Discussion in 'Continuous Glucose Sensing' started by ecs1516, Jun 3, 2013.
Has Tandem submitted anything for future T:Slim / Dex combo ?
How do I search FDA for that?
You can't search for it, but they haven't announced any submission yet.
No, Tandem has not.
I was told that they did about 2 weeks ago. They're expecting it to take about 6 months for approval.
Who told you?
I was told by one of the high up tandem reps (the one who met with my Dr and myself). We had this meeting on the 10th of may, and she said that they were submitting it the next week.
I asked my clinical rep when I had her on the phone yesterday, and she told me it had not been submitted. That they're still finishing up clinical trials.
Hmm, alright. Thank you for clearing that up. I know reps don't always have the most correct info, so she may have been wrong, or something took longer than expected.
At FFL, they said they have not yet submitted but intend to before the end of the year. The typical process from there is 6 months, depending on questions/issues from FDA.
They are intending / hoping to have the integrated system approved and available before the end of 2014.
I've read enough "the rep said" stories (from all companies) to ignore them. At some point Tandem is likely to publicly confirm that they have officially submitted and you can guesstimate from there. Kudos to Tandem for working on this so soon after their debut.
So does anyone know, lets say for instance, that I got a T-slim in the next few months. Will those pumps have a software push that will enable the Dex system to work with it? Or should I hold off? My insurance is good anytime for a new pump as my current one was purchased with previous insurance. And I do want the integration, but if current pumps wont be able to upgrade, then I may wait.
I just read yesterday that the answer is no. A new pump will have to be purchased.
As Tandem's Lecanu-Fayet tells us: "Tandem Diabetes Care is working closely with Dexcom on integration of the Dexcom G4 Platinum so the t:slim Insulin Pump. We expect to submit . . . to the FDA by the end of 2013. We cannot predict the length of time of the regulatory review or when the product will be available. However we are integrating to existing products that were recently approved by the FDA. The Dexcom G4 Platinum's transmitter uses a different radio frequency than the low-energy Bluetooth that is currently in every t:slim pump. Therefore we will offer an upgrade program to t:slim pump users when the integrated product becomes available. We have no details at this time on the cost of such upgrade as it would be considered to be promoting the product by the FDA. It will be competitively priced. Regarding the linking with BG meter, we are looking at options for future iterations."
Does anyone else have concerns about replacements with problems when pumps integrate with Dexcom? On Medtronic, it's all the same company, so not a big issue. We just received our 3rd receiver this year from Dexcom, and I'm wondering whether the pump companies will be frustrated with replacing integrated units if the CGM starts to display problems. At this point, I would prefer separate devices but integrated data software.
well thats slightly disappointing..........oh well im under warranty until 6/14 so i may just wait and see what happens.
What disappoints me the most is that Medtronic has made the decision to stop offering its stand-alone Revel pumps to most of us adult type 1s. Meaning, if we have a 722/723 now and a Dexcom CGM, we'll either have to go all in with a Minimed 530G or go somewhere else.
I'm glad Tandem is filing by year's end, and hopefully it won't take FDA very long so that then people will have another integrated option. Plus, whatever happens with the Animas Vibe that was submitted in April...
Yeah, I think that sucks too. It just reaffirms my decision to go with t:slim and the Dex after 5 years with MM. We had a Guardian unit with our MM from almost the beginning, and once I heard that they no longer planned to offer a stand-alone device, I knew our time with MM was limited. We relied on the Guardian so that I could hear the alarms at night, and so I wouldn't have to constantly bother him during the day to check the CGM readings. Having them integrated and a stand-alone is the best of both worlds, but if I had to pick one, I'd pick the stand-alone for the parent of a young child.
We just saw the endo today and she said if the vibe has been submitted it can take about a yr for approval. She did say it may be longer now since the government has shut everything down. Not sure if FDA is on shutdown or not.
The FDA is partially shut down, but there are some essential duties that remain ongoing -and those that are supported by medical device user fees can continue, too. So, there is some question about whether review of submitted medical devices like Animas Vibe and Dexcom Share might actually be ongoing... but you really can't get an answer from anyone, as that's not "essential." But to the point: Vibe was submitted in April 2013. Some wonder if it might not take as long as it has in the past, because you're talking to already-approved things - the Ping pump and Dex G4. Plus, MedT has already paved the way with integration with a few different pump generations now through the FDA. There's just really no way to know how long it could take, or if the shutdown (depending on how long it lasts) would have any impact anyhow. We shall see...
We are having problems with software in the Vibe with it saying there is IOB when the DIA should have been completed. The suppliers of Vibe in the UK and NZ are saying there is NOT a problem..(or that they can't find one).. Hopefully the FDA will have a more stringent testing procedure..
In Dexcom's Q3 investor call on Wednesday, Nov. 6, CEO Terry Gregg said that Tandem had been planning to submit the t:slim for G4 integration by year's end. But with Tandem going public and doing its IPO, that time-table has been delayed and isn't expected now until sometime in early 2014. That coincides with what a Tandem sales rep said at an early November local event, that they're being told from corporate to not say anything about timing at this point as they had been promoting year-end 2013 for FDA submission.
On that same Dexcom call, Gregg said that Animas is currently doing more testing (verification and validation testing, along with human factors testing) as requested from the FDA regarding the G4-integrated Vibe. From what Dexcom knows, the expectation is that Animas should be submitting a report on all that to the regulators at end of January... so, it looks like the FDA approval on Vibe isn't going to be happening until AT LEAST February, if not further out from there...
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