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Post by Clement on Jan 30, 2020 8:56:13 GMT -5
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Post by rockstarrick on Jan 30, 2020 9:05:48 GMT -5
This will be big if the studies were ran to show the true TIR, meaning Afrezza was dosed at the start of the meal, rather than taken at the same time as a turtle prandial such as humalog or novalog. And the trial is big enough to justify using the data.
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Post by Clement on Jan 30, 2020 9:10:31 GMT -5
This will be big if the studies were ran to show the true TIR, meaning Afrezza was dosed at the start of the meal, rather than taken at the same time as a turtle prandial such as humalog or novalog. And the trial is big enough to justify using the data. It's a small trial. However, step by step, inch by inch .........
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Post by mango on Jan 30, 2020 9:46:47 GMT -5
What is Kipnes?
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Post by neil36 on Jan 30, 2020 9:50:13 GMT -5
Kipnes is an endo in San Antonio.
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Post by neil36 on Jan 30, 2020 10:04:51 GMT -5
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Post by mango on Jan 30, 2020 10:30:01 GMT -5
Kipnes is an endo in San Antonio. Is he the PI?
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Post by mango on Jan 30, 2020 10:33:12 GMT -5
I cannot wait to see the results of this study. We all know Afrezza + basal will out perform multiple daily injections.
I don’t care if this is a small trial, it will just further demonstrate and replicate and verify what is being done in the real-world, which is just as credible as a randomized controlled clinical trial (despite what the naysayers think, it is a fact). Looks like this trial is also a real-life clinical trial.
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Post by sellhighdrinklow on Jan 30, 2020 11:52:32 GMT -5
Quality of Life data will show BIG IMPROVEMENT . IMHO
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Post by rfogel on Jan 30, 2020 12:04:07 GMT -5
This will be big if the studies were ran to show the true TIR, meaning Afrezza was dosed at the start of the meal, rather than taken at the same time as a turtle prandial such as humalog or novalog. And the trial is big enough to justify using the data. The problem I see is that there won't be any follow-up doses as in the Affinity study. Given the short duration of afrezza, that could cause TIR problems. Also, they appear to be titrating the dose only once every week for the first four weeks and then every four weeks after that. In afrezza's case, it seems it would be more logical to titrate daily.
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Post by mango on Jan 30, 2020 12:08:37 GMT -5
This will be big if the studies were ran to show the true TIR, meaning Afrezza was dosed at the start of the meal, rather than taken at the same time as a turtle prandial such as humalog or novalog. And the trial is big enough to justify using the data. The problem I see is that there won't be any follow-up doses as in the Affinity study. Given the short duration of afrezza, that could cause TIR problems. Also, they appear to be titrating the dose only once every week for the first four weeks and then every four weeks after that. In afrezza's case, it seems it would be more logical to titrate daily. The PWD participating in the trial can (and more than likely will) adjust accordingly on his/her own. No one needs permission to take a follow up dose of Afrezza in the trial. “Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments.” Follow up dosing may fall under “Corrective insulin dose adjustments.” Regardless, nothing in this real-life clinical trial is preventing participants to take a second dose of Afrezza.
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Post by seanismorris on Jan 30, 2020 12:15:16 GMT -5
Don’t expect results on March 15, 2020. It seems to take 3 to 6 months to “analyze” the data...
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Post by rfogel on Jan 30, 2020 12:21:52 GMT -5
The problem I see is that there won't be any follow-up doses as in the Affinity study. Given the short duration of afrezza, that could cause TIR problems. Also, they appear to be titrating the dose only once every week for the first four weeks and then every four weeks after that. In afrezza's case, it seems it would be more logical to titrate daily. The PWD participating in the trial can (and more than likely will) adjust accordingly on his/her own. No one needs permission to take a follow up dose of Afrezza in the trial. It doesn't say that: "Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments." That sounds like they will be allowed one dose before each meal with titration occurring only every week the furst 4 weeks and then every 4 weeks thereafter. Indeed, I don't see how they could allow the patients to dose themselves as needed or desired. They'd need to keep some sort of record in order to make any valid conclusions of the TIR effectiveness. The "instruction in carbohydrate counting and corrective insulin dose adjustments" I think just refers to adjusting the premeal dose according to the carb count of the meal.
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Post by mango on Jan 30, 2020 12:23:39 GMT -5
The PWD participating in the trial can (and more than likely will) adjust accordingly on his/her own. No one needs permission to take a follow up dose of Afrezza in the trial. It doesn't say that: "Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments." That sounds like they will be allowed one dose before each meal with titration occurring only every week the furst 4 weeks and then every 4 weeks thereafter. Indeed, I don't see how they could allow the patients to dose themselves as needed or desired. They'd need to keep some sort of record in order to make any valid conclusions of the TIR effectiveness. It doesn’t have to say that. Participants do not need permission, fact. This is a real-life clinical trial. Participants can do whatever the *uck they want. If someone takes a follow up dose the CGM will show it.
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Post by rfogel on Jan 30, 2020 12:31:16 GMT -5
It doesn't say that: "Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments." That sounds like they will be allowed one dose before each meal with titration occurring only every week the furst 4 weeks and then every 4 weeks thereafter. Indeed, I don't see how they could allow the patients to dose themselves as needed or desired. They'd need to keep some sort of record in order to make any valid conclusions of the TIR effectiveness. It doesn’t have to say that. Participants do not need permission, fact. This is a real-life clinical trial. Participants can do whatever the *uck they want. If someone takes a follow up dose the CGM will show it. We'll have to agree to disagree. I just don't see how they could allow the subjects to dose whenever they want and not keep some sort of record as to how much they're taking.
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