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Post by mango on Jan 30, 2020 12:34:35 GMT -5
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. How would they prevent someone from taking a second dose? You’re not thinking logically, but ok. The participant would report he/she took a followup dose Monday afternoon at lunch around 1145...CGM is evaluated and sure enough confirmation at 11:45 is noted and all this info is documented. This is a real-life clinical trial. Participants are not monitored and restricted and controlled like they are in a RCT. |
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Post by sellhighdrinklow on Jan 30, 2020 12:54:40 GMT -5
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. “Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments.” straight forward, they can and will take an additional dose aka , 'a corrective dose' |
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Post by ktim on Jan 30, 2020 15:19:04 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. 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. Correction of hyperglycemia with rapid insulin is a standard for diabetes treatment. It would seem they wouldn't stipulate that it cannot be done during the trial period. Though it seems in reality patients are reluctant or negligent in doing that quite often, as we saw from STAT. |
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Post by ktim on Jan 30, 2020 15:28:56 GMT -5
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. How would they prevent someone from taking a second dose? You’re not thinking logically, but ok. The participant would report he/she took a followup dose Monday afternoon at lunch around 1145...CGM is evaluated and sure enough confirmation at 11:45 is noted and all this info is documented. This is a real-life clinical trial. Participants are not monitored and restricted and controlled like they are in a RCT. Most RCTs are in real-life clinics. I don't think whether it's randomized really has any relevance to the study design and amount of monitoring and control. A randomized trial is simply comparing two arms of real patients. All randomized Phase III are supposed to be representing the real life use and results that would be expected. It may be true that prior MNKD trials were not designed properly. Hopefully this one will be, but that isn't guaranteed. Wording isn't exactly clear, but the doctors could conceivably tell patients to not do corrections, or they could remain silent on the topic, or they could specifically encourage it as needed. Obviously the latter is what they should be doing, and I'd assume they will. |
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Post by agedhippie on Jan 30, 2020 15:36:44 GMT -5
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. “Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments.” straight forward, they can and will take an additional dose aka , 'a corrective dose' I agree with this 100%. That is the standard advice given with all insulin so there is no way they would change it for Afrezza. It could potentially be dangerous not to correct. |
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