Omnipod 5 announced

Pulling a new topic from TomH’s post, Omnipod 5 gets clearance.

https://www.omnipod.com/what-is-omnipod/omnipod-5

A few quick thoughts:
Ages 6 and up- Congrats to all the kiddos out there.
Laughable smartphone compatibility list- Just the S10 4g, a 3 generation old phone.
Edit: I misread, there is smartbolus, or something like it. Cool.
What about the external controller they reference? Are they just updating the PDM or giving me a new one? Dash doesn’t have a charge for the PDM, the price is rolled into the pods.

I’m interested but probably only if the PDM is free/upgradable.

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@Karl.n I’m with you on the questions! Particularly the PDM part, given the other discussion here on FUD. I share your concerns about the supported devices; I’d have thought app development would be done in tandem, vice sequentially, but they announced the sequential nature earlier, so can’t complain. Some questions for those in the know:

  1. How long does it take for Medicare and other insurance to get a new item like this in their formulary? And, into inventory/supply?

  2. I suspect Insulet has the supply chain/production ramp up capability, anyone know? Heard?

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I would hope that the answer to both your questions is its the exact same hardware, just updated firmware/software. Especially as they continue to supply the legacy products it makes sense for them to minimize configurations. But things aren’t always as simple as that.

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It’s good to see that it doesn’t require a controller to work. Remember that this is their first attempt at cellphone compatibility - the Dash pods aren’t compatible with anything, neither are the Eros ones; you either have to have the controller or control the Eros pods with a RileyLink and your own software.

From my point of view it’s several orders of magnitude better than anything so far, but we will have to see how good the CGM directed control is. I wonder how they deal with the G6 dropouts and rewriting of history. It probably doesn’t make much difference; the dropout/recovery takes about 30 minutes but they need an algorithm to handle it.

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Just caught wind of this

This is the first pump that I find potentially appealing.

Reached out to insulet for insurance confirmation

Really looking forward to hearing some user reviews

If I can get my hands on it at least month or so before cruise ship season I’ll love to give it a trial run… otherwise I think I should stick with what I know until fall at least

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@Sam Hope you have the right phone to use with it, unless you’re going to use the PDM, there’s currently only one phone supported, think it’s the Samsung 10. The alternative is to use the PDM they include with the first order (supposedly free of charge). On the other hand, you may follow the old computer adage: “Don’t by version 1.0 of anything!” Let the more adventurous work out the bugs and wait for 1.1, if not 2.0!

Either way, look forward to your report of progress with it!

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That’s dumb! Well I’m not that interested…

Since iPhone is the most popular phone on the planet I think I would assume that would be a fairly high priority

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It’s in “the works”, but not available, and Insulet is silent on a timeframe, not even “soon”, “weeks”, “six months”, (I talked with them yesterday on it, though primary discussion was a pod issue). Given the time the 5 has been in development and the relative ease of porting software from one device to another (possible overstatement, but its not completely different code), you’d think Insulet would have been ready with both Android and iPhone capability…unless, of course, its and FDA approval of software that’s the hold up (I admit I don’t know the whole process, perhaps someone else here?).

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I’d be willing to bed it’s a hold up with the fda somehow it’s not like there aren’t very many good iPhone app developers out there

Really interested to hear the reviews start trickling in… Eg there was a huge difference in apparent satisfaction with Medtronic vs tandem reviews with their closed loop systems

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They have to get Apple to approve it; it’s a health application and it is one that actually controls the delivery of a medication. Given all the problems of getting xDrip+ on the iPhone (Spike is still build-yourself-at-your-own-risk) which doesn’t deliver any medication I’m pretty sure Apple will make things hard.

Here’s a summary page I found (randomly):

Halfway down:

1.4.2 Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, or other approved entity, or receive approval by the FDA or one of its international counterparts.

Of course it is not just calculating a drug dose, it’s also causing it to be delivered and it is doing so without patient oversight (i.e. it happens automatically, that after all is the point.)

Samsung have control of their own app space and are not US based so are probably less concerned about the US sue-first-ask-questions-later culture.

I originally swapped to the iPhone because the Insulet support seemed iPhone oriented, but if they hit problems I’d be very happy to swap back to Android and get easy access to xDrip+ again! In fact I’m tempted to just do it, although the phone, the SM-G973U seems overpriced ($500); I wish they would take care to make stuff available on cheaper phones.

I certainly don’t need 128GByte of memory; I use 53.7GByte on my iPhone XR and that is mostly 25.8GB of Amazon Music, next up is 3GB of “Photos” (which shouldn’t be there, need to check that out) and 1GB used by Bitesnap! If I exclude the stuff I’d offload to an SD card on Android (all the music - much much easier on an SD card) then I’m using under 32GByte of flash.

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The company line my rep gave me was “there are more android phones in the world than apple phones”. While thats technically true, any developer will tell you that a large chuck of those are entry level phones that don’t get the same use rate as iphones, and the FDA doesn’t approve an ‘android’, they approve a model.

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Thanks @jbowler for the references, I hadn’t looked at them previously and should have. I appreciate the software not only reports/mimics data from the pod, but also calculates and gives the pod drug delivery instructions, not an inconsequential task. I also appreciate Apple has a review process with specific health requirements, though I suspect its to limit liability more than to protect me/us, and takes some time to complete. However, Insulet has been through this process a few times already, so to be perceived as, if not actually, being reactive and lagging significantly…only one device approved on one platform…particularly with a lack of projected timeline for other devices. Perhaps they’re just non-committal out of an “abundance of caution” of disappointing current and prospective clients, but they’ve also disappointed many people by not being more prepared and transparent on estimated availability of more devices their customers use. Insulet, though it has a good product and I’m glad to use it, is and has been reactive and behind the technology power curve…one need only look at their PDM. They need a future focus on what’s probably/possible and what their customer’s want/need, while acknowledging current limitations, vice being reactive to the current state. Too much of their software, what customers actually see, looks like it was designed and intended for a software engineer to be “good enough” vice being a polished simple interface for the average user. If they don’t apply more customer focus, the likes of Tandem will eat their lunch and Insulet become an “also ran” vice the successful company they could be.

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OK, I have to apologize for my impatience and impudence. I’m only a year + into T1, haven’t fully appreciated those of you that lived thru multiple releases of T1 tech, and apparently am slow to learn the in’s and outs of the processes established “for our benefit and safety.” I just received the Insulet notification they are just now working on insurance approvals for the Omnipod 5, that they expect it will take a “couple of months” and then they’ll start working switching people over. I should have realized the sequential, vice concurrent, nature of the efforts required for getting a medical product to those that need it. I should have realized the government was involved (slowdown #1), it was the FDA and Medicare parts of the government at that (slowdowns #2 and 3), insurance is involved (slowdown #4, though its probably multiple, done one at a time), Google and Apple approvals were required (slowdowns #5 and 6, though probably faster than any of the above). I’m sure there are a wealth of other factors I’ve failed to consider. I beg your indulgence and forgiveness for thinking anything related to a person’s life/health could be relatively quickly achieved by concurrent processes! Thank God Congress (is that two different things?) isn’t overly involved, we’d have to get a “continuing resolution” at best/least! I promise to try to do better in the future!:stuck_out_tongue_winking_eye:

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We just got a refurb Samsung S10 from Amazon for less than $250 and it’s working great. I’ve had lots of success with refurb Samsung phones- there are so many out in the wild and people seem to upgrade so much there are a lot of good and cheap refurbs available.

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Yes; I found that too. Like new cars these things lose half their value in the first couple of years :slight_smile: They’re also quite repairable (I repaired my wife’s S7 a couple of times, including a screen replacement). There are lots available, the only problem seems to be working out which ones correspond to the required model numbers - only two models are approved and I think those are just US specific carrier variations of the same underlying model.

It’s a reasonable argument that the cost is actually much lower than the MSRP and, of course, it avoids going with the latest/greatest/untested/brokenest model.

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One is that Dexcom’s approval process itself is known to be glacial, as demonstrated by the SugarMate fiasco. This is also new tech for Dexcom; either they are integrating their existing G6 code into another company’s app or, more likely, Insulet engineers are having to deal with stuff they’ve never seen before and aren’t permitted to speak about.

Another is that Dexcom’s software does have bluetooth dropout issues, possibly a result of supporting many different phones and OS revisions, and likewise Insulet’s Omnipod Display app, at least on the iPhone XR, goes dead for days unless it is revived periodically (from personal experience.)

Unlike the locked-down Dash PDM both apps can be backgrounded by the user and, even, hard stopped. If I were the FDA I might not care that a BG meter did that but I would need convincing about a drug delivery system. Is that why the app is not required? The algo seems to be set up to run entirely on the pod. I wonder if Insulet patented that; a missed opportunity if they didn’t. From Insulet’s marketing page (emphasis added):

To simplify things even more, you can control the whole Omnipod 5 System from a compatible smartphone through the Omnipod 5 App. With the Pod and CGM continuously talking, they’ll do most of the work automatically, but, when you need to, you can control your insulin delivery, give yourself a mealtime dose, and easily share data

Believe me that text in bold is much more important to me that having yet another broken app.

They also claim to have an activity detector. From their wording it sounds like it is on the phone/controller, but it could even be on the pod - accelerometers are dirt cheap. I wouldn’t trust it though; my iPhone goes into “car” mode when I’m skiing, my BG spikes up when I drive and down when I ski…

The fact that the controller now obviates the need for the G6 app is certainly a big plus. Now if they could just unlock it a bit. The Dash controller takes a SIM card and an SD Card, it has a camera and a flashlight, but none of these things work. It’s kind of useful to be able to make an emergency call, store pictures (128GByte SD card: $14, or $18 if you want one that works for more than a year), take a photo of the damage to your car, find the darned light switch in the middle of the night…

Give us access to cellular data on GSM (so it works outside the US) and the controller can send out emergency texts with location information (from the built in but inaccessible GPS) actually manage the time correctly (I just leave mine on winter time all year) and even provide crude email and messaging to the user. Obviously it can’t do Pegasus enabled data coms, but simple true text messaging using Telegram or Signal shouldn’t be a safety issue and simple text email shouldn’t either; I’m certainly not suggesting putting WebKit in there, that would definitely be a safety issue (it’s too big.)

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The old pods do not need the PDM to be functional, other than activation and bolus.

If I put on a pod, I can throw the PDM away, and that pod will work for 3 days. The basal program that is initially on the pod will run for 3 days.

Or if I put on a X hour temp basal, and then throw my PDM away, that temp basal will run for X hours and then return to the normal program.

So the normal “runs by itself” pod has always just done it’s thing independently. The only time you needed the PDM was for basal changes or for bolus.

So really, if you close the app on your phone, all you are doing is returning to the original setup after whatever temp basal or extended bolus finishes. It seems very much like what they have had with the old PDM’s for many years.

What changes though is when they need constant interaction with the CGM numbers so they can constantly make adjustments to your basal. That is when shutting down the app could be a problem for people.

(As I have stated before, for myself, I’ve never really liked the idea of automated basal changes. I only want that type of automation at night when I am asleep.)

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As I understand it that is how Dash and 5 will work as well. It was explained to me that 5 has a SoC capable of running in automode without PDM interaction. Tidepool and others will need constant interaction to run in automode, or they will revert back to the baseline basal programmed from the PDM. This was all from a rep trying to sell me on Insulet products that have not yet been released, so take it with all the salt you can get your hands on.

It is still unclear to me if there is any difference in hardware between 5/Dash or if they are just updating PDM software and pod firmware.

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If that is true, there is even less reason for them to lock the phone app so it can’t be shutdown, right?

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I suspect your concerns were raised repeatedly by the FDA, but what they have approved seems to be precisely this; a completely self-contained closed loop system. Tandem had laid the group work of course, but they did it in baby steps. Insulet seems to have jumped all in and made as close to the “artificial pancreas” as they can with current tech.

I can understand why this might slow the FDA down; taking away the ability to override, or consent to, or approve, boluses by separating the controller from the closed-loop probably seemed like a big issue initially.

Having Dexcom on board must have helped; they’ve managed to convince the Feds that their product is sufficiently accurate for dosage calculation. Funny that; my current BG is 135mg/dL, my G6 has been saying it is around 40 for the last two hours (it’s a new sensor.)

Anyway, I think we agree, sort of - removing the need for “constant interaction with the CGM numbers” by moving the control to the pod (which does the “constant interaction”) is going to make controller approval much easier. Now the device has a real fail-safe.

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