, we thought it was worth looking into exactly when some of these and other new products are realistically expected to hit the market.
So here's our up-to-the-minute reality check on what to expect in 2013 (or at least "word" from the vendors themselves):
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
Abbott FreeStyle Navigator II
Remember the now-defunct FreeStyle Navigator CGM (continuous glucose monitoring) system that was discontinued in the U.S. by Abbott back in August 2011 (after we were led on for a looong time that it was just "suspended" for a bit)? Well, we got word following the EASD (European Association for the Study of Diabetes) conference in October that Abbott was exploring a quiet launch of its next-gen Navigator for the U.S. At the time, the company's public affairs director told us no formal presentation was made at EASD, and that nothing was happening in regard to a U.S. launch.
But we stayed curious. Especially after learning about an FDA-approved clinical trial here in Santa Fe, NM, and Atlanta, GA, involving the Navigator II. And after seeing pictures and details appear online at the company's German website.
We reached out at the start of this new year to PR director Jeff Christensen, and he told us:
"As you're aware, the original FreeStyle Navigator System was discontinued in the U.S. That status continues unchanged. As to FreeStyle Navigator II, we don't typically disclose specific business strategy or our plans for regulatory filings. However, I can confirm that we continue to develop our next-generation of products based on the sensing technology at the heart of FreeStyle Navigator...
"The specific study to which you referred involved 31 enrollees and has been completed, as noted in the entry on ClinicalTrials.gov. The information that we have available on that study is what is posted (there)."
Sure, we get it -- there's stuff you just can't say. But for a company that pulled the rug out from so many loyal customers with the lapse in original Navigator availability, we'd hope for a little more. Personally, it's tough to see how anyone could look beyond the past behavior by Abbott and sign on with the company in the future... but, who knows. It all depends on the device, apparently.
As of now, Christensen says the Nav II is available in Belgium, Denmark, France, Germany, Israel, the Netherlands, Norway, Sweden and the UK. So, we'll just have to wait and see for it to reach us Stateside.
Animas Vibe Integrated Pump & CGM System
Everyone's been waiting for the next integrated pump and CGM, and the one that seems to be on the horizon in the near future is Animas Vibe (which got European approval back in Summer 2011). With last year's exciting approval of the Dexcom G4 Platinum CGM, the final piece for the Vibe seemed to have fallen into place. Company officials said they'd been waiting for the G4 approval in order to submit the updated Vibe to the FDA for approval.
Well, that hasn't happened yet. Global communications director Caroline Pavis at Animas tells us this:
"Bringing Animas Vibe to the U.S. and Canada is one of our highest priorities. We are committed to submitting the PMA (pre-market approval request) for the Animas Vibe Glucose Management System as soon as possible in 2013."
Once again, little detail except "soon, we hope."
The company had more to say about a different clock, though. In December, Animas sent a letter out to customers about a technical problem with its older 2020 insulin pump models (the ones before the Ping). Basically, the software in those pumps has a glitch that means the 2020 pump will no longer deliver insulin after midnight on Dec. 31, 2015 (!)
A "call service alarm" will materialize. So, about three years before this problem manifests for a pump that's recently been discontinued in the U.S. and Canada, Animas is alerting everyone, with the note that the product label will be updated to reflect this issue. Nothing will affect pump operations before 2016, so pumpers don't need to do anything now, and replacement warranties for a free pump before then are being honored.
Too bad the same kind of proactive communication isn't being applied to the Animas Vibe and the filing of paperwork, which is "likely" happening in the first half of this year, we're told.
Asante Pearl Pump
Little has happened with Sunnyvale, CA-based Asante Solutions since it received FDA approval for a new partially-disposable insulin pump in May 2011. The Asante Pearl was expected to be well on the market by now, but that hasn't come to be. We saw Asante at a presentation during the ADA Scientific Sessions in June, and they've also been hiring new execs throughout 2012. But there hasn't been much else from them...
When queried, company spokesman Steve Bubrick tells us that Asante expects the Pearl Pump to be launched on a small scale by the middle of 2013, taking a regional rather than national approach to "get the recipe right." They've been building up inventory and getting ready for the impending launch, he says.
It's an appealing design, we have to admit -- one with a fun motto: Introducing Pearl, "the Sensible Pump."
Sensible because you don't have to fill a reservoir like with traditional pumps. Instead, it uses a pre-filled 300-unit cartridge that fits into a disposal slot at the back side of the pump (the black thing pictured). This portion attaches and detaches to the non-disposable "brain" of the pump (controller with buttons and screen) that looks similar to many others out there. Every seven days, you detach the cartridge portion and throw it away before connecting a new one. The pump uses a proprietary infusion set with built-in occlusion technology that, like any other set on the market, needs to be changed every 2 or 3 days. As of now, Pearl only takes a Humalog cartridge -- but Bubrick says they hope to expand to other insulins like Novolog in the near future.
Insurance should cover this pump just like any other, Bubrick said. The cost will be similiar to OmniPod, except he describes it as a "more economical device" because you don't have to change the cartridge as often as you must change a Pod. The company plans to market their Pearl Pumps through DMEs (durable medical equipment) distributors in order to leverage existing pump contracts, so patients' insurance coverage would remain pretty much unaffected.
In the coming months, Asante plans to begin actively marketing the pump and also re-launch its website. As to the future, Bubrick says they have their eye on the CGM integration like every other D-device maker. Nothing has been decided or announced at this time, but he maintains that Asante is pumping and CGM integration "will be our next-gen focus."
Insulet's Next-Gen OmniPod
It's hard to have missed the mid-December news about the next-gen OmniPod getting FDA approval. Smaller, sleeker, thinner. But with that hurdle cleared, how long will it take for the newest Pods to get out to PWDs? Insulet's been updating its website regularly, and as of now, the timeline looks to be late February or by the end of March. But some people have been hearing other dates, like some Children With Diabetes D-parents who say in forums that they've been told the newest pump won't be available until April.
Stephanie Marks, a PR rep for the company, says that nothing has changed in the timeline and that the new pods are still expected to be available by the end of March. Perhaps those parents were referring to the updated PDM (controller), rather than just the new Pods? Marks says she isn't aware of any differing ship dates.
Medtronic 530G Insulin Pump System (with Enlite Sensor)
In June 2012, Medtronic submitted their next gen pump-CGM system to the FDA for evaluation. What's known as the Medtronic Veo pump in Europe (available there since 2009!), this pump has the Low-Glucose Suspend (LGS) feature that uses CGM-tech to detect a person's low blood sugar and automatically suspend insulin delivery for up to two hours if they don't respond to alarms. This is the next step toward the Artificial Pancreas, and our community has been excitedly anticipating this smarter pump's arrival the U.S.
That new pump will include the long-awaited next-generation CGM sensor called the Enlite (available overseas since 2011). Those of us who've used the current Medtronic CGM sensor refer to it as "the harpoon" since it uses a long needle that can often be a little painful on injection and then flop and pull a bit during wear. So we're giddy about this new Enlite sensor that's supposedly less painful, more accurate, and has a wear-time of six days rather than three.
Medtronic submitted the new pump and sensor as a system package deal this past summer, under the name Medtronic 530G (catchy name, ay? NOT).
Many online speculate that the FDA won't approve one without the other, specifically since the Enlite sensor designed for a longer life will not work with the current-gen insulin pumps. Instead, the Enlite would need the 530G pump to be approved. Word on CWD forums and in doctors offices everywhere is that this is "coming soon."As in, early 2013, we all hope...
Still, that could mean anything.
A recent year-end promotion by Medtronic helped fuel that message. Dubbed the "New Technology Guarantee," this program encouraged people to buy the latest Paradigm Revel (523 or 723) insulin pump between Nov. 15 and Dec. 31, 2012, with a guarantee for a free upgrade to the newest pump system before April 13, 2013. The problem with that? Well, as of now, the Revel IS the latest and most current pump model -- so you'd be buying the newest model with what's basically a false upgrade guarantee. UNLESS the 530G gets approved before April and Medtronic made it available to fill that guarantee.
Hmmm.... maybe Medtronic knows something they haven't told us yet. So, we asked.
They can't comment on anything pending FDA approval. But what about the new tech guarantee before mid-April 2013?
PR director Amanda Sheldon writes: "We run a variety of promotions throughout the year... We ran this end-of-year promotion to help patients take advantage of year-end deductibles or additional funds within their health saving account, without fear of missing out on any new technology (given that our pumps have 4-year warranties). Regarding the time period, every promotion we have has to have a start and end date. We chose the start date at the end of year for the reason stated above. Information pertaining to the number of customers participating in the promotion is confidential."
Despite claims to the contrary, Sheldon says Medtronic is not able to market the 530G before FDA approval. The FDA's considering this as part of an entirely new category, Threshold Suspend Devices. And she says that the company's regulatory head points out that this new pump system is not being considered on an "expedited review."
So, like the other D-devices, only time will tell if/when Medtronic gets approval in 2013.
Roche Diabetes' Solo Micropump
Almost three years ago, Roche Diabetes acquired the Medingo Solo Micropump. And there hasn't been much word since, except for repeated delays in the product being ready for production here in the U.S. At the Roche Diabetes Social Media Summit in August, we learned that despite the FDA's approval of the initial Solo pump, Roche wasn't planning to commercially sell the initial device because it didn't have an integrated blood sugar monitor or CGM integration. It seems they felt it wouldn't be able to compete against existing patch pumps (OmniPod!) without those features.
Company spokesman Rob Muller says there's "nothing new to report" on Solo since the August 2012 summit.
Other company execs have also been tight-lipped about when any Solo model might come to market in the U.S., but they've hinted that the future could be seen by looking to Europe; the newest model pump system expected overseas in 2013 will likely have a built-in bolus calculator and will be able to read CGM data.
We also put out queries on the CellNovo Patch Pump and Dario smartphone/glucose meter adaptor, but neither company responded. In any case, both of those are just now trying to get off the ground in Europe, so we have basically zero expectation of seeing them Stateside in 2013.
Yet once again, to get a sense of what might be on the horizon here in the U.S., we'll have to stay tuned to the European market this year.
Hopefully, we'll see some quick turnaround on regulatory approval and some of these D-devices will be ready for U.S. PWD use before long! After all, it's our (health) clocks that are ticking loudest.