Hi guys, we had a meeting tonight with a local group of pumpers and all the of the Pump Reps were there advertising and answering questions about their latest generation pumps. I asked our Rep about the Omnipod / Dexcom Integration and she was able to verify a couple of things. 1) It was submitted by Dexcom for approval in April. 2) They still hope to have it on the market before the end of 2010. 3) It will require a new PDM. Apparently they made some other changes to the programming so that the CGM functions would integrate while with everything else and decided that it could not be upgraded with just a software download. This is kinda crummy for all of us who just bought new PDMs this time last year. Also on a side note my Rep is still promising the 45% smaller pods before next summer. Just wanted to bring you all up to date with my findings!
Thanks. This is all good news. The new PDM will probably be like an iPad. The current one isnât all that petite. 
I got the feeling that the general casing and whatnot of the new PDM would be identical to the old one. There were just to many software changes to make a downloadable âupgradeâ possible.
This time last year? What about 2 months ago???
Grr. Insurance wonât be happy when i submit for the Dexcom PDM and Dexcom systemâŚ
If you get insurance to cover it then let us know how. Last time they offered the upgrade for a reduced price (I think it was $150) for current customers. It came out of pocket but I still think it was worth it. They had an even greater price reduction for those whose systems were less than 4 months old I think.
I like the sound of this!!!
Iâm with Stephen. Iâve only had my PDM for about 2 !/2 months. And my insurane didnt pay for it. So if I get another one I would have to pay for it again by myself. That kind of sucks.
I just went on the Omnipod and even though my insurance wouldâve paid for it, I elected to pay out of pocket via the $300 cut the cord program. That way, I can get insurance to pay for the new integrated PDF when it comes out⌠hope itâs soon, though. I love my Dex, but carrying 2 devices stinks.
Rebecca,
Itâs possible that you wonât need a new PDM, just a new version of the software in it. Check with Insulet later in the year to find that out.
Cheers,
Gil
Ex-Insulet OmniPod Engineering Team Member
I specifically asked the Rep about that because your version is what I had heard before but she was very certain that we would need a whole new device, not just a software upgrade. I can still hope and pray youâre right but it doesnât look promising.
Hard to imagine that a CGM will not require some new hardware. Also, It is worth pointing out that many ins companies do not cover CGM and view them as experimental in nature. So, when we see the upgrade be careful to check for that. The CGM portion will require its own sensors which will be an added cost.
We wait and see:)
I have heard the rumors about the joining of omnipod and a cgm. Lots of talk about dexcom but what about freestyle.I did a clinical trial for both and then basically was able to chose after a very intensive trial between the two and freestyle wins hands downâŚno comparison. Anyone who wants or I should say there insurance will pay for a cgm go freestyle overtime and no I donât work for about lol. Itâs readings are so close and accurate I rarely prick my finger unless it is to calibrate a new sensor which has to be done every five days and the calibration is 5 times in 5 days and three are on day one. If I had to choose ji hope the team up with freestyle to not like their meter is not in all are pumps. I have heard rumors the same thing is happening there. Like I mention I have had both and you could pay me to have any dexcom product, just my preference. I read a lot of negative stuff about freestyle but I was one of the first in the country to use it and to this day still use it. I am actually doing mother trial for their next generation navigatorâŚawesome is all I can say.
Steven,
In the initial stages, Insulet corp. was talking with both Dexcom and Abbott. I believe Abbott and Insulet may still be talking, but the first integerated CGM/PDM combo will be with the Dex.
It would be nice if they eventually came out with a general PDM that could be âpairedâ with whichever sensor/transmitter you prefer. I hope it happens some day, so we can have the âbest of all the worldsâ, so to speak, but in the meantime Iâm looking forward to any updates they may be working on, including Dex integration
That would be amazing. I just started on both the Omnipod and Dexcom and love them both. I canât wait for integration. I have oxford and they covered both as just $30 copays each. Although my premiums are sky high. The omnipod people said they have submitted the paperwork for integration with the FDA for the Dexcom.
Iâm not going to hold my breath on OmniPod / Dexcom integration. I love my OmniPod and my Dexcom, but it looks like Dexcom is dealing with some rather serious FDA scrutiny over the last several months for the following:
- Failure to adequately submit to FDA reports of sensor wire fractures that occur under the skin;
- Off-label usage (i.e., usage unapproved by FDA) in pediatric and adolescent patients, pregnant women and patients on dialysis; and
- Off-label usage of sensors in areas other than the abdomen.
I think the most recent letter relating to this is about a month old, and you can read it here âhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm21341 .
Unfortunately, my suspicion is that this will further delay FDA approval of an integrated OmniPod / Dexcom system. Total bummer.
Iâm gonna be really upset if either 2 or 3 result in a delay because those are NOT Dexcomâs fault. Off-label usage either falls on the shoulderâs of the doctors (for prescribing it) or the patients (for not wearing it properly). I mean, if you really want to talk off-label usage, each of us who restarts our sensor after 7 days to get more wear-time out of it is using it off-label. Your first point, failure to report, is Dexcomâs fault though⌠I really hope it doesnât delay our integration too much.
I agree, the first issue is by far the most serious of the three issues. The other issues can be addressed through global changes to manuals, labels, marketing materials, etc. I think FDA is ticked because its evidence suggests that Dexcom is aware of the off label uses and (perhaps) is not doing enough to discourage them.
Regardless, all three of these issues will take time to address, and I cannot imagine that this will not be a speedbump in approval of the integrated system given. I am sure that the application for the integrated system relies upon the application for the standalone Seven Plus system.
I agree with both of you because I also love my OmniPod and my Dexcom. When I first started the Dexcom last September my CDE was the one who said âsome people are wearing the sensors in places other than the abdomenâ. While she didnât exactly recommend other sites, she did not discourage it either. Even though Iâm considered obese by my doctor, my abdomen is the worst place for decent readings. Iâve just had too many years of multiple daily injections and too much scar tissue.
As far as the integrated systemâŚat least we can still hope because so far we havenât heard that the plans for this have been abandoned.
I waited a long time to get a Dexcom because of the proposed integration, and finally said âenough!â in late May and got it.
Now that I have it⌠Iâm not sure I want the integrated version, unless they really make the Omnipod PDM smaller. The Dexcom is about the same length as the Omnipod, but itâs egg-shaped and fits into a pocket a lot easier than the Omnipod PDM. Also, the Omnipod PDM is important⌠you break it, itâs a real hassle until you get a replacement. I like it in its case, safe in my purse or desk drawer until I need it. If the Dexcom gets dropped & broken, itâs a hassle, but definitely easier to live without than the Omnipod.
I thought it would be a hassle to have two PDMs, but Iâm really rethinking that now.
I am in the process of getting a dexcom. I am really curious what you do with it when you are wearing a dress or skirt (assuming you do). I wear business casual clothes to work, which means a lot of skirts/dresses w/o pockets. Any suggestions? Thanks!