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.
Enjoying the recent burst of posts! Insightful as always.
I have a Vibe so will be in the market for a new pump over the next couple of years, but so far none of what I see particularly appeals to me as a great leap forward.
I’d really love a loopable pump, so if this could be made to work with AAPS, that would be wonderful.
Thanks for the detailed intro to the Roche Solo. I’ve been looking for something similar (my Medtronic 640G is starting to feel clunky) and if it did support Android APS it’d be a massive plus for me.
Any guess as to how it would compare to the Kaleido?
To be honest, I’m not sure. The Kaleido never made it on to pump lists in the UK, and I’ve not physically seen the Solo. I’m guessing it’s a bit more compact, but it would be worth researching the Kaleido a bit more.
Got a feeling that given some of the Bluetooth specs relating to Insulin use, it’s going to be an interesting pump.
Yes, same. I was quite lucky in that I took part in some marketing research involving the Kaleido so I was able to play around with it a bit. The Bluetooth + the fact that their pumps are rechargeable makes it interesting for me. But apparently they’re focused on the Netherlands and I’ve been told there’s no definite date for a UK launch 🙁
so does this work in an openAPS setup? what CGM will I need?
At the moment, it’s not properly on the market, so we haven’t been able to find out the protocol that it speaks or test anything with it. CGM use can be almost any of those available. Read https://www.diabettech.com/looping-a-guide for more information.
thanks admin. Yes definitely the new kid on the block I may have the option of being able to use this but will only use if I know i can setup a loop system. I will take a look at the guide for CGMs thanks
Is there any update on using this pump in a loop? Reply extremely appreciated.
Nothing that I’ve yet seen. Sorry!
When would this be available in the US?
I suspect it won’t be. Roche have withdrawn from the US.
Entonces donde lo van a vender? No podrias dar una pagina o donde comprar
Es una muy buena pregunta. Desafortunadamente, no he visto nada de Roche.
Be aware that this after purchasing this pump in November 2019, you will find it is not waterproof and needs to be turned off and removed each time you have a shower. It is not a looping system and still needs constant blood sugar testing.
It is not reliable.
Do not expect reliability having had 3 faulty pumps replaced by Roche in 2 months. Whatever you do always carry your pen and testing kit, otherwise you may be left stranded without insulin.
I don’t think anyone was expecting it to be a looping system, although the IP rating on the original pump was rubbish and from what you’re saying,m hasn’t been updated, which is a pity.
It’s not good news to hear about the reliability though. WHat have Roche said in this regard?
Roche just seem happy to replace the faulty pumps. It seems they know they may have problems and the simplest solution is to replace the pump. The user guide too has lots of anomaly’s and doesn’t answer many user questions. For example “what is an occlusion”, it’s not even mentioned in the manual but the system manager displays it on its screen.
To be fair to Roche, I don’t think any pump manual explains what an occlusion is, as pump users are expected to be familiar with the term from training.
It gas been a while since last post on the Solo pump?
Is there any new information available?
How does it compare with the Omnipod?
Is there a compatible CGM for the Solo?
Not much. There area a couple of forums/Facebook groups with people using it, but I’ve not got my hands on one in the flesh.
In answer to your questions:
1. It’s not waterproof, so you have to remove the pump component from the cannula component when showering, bathing or swimming. There’s a study running at the moment that should answer many of the questions people have.
2. Not as far as I’m aware. It’s a standalone pump, that I think Roche may consider marketing to AID system providers, rather than integrating CGM in the package.
Now 6 months in from starting to use the Roche Solo pump, we have had some small successes with its usage.
After a bad start with 2 x faulty pumps, both confirmed as faulty and replaced by Roche at no charge.
Let’s make it very clear, unless you are technology savvy, you are likely to have problems driving this pump. It’s an excellent concept, but is sadly in need of a software/firmware update on the Manager unit.
My guess it is still the original 10 year old software on the current manager.
Whilst we have had some success with driving the pump, the manager continues to flounder and frequently needs to be reset.
The most frustrating times for it requiring to be reset, is when it loses its settings in the middle of a reservoir changeover.
The pump is also very sensitive to air bubbles after filing the reservoir which can be very frustrating. Roche claim the way to solve this is to keep the refill insulin at room temperature rather than storing it the fridge. In our experience, it makes little to no difference, you just have to spend an amount of time clearing the air bubbles before inserting the reservoir to the pump. This can mean that a five minute changeover refill could take 20 minutes or more.
Roche don’t have a compatible CGM, so initially we tried the Freestyle Libre. It is an excellent CGM with great supportive software, but at this stage it is only readable on your your personal mobile phone and doesn’t have a transmitter as such.
We have now moved to the Dexcom 5, and with its clip on transmitter, it has many advantages over the Freestyle Libre with the ability to read the results on any mobile phone anywhere in the world if it’s connected to the internet.
We are now awaiting the availability of the Dexcom 6 as this has many advanced features that we are eagerly wanting to try.