With the recent news that Tidepool’s Loop has been approved by the FDA, the detail, that there are no pumps available that work with it, came as a bit of a shock to many.
The news was that neither Omnipod nor Medtronic pumps would be available at launch as both pump manufacturers had declined to continue the partnership, having helped fund the development of Tidepool Loop.
While this is unfortunate, is it really that much of a surprise? Both partnerships were announced long before Omnipod had a working Automated Insulin Delivery (AID) system, and well before Medtronic had announced their 2nd generation AID system.
Therein lies the rub in all of this.
Two large commercial companies that have their own systems available commercially for dollars. Ultimately, a net (positive) P&L on their bottom line.
And to add to this further, both the products that these manufacturers have are tightly integrated across software and the hardware device and have had successful trials at considerable cost with good outcomes.
The statements from the pump companies are (courtesy of the Tidepool website):
So let’s break this down a bit.
It’s all about the money. At the very basic level, I suspect there are two pieces to this.
The first: Don’t cannibalise sales of your own product and give away money to a third party as part of having to “pay to play” with a third party app.
The second: Don’t increase your own costs for a perceived minimal benefit. Supporting connectivity of your own ACE pump connected to a third party app can’t come without additional support overheads, and potentially (as many in the open source AID world can verify) quite significant resource need for minimal benefit to you as a company directly.
This obviously completely disregards what users might think of the experience and benefot of using a commercially supported version of Loop.
The JABE Loop Observational study shows new starters on Loop increasing Time In Range from a baseline of 67% to 73%.
In comparison, Omnipod 5 went from 52.5% to 68% in children and 64.7% to 73.9% in adults and 780G studies reported a variety of outcomes, showing an improvement in TIR of between 7% and 13%, depending on study and starting community. Additionally, both these systems have a level of learning built in that adapts the system from initial user set-up.
As the director of medical devices of either of these companies, presented with any of these sets of data, and the feature set, it would be hard to confirm support for a system that you might view as not giving you much of an advantage compared to your own system, based on the clinical data. Certainly not enough to justify the added investment required from the Money section, at least.
What next for Tidepool?
It’s obviously worth mentioning that these are not the only pump manufacturers, however, the only other one with a current ACE pump is Tandem. It would seem as though they might fall into the same category as the two we’ve already mentioned.
So who else is there?
Right now, in Europe, Ypsopump has partnered with CamAPS to offer an Android phone based solution. We also know that Ypsopump had a deal with Lilly that has since fallen through, which was to distribute the Ypsopump in the US.
Could Ypsopump be seeking ACE designation and be working with Tidepool on this to broaden their integration offering?
We know that in the UK, they supply to the NHS alongside CamAPS FX, with a MyLife branded version of the app in the app store, and the cost of the pump includes the “license” for CamAPS, so there’s no explicit cost for the software to the NHS.
This might be a commercial model that would work for Tidepool Loop, where the cost of the software is, essentially, free to the end user, and hidden in the pump costs.
Other pump manufacturers?
Roche have been focused on distribution of their Solo patch pump, although the user response to it hasn’t always been positive. Could this be an option? There are rumours that Roche has been focusing on its own CGM and AID system, so that may suffer the same concerns as the other big brands here.
Secondly, Kaleido, who already partner with Diabeloop to offer AID, have recently been in the news for increasing their supply. Could they be another option that might be looking at the US market and ACE designation?
And finally, what of the Korean manufacturers? Sooil have been distributing the Dana-i in Europe for use with CamAPS FX for some time now, and EO Flow have partnered with Menarini to offer their pump in connected package in Europe (although with limited penetration so far). Could either of these be seeking ACE designation?
What we know at this stage is that Tidepool is keeping their cards close to their chest, so until something is properly inked, this all remains speculation.
Needless to say, that when the commercial launch finally takes place, I’m confident they’ll have the options they need in place.
I don’t think FDA Clearance is the same as FDA Approval.
They have 501k clearance, agreed, which means they can market it and distribute it freely as the FDA has deemed it to be “Substantially Equivalent” to a predicate device (in this case control IQ I believe).
I guess in the most technical sense of “FDA Approval” it’s not classified like that, but in terms of restrictions on distribution it is a type of FDA approval without a capital A.
In the UK the Ypsopump doesn’t come with a CamAPS license in the adult prescribing. I know as I gave just had to self fund the license.
Sorry to hear that. I was informed that that is what is supposed to be happening…
I think you are missing a major factor in your analysis of why Insulet and Medtronic won’t support Tidepool Loop. I suggest it’s not about the products they have right now, it’s about the new products they have in the development. For all its advantages, Tidepool Loop is still only an FDA-approved version of Loop.app, which can be used with both these manufacturers’ pumps and is well-supported by the Loop community. It’s existing technology that requires a high degree of user technical competence and involvement and does not guarantee 100% TIR for any user. In short, it isn’t the long-desired, self-regulating, Artificial Pancreas. That’s the goal and where the money will be generated in future. So rather than investing any resources into Tidepool Loop, they’ve decided that their own product R&D is more important.
I don’t disagree with you, but I think this is just a part of the “money equation”. I think all the factors stated point to a severe lack of 3rd party ACE pumps from the embedded manufacturers. I alluded to the point you make in the time in range data, but yes, Loop is a first generation system with a lot of human involvement and the Jaeb Observational study, which was done amongst motivated individuals returned lower increases in TIR than the pivotal trials of Gen 2 systems. The data is there and it sadly isn’t pretty.
Ypsomed is also supplying pumps with CamAPS FX in Australia since late last year.
As always Tim, the into that’s needed clearly written, thank you!
My partner has recently added the Cam-apps control app to her Ypsomed pump with a Dexcom 6 sensor.
It has certainly been a learning curve, but gradually as she gets to know and work with the app switched into the ‘automatic’ mode, it is proving very successful, especially with its built-in features of boost and ease-off in the automatic mode.
She is now able to maintain over 80% in range as opposed to about 50% previously, and I think this will improve over time with more familiarity.
Also to mention, the alarms and information regarding insulin levels, etc. are all texted to me on my phone too, which keeps me in the proverbial loop.
The sad thing about Cam-apps is that their app will only work on an android phone. This meant that my partner had to purchase a new compact android pocket phone which not only entailed more cost but another learning curve, especially being that she has only ever used an iPhone.
From my research and observations of Cam-apps over the last couple of months, I believe that Cam-apps have put a huge amount of research into developing this phone app, and it would be well worth paying extra to incorporate the Cam-apps app with your pump and sensor if you can.
Apparently there are two tariffs one with and one without. Many CCG are lacking in funds so they are only buying the without option. This is Adult though the Paediatric side is different.