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Post by agedhippie on Oct 14, 2019 22:01:11 GMT -5
Positive outcomes from this clinical trial will warrant revision to ADA’s SoC, IMO. The size is still too small. There need a couple of hundred in each of the two arms rather than 30 in total, and also for longer than three months. It is definitely an improvement over STAT though with the duration making for a big difference. This is moving in the right direction, but it will not get a revision of the SoC alone. Where this may well help is later in a balance of evidence, especially when some of the work on the importance of TIR starts to arrive. |
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Post by majorwood on Oct 15, 2019 0:00:53 GMT -5
Great News Indeed! Thanks Harry
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Post by Clement on Oct 15, 2019 9:56:58 GMT -5
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Post by akemp3000 on Oct 15, 2019 13:02:44 GMT -5
While this study may be too small to influence a change in SOC in the near term, the results may be too significant for all associated with the diabetic community/industry to ignore. If so, it could turn out to be the fuse that ignites serious discussion and considerations regarding SOC. This is especially true since the current SOC has not been sufficiently effective for years and treats to failure. I can see Dr. Kendall pushing the results of this study with Mannkind's scientific advisory board and other thought leaders in the industry.
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Post by mannmade on Oct 15, 2019 14:58:12 GMT -5
Positive outcomes from this clinical trial will warrant revision to ADA’s SoC, IMO. The size is still too small. There need a couple of hundred in each of the two arms rather than 30 in total, and also for longer than three months. It is definitely an improvement over STAT though with the duration making for a big difference. This is moving in the right direction, but it will not get a revision of the SoC alone. Where this may well help is later in a balance of evidence, especially when some of the work on the importance of TIR starts to arrive. The study may not be large enough but Dexcom is...  |
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Post by mango on Oct 15, 2019 15:38:28 GMT -5
Positive outcomes from this clinical trial may warrant DexCom to fund a larger clinical trial, or maybe, also form a partnership (co-promote).
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Post by letitride on Oct 15, 2019 17:49:07 GMT -5
If you want to get the most out of your CGM who you gonna call. Mannkind
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Post by shawnonafrezza on Oct 15, 2019 18:01:25 GMT -5
Positive outcomes from this clinical trial will warrant revision to ADA’s SoC, IMO. The size is still too small. There need a couple of hundred in each of the two arms rather than 30 in total, and also for longer than three months. It is definitely an improvement over STAT though with the duration making for a big difference. This is moving in the right direction, but it will not get a revision of the SoC alone. Where this may well help is later in a balance of evidence, especially when some of the work on the importance of TIR starts to arrive. Yup. I'm super stoked for this because TIR is dear to me but without X == Y this doesn't change SOC. |
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Post by agedhippie on Oct 15, 2019 18:11:16 GMT -5
The size is still too small. There need a couple of hundred in each of the two arms rather than 30 in total, and also for longer than three months. It is definitely an improvement over STAT though with the duration making for a big difference. This is moving in the right direction, but it will not get a revision of the SoC alone. Where this may well help is later in a balance of evidence, especially when some of the work on the importance of TIR starts to arrive. The study may not be large enough but Dexcom is... At the moment Dexcom is trying to drive the case for CGMs for Type 2s so they are in favor of anything that puts Type 2 and Dexcom next to each other. The trial entry reads like this is the clinic running the trial for their own purposes (same as VDEX I suspect) with Dexcom and Mannkind providing drugs and equipment. Either way it is a registered trial so the results can be published. |
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Post by agedhippie on Oct 15, 2019 18:19:16 GMT -5
Positive outcomes from this clinical trial may warrant DexCom to fund a larger clinical trial, or maybe, also form a partnership (co-promote). The problem for Dexcom would be that any CGM would work as well as any other in this case so there is no value add in having a Dexcom. Dexcom would spend the money and the other CGM makers would capitalize on any benefits as well. Dexcom is not going to co-promote Afrezza (or any other insulin) - there is nothing in that for them. |
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Post by mannmade on Oct 15, 2019 18:53:00 GMT -5
Aged, you are missing the point I beleive. It is about promoting TIR over a1c. And whether it is dexcom or libre does not matter as only Afrezza can do real time TIR managment this well.
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Post by letitride on Oct 15, 2019 19:39:12 GMT -5
If Dexcom can show best TIR with afrezza. Then it is obvious all CGM manufactures will have to promote afrezza to get the same results or better. Its like a win, win a lot more for afrezza.
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Post by mango on Oct 15, 2019 20:32:16 GMT -5
If Dexcom can show best TIR with afrezza. Then it is obvious all CGM manufactures will have to promote afrezza to get the same results or better. Its like a win, win a lot more for afrezza. Exactly. It’s in every single CGM manufacturer’s best interests to know which insulins provides the best results (ie: TIR, less hypos, less PPGE, etc) in conjunction with CGMs, and in this case—for mealtime insulins—Afrezza is just simply superior as evidenced by CGMs. Not to mention simpler to use, less painful and safer. |
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Post by shawnonafrezza on Oct 15, 2019 21:33:23 GMT -5
If Dexcom can show best TIR with afrezza. Then it is obvious all CGM manufactures will have to promote afrezza to get the same results or better. Its like a win, win a lot more for afrezza. Exactly. It’s in every single CGM manufacturer’s best interests to know which insulins provides the best results (ie: TIR, less hypos, less PPGE, etc) in conjunction with CGMs, and in this case—for mealtime insulins—Afrezza is just simply superior as evidenced by CGMs. Not to mention simpler to use, less painful and safer. I respectively disagree. It's in every CGMs maker best interest to get a CGM attached to a body. The how they have no attachment towards whether that is afrezza, a closed loop pump, or mdi and smart pen integration. They do not even have to care about TIR, they have to care about you caring about TIR. Maybe a subtle difference but do not get fooled on Dexcom caring about any insulin. You all already speak as if TIR is the SOC which is sadly still is not. Most endos do not use it, most patients still go by A1C. This study could be the first domino in changing that but I caution you to not see it as more than it is; the first step. Also this study with no control groups will not be able to be used to say afrezza gives the best TIR, only that it gives some percentage TIR. |
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Post by agedhippie on Oct 15, 2019 22:10:38 GMT -5
Aged, you are missing the point I beleive. It is about promoting TIR over a1c. And whether it is dexcom or libre does not matter as only Afrezza can do real time TIR managment this well. I think the trial promotes TIR, but I don't think that's why Dexcom is involved. Dexcom is in the middle of a campaign to get CGMs available to Type 2 and this is part of that. I agree with TIR, and that is how I manage my diabetes. Currently the ADA and EASD do have targets for TIR, but you can hit those without using Afrezza if you have a CGM and work with it. My TIR with RAA is better than the TIR achieved in STAT using Afrezza so for me the key is the CGM rather than the insulin. That is not true for all diabetics though, but it is certainly true for some percentage and that percentage needs to be quantified. |
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