Tidepool Loop Received FDA clearance

We won’t be converting from Omniloop but for those who have been waiting…

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I’m sticking with Loop too but this should make looping available to a broader group of users!!

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Do you need a Riley/link or similar for Tidepool Loop or does it work directly on your phone?

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Riley Link is only an omniloop thing, I believe. I don’t know a lot about Tidepool loop but I know it’s not affiliated with Omniloop and I “believe” no extra radio frequency device for it to operate.

Hope you are doing well, Tia!!! It’s been a while!

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Thanks, you too! To me, that would be the main incentive of using Tidepool Loop. That and if it’s possible to use G7 on it, because the 30 minute warmup sounds amazingly appealing given how many of our super highs and lows happen in the warmup period.

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You can now loop (DIY with Omniloop and with dash pods), without RL.

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There are now multiple Loop mods that are easily built just using your phone, Mac, or Windows, but don’t require a Mac, Xcode, OL, RL, and implement various features. Check out ZulipChat or LoopandLearn websites. Tidepool Loop has yet to announce agreements, except for Dexcom, with pump makers. Everyone’s holding their breath. LnL has a forum this Monday w/Tidepool’s CEO…probably will be maxed out…to hear more.

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Thanks @TomH we’ve been out of the loop (haha!) when it comes to Loop for the last few years. Seems like a lot of progress has been made.

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G7 is also supported in DIY Loop. I believe in the dev branch only.

Also, you can now build loop online via TestFlight so Mac is not needed. I haven’t tried it though.

I’m sticking with DIY Loop, too.

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The more experimental dev branch is no longer necessary. Dexcom G7 and Omnipod Dash are now included in the main version as of loop 3.0.

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Here’s another link with a little more info on time and FDA rules on compatibility: https://t1dexchange.org/tidepool-loop-fda/. There’s also a LoopandLearn.org presentation tonight with Howard Look, CEO.

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  • Anticipated compatible technology includes: Dexcom CGM, Medtronic Guardian CGM, Minimed insulin pump, Omnipod DASH and Omnipod 5.

Thats a lot of hardware! I’m guessing no timeline. Maybe “minimed insulin pump” is the 515, wasn’t that the first one compatible with Loop? :stuck_out_tongue:

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@Karl.n Actually, there’s a reference to mid-2023 for availability. I suspect it could be sooner given the agreements that are/were already in place with Dexcom and length of time it’s been compatible with Medtronic and Insulet. It can’t help but sell more of those products already in service. I’m planning on trying to be on the LnL forum tonight, though I suspect it may be a “sold out crowd,” will probably test the servers in use…

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Here’s my notes for those interested in Tidepool Loop from the LoopandLearn event last night. Howard Look, Tidepool CEO, and Brandon Arbiter, Tidepool Business Development, were the guests. Here’s what was related:

  • FDA was impressed with the user data submitted: 176K data points, nearly 4x the data from any other submission.
  • Agreement with FDA that iAGC’s (Interoperable Automated Glycemic Controller, what Tidepool Loop represents) does not require re-submission for approval for use with any FDA approved iCGM or ACE (Alternate Controller Enabled) pump unless changes are made to the algorithm requiring clinical study evidence. Any iAGC can be used with any FDA approved iCGM and any FDA approved ACE pump as what is termed a “predicate device.”
  • Tide pool Loop includes most all the code DIY Loop had as of mid-2020 and includes:
    ** Apple Watch control
    ** Insulin On Board (IOB) on the screen
    ** Pre-meal setting down to 67 BG dependent on other settings (Safety, etc.)
    ** Carbs can be entered proactively and retroactively
    ** Training will occur 3 ways: in-app, via Tidepool website, via medical provider
    ** Auto-bolus therapy is NOT part of the submitted program, may be part of an FDA re-submission requiring clinical study
    ** Program download requires a provider prescription: provider accesses portal to Apple store, enter client data (email address and initial settings), portal sends patient activation code. patient goes to store, downloads code with initial settings (app cannot be used without activation code), enters activation code, patient can change settings as needed.
    ** Compatible with Humalog and Novolog; no FIASP (wasn’t widely available during clinical data collection)
  • Compatibility/Partners:
    ** Dexcom remains a partner and has iCGM status
    ** Insulet, despite having had an agreement with Tidepool and having supported development, has reneged and will NOT be a partner at launch
    ** Medtronic has also chosen NOT to be a partner at launch
    ** Tidepool has one major player (Who’s left? Is it tubed?) that DOES want to be a partner at launch, but is not prepared to have their name released and has not set a timeline for doing so
    ** An Android product is in development and will have to go thru FDA clearance process
  • Cost: There is no information available on cost for the product or any maintenance fee; it may depend on agreements with on coming partners (you could tell this was an uncomfortable topic; when you consider they used code developed by a lot of volunteers, it understandable; however, given some thought, its inevitable, there was a lot of investment of time, money, effort, already, and continued support/refinement is required, it’s at that awkward DIY to commercial transition point and can’t rely on charity investment only; who pays (users, partners, insurance, etc. and how much is TBD).
  • Timeframe for release: Unknown, probably measured in months, partly dependent on partners, FDA designation of iCGM and ACE status; European CE and and other sanctioning organizations in the future.

Thoughts:
iAGC, iCGM, and ACE pumps seem a desirable future from the perspectives of T1s, some T2s, the FDA, and some nascent players in the diabetes industry: mix and match what’s affordable to people, insurance, and makes economic sense to the people vice corporations…but it isn’t guaranteed. Corporate trust of partners can be fleeting as they jockey for position in a relatively small market. Further, PBM’s seemed a good idea at first, now they’re a stumbling block to medical affordability; diabetes treatment corporate entities are no different and seem to like the monopolistic model more than a mixed cooperative form, seemingly preferring individual patents and modifications to extend them combined with any of their own, certainly not others, improvements, software, and hardware (ala Insulet). We’ll see what strategy wins out…it’s not like its impacting the lives and health of anyone…

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Thanks for your excellent notes! I had no idea that Insulet reneged on their partnership. I suppose it is competition to their O5 (not really!)?

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Thanks for summarizing all that new news! Overall a very exciting development…but surprising that the pump manufacturers are backing away from partnering for the launch. I hope Insulet gets back on board pretty quickly. My cynical self says Insulet wants $$$ and negotiations will continue until some kind of payoff is made.

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@Trying Insulet hasn’t directly commented on their reasoning, though their recent email to Eros users about discontinuing it in December can be interpretted as they’re focusing on O5 as an AID and don’t want to support a competitor to it. I personally think they’re being narrow minded. They could be dual tracking, supporting both O5 development and continuing support to Tidepool Loop and selling more product all the way around. It’s possible they’re cash strapped, what with the Dash PDM debacle and debatable success of O5 after significant investment in it; though the lack of iPhone support of O5 a year after release is troubling. I can’t shake the feeling theirs another shoe to fall with Insulet…

I personally emailed Insulet’s Investor Relations folks and gave them a piece of my mind…hope other Omnipod users will follow suit! I got a response it had forwarded to the “correct department”…hope it was the head shed, but doubt it.

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I look at it as moving forward…they can’t support all products they’ve ever made, forever. At some point, technology becomes antiquated or they discover better tech, better gadgets and they want people using it. So, I think it’s normal for them (and all companies that produce products) to update to the newest technology, then give old technologies an End-of-Life (EoL) for support especially…support for those products takes resources, which means more money to support. I don’t find their EoL statement for Eros to be anomolous because all companies do it eventually as new products are created, the old products become extinct (and the support for those products).

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I agree! Especially as the DIY Loop group has been so involved and helpful (I would assume!) to the Tidepool implementation. Insulet should not pass up on this group!

@ClaudnDaye I agree, we all have EoL at some point!