In a development that many an thought would never actually happen, the Roche Accu-Chek Solo micro mend ticker has snagged regulatory approval overseas and Crataegus laevigata actually be close to acquiring into the hands of people with diabetes.

Finally, after the better part of a decade.

On July 23, Roche announced information technology had gotten CE Mark approval for the Solo patch heart in Europe. We're told they plan to launch the tubeless insulin delivery device overseas in the coming months and are preparation to play this to the United States shortly.

Of course, if you think regulatory favorable reception guarantees an actual product launch, have a look back at story…

It was originally approved in 2009, the year earlier Roche bought the Solo from startup company Medingo. At that metre, Roche made the executive decision to not plunge the device because information technology didn't take in an introjected glucose m, like its flourishing rival OmniPod did. Instead, they beautiful more than kicked the can down the road, promising a future launch but ne'er delivering. Many another in the D-tech space (ourselves enclosed) believed the Solo had reached mythical position, relegated to the forfeited diabetes technology category.

Until straightaway.

Finally, the Alone appears to be prepared to actually make it to market.

What is the Unaccompanied?

The bedroc on this little patch pump twist are:

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  • Micropump – it's a thin little device that weighs entirely 28g, fashioning IT just a tiny bit larger than the OmniPod patch heart. This is semi-disposable, which means the Solo has a reusable part that lasts for four months and another that is used once and thrown away.
  • Holds 200 Units – information technology contains a exculpate refillable reservoir that fits into the lateral of the Solo, holding 200 units of insulin that can endmost a maximum of 96 hours (in the international reading).
  • Direct Dosing from Pump (!) – unlike the OmniPod that you can only operate from the handheld receiving system, the Solo stands out because you can tranquillize manually administer boluses from the little fleck pump itself past pushing a button, in case you Don't have the remote control or manual use is preferred. Bolus increments range from .2u to 50 units.
  • Detachable (!) – also unlike the OmniPod, you give the sack take off the Solo at any channelis, for a shower or swimming or sporting because you want to. The refillable insulin-holding part of the Unaccompanied clicks into a very thin pitchy bed that sticks onto the skin and holds the Solo in identify, from which the heart personify can easily uninvolved and reattached.
  • Basal Rates – there are five programmable basal settings that vary from .1u to 25 units per hour, and it allows temp basals ranging from 0-250% of a pattern basal dose.
  • Zinc Barrage – Alone uses a zinc aura battery to power the ticker.
  • Handheld Receiving system – there is a separate, rechargeable handheld receiver with coloring material touchscreen connected to the pump via Bluetooth that displays insulin and BG data from BT-enabled Accu-Chek meters. It's clay TBD whether using the receiver will in reality be required for whol patients, depending along how Roche handles its FDA submission and what the agency approves.
  • Built-In Meter – the receiving system has an integrated Accu-Chek BG beat with a light-up strip port. Now that OmniPod is doing away with their integral metre, Alone could be the only patch pump offering this feature film.
  • Remote Bolusing? Open-air the US, it appears that far-bolusing from the handheld is possible. Simply IT's unknown whether Roche bequeath try to amaze FDA approval for smartphone-compulsive dosing capability.
  • Nary CGM Information (All the same) – Roche tells us, "The first generation of the Accu-Chek Solo micropump being delivered in Europe volition not offer CGM integration. For emerging product iterations, we plan to mix CGM information into the system. As this and far product iterations are under development, we cannot disclose any detailed timelines yet." Course, IT's also deserving noting that Roche has partnered sprouted with Senseonics to wont their implantable Eversense CGM, so expect to see that at some breaker point down the road.
  • Back-End Data-Sharing? Patc in that respect won't be a pointed CGM connection, we're guessing it may still be assertable. With Roche using the mySugr and Accu-Chek data platforms, and Dexcom CGM or Abbott Libre Flash data future in via Apple Health, it can be viewed in concert — and we're told the mySugr team is actively working to bring off those data sets together inside their platform. We'd think it might also possible with a third-party platform care Glooko OR Tidepool, to visualize all the D-information could be incorporate into extraordinary place.

Roche plans to found the Solo first in Austria, Poland, Switzerland and the Great Britain by year's oddment 2018, and to a greater extent European countries and beyond after that.

Of of course, we asked well-nig timing for this in the US but Roche isn't disclosing any details. A spokeswoman there tells the States:

"As with previous product launches, we will start with a pilot launch phase in Europe subsequently followed by a broader launch roll-out. The launch in the U.S. is significant for our insulin deliverance commercial enterprise and is therefore our focus. The launch will be gated by FDA clearance, and we are engaging with the FDA to determine the most expeditious pathway to market."

Whatever the timing, we hope to get wind this sooner rather than later (or at all, supported past history).

Importantly, we also fundament't overlook the huge elephant in the room — the fact that in 2017, Roche pulled its longsighted-standing Accu-Chek insulin pumps off the marketplace in the US and dispatched all existing customers to Medtronic for needed supplies.The Solo therefore could set a return to the US insulin pump market for this Swiss-based society — substance they'll have to start from stratch or somehow Ra-establish customers they've since irrecoverable.

Other Patch Pump Possibilities

Beyond the Solo's future day promise, we still receive only one tubeless / patch ticker on the market in most of the world:

OmniPod: Insulet's popular tubeless OmniPod has been on the market since 2005, and so far No one has launched a straightaway competing product. Alone may constitute the first. We are stimulated to see the Bluetooth-enabled OmniPod DASH platform nowadays approved as of June 2018 and is about ready for launch.

There are also individual other patch pump devices in development that we've had our eyes on over the days:

Mini ePump: We've been hearing for long time about the Land of Opportunity-supported med-technical school ship's company SFC Fluidics developing a bandage pump (arsenic well as some other D-devices). Their so-called "Miniskirt ePump" has promised to be the next patch pump able to hold 300 units for three days, but uncomparable that doesn't exercise mechanical parts for movement. Rather, it uses only when a low-voltage electrical current to deliver insulin through an elastic membrane. It too had a separate handheld controller at one point.

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SFC Fluidics has been in fundraising mood for years, and in early 2018 the JDRF announced information technology's teamed up with this  venture-investment funds capital company to develop the patch pump. It's an aboriginal R&D announcement with a two-year agreement to start — signification this isn't coming anytime presently. On July 30, a related proclamation came in that SFC Fluidics technology would let in open protocols, meaning it will be designed to personify interoperable with #WeAreNotWaiting DIY devices and apps.

JewelPUMP: Remember this one, that way back in 2010 got our vote for "best in show" vote at the summer ADA SciSessions? IT's another patch pump model that's been in the works for a years, promising detachability and bigger insulin capacity than the OmniPod, and its controller sports vibrant colors (IT looks a little comparable the old-civilis Simon stir up game, no?…) The Swiss-based startup Debiotech designing this device is inferior vocal than they at one time were about making promises, but when queried, the upper side exec told US: "We remain highly involved in finalizing the JewelPUMP, although we have distinct not to communicate until product clearance and launch."

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Empire Maculatio Heart (now owned by Amgen): We wrote about this one few years ago and at the time, the PA system-supported company Unilife was very excited virtually acquiring ready to launch their new patch up pump, which was also detachable and had a button happening it to bolus insulin. Well, soon afterward that Imperium sold everything to Amgen and we haven't been fit to prevail any updates since, so we aren't holding our breath on this one.

Cellnovo, Maybe? This is actually a hybrid of some tubed and tubeless pump, a gimmick that's been available sea but has not been cleared through the FDA until no. It's a slim rectangular twist that adheres to the skin, just also has an extract set with short tubing; everything connects via a handheld wireless controller unit. This was originally filed with the FDA in November 2016, and we'atomic number 75 told the latest update in April 2018 cadaver the status quo: the UK company is continuing to talk with US regulators and updating the submission. So, TBD on timing there.

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Lilly's Crossed Device: Same as the Cellnovo device above, Lilly Diabetes is also working connected its own D-tech that's a cross between a tubed and tubeless pump. We eldest reported on this development in late 2017, and then subsequently our ain Wil Dubois got much detail and saw an current prototype in Spring 2018 when he visited the Lilly Cambridge Innovation Midway. With a small round phase factor, we're told IT looks suchlike a Skoal tin and wish have a disposable bottom holding an insulin reservoir and a top durable set off with the electronics, rechargeable battery, and a excitable-bolus button. It will be operated via smartphone. That's still years out, but it clay a tense possibility along wih the others.

Naturally, we're eager to see who's first to chase OmniPod in this nonindustrial plot pump space. The more the improved, we like to say when it comes to D-technical school choices.