In a development that many thought would never actually happen, the Roche Accu-Chek Solo micro patch pump has snagged regulatory approval overseas and may actually be close to getting into the hands of people with diabetes.

Finally, after the better part of a decade.

On July 23, Roche announced it had gotten CE Mark approval for the Solo patch pump in Europe. We're told they plan to launch the tubeless insulin delivery device overseas in the coming months and are planning to bring this to the United States before long.

Of course, if you think regulatory approval guarantees an actual product launch, take a look back at history...

It was originally approved in 2009, the year before Roche bought the Solo from startup company Medingo. At that time, Roche made the executive decision to not launch the device because it didn't have an integrated glucose meter, like its successful competitor OmniPod did. Instead, they pretty much kicked the can down the road, promising a future launch but never delivering. Many in the D-tech space (ourselves included) believed the Solo had reached mythical status, relegated to the lost diabetes technology category.

Until now. 

Finally, the Solo appears to be ready to actually make it to market.

 

What is the Solo?

The basics on this micro patch pump device are:

  • Micropump - it's a thin little device that weighs only 28g, making it just a tiny bit larger than the OmniPod patch pump. 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 - it contains a clear refillable reservoir that fits into the side of the Solo, holding 200 units of insulin that can last a maximum of 96 hours (in the international version).
  • Direct Dosing from Pump (!) - unlike the OmniPod that you can only operate from the handheld receiver, the Solo stands out because you can still manually administer boluses from the little patch pump itself by 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 can take off the Solo at any point, for a shower or swimming or just because you want to. The refillable insulin-holding part of the Solo clicks into a very thin adhesive bed that sticks onto the skin and holds the Solo in place, from which the pump body can easily detached 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 normal basal dose.
  • Zinc Battery - Solo uses a zinc air battery to power the pump.
  • Handheld Receiver - there is a separate, rechargeable handheld receiver with color touchscreen connected to the pump via Bluetooth that displays insulin and BG data from BT-enabled Accu-Chek meters. It's remains TBD whether using the receiver will actually be required for all patients, depending on how Roche handles its FDA submission and what the agency approves.
  • Built-In Meter - the receiver has an integrated Accu-Chek BG meter with a light-up strip port. Now that OmniPod is doing away with their built-in meter, Solo could be the only patch pump offering this feature.
  • Remote Bolusing? Outside the US, it appears that remote-bolusing from the handheld is possible. But it's unknown whether Roche will try to get FDA approval for smartphone-driven dosing capability.
  • No CGM Data (Yet) - Roche tells us, "The first generation of the Accu-Chek Solo micropump being delivered in Europe will not offer CGM integration. For future product iterations, we plan to integrate CGM data into the system. As this and further product iterations are under development, we cannot disclose any detailed timelines yet." Of course, it's also worth noting that Roche has partnered up with Senseonics to use their implantable Eversense CGM, so expect to see that at some point down the road.
  • Back-End Data-Sharing? While there won't be a direct CGM connection, we're guessing it may still be possible. With Roche using the mySugr and Accu-Chek data platforms, and Dexcom CGM or Abbott Libre Flash data coming in via Apple Health, it can be viewed together -- and we're told the mySugr team is actively working to bring those data sets together within their platform. We'd think it might also possible with a third-party platform like Glooko or Tidepool, to see all the D-data could be merged into one place.

Roche plans to launch the Solo first in Austria, Poland, Switzerland and the UK by year's end 2018, and more European countries and beyond after that.

Of course, we asked about timing for this in the US but Roche isn't disclosing any details. A spokeswoman there tells us:

"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 US is important for our insulin delivery business 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 see this sooner rather than later (or at all, based on past history).

Importantly, we also can't overlook the huge elephant in the room -- the fact that in 2017, Roche pulled its long-standing Accu-Chek insulin pumps off the market in the US and sent all existing customers to Medtronic for needed supplies.The Solo therefore could mark a return to the US insulin pump market for this Swiss-based company -- meaning they'll have to start from stratch or somehow re-establish customers they've since lost.

 

Other Patch Pump Possibilities

Beyond the Solo's future promise, we still have only one tubeless / patch pump 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 directly competing product. Solo may be the first. We are excited to see the Bluetooth-enabled OmniPod DASH platform now approved as of June 2018 and is about ready for launch.

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

Mini ePump: We've been hearing for years about the Arkansas-based med-tech company SFC Fluidics developing a patch pump (as well as some other D-devices). Their so-called "Mini ePump" has promised to be the next patch pump able to hold 300 units for three days, but one that doesn't use mechanical parts for movement. Instead, it uses only a low-voltage electrical current to deliver insulin through an elastic membrane. It also had a separate handheld controller at one point.

SFC Fluidics has been in fundraising mode for years, and in early 2018 the JDRF announced it's teamed up with this  venture-investment capital company to develop the patch pump. It's an early R&D announcement with a two-year agreement to start -- meaning this isn't coming anytime soon. On July 30, a related announcement came in that SFC Fluidics technology would include open protocols, meaning it will be designed to be 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 long time, promising detachability and bigger insulin capacity than the OmniPod, and its controller sports vibrant colors (it looks a bit like the old-school Simon touch game, no?...) The Swiss-based startup Debiotech designing this device is less vocal than they once were about making promises, but when queried, the top exec told us: "We remain highly involved in finalizing the JewelPUMP, although we have decided not to communicate until product clearance and launch."

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Imperium Patch Pump (now owned by Amgen): We wrote about this one a few years ago and at the time, the PA-based company Unilife was very excited about getting ready to launch their new patch pump, which was also detachable and had a button on it to bolus insulin. Well, soon after that Imperium sold everything to Amgen and we haven't been able to obtain any updates since, so we aren't holding our breath on this one. 

Cellnovo, Maybe? This is actually a hybrid of both tubed and tubeless pump, a device that's been available overseas but has not been cleared through the FDA yet. It's a slim rectangular device that adheres to the skin, but also has an infusion set with short tubing; everything connects via a handheld wireless controller unit. This was originally filed with the FDA in November 2016, and we're told the latest update in April 2018 remains the status quo: the UK company is continuing to talk with US regulators and updating the submission. So, TBD on timing there.

Lilly's Hybrid Device: Same as the Cellnovo device above, Lilly Diabetes is also working on its own D-tech that's a cross between a tubed and tubeless pump. We first reported on this development in late 2017, and then later our own Wil Dubois got more detail and saw an actual prototype in Spring 2018 when he visited the Lilly Cambridge Innovation Center. With a small round form factor, we're told it looks like a Skoal tin and will have a disposable bottom holding an insulin reservoir and a top durable part with the electronics, rechargeable battery, and a quick-bolus button. It will be operated via smartphone. That's still years out, but it remains a future possibility along wih the others. 

 

Naturally, we're eager to see who's first to chase OmniPod in this developing patch pump space. The more the better, we like to say when it comes to D-tech choices.