FUDiabetes

Tidepool plans to push out an FDA-approved version of Loop

What do folks think about this? I think, if they can get the FDA to approve the app without all the dumb safety features that were required for the Medtronic 670G, this would be GREAT!!
https://tidepool.org/tidepool-delivering-loop/

I’m just worried that this plan won’t make it all the way to completion and that it will therefore just make Loop unavailable for people.

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If the Tidepool is intended to work with Medtronic equipment, my take on it would be this has a prerequistite for the Medtronic cgm to first be approved by the FDA as an iCGM system as well for the Medtronic pump to first be approved by the FDA as in iPump.

Although perhaps I have misunderstood what they are talking about and their plans.

EDIT: AFAIK, Tandem is the only pump manufacturer who is currently and actively working with the FDA to have their pump designated as an iPump.

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I think they are working with multiple manufacturers but probably not Medtronic. Just my guess, as the Medtronic old pumps already do work with the system. Currently Loop works with any CGM data that is uploaded to NightScout, so most people who are using Loop use Dexcom. If the data from Dexcom is approved for dosing decisions (as it is) then I don’t think it’s that much of a leap to approve the algorithm for use with a pump.

Basically Loop takes data from Dexcom (or I guess Libre), then uses the algorithm to make BG predictions and sends commands to the pump via something called a Riley Link. My guess is the plan is to eliminate the Riley Link element and actually find out the pump communication protocols from other companies so that they can have it run on a phone.

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I am very happy for the iPhone users. Maybe it will cross over to Android-land too. My already high opinion of Tidepool just went stratospheric! :ghost:

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Medtronic has agreed to work on a future bluetooth-enabled pump that will be compatible with Tidepool Loop.

Please ignore the title shown for the following link. It actually does go to the press release that announces Medtronic’s agreement to support Tidepool Loop.

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Yup, very exciting news: today Tidepool announced a collaboration with Medtronic to develop Tidepool Loop to work with a (future) BLE-enabled Medtronic pump, as well as a partnership with Dexcom to officially integrate G6 with Tidepool Loop.

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I wonder what this means for FDA approval – do they anticipate that being pretty easy???

What do you think the timeline is for these products to be available? I mean how long does it take for a completely new pump to go from aspirational to on the market??

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This is a 2 fold problem:
PUMP: the pumps need to change so individuals can choose target range and delivery protocol (bolus vs basal). Currently the 670g aims for a BS of 120 and tries to keeps you in a “range” that tops at 180. Has ANYONE ever had a physician tell them to shoot for BS of 180? Changing a pumps method of delivery (predetermined bolus vs basal), and allowing me to mix and match pump/CGM to get me at 120-180 faster, seems like not much of an improvement at all. Giving me what people who LOOP and openAPS have, the ability to choose my own target BS AND mix and match the pumo/CGM AND use both blouses and fluctuating basal rates as they work best for ME to get me there quickly, would be a significant improvement for commercial pump manufacturers.
SENSORS: the lowest variance I can find in a journal study for high ends BS to ISF is 32%. That means an ISF of 160 could represent a BS of 160 to 109. Until industry can lower that 32% variance, I doubt the FDA will allow us to have a device which allows us to set a target range that varies significantly from what’s already out there.

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But the target range is set in the Loop app currently. So what I’m imagining is they’re just creating an old-school, manual pump that simply has the communication protocols to enable Loop to send it commands built in. And almost every manual pump I’ve ever seen allows users to set their own target range.

Based on what I have read about LOOP/openAPS, users get to choose
their own target - “Currently, my Loop system is set to target 100 mg/dl.”

I do not know, but I am pretty sure the interoperable Medtronic pump will not be a completely new pump. They will simply have one of their already approved pumps retrofitted with a different radio (BLE) and different software that allows remote communication and control. None of that is a huge engineering undertaking - they probably already have it in the works. That “new-old” pump will need to get ACE (alternate controller enabled) designation from FDA. Quoting from the FDA announcement when ACE designation was approved for Tandem t:Slim X2:

The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.

Note that there are no clinical trials or outcomes mentioned, it’s just a technical review. I have no doubts Medtronic will be able to get that ACE designation pretty easily.

I really wish this were the case. They could just take 523/723 pumps and retrofit them with BLE, so we could ditch RileyLinks and use Loop with simple, proven in-warranty pumps. Unfortunately, I suspect the Medtronic ACE pump will likely be based on their newer style (such as 670g). We do not really know, maybe they surprise us all and come out with a BLE enabled ACE-designated 523/723 - I’d love that.

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Very exciting the movement we are seeing in this space. Excited to see what the next 2-5 years has in store.

FYI… Tandem has a Conference call tonight at 8 EST I believe to talk Control IQ.

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The forthcoming 780G already has bluetooth, presumably for display on phones. It would be a straightforward firmware upgrade to add data access and dosing commands to the interface, of course followed by getting FDA approval for the ACE designation as you mentioned.

The 780G is described at https://diatribe.org/news-medtronic-hypoglycemia-prediction-iqcast-sugariq-and-timing-next-gen-minimed-780g-closed-loop where they mention automated bolus for corrections, bluetooth, remote monitoring for caregivers, software updates, about 2 hours better time in range than with the 670G, and having the Guardian 3 sensor approved for non-adjunctive use (no confirmatory fingersticks.) But I bet the 780G is still upside-down, because they would have to admit they were wrong to correct that.

Thanks for pointing to 780G. It looks very likely that the future ACE-designated Medtronic pump will be its close relative, oh well.

780g trial is estimated to be completed in January 2020, with results presented in July 2020.

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle_Print&ID=2400974