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Post by agedhippie on Jul 22, 2018 19:29:58 GMT -5
Aged - at this point I suspect you are about max'ed out on what adjustments you can make. I doubt if you factor out sleeping hours you are beating the compliant group's TIR which if I remember correctly was 100%. With both the compliant and non-compliant groups their basal can be increased which would not only beat your TIR but also improve their A1c. What was the game changing line from ADA2018 "A1c 8.0 to 6.8 with no additional hypoglycemia". The reality is afrezza takes less effort and when properly dosed will out-perform all RAAs. Next up should be the pediatric results. What kid wants to stick themselves when they can puff with better control? Once the kids start using its the beginning of the end for the RAAs. I guess Dr. Kendall can also use these results to support updating the standard. The only way I could improve my numbers at this point would be by paying far more attention to them than I am prepared to do. So yes I probably am max'ed out for the level of engagement I am prepared to have. The basal cannot simply be increased because that will increase the risk of night time basal hypos (probably why they are running high in the first place). Also it is going to drop the day time level so they are going to get more hypos there initially which is likely to drive them to run higher levels during the day. Put simply - basal from an injection is a blunt instrument since it is a fixed continuous output (sort of, there are peaks and troughs contrary to the makers publicity) so you have to thread a needle between the high and low basal glucose outputs, and fluctuating insulin sensitivities of the day. This is why just saying if they increase the basal they will beat you is a gross oversimplification. If they really can do that then they should because right now those results are good but hardly earthshattering. This is a lot more complicated than people think, there is not an Easy button (sadly). |
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Post by mnholdem on Jul 23, 2018 2:51:24 GMT -5
WTF? If they were on target with their CGM there is no need for the second dose and they are compliant. And the non-compliant TIR was far worse than the Novolog arm - 48% to 55% Afrezza to Novolog (slide 69) For completeness - the compliant arm was about 62% TIR so the compliant users out-performed the RAA arm by about the same amount that the RAA arm TIR out-performed the non-compliant arm The compliance graph on the STAT poster doesn’t have a non-compliant column for RAA so your comparison is faulty because you’re comparing the non-compliant numbers of TI patients to compliant RAA patients. IMO the argument about percentage of compliance is irrelevant anyway. Whether diabetes or cancer, if a patient doesn’t comply with a treatment protocol, whether because of fear, laziness or poor doctor instructions the results will be negatively affected. What is relevant in the STAT trial is that when patients followed the treatment protocol they achieved significantly better TIR control. That’s what MannKind should be (and are) telling the medical community. The rest is just noise. |
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Post by agedhippie on Jul 23, 2018 9:06:59 GMT -5
For completeness - the compliant arm was about 62% TIR so the compliant users out-performed the RAA arm by about the same amount that the RAA arm TIR out-performed the non-compliant arm The compliance graph on the STAT poster doesn’t have a non-compliant column for RAA so your comparison is faulty because you’re comparing the non-compliant numbers of TI patients to compliant RAA patients. IMO the argument about percentage of compliance is irrelevant anyway. Whether diabetes or cancer, if a patient doesn’t comply with a treatment protocol, whether because of fear, laziness or poor doctor instructions the results will be negatively affected. What is relevant in the STAT trial is that when patients followed the treatment protocol they achieved significantly better TIR control. That’s what MannKind should be (and are) telling the medical community. The rest is just noise. What I did was what I suspect most of the medical world would do when presented with that graph - there are three bars, which group is top, which group is bottom, and what does the spread look like. If you don't want people to make that judgement then don't present the graph. However if you don't present that graph people are going to ask where the TIR data is given that this was a TIR trial. That leads to what (I am guessing) is a problem with the results, no bright line between TIR for the two trial arms. Given the spread if you merged the compliant/non-compliant groups you are going to end up with a marginal improvement over the RAA group which is not exactly a compelling story. To improve the differentiation they created the compliant/non-compliant split after the fact (it wasn't part of the trial). Creating that split is perfectly fair because this is a pilot study and big part of a pilot is chopping up data to help design the follow on trial. However it is not going to help with the medical community because it raises questions about the data presented. As to saying we should only look at compliant patients - that's a nice idea, but in the real world patient compliance comes in all shapes and sizes. A big question is always as how compliant will people be and as compliance declines how are the results impacted - do results decline gracefully or go off a cliff? That really matters for population outcomes. |
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Post by mnholdem on Jul 23, 2018 9:42:19 GMT -5
I think that it help with the medical community because, like the many patients you often refer to, most doctors don't have the time to research. Whether they read that compliant TI patients showed significant TIR improvement, or that TI insulin resulted in less hypos and severe hypos compared to RAA insulin (another poster) they probably won't go digging into the fine details. They may remember Afrezza outperformed RAA, however, and that's the reason for MannKind publishing.
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