FDA Approves New Tubeless Insulin Pump

FDA Approves New Tubeless Insulin Pump

Miriam E. Tucker

August 23, 2023

The US Food and Drug Administration (FDA) has granted clearance for Roche’s Accu-Chek Solo micropump system, a tubing-free “patch” pump for people with diabetes who use insulin.

Here is link

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The Accu-Check Solo is a tubeless pump first approved in Europe in 2018. Roche hasn’t updated their web site to reflect the FDA approval and hasn’t published US documentation for the pump.

Patients must either use accu-check test strips or manually enter a BG value into the controller to use the controller’s integrated dosing tools. The Solo does not communicate with a CGM. Roche has not published a smartphone app.

The pump is designed to last for 4 months. The disposable reservoir holds 80-200 units and must be replaced when empty or within 4 days. The pump must be moved to a new site every 3 days. The pump has a rechargeable battery.

Roche submitted the pump to the FDA in 2021. FDA 510(k) decision summary:

The pump FAQ is at this link, scroll down past the virtual trainer section:
Accu-Check Solo FAQ


This is a little weird because it was already approved back in 2009, but never released. This new approval statement just seems to give it interoperability status to work with iCGMs and AID algorithms. The downloadable pdf mentions future automation and it does have Bluetooth. I suspect they’re going to partner with Tidepool Loop, since it has already been approved but hasn’t actually found a pump partner yet to pair it with. And pretty much no pump is marketable today without insulin automation.

There are things I really like about this pump and some major turn-offs.

Love that the cannulas are 90-degrees and there are options. I’ve never seen interchangeable cannulas like that, so it’s definitely unique! On the other side, though, it’s a little disappointing that there’s only 2 choices.

Love that there are bolus buttons directly on it, so you’re not tied to the managing device.

Love that it’s detachable.

Love that there’s less plastic waste then with Omnipod.

Love that you can see the reservoir and that you can change it independent of the other components.

I really hate that it’s not waterproof and barely water resistant. It only has an IP22 rating, which means it’s resistant to:

  • Touch by fingers and objects greater than 12 millimeters
  • Water spray less than 15 degrees from vertical
  • Condensation

I also really hate that you’re still throwing a battery away every few days, like the Omnipod. There’s a zinc-air battery attached to the reservoir which does contain cobalt, which is really rare and obtained in atrocious ways. It’s really not conscionable to dispose of them so readily. Though, @spdif mentioned a rechargeable battery. I haven’t found anything on that, personally, but I certainly hope they added that modification!

If currently has no interoperability, which is a deal-breaker. Hopefully, a short-lived deal-breaker and they’ll remedy that soon. It may be compatible with DIY systems, but nobody has gotten that worked out yet even though it’s been available in other countries for quite a few years already.

It also has the same limitation as the Omnipod in that it’s big and bulky at the infusion site, which limits placement possibilities and sleeping positions. And when interoperability is added, you’ll loose Bluetooth communication with it when/if you lay on it.