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Post by agedhippie on Mar 10, 2020 9:57:06 GMT -5
What are the FDA rules on showing CGM's?  You mean something like this using Fiasp?  This is why nobody cares about CGM graphs. That took me literally a minute to find. There is good and bad, and if you are promoting a product everyone expects you to cherry pick the good. This is why the FDA will stamp on you if you try and do it without all the usual "don't expect this result yourself" disclaimers. These graphs are casually interesting, but not really material to the case. |
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Post by peppy on Mar 10, 2020 11:04:22 GMT -5
What are the FDA rules on showing CGM's? You mean something like this using Fiasp? This is why nobody cares about CGM graphs. That took me literally a minute to find. There is good and bad, and if you are promoting a product everyone expects you to cherry pick the good. This is why the FDA will stamp on you if you try and do it without all the usual "don't expect this result yourself" disclaimers. These graphs are casually interesting, but not really material to the case. I disagree. These graphs show the case. Talk about it only took a minute.  |
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Post by mango on Mar 10, 2020 11:56:59 GMT -5
What about on one side of the VW we show off to everyone ADA's SoC for T2D?  |
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Post by agedhippie on Mar 10, 2020 12:11:37 GMT -5
You mean something like this using Fiasp? This is why nobody cares about CGM graphs. That took me literally a minute to find. There is good and bad, and if you are promoting a product everyone expects you to cherry pick the good. This is why the FDA will stamp on you if you try and do it without all the usual "don't expect this result yourself" disclaimers. These graphs are casually interesting, but not really material to the case. I disagree. These graphs show the case. Talk about it only took a minute. It took less than a minute, that's an image I gave you!  It makes my point though, which is that people will cherry pick the image they want to show and the everyone knows that and dismisses the images accordingly unless it supports their beliefs. The images lack context so you don't know if they are impressive or "meh". The graph you posted was someone saying that it was a bad day triggered by a night time low followed by over-correcting both with insulin and carbs. In other words the context was what happens if you over-correct. However the explanation gets dropped and the picture gets posted as "look, a typical RAA response" at which point the insulin using audience laughs because they know better and dismisses everything else you say as a result even when it's correct. |
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Post by peppy on Mar 10, 2020 12:15:57 GMT -5
oh, baby, you know I can cherry.
aged, do you live around New Rochelle?
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Post by agedhippie on Mar 10, 2020 12:22:50 GMT -5
What about on one side of the VW we show off to everyone ADA's SoC for T2D? Figure 2.d looks pretty good. The standard deviation is low, and it returns to baseline nicely. It shows the effect of taking the correct dose of metformin quite nicely (the dose doubles from from 2.a. to 2.d). There is the question though of what happens next. Metformin takes about a month for a change to fully take effect so I am curious where they ended up. My guess would be that the baseline comes down to where it should be. I also wonder if the 1500mg would have worked given more time. And what did they eat for breakfast!  |
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Post by agedhippie on Mar 10, 2020 12:43:48 GMT -5
oh, baby, you know I can cherry. aged, do you live around New Rochelle? Thankfully no. Although I live in Manhattan which is where everyone in New Rochelle goes to work.  We have been told not to come into the office, but rather to work from home. Lots of companies here are doing that include almost all the bank head offices. I don't think CGM pictures are going to work. If you want to engage people then my feeling is give them the data and show them a possible association. Let them draw their own conclusions. As an example I would focus on the reliable fast onset and let people think about how that would be different from what they have today, that's the sort of thing that changes minds. There is a dissonance that is introduced when you tell people something that runs counter to their personal experience. The ice cream advert was a classic for that. The advert claims that you will not be eating the ice cream for 15 minutes because you you must pre-bolus. The audience knows that this is utterly untrue because personal experience says that ice cream will be gone immediately! At that point they stop listening because the advert's credibility is destroyed. |
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Post by ktim on Mar 10, 2020 20:42:08 GMT -5
What are the FDA rules on showing CGM's? You mean something like this using Fiasp? This is why nobody cares about CGM graphs. That took me literally a minute to find. There is good and bad, and if you are promoting a product everyone expects you to cherry pick the good. This is why the FDA will stamp on you if you try and do it without all the usual "don't expect this result yourself" disclaimers.These graphs are casually interesting, but not really material to the case. FDA flatly disallows it... there is no option to present anecdotal results with a disclaimer for FDA regulated prescription drugs. If Afrezza were a dietary supplement you could with a disclaimer... and doctors such as VDex can. |
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Post by agedhippie on Mar 10, 2020 21:37:04 GMT -5
You mean something like this using Fiasp? This is why nobody cares about CGM graphs. That took me literally a minute to find. There is good and bad, and if you are promoting a product everyone expects you to cherry pick the good. This is why the FDA will stamp on you if you try and do it without all the usual "don't expect this result yourself" disclaimers.These graphs are casually interesting, but not really material to the case. FDA flatly disallows it... there is no option to present anecdotal results with a disclaimer for FDA regulated prescription drugs. If Afrezza were a dietary supplement you could with a disclaimer... and doctors such as VDex can. Whoops. My mistake. I think the regulations are even tighter on black box drugs. |
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It makes my point though, which is that people will cherry pick the image they want to show and the everyone knows that and dismisses the images accordingly unless it supports their beliefs. The images lack context so you don't know if they are impressive or "meh". 
