Tidepool and Sequel Twiist

FYI, Tidepool (the FDA approved version of the Loop algorithm) announced FDA approval of Sequel twiist powered by Tidepool today at: The twiist™ AID system powered by Tidepool receives 510(k) clearance

The Sequel announcement can be seen at: https://www.globenewswire.com/news-release/2024/03/18/2847675/0/en/Sequel-s-twiist-Automated-Insulin-Delivery-System-Receives-FDA-510-k-Clearance.html?mkt_tok=MjQ4LUlTWi01MzYAAAGR8V74vpQbDofnwHfNcGVP5PLQaVSdPGnAtZ5BzgObHL63_TLG0F8ilgK1oNwblu-jl95hv9NBtAzWq3RjeTJijduuWg_OibKRasB-Bku4

Note both of them left off the “Loop” moniker. The Tidepool announcement says further information will follow. Sequel announcement indicated a partnership with DEKA (Dean Kamen’s organization). Neither indicates a pump the AID would work with, though DEKA did produce an “investigational pump” back about 2021. Lots of questions outstanding…

5 Likes

I couldn’t find what pumps it is compatible with. Do you know?

It would be ideal if it was compatible with the Dash pods but NOT compatible with the O5.

That would help keep Dash in the game longer!

4 Likes

The medical industry has some very strange naming conventions.

Hopefully the Twiist has all the basic features as the other devices.

https://twiist.com/

1 Like

Lyumjev anyone?
:joy:

Surprised Sequel was spelled correctly.

Could’ve gone for Sequellè

The shareholders would’ve loved that.

Lyumjev should be the affordable insulin you get at ikea.

2 Likes

:rofl:

Some assembly required…

3 Likes

@Eric Yep, that’s one of the questions! Most of the reporting just mimic’s Sequel’s FDA release. Many show either a pump or infusion set device (a round object on one end, 3-4” in diameter, then a tube and a tube connector) that Sequel has available for download on their website). I mentioned potential for compatibility with the DEKA pump, but that’s pure speculation on my part. It could be they’re looking at putting the AID software out there with at least one pump manufacturer willing to make their pump(s) accessible by it and hoping others will do so as well…though that seems like a financial recipe for disaster.

It’s interesting what we get excited by, eh?! (Hey, it COULD be life impacting…)

2 Likes

Saw this in JDRF Pipeline article:

  • twiist™, an Automated Insulin Delivery (AID) by Sequel Med Tech that features a pump by DEKA, the Tidepool Loop algorithm, and the Dexcom G6 CGM, received FDA clearance for individuals ages 6 and up with T1D.
  • Per the release, this is “the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose.”
  • JDRF is a longtime supporter of Tidepool Loop, an automated insulin delivery app for managing T1D, which received FDA clearance in January 2023.

Seems to confirm the DEKA pump connection.

4 Likes

The CEO Alan Lotvin has been doing interviews podcasters that have come out this week.

Sooo I’m thinking this pump sounds really good. The CEO said something to the effect that it will know if there is an insulin flow problem 17 seconds after it happens even in people who use small amounts of insulin. I’ve had a lot of clogged Omnipod cannulas but have never once received an alert. I only realize it’s clogged once I get into the 250s. I believe this is due to the fact that I use a low amount of insulin but I’m not sure. I would be thrilled with this sort of feature.

There were a few other differences from the Mobi as well. Such as the Loop algorithm, bolus from Apple Watch, and no need to take off for short swims or showers. IOS only for now but I don’t think it’s going to be available for awhile?

Algorithm is actually on the pump in the same way that Mobi and OP5 are. I see this as a big advantage over DIY.

I think l I will try this out when it’s commercially available. The only problem will be I’m going to have to learn LOOP. :rofl:

4 Likes

@Josie Thanks for posting this, I hadn’t seen it and it offers some additional info on the system and good reference for size. Seems slightly larger than my Dash pods, due to the round design, and possibly a little bit thicker, but not much. Having the software in firmware and onboard would seem a plus though it would seem to ensure no “tinkering” by users (this presumes they add some form of security to their code other than limiting the connections).

That happened to me recently so a pump that detected problems in real time would be awesome!

I’m forgetting that you all can make changes to the code. That would definitely be a negative for some. I really do know so little of loop.

1 Like

@Josie The fact the code can be relatively easily modified is a plus for all those that use Loop, iAPS, AAPS, etc. The Tidepool folks are upfront the Tidepool app is about 3 years behind the current Loop program and wont likely catch-up to the DIY effort; the reason is Tidepool and other manufacturers have to go thru the FDA approval process and it takes time. On the good side, Tidepool and others can pretty much pick, choose, and use any of the new code developed in the open-source community as long as they give appropriate credit or modify it for their own purpose(s), but it still has to get by the FDA with testing to prove safety and effectiveness. (Note: I probably sound like I don’t like the FDA; in fact, I think they serve an essential service, but too often they’re overly conservative (except when they aren’t), bound by law that can’t/doesn’t keep up with tech capability, and their process(es) too slow, often due to manpower availability.)

3 Likes