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):
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 ha
ve 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.
Unfortunately, like the rest of the D-device companies, Medtronic isn’t saying much officially that means anything
.
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.
There is word that is used in the computer industry to describe these products. “VaporWare”.
I saw the new Solo (with the integrated glucose monitor) about a year ago. It looked like an old device, with a large PDM that has a small screen. While the world has evolved the Solo has basically remained the same for the last 3 years since Roche acquired Medingo.
When I saw the Solo it was still being developed (last stages) by the Medingo group, but since then Roche has closed down the IL operation.
Asante pump sounds interesting. I remember when I switched from pens to pump wondering why I had to fill it like a syringe rather than just popping in a cartridge. Back on syringes and pen now and will be until some manufacturer finds a way to prevent bubbles forming in the reservoir. This way I at least know how much insulin I’ve taken.
(And yes, I always used room temperature insulin. Just got tired of flushing bubbles several times a day to keep my glucose below 400)
Tx for the report. Waiting for new diabetes tech is like watching grass grow…
“stay tuned to the European market” ?? I live in the “capital” of the EU and most of these products or there former generations aren’t very accessible here. When i asked around, no endocrinologist or practitioner had ever heard of the omnipod or was familiar with a similar concept …. just saying….
That might have something to do with the fact that no CGMS whatsoever is supported by our social security system.
I have been consistently reading this blog for years, and I need to be brutally honest: I am sick of the negative tones radiating from this site. Why do you all (Mike, especially) use every post as a chance to negatively portray device manufacturers and the FDA? While things could more faster, these companies are changing our lives, even if it may not be at lightning speed. I’d rather wait a little longer than have a potentially faulty device, thank you very much. Please remember how far we’ve come in only a short period of time and also remember that negativity does not get anyone far at all. So cheers to all that we, as a diabetes community (pharma and FDA included) have achieved!
@Emily – this might surprise you, but we’re not nearly as critical as some in the diabetes community.
Also, at this year’s DiabetesMine Innovation Summit, FDA folks themselves were quite self-critical and admitted they’ve made mistakes and been the bottleneck in the past. They seem committed to improving their processes, which is wonderful!
Finally, I see us at the ‘Mine as the biggest cheerleaders on all that we in the DOC, along with pharma and FDA have achieved in the past years! But we can’t just cheerlead; we have to also be honest and critical when necessary.
All of these devices are toys and jokes unless the medical device companies decide on using *the standard* protocol for dealing with medical device data.
It is called IEEE 11073. Google it, Amy and Mike. There is even a detailed wikipedia page on this protocol.
Instead of advocating for cute little pieces of eye candy medical devices and other gimmicks for technologies that are now refined (BG Meters, Insulin Pumps, CGMS Devices), your team should be advocating for standards for dealing with data and putting pressure on the medical device companies to stop using proprietary data storage and encryption.
The next step to truly improving diabetes care is to create a “diabetes operating system” (and a device using the IEEE 11073 standard) that can control all of your diabetes devices wirelessly, receive the data generated from the diabetes devices, and help you make decisions in real time.
Without the IEEE 11073 standard, this feat is virtually impossible. Also, “current solutions” such as being locked in to an integrated insulin pump (e.g. Minimed 522/722), which uses proprietary data storage, is not a solution. It is not pragmatic-the user interface is garbage, and it is not practical for a lot of people.
Also, your technology “correspondents” do not have realistic opinions or decent insight regarding emerging or future technologies. As an engineering student (who, by the way, should had graduated by now but has a RARE autoimmune disease-and also had to decline a six month internship with a company that starts with IN and ends with TEL due to her health), you need either a technologist or an engineer as a consultant. Bernard Farrell or Jeff Mather from the DOC would be much more realistic.
I am also EXTREMELY tired of all of you proposing using a smartphone to control diabetes related devices. From an engineering standpoint these are the BASIC problems, in principle:
1. It is insecure
2. It is not equipped to handle powerful data structures/process complicated data
3. Cannot multitask efficiently/effectively
4. Cannot handle data in the real time (you have to (explicitly) upload the data to your phone)
5. Is not meant to handle rough use and abuse
Plus, wouldn’t you want something much more powerful than a smartphone to deal with diabetes-related data?
My personal solution for the time being is this- I carry around a netbook loaded with programs, a scale, and diabetes care equipment, and I upload data to the netbook, I run the data through programs I wrote in MatLab in order to make virtually all of my dosing decisions with the netbook. If I am not using my netbook, I am using my HP 50g calculator with various programs for dosing.
I used to be a huge fan of your site. Now, I cannot help but cringe (and even want to bang my head against the wall) when you and your consultants write about new and emerging devices on this website. Amy and the DiabetesMine team, you really should be consulting engineers and technologists and weighing in their statements and positions with highest priority before ever writing about emerging technologies.
Otherwise all of the advocacy you do for the DOC, such as the above article and the DiabetesMine Innovation Summit are not going to be paving the way to better diabetes care.
But, this post is probably futile and nobody will read it.
@type1engineer – First off, we are fully aware of the standard you mention, and the need for such standards was the focus of this year’s DiabetesMine Innovation Summit event.
Secondly, wow — you are incredibly negative. How ironic that you accuse us of being overly enthusiastic given that reader Emily, above, accuses us of just the opposite.
Third, we are in contact with many engineers and technologists, and if you personally have something of value to add — other than complaints and put-downs — we would be happy to discuss including you in the 2013 DiabetesMine Innovation Summit efforts.
Email us at info@diabetesmine.com if you wish to discuss your potential contributions.
Thank you.
Thanks for reading and leaving a comment, Type 1 Engineer.
And just to clarify one more thing, about the post above: I’m not advocating for cute little eye candy tech that’s unrealistic and a pipe-dream. These are diabetes devices that are being created, and some of them are available overseas and working quite nicely for people to manage diabetes. We are simply reporting on these D-devices and asking questions to let people know the status of these items. And using a smartphone to manage these devices? That is where we are going in this industry. People with diabetes want it. Companies are developing it and already using it in part. Researchers are using this in their studies. You or I may not want to use it, for some or all of the concerns listed above, but it’s happening and will be an option regardless for those PWDs who choose it. Thanks again.
@type1engineer there’s been a number of us in the DOC working to ‘persuade’ device makers to support a standard protocol and API. I talked with the JDRF CEO about this 2 years ago, and told him that the artificial pancreas project should require participants to support a standard format.
Last year’s DiabetesMine Innovation Summit started the day with a talk about data standards, a topic that continued to popup. @AmyT, did anyone record that, any chance the audio could be shared?)
FYI I’m a long-time software engineer with lots of experience in UX/UI, most current devices make me cringe, though the Dexcom G4 and Tandem t:slim are big improvements…though still no standards support. Oh, and T1 for 40+ years.
Re using a smartphone. I think many of the issues you raise are solveable. I don’t know of any diabetes device that can handle rough use easily. I’ve participated in triathlons, try swimming 0.5 miles with a Dexcom receiver in an Aquapac bag round your neck. I think smartphone integration will succeed.
Re the IEEE 11073 protocol. One concern I have with this is general access to the docs/details at $180 it’s cheap in standards terms, but I’d like a public document we can all access and use.
Take up Amy’s offer about the Inno summit, these are incredible, invaluable events.
I disagree with the abuse comment – I have dropped my Dexcom sevin probably over 100 times and just like a timex it took a licking and kept on ticking – same with my old minimed, diesetronic cozmo and now Animas pumps. One wrong drop of an Android or I phone and it is toast! I am sure it is solvable – if they can build pumps and cgm’sthat are durable, they should be able to build durable phones. I carry my smartphone in aa tough case and so far so good
Also forgot to point out my Diabetes Forecast article which has a wish list starting with
Device makers: Form a consortium and agree on ways to get data out of all our devices. We can’t hope to get a clear understanding of our situation without this. A beneficial side effect? We won’t need logbooks anymore. Use standard cables, or Bluetooth, and make devices rechargeable. And please make control software work on Macs and PCs or, if on mobile phones, iOS and Android.
This is fascinating to see a column re Diabetes products – over the past month or so I’ve been contacting a variety of companies to get their version of what their most up to date diabetes products can do. Needless to say – not much feedback re advancement in this arena. Perhaps there is a postprandial holiday wave affecting us all! One of the reason’s I was phoning was to find out if tablets could be used – of course not! At any rate I finally started suggesting that rather than using a phone / tablet – not all of us out here want or use a smartphone on a daily basis – expensive / no need if not working [retired]/ just old habits
– this would be to our Type1engineer – I agree – a bluetooth link would be more than ideal – what’s the issue? My wireless mouse works well with a USB plug-in – why can’t the same be done with Glucose Monitors that record just about everything already? They already have adapters on the PCI connecting cables….chips? The only logbook I have is my Glucose monitor / PCI – and has been since ~ 2000 and not much has changed. In my searching I asked about the attachment of cardiac / BP monitors to the glucose m – of course that sounded like greek to the listeners. And this of course has to do with time ticking – other issues eventually cloud the diabetes picture – so if everything is viewd as a whole / rather than bits of the pouzzle – gee whiz we might actually get preventative care!
[...] The Clock’s Ticking on New D-Products for 2013 [...]
I have been wearing the Minimed pumps for 10 years and just switched to the Omnipod about a year ago. While I love not having the tubing to deal with since I have 4 young kids, I am severely allergic to the materials used in this device. I have spoken with the company several times about this and tried everything they and my doctors have suggested, but the bottom line is that my body can’t tolerate it. So… my question is, are there any other pumps out there like the Omnipod that stick to your skin and don’t have tubing? I’ve searched the Internet but have only come up with the Solo which apparently isn’t available. Please help! Thanks!
Hi, Sarah. Thanks for the comment. Sorry to hear of your issues with OmniPod. At this time, there is not another “patch” pump like the OmniPod on the market. There are others in development, such as the Solo mentioned above in this post and also another one known as the Jewel (that we have written about here on the ‘Mine in the past). Others are in the works, but only time will tell how soon these are available.
I’m right there with Sarah. I uses the OmniPod but the tape is highly irritating and I have tried all of the tips available but I’m about to ask the doctor to put me back on injections. I never had this trouble with the Medtronic tape but with two kids under 4 years old, the tubing is impractical. But it doesn’t sound like the Solo will be as sophisticated as the OmniPod. I’d like to try the Jewel but who knows when that will be available in the US. I don’t think it is even FDA approved at this time.