The Kaleido pump has been around for some time, @Boerenkool posted about a recall issue in 2020:
I didn’t follow up by looking at it in detail but then I just noticed it again while searching for other stuff. Their web site (also linked above) seems pretty interesting:
It’s a bit like the US twiist pump; it seems to be a “true” pump which actually pumps the insulin in directly, like the twiist, rather than using a syringe/cartridge and a motor which drives the plunger to inject insulin. I was initially interested by the YouTube of the cartridge fill process:
That’s one the manufacturer has published (so it should be ad free for everyone). I find it strange that it’s in English (and British English at that!) I like the apparent intention to reusability and minimisation of waste; see the “reusable/consumable” picture 3/5ths of the way down the Kaleido web page (first link).
It also seems that, unlike all the current US hybrid-closed-loop pumps which use a controller embedded in the pump, the Kaleido pumps use a separate, smartphone based, “iAGC” which, yes, even has US approval!
So, given that AIDS are supposedly now approved “in principle” by the FDA I’m very interested in anyone who has experience with Kaleido and DBLG, particularly DBLG2 (though that’s only available in Germany ATM.)
Of course I use an AIDS but it is certainly not FDA approved! I’d really like to see pumps like Kaleido and DANA-i here. Maybe, given that there is an approved commercial iAGC that works with them, they can enter the market as acePumps, but maybe not; it’s a lot of work for them and the US market is, well, weird.
TidePool is FDA approved as an iAGC, but the only US implementations are traditional pump embedded derivatives (so far as I know). They are not a true AIDS but rather just a proprietary hybrid-closed-loop system, like the Omnipod 5. Kaleido and Dana-i seem, on the other hand, to be part of a true AIDS when used with DBLG1 or DBLG2; acePumps combined with an iAGC and an iCGM.
DBLG only supports Dexcom ATM; G6 for DBLG1 or G7 for DBLG2. However given the architecture future versions could support any iCGM. The iAGC is the centre of the AIDS; the acePump does not need to “support” a particular CGM, that happens in the iAGC.
We can already do this of course, but without regulatory approval; we have the technology to create the US’s first AIDS, we’ve already done it, several times. But it would be nice not to have to do it in secret.