That’s a very blunt headline making a pretty clear statement about my point of view on this topic, but what is the topic?
If you are aware of the DIY diabetes technology world, you’ll be likely to have seen, over the past few years, a product marketed using OpenAPS and Loop terminology, by a gentleman named Chris Fardmanesh.
Chris is an Electro-Mechanical Design Engineer with over 30 years of experience, who owns ProSul Technology.
It claims to be an integrated artificial pancreas all built around a pump as shown below:
In the past you may have seen it marketed as ProsulPump, amongst other names. But does it do what it says on the tin, and just what is it?
When you dig further into the pump, you find yourself directed to a facebook page, which seems to change names/identities fairly frequently. It’s often named something along the lines of Artificial Pancreas-Looped or Artificial Pancreas-OpenAPS and you’ll also find the pump known as OpenAPS-Pump while in reality there is no link between any of the DIY platforms and this system, and it’s being used for marketing purposes alone.
Once you dig further into this platform, your eyebrows may be raised further.
The pump…
Reading the documentation around the pump, it’s clearly never been certified by any regulatory body, which should raise red flags to anyone involved. There’s also a level of obfuscation going on, as there are statements about the infusion set being FDA approved, however, if you dig through all the information available, the pump uses Animas reservoirs and Medtronic infusion sets, which of it’s self, is an unusual combination to build a pump around.
There are numerous videos on YouTube purporting to show the accuracy of the delivery, comparing what appears to be a 722 and this pump delivering a single unit as a drop, inviting the watcher to draw the conclusion that the non-FDA approved ProSul pump delivers the same amount of insulin as the FDA-approved 722. It’s an entirely non-scientific test and there is no evidence of repeated testing that this system is delivering the same amount of insulin every time over varying doses, or has any safety provisions in place to limit insulin delivery.
If you read through the claims, you’d also believe that you had an all-in-one device that could be used perfectly safely, and yet, as you dig further through, you find that while the pump itself appears to have bluetooth, it doesn’t accept sensor glucose data directly from any form of CGM, despite the marketing claims.
Whether the pump operates as an APS of any sort would require the ability to get my hands on the pump and test it out, but that seems unlikely, given the next set of challenges.
The Service
If you decide to run with this programme, then there is a service component involved. Chris (I assume it’s Chris, rather than a team, but it’s further obfuscated behind a facebook ID) requests that you provide him with three days of data to “tune” the loop/pump and show you how it’s working before handing it over to you, but you have to provide your Mongo API to him to do this. He will then show you how it is performing over that three day period so you can see what it does compared to what you expect. If you want the system after this, it will cost you $900 plus shipping.
Yes, that’s right. A system that suggests that it is using a DIY algorithm in an unapproved pump is asking for $900. And that’s before we look at how you get sensor data into it. Alternatively you can purchase what appears to be a 3D printed pump from various Indian sites, at a price of around $2,000.
This system doesn’t just run on its own. Oh no. It also requires that you download an app from the app store (and claims that this is possible on both iPhone and Android, although I’ve not seen anything in the Apple App Store to back this up).
But perhaps the most amazing thing here is the price. Take a look at the Android Play Store image below:
Yup. That does say £299.99, for what’s either an app providing glucose data to this pump, or some sort of wrapping up of the free OpenAPS algorithm. And that’s on top of the $900 you’ve just paid for the pump.
Either way, it seems like an attempt to obtain money, and in doing so, uses the terms related to DIY Diabetes nefariously.
Does it work?
I’ve no idea what the answer to this question is. I’ve never laid hands on one of these, and I’d never connect it to myself as there’s no evidence that it’s even safe. There are comments in one of the facebook groups from the admin team that there’s clinical trial evidence to back up use of the system, however, when I asked for a copy of the outcomes paper, I was swiftly kicked out of the group, leading me to suspect that this doesn’t exist.
The testing that Chris says he does will allow you to compare the system to others and see how it is better, but he’s talking about systems that aren’t available or often are low glucose suspend based. So again, it sets off alarms.
Would I use it?
Now as I’ve said, this isn’t that I think this is a scam. It appears to cost a lot of money and doesn’t pass the “If it appears to be too good to be true on the internet, it probably is” test. No-one can present any evidence of safety, or anything else, and it’s impossible to get your hands on one without giving any money to someone.
So in this respect, no I wouldn’t use it. I’d welcome the team behind it sending me one that I could put to the test and check out their claims, but this one has, right now, big red letters saying
STAY AWAY
on it for me.
And that’s what I’d recommend others do as well.
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