There's always a lot of talk ricocheting around the Diabetes World about the latest and greatest gadgets and what's happening with the biggest industry players.
Of course, we're always anxious to substantiate these things, but many are pre-public announcement and therefore kept close to the vest. Sometimes it's possible to find some of the puzzle pieces by watching SEC and FDA filings, public disclosures, patent office documents, and of course just by keeping your ear to the ground on bits of info trickling out from high-level execs, public relations and media coverage, industry experts and observers, sales reps and even fellow patients and doctors who may have heard interesting bits.
We never wish to spread pure gossip, but there are solid clues to some very intriguing developments in new CGM (continuous glucose monitor)/integrated products at the moment that we think are worth sharing now. Some of you may even know more and have info to add.
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We know there's been talk about delays in getting the integrated t:slim insulin pump and Dexcom G4 CGM submitted for FDA approval, along with other new devices in the Tandem Diabetes Care pipeline. We've had conversations with sales reps and execs from both companies who say they've seen prototypes of still-in-development devices being worn around internally.
Some detail on the new Tandem devices was aired during the March 6 earnings call, which covered the Fourth Quarter and all of last year. Tandem CEO Kim Blickenstaff said the G4-integrated insulin pump known as the "t:sensor" is a top priority and will be filed with the FDA in the Second Quarter of this year. With that review possibly taking as long as a year, it will likely be at least mid-2015 by the time that integrated pump is available. It was exciting to hear Blickenstaff say that the development of that product is already complete. We've been hoping to get our hands on images or sketches of that product, and also of the prototype combined dual-chamber insulin pump that Tandem and the JDRF have been developing, announced in early 2013.
Blickenstaff also said the bigger 480-unit t:slim, named the "t:flex," is expected for 510(k) submission mid-year. Those filings have a shorter review time of about 6 months, so we could actually see that device -- aimed at the type 2s and those needing higher insulin dosing -- by year's end!
Hopefully we'll be able to get a look at these new devices soon, at least at the upcoming ADA Scientific Sessions in June in San Francisco, where some of the prototypes could likely be on display (under glass, of course, if they're not yet FDA-approved).
Dexcom's Next Gen Pipeline
One industry insider told us recently that there's talk that Dexcom might actually be thinking about bypassing the smartphone-specific G5 model it's been developing, and going right to the next-level G6. Whoa!
Some think that's an internal discussion Dexcom officials are exploring. Some patients have even told us that G5 clinical trials they were slated to take part in had been mysteriously cancelled. And another clue that could fit in here was the $4 million grant the San Diego CGM company received in 2013 from the Helmsley Charitable Trust, aimed at the G6 creation and supposedly speeding up that development process by two years. As mentioned last year when that all became public, Dexcom's timeline has been to file the G5 (which would eliminate the iPod-esque receiver altogether and talk directly to a smartphone) at some point in 2015 and then look to newer, more accurate G6 sensing technology a couple years after that. Taking into account the company's FDA filing last summer of its Dexcom Share docking station and the expected approval of that this year, it seems like that G5 to G6 leap could be a feasible path.
Not so, Dexcom's VP of strategic marketing tells us. Communication Chief Steve Pacelli offered the official "we don't comment on rumor" line, but it was also interesting to hear him talk about how Dexcom has made an internal policy decision in recent months to be less descriptive about its future pipeline because of intellectual property concerns. Apparently, other companies are in a position to copy Dexcom's IP, so they're being more cautious these days.
This may also stem from the firestorm earlier this year, when media coverage swarmed over a supposedly new patent-filing by Dexcom -- one that offered some interesting illustrations of a smartphone device that was described vaguely enough that it could involve anything from a smartphone app to a smartphone capable of being the CGM receiver all on its own. Of course, what most didn't realize is that the patent document wasn't new; it only became publicly accessible after being filed close to two years ago. And Pacelli tells us the whole point behind that filing was to "keep the company's options open" for whatever they choose to do with smartphone integration. It's not likely a smartphone-CGM will be developed, but at least the patent is there if that's ever on the table.
Dexcom's most recent earnings call on Feb. 20 offered more detail from Kevin Sayer, current Chief Operating Officer who will be taking over as CEO on Jan. 1, 2015:
"The G5 is going to be focused largely on connectivity, mobility and convenience. It will more than likely come out as a series of launches rather than one single launch, with the end goal of offering a 'simplified application system.' This means connectivity to a phone and cloud-based data. We'll go there in a series of steps.
That system will use the current Gen4 sensors but with new algorithms they've developed over the course of the past few years that will improve accuracy and reliability.
With respect to the Gen6 system, that's our first step towards doing three things: culminating some of the calibrations, getting the replacement claim or dosing claim approved so we can recommend patients make insulin dosing choices based on the data, and then ultimately eliminating finger sticks altogether."
Sounds good to us!
Beyond Animas Vibe?
We've also heard rumblings that there may be something in the works between Dexcom and Johnson & Johnson, even beyond the anticipated Animas Vibe release coming down the wire (as soon as the FDA gives a thumbs up, of course). No one's talking details yet, which is understandable given SEC regulations. Neither could we find any official filings or documents in combing through online databases and reports, so who knows if there's anything to this claim?
Of course, this just adds fuel to the fire when looking at all the chatter this past November, when JnJ/Lifescan announced it would be restructuring and spinning Animas into a separate entity. Word is the company was trying to sell the pump division, but nothing official was ever out there and it was left pretty much to the rumor mill as relayed from competing device reps, and even doctors' offices that didn't know the full story. With how Roche, Bayer and Abbott tried to sell off their meter divisions, it's no wonder that this could be on tap for Lifescan, too. So far, all we know is what Lifescan's communication chief tells us: That the Lifescan reps are now working for Janssen. The rest, is fodder for the rumor mill.
As far as FDA's ongoing review of the integrated Animas Vibe, there's a lot of frustration and speculation in the patient community about how long it's taking for that to come to market Stateside. Animas didn't even file for regulatory approval until April 2013, and there's been some delay since then because the FDA apparently wanted more human factor testing data by Feb. 1. But who knows what else may be going on with this evaluation behind the scenes?
And so, of course, we wait.
A Bunch About Roche
The new Accu-Chek Insight insulin pump was launched in Europe at the ATTD conference in February. This device uses pre-filled insulin cartridges. We'd mentioned this in a D-tech post at the start of the year, but wanted to find out more about possible plans for the U.S. launch. Unfortunately, Roche spokespeople offered nothing, saying there's no update to what's already in the public realm. Disappointing.
Then there's the big CGM question: What's Roche doing after ending its 2011-adopted integration agreement with Dexcom last year? Well, we received this statement from Anne Gill, new head of communications for Roche Diabetes Care North America:
"In February 2013, Roche and Dexcom terminated the development to integrate the G4 with our Accu-Chek insulin delivery system. Roche is committed to a CGM solution as soon as possible. Roche decided to focus on our own internal CGM solution, which is the next step on our strategic path of providing integrated diabetes management solutions for our customers."
Wait... so is Roche developing its own CGM?! Whoa! We asked for more detail, but of course that is classified.
Naturally many of us might be thinking this is tied in with the mystery of the Solo patch pump, which has been under Roche's roof since the company acquired Medingo in 2010. We reported here at the 'Mine in 2012 that Roche had decided not to release the first-generation of this device, despite having FDA approval, because the powers-that-be were holding out for built-in meter integration and possibly even CGM sensing capabilities. More recently, we've heard talk that this delay was also related to manufacturing issues... specifically, that it'd be too expensive to produce the necessary parts. But the company remains tight-lipped on Solo, for now.
However, they are willing to share that there's a new Bluetooth-enabled glucose meter in the works! We kn ow that Roche has been working with the famous firm Frog Design on the Solo, and ostensibly on this new meter too, which will be called the Accu-Chek Connect -- not to be confused with the company's existing "Accu-Chek Connect" program that's a program to help customers find specific Accu-Chek products rather than a device itself.
Here's what we're told about the new device: "Roche is currently developing a new product called Accu-Chek Connect, which is being designed to use web and mobile technologies for the management of diabetes. The system is still under development and is not yet commercially available. We will begin introducing it in the second half of 2014 in the first markets." And yes, that means outside the U.S., in case you were wondering.
And On Those BD Sensors...
There's no question BD is exploring new continuous glucose monitoring tech -- ironic, since BD abandoned the traditional glucose monitoring world back in 2007. Anyhow, it's no secret they have a JDRF partnership and we've have heard tidbits about what's being developed, but it's tough to get an inside line on that. Exploring clinical trials, we came across this BD CGM study in Canada that mirrors another that's also been done at the University of Virginia.
Also, from a scientific study abstract presented at last summer's ADA Scientific Sessions, we found this:
"Becton Dickinson (BD) presented positive results from a pilot clinical trial that tested a novel type of CGM that uses optical sensing of a glucose-specific protein. An optical sensor uses a tiny optical fiber that is inserted under the skin. In BD's new device, the sensor measures blood-glucose levels by detecting the change in intensity of the fluorescent dye in the sensor system worn by study participants. The study, which was co-funded by The Helmsley Charitable Trust, showed that this type of sensor was consistently accurate and has the potential to be used in overnight closed-loop and low-glucose suspension systems."
A few who say they've seen this new BD sensor describe it as pretty sleek and cool-looking. Unfortunately, BD won't even acknowledge that just yet.
Of course, we can't forget about the ever-evasive Abbott Diabetes that many believe might bring a CGM option back here to the States after it pulled the FreeStyle Navigator CGM from market several years ago; could we see the Navigator 2 or the Flash Glucose Monitoring tech it's developing? Who knows, really... but it could be possible Abbott is the "unnamed partner" that Insulet's working with on its own vision for a next-gen device involving one site for both insulin infusing and CGM sensor. We just don't know, right now.
Gosh, how we hate to wait in the dark for all these exciting new developments! We'll have to just keep tabs on clinical trials and other "clues to the news" coming down the pike.
We'd love to know... what have you been hearing?