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.

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.