So my initial question and assumption was correct then.
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[quote=āSjwprod, post:61, topic:15235ā]
There are no completed studies for the lower age, once that has been done the data will be presented to the FDA for approval.[/quote]
Generally speaking, the public doesnāt know that as they have no access to that info. They typically only see what is cleared/approved by FDA. Companies may decide not to submit clinical data if they determine that the study is not successful. Or they could submit the data and FDA rejects it.
Approximately 90% of drug trials fail. We typically only hear about the successes.
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It you read published studies and the description of clinical testing much other than the info is available, but without gathering that info, guessing or trashing products or products development for medical products it does not help. A medical equipment manufacturer uses clinical studies and peer reviewed article to develop a plan for their studies so they are not waisting money and time, no profit in that. The clinical testing data is available from the FDA if you want to review it.
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I think the answers said that this is one possibility but the other was that tests on <18 had not worked well enough for Dexcom to submit them.
Dexcom G6 has always been hit or miss with us either way, so moving to the G7 15 day sounds like more of the same to me. At least weād have 15 days (when it didnāt crap out), instead of 10 (plus no restarts). Iād take our chances if we were allowed to use them. G6 has never been great at telling us what @Liam-Mās actual BG number isā¦the biggest benefit that theyāve always been to me is in seeing the trending dataā¦.seeing the arrows, especially the double downs and ups.
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The message you received from Tandem is interesting. The G7 is, supposedly, approved as an āiCGMā, which means that interoperability testing with the corresponding āiPumpsā, which got named āACE Pumpsā, does not require testing of the individual pairing:
(āIPumpā is trademarked so couldnāt be used.) It sounds like even though at least one Tandem pump is an ACE Pump the algo (inside the pump in this case) isnāt an iController.
That would not be specific to the 15-day variant although it is also possible than only the 10-day meets the requirements for an iCGM.
I have the same feeling; G7s (10 day) donāt start working for me for at least 2 hours and more often closer to 12 so I would really benefit from a G7 which worked for 15 days.
The main issue I see with the G7/15 is that the failure rate near end-of-life seems to be much higher (this is my interpretation of the Dexcom reported numbers.) For me that means my āoverlapā may be clobbered; I canāt do an overlap unless I know when the G7 will stop working.
The second issue is much more specific to my setup; at present there is no support for the G7/15 in xDrip+. Getting that support requires having a G7/15 and being willing to run a ādebugā version of xDrip+. Iām happy with the second bit but I donāt have a 15-day yet and Iām not happy making a swap (effectively a 3-month supply) and finding it cannot be made to work. I may be able to get a sample which would solve that problem.
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