PDM With No BG Meter... J&J OneTouch PDM?

This is a quote from the FDA 510(k) application (cleared 29 Aug 2013):

The OmniPod Insulin Management System is a tubeless insulin pump and is intended for intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. This system is comprised of two primary components, the insulin pump (pod) and the remote controller (Personal Diabetes Manager). The proposed device is a modification to the OmniPod Insulin Management System that removes the integrated blood glucose meter from the Personal Diabetes Manager.

What are they up to?? Making a PDM with no BG meter is lame, so I doubt that is the end goal. Hopefully this is a modular approach so that a BG meter can be paired to the PDM (think Legos), then any approved BG meter company (no doubt someone not in my formulary) can build a meter that snaps into the PDM.

Does anyone know?

[1124-K131294.pdf|attachment](upload://3wxLBtOXcNrk6MGp4rXQ3Iwnheh.pdf) (139 KB)

Maybe they've got fed up with Abbott; the recent thread about the very major discrepancies between the Omnipod BG readings and the FreeStyle ones suggest that bad things are happening.

John Bowler

Interesting. Good Find and thanks for sharing.

I think they are considering removing the meter to allow for CGM to be put in it's place.

Now that would be a great thing. Hope to hear more about this

My insurer has dropped freestyle from their standard formulary. I can get coverage when my doctor pushes for an exception based on the PDM only accepting freestyle. This started last summer (a few months before this application) so maybe Insulet has been hearing from lots of users about this.

I'd like more options but there needs to be some interaction. I'd not want to need to dial in a result each time....

Insulet has just signed a agreement to supply OmniPods for delivery of other types of medication. Perhaps this is what's it's about.


I agree down the road, but the only difference here was the meter removal, so all the software is written for insulin delivery.

Do you have the link to this info?

The link is embedded in my post, and I attached a pdf version as well. http://www.accessdata.fda.gov/cdrh_docs/pdf13/K131294.pdf

Sorry just saw your pdf above... btw that link you have gets "Page Not Found" This link does work: http://www.accessdata.fda.gov/cdrh_docs/pdf13/k131294.pdf

Since I've started using my Dexcom CGM, I don't use the meter in my PDM any more. I wouldn't miss it.

Has anyone won an appeal over the Ins. companies non coverage of Freestyle strips? I'm going to hate carrying two devices. Maybe I should just go Dexcom, which they pay for. Is that dumb or what?

I had my endo write a letter stating that Freestyle strips are required and an alternative is not acceptable according to his medical prescription for me (to use OmniPod). BCBS accepted that.
Wish I saved the letter so I could share the exact wording, but I didn't.