If you keep your eyes on Diabetes and medical media, you can’t fail to have noticed that Roche’s Solo Micropump, a new patch pump from Roche, received its CE mark today. But what is the Solo Micropump?
If you have a dig around on Google, it appears this is the former Medingo pump, that received FDA approval in 2009 and was bought by Roche in 2010.
Roche had assured everyone it would be released in 2012, but of course it never made it. The above picture is from a 2013 article about Diabetes technologies that never made it.
Digging through my favourite place to find useful information about upcoming Diabetes technology, the FCC database, I uncovered the User Guide for the latest version of this pump.
It’s made up of a number of components:
- The Diabetes Manager
- Pump holder
- (Insertion device)
All of which are shown in this image from the User Guide:
And the characteristics of this pump are described thus by Roche:
So we can see from this that it’s a refillable patch pump with a removable 2ml reservoir. The thing I also noted in this shot is that the handset also allows reversion to MDI and still captures that information in the Diabetes Manager if you choose to take a pump break.
Given that it’s made up of so many components, application looks somewhat different from what we’re used to with patch pumps:
- Attach the cannula to yourself
2. Fill the reservoir
3. Attach the reservoir to the pump body
4. Make sure the pump and handset are communcating
5. Attach the pump to the infusion set
Not a simple process, but I’m sure it’s one that people can manage.
What we can also see with this is that it’s a piston based pump so the dosing accuracy is likely to be good, unlike some of the other patch pumps on the market.
The breakdown of dosing is seen below:
We can see that it will deliver basal below 5u in 0.01u increments, which is good news for small children, and that there are 15 minute TBRs available. We can also see that bolus delivery can be varied, again good news. All in all then, things we’d expect to see from a modern pump.
But what of the pump “base”? Is it rechargeable? Not according to a point later in the user guide, which suggests that it lasts for four months and will remind you regularly when it needs replacing…
Although the “Diabetes Manager” is rechargeable.
The Diabetes Manager looks to be a little smaller than the Insight handset:
Although it has been updated from the original handset for the Solo back in 2009/2010:
In terms of sizing, the handset for the solo is 124 x 64 x 17 mm and weighs 140g making it similar in size to the Omnipod PDM which is 114 x 64 x 25 mm
The pump itself is 68 x 40 x 15 mm, compared to the Omnipod which is 52 x 39 x 15mm, meaning it’s slightly larger, but remember, without the handset, you can still bolus from the Solo, which you can’t do from the Pod.
A further point is that the Solo handset has functionality that allows entering of MDI details when not using the pump, or what is known as “Injection Therapy Mode”.
This allows you to switch over to MDI and includes things like Basal reminders and logging, whilst appearing to also provide the full bolus calculator functionality. I wonder if we’ll see this in a new blood testing meter from Roche? Having said that, the bolus calculator does seem to only take bolus insulin into account….
It also looks as though we’re looking at a Bluetooth connection to the pump, so if, and it’s a big “IF”, it uses the same protocols as the Insight, it’s possible that we could see it working on AndroidAPS sooner rather than later.
All of this is a brief introduction to the new-old pump coming soon from Roche. It’s a pump that has been in existence for nine years, was bought out by a large pharmaceutical company eight years ago and looks like it is finally making its way to market in 2018/2019. About when others are releasing Artificial Pancreas systems.
This then begs the question, is this the pump that will be at the core of whatever offering Roche have planned for their own Artificial Pancreas system, given the widespread lack of happiness over the Insight.
And of course there’s the fact that I found all these documents on the FCC website, plus the FDA approval of the original Solo in 2009. Could this mark a re-entry into the US market for Roche?
And finally, why has it taken so long? The approvals and technology have been around for nearly a decade, and yet we’re only seeing this now! That’s a bit of an indictment on delivery of new technologies, and it’s no surprise that Automated Insulin Delivery systems have taken so long to appear.
While I welcome another option in the pumping realm, I’m hopeful that future products can come to market much more quickly. That needs co-operation from both the manufacturers and the regulators.