OmniPod 5 "FDA-Cleared"

The OmniPod 5 is now “cleared” for use in the US by FDA. This is a three part system comprised of the OmniPod 5, the Dexcom G6 glucose sensor, and a compatible smart phone making this an Automated Insulin Delivery system [AIDs]. This is Cleared for ages six (6) and older.

With an optimal free phone app, SmartAdjust™ technology, Omnipod 5 and the Dexcom G6 CGM are in constant communication, enabling automatic insulin adjustments.

I have very little information at this time, but more [including a list of compatible phones] can be found on the Insulet webpage, Omnipod® 5 | Omnipod


Thanks for posting that news, Dennis. Are you considering switching to Omnipod? (Am I wrong in assuming you currently use the Tandem X2 T-slim pump?)

Exciting news! Thank you for sharing.

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You are welcome Dani @dsiizuka and I am very pleased with the results I have with the Tandem and Control IQ.
At this point, I’m not planning to switch partly because I still have some questions about SmartAdjust and how it works - the Insulet “Release” I read, and the OmniPod website left me with open questions. Later, I will read the FDA clearance letter and see what I can learn.

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When it was initially to be released last summer it was to connect with Android first and later with Apple. That may have changed as there was delays in the release. I am on Omni Pod and have not been notified of ay change over /upgrade yet.

Just checked the Omni Pod Web site and they are still working with the Apple connection. I put myself on their list as being interested in the up grade. The freedom of no tubing and easy site changes has been a mental boost for me over the past few years. The fact that the Omni pod 5 will now pair with my Dexcom will be an added bonus.

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I am intrigued by the algorithm on Omnipod 5. Unfortunately, as I live outside of the US I’m unable to get more details. My outstanding questions would be if the AIT can be adjusted, is the ISF input or calculated by the algorithm, at which level the auto-bolus kicks in, and how it is calculated, if the auto-bolus is “treat to target” or “treat to range” and if the auto-basal is automatically calculated (780g) or if it is “tethered” to the basal schema set by the endo/patient. My issues with the Omnipod pump are the quantity of insulin (I use 100 u/day) and it seems that if there is any question of blockage, site issues, or insulin effectiveness that the only response is to replace the pump.


Andrew @DT1Lada , you are not the only person who has questions about the algorithm. In what has been published on the Insulet / OmniPod webpage and in the release provided to shareholders on the day before I posted this announcement, leaves more unsaid than said.; your questions asked are very much like my questions.

I haven’t checked in the last few days, but the last time I queried the US FDA, the “Letter of Clearance” had not yet been made available to the public. This letter will have those details along with validation information.

The warranty for my medtronics pump is over in a couple months and am looking at my options. My main worry about the omnipod is the very limited phone compatibility. I would not want to have to carry another gadget to bolus etc. I currently have a samsung galaxy s21 which is about a year and a half old. The most current one that they support is the s 20 which came out a year before that. I realize that it takes a lot of testing, but they are not compatible with IOS or phones less than 2 years old. With my insurance I would have to pay for the starter kit and then get a preauthorization to the the omnipod 5 through my prescription plan. It might work out a little cheaper, but I am not going to go back 3 generations of phones to use it. I am not one of those people that has the newest phones. I keep my phones until they break or wear out and then usually get last years model which is cheaper. If their pump doesn’t have a display they need to keep up a little better with phones.

I am interesting in the Omnipod 5 and would like to know if anyone has used it and what do you like about and what do you not like about. I am on the tandem pump now and my warrenty is just about up so I was wondering about the pod.

I hope when the dexcom g7 is ready it will work with the omni pod. that would be the best of both world. I dont have the pod yet but am thinking about it. what do you like about it.

Edited post - thanks to my friend @Dennis so pointed out some errors in my early morning writing. Hopefully this makes more sense🤪.

Hi @amytid . Like you I decided to try the Omnipod5 when my Tandem warranty was up. I just started a week ago and am loving it! I like to read reviews of real time users, and read what I could find given that the system is relatively new. A common complaint was that numbers ran high the first or first few pods (number of pods - which must be changed every 3 days, varied).

This is my own own experience - I was not thrilled to be in the low and mix 200s for the better part of the time. I started with my same settings with my Tandem pump and while I could have tweaked them a bit before the change, I wasn’t consistently high like that. But with the first pod change my numbers immediately improved - literally. And I do not mis-use the word literally.

I asked my trainer and she told that during the first 3 days/1st pod, the system is learning your body’s patterns but the adaptive technology does not kick in until that change. For some it may take more.

I noticed my total daily dose with the first pod was much less than with Tandem and asked my trainer about that. To be honest I didn’t write down her response and don’t want to say the wrong thing here but that’s something you can ask your trainer or rep. When I was running high those three days the correction bolus didn’t work very well which was both concerning and frustrating, and I don’t understand why (a lame thing to say here but I’m being frank about my experience). With Tandem when I was high it could take a couple of hours at least to come down, and sometimes the correction took me too low. Of course the idea is to have good background settings, and getting those right can be frustrating. I used my Tandem settings as my Omnipod baseline and its adaptive tech used that as a starting point and adjusts accordingly, so (again, my explanation - check the tech with Omnipod) it takes some of the guesswork (for lack of a better term) out of deciding what to change.

Please please please use these comments as a starting point with an Omnipod rep or trainer. I may not be explaining the technicalities well or correctly but can only say the system is working well for me. I’m even considering tightening up my range. With Tandem - which was great when my background settings were great - I still had to leave a cushion so I wouldn’t drop too low with corrections. I know I’m going to get feedback about having good settings - it was just very frustrating for me to keep good ones in place. I’m not knocking Tandem but for me the Omnipod’s adaptive technology has been even better. I started with a range of 130-180 for that cushion but am thinking about tightening up now.

I really liked T:Connect software and used it in lieu of Dexcom (which I ran in the background) for my graphs - personal prefence. You have to use Glooko with Omnipod instead and can share with your doctor by linking to their office. Glooko can be used with Tandem’s CIQ but I never used it before so I’m getting used to the change. One good thing - I can record my food in Glooko so that info gets shared with my doctor as well. Our maybe that’s not a good thing🤔… I just connected the other day and don’t know if she’s looked yet.

I’m super happy with Omnipod myself. For all the concerns I expressed elsewhere on the forum about being tied to the PDM for control, I’ve found a way to pretty much ensure I keep it with me: I put my car keys on it and have an Apple airtag set to let me know if I leave it behind. And I’m just making a habit of keeping it with me. The PDM itself in not crazy about but it’s a matter of personal preference, not the operation itself.

That’s about it for now. I’ll add thoughts as they come to me but all I can say is, for me this is great!

Additional thought: I got an alert last night and kept trying to find it on me pdm. It took a while for me to realize it was coming from my iPhone (duh!). So far only certain Android phones can be used as controllers. I don’t know when that will change.

thank you for all the great information about the omnipod. I contacted my doctor and can’t wait to get it going. She told me the first 2 to 6 pods will be challenging but once it get used to me it will be smooth sailing. i am looking forward to being cordless.

Please keep in touch! I don’t know enough about it yet to share “tips and tricks” but it would be nice to share our progress. I just looked at Glooko to see my TIR.
TIR week 1 (which starts on Sunday, regardless of the day you start your pod. I started on a Thursday so that confused me for a minute) since my first week was really only 3 days. I was 40%. Unlike T:Connect, with Glooko you cannot customize your ranges - at least I haven’t found a way to.
TIR week 2 - which did start on Sunday - is 75% - I thought it was better than that. I set my target range between 130-180, which would allow me a cushion if the system over corrected. I have gone below 130 but for the most part not significantly, and had a few highs for forgetting to bolus (you can set reminders to help with that). I am planning on lowering the low end a bit now that I’m more comfortable, but will do that after I see my endo on Weds. - she can see how the current pattern is working and it will be less confusing than adding something new…
One tip I might suggest: I filled my first pod with the amount of insulin I typically use in 3 days, but ended up wasting a lot because the system was so very conservative. You might want to fill maybe 2/3 of what you normally do, and if you don’t have enough for the 3 days you can always start a new pod a little early. Run this by your trainer though - I don’t know if doing it before Day 3 will affect its learning curve. On a happy note, I’m finding I use a little less per day - around 35-37 units vs 45 with Tandem.
Be sure to ask your trainer or rep how Omnipod’s correction and frequency compares with Tandem’s: the pod corrects “in the moment” - well every 5 minutes, and personally I’ve found that very helpful.
Regarding number of pods needed to “settle in” I asked my trainer why the variance. She said some users were not very vigilant about recording their meals, and a pump can do only so much to help rises if it doesn’t know what you’ve taken in. If it doesn’t know what you’re doing it doesn’t know the pattern. I hope that makes sense.
Keep in mind these are all my personal thoughts so do discuss with your trainer or rep.

How are you feeling today i’m not sure if you received my response on JDRF but I was very appreciative and looking forward to getting the pod in a couple months after my warranty is over yay

I will keep all these good notes that you are telling me. Its very helpful. I need to wait until after november 14 2022 to get the pod. But I am so looking forward to the change. I will definitely have my doctor and training make all necessary changes. I am not really confident on doing that. I think tandem correct in the moment every 5 mintues too. Do you live in the bay area. I am looking for a bubby to talk to about diabeties and sometime things can get difficult. I am sure you know that.
once again I appreciate all your great info.