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Post by peppy on Oct 27, 2017 17:41:40 GMT -5
Let's be clear regarding the use of injectable insulin. It doesn't matter if I'm on a study or not - if I, as a diabetic subject under study feel I need another does of injected insulin to control my blood sugar, I will take it. It will be recorded by the CGM and it will be recorded by me. In the end, the CGM will provided all data to be examined. The number of injectable doses of insulin will not matter one bit.
The protocol states that the 30 who remain on their usual insulin are to treat themselves as they usually do. Maybe there will be a few who take a second dose of injected - who knows. Even if they do, the data will tell us so and we will still analyze the endpoints as stated in the protocol. Safety first. There is no argument here about any additional injectable insulins being problematic. It does not disqualify the subject if they decide they need to take another dose of injectable insulin. The statistical section of the protocol will set that straight. Got it? Thanks for reading the study protocol. This makes sense. quote; It will be recorded by the CGM and it will be recorded by me. In the end, the CGM will provided all data to be examined. The number of injectable doses of insulin will not matter one bit. reply: we know what that the Continuous glucose monitors of the RAA's will look terrible in comparison to the TI CGM.
www.slideshare.net/StephenPonder/sugar-surfing-with-a-cgm-copyright-tlc-advanced-diabetes-retreat-april-26-2014 twitter.com/hashtag/afrezza?lang=en
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Post by sayhey24 on Oct 27, 2017 18:26:22 GMT -5
Mango - Dr. DeFronzo built his career on the belief that the use of insulin is dangerous and should be a last resort. I view him as the Edison of diabetes while Al Mann is the Tesla. The cap on his career is the Qatar study. care.diabetesjournals.org/content/early/2017/01/11/dc16-1738What has been determined by this study is if you keep a tight near non-diabetic range the PWD has a pretty good chance of beta cell regeneration. Does this sound familiar??? I think we have heard Al Mann say this a few times. The difference is Al provided a safe easy to use solution which is natural to the body - insulin. Ralph's approach is to use a cocktail of drugs which cause all sorts of other issues. In the video they even joke about how losing a few toes is not going to kill you. Now if you listen to the interview closely Ralph says many things which mimic what Al said concerning the positive effects of tight control. The big difference is how they get there. Afrezza or the potentially toxic cocktail, is the question. I had the feeling that the BeyoundA1c forum back in July was the first time Ralph was exposed to the afrezza results guys like Steve Edelman were reporting.
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Post by digger on Oct 28, 2017 10:44:29 GMT -5
One thing about this trial that I find worrisome is that doesn't seem to account for an afrezza learning curve.
The lispro group comes in with who knows how many years of experience managing blood sugar using it. The afrezza group, however, comes in and apparently just switches to afrezza with no time allowed for adjustment to the new regimen.
Since the trial is only four weeks, if that adjustment proved to be difficult, it seems a real possibility that it might actually result in data indicating lispro is as good or even better than afrezza at controlling PPGE, etc.
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Post by agedhippie on Oct 28, 2017 13:21:23 GMT -5
One thing about this trial that I find worrisome is that doesn't seem to account for an afrezza learning curve. The lispro group comes in with who knows how many years of experience managing blood sugar using it. The afrezza group, however, comes in and apparently just switches to afrezza with no time allowed for adjustment to the new regimen. Since the trial is only four weeks, if that adjustment proved to be difficult, it seems a real possibility that it might actually result in data indicating lispro is as good or even better than afrezza at controlling PPGE, etc. The problem with dialing in insulin doses is the gap between visits to adjust the dose. Here you are going to have people on hand 24x7 so the dosing can be tweaked immediately. It's really not that hard to use insulin.
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Post by mnholdem on Oct 28, 2017 18:18:12 GMT -5
...especially considering they'll each have a CGM..
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Post by digger on Oct 29, 2017 8:46:42 GMT -5
One thing about this trial that I find worrisome is that doesn't seem to account for an afrezza learning curve. The lispro group comes in with who knows how many years of experience managing blood sugar using it. The afrezza group, however, comes in and apparently just switches to afrezza with no time allowed for adjustment to the new regimen. Since the trial is only four weeks, if that adjustment proved to be difficult, it seems a real possibility that it might actually result in data indicating lispro is as good or even better than afrezza at controlling PPGE, etc. The problem with dialing in insulin doses is the gap between visits to adjust the dose. Here you are going to have people on hand 24x7 so the dosing can be tweaked immediately. It's really not that hard to use insulin. In the description, I see no indication of 24/7 advice; all I see is "There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." Also, that brings up the point someone else made, that the lispro group won't have the opportunity to adjust their doses post-meal, so any comparison won't carry much weight. Regardless, why even have the lispro group? It just seems to run the risk either of failing or of attracting criticism for how the trial was conducted. Besides, I would think there ought to be data already floating around regarding how well lispro controls PPGE, etc. Seems like it would make more sense to do the pilot study with just afrezza in order to see how well it accomplishes the goals.
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Post by agedhippie on Oct 29, 2017 8:59:23 GMT -5
The problem with dialing in insulin doses is the gap between visits to adjust the dose. Here you are going to have people on hand 24x7 so the dosing can be tweaked immediately. It's really not that hard to use insulin. In the description, I see no indication of 24/7 advice; all I see is "There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits)." Also, that brings up the point someone else made, that the lispro group won't have the opportunity to adjust their doses post-meal, so any comparison won't carry much weight. Regardless, why even have the lispro group? It just seems to run the risk either of failing or of attracting criticism for how the trial was conducted. Besides, I would think there ought to be data already floating around regarding how well lispro controls PPGE, etc. Seems like it would make more sense to do the pilot study with just afrezza in order to see how well it accomplishes the goals. 24x7 is a requirement for trial safety, there has to be someone you can phone. The study visits are to gain data for the results as they want to see progress throughout the period. Anyone on RAA like lispro or aspart (can't remember what Apidra is but them too) has already told to check and correct if they are over 140 at the two hour mark. The fact almost nobody does (me included) is a compliance rather than process issue. Lispro is the control arm for the trial and by using the same team of investigators running both the arms of the trial you remove a variable for the trial. You have to be sure you are comparing like with like and that the data aligns for both arms of the trial.
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Post by mnholdem on Oct 29, 2017 9:21:48 GMT -5
The trial document explains: "Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals." The purpose of the trial is simply to provide evidence that post-meal adjustment with Afrezza will result in improved primary and secondary outcomes. If the other drug makers want to prove that their insulin can do the same, they can pay for their own trial. Fiasp comes to mind, but with that long tail that Novo Nordisk hasn't managed to eliminate, it could be a risky trial for Novo to have patients stack Fiasp for better control. Regardless, the University of Colorado is not using Fiasp. They're using Novolog in the comparitor arm of the trial and my guess is that the researchers don't want to put those patients in the hospital. Most, if not all Novolog patients don't use post-meal doses to adjust their BG levels because of the risks associated with over-stacking and severe hypoglycemic excursions.
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Post by agedhippie on Oct 29, 2017 11:44:31 GMT -5
Most, if not all Novolog patients don't use post-meal doses to adjust their BG levels because of the risks associated with over-stacking and severe hypoglycemic excursions. Really it's because we can't be bothered and will correct at the next meal.
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Post by mnkdnut on Oct 29, 2017 17:02:41 GMT -5
One thing about this trial that I find worrisome is that doesn't seem to account for an afrezza learning curve. The lispro group comes in with who knows how many years of experience managing blood sugar using it. The afrezza group, however, comes in and apparently just switches to afrezza with no time allowed for adjustment to the new regimen. Since the trial is only four weeks, if that adjustment proved to be difficult, it seems a real possibility that it might actually result in data indicating lispro is as good or even better than afrezza at controlling PPGE, etc. I agree completely with the concern. We can't see the protocol so we don't know if there's any run-in for the new Afrezza users. Reading various accounts from new users (one recent example: integrateddiabetes.com/my-review-of-afrezza-fast-acting-inhaled-insulin/) we can expect new users to have to figure out things like: holding the inhaler level, overcoming the initial coughing, exhaling before inhaling, taking it just after the start of the meal instead vs. before, taking enough (insufficient dosing), and follow-up dosing). I can imagine the protocol and the CGM help with some of these - but how many and how well? Would anyone disagree that a user who has one month of titration experience under their belt would handily beat their initial month's performance? My guess is that the body needs some time to get used to it as well. Anyway, we can only hope the whole titration subject was discussed with Dr. Garg in advance and that has been factored into the study protocol. We NEED "no excuses" clinical data demonstrating superiority if we are to make any headway with the insurance giants.
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Post by mnholdem on Oct 30, 2017 7:51:54 GMT -5
Most, if not all Novolog patients don't use post-meal doses to adjust their BG levels because of the risks associated with over-stacking and severe hypoglycemic excursions. Really it's because we can't be bothered and will correct at the next meal. Either way, the TI trial arm uses post-meal adjustments using Afrezza to compare to the "usual" practice of injecting RAA prandial insulin, whether it's a patient who doesn't inject dose post-meal RAA insulin out of safety concerns or a patient who cannot be bothered, as you suggest.
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Post by peppy on Oct 30, 2017 8:23:26 GMT -5
Really it's because we can't be bothered and will correct at the next meal. Either way, the TI trial arm uses post-meal adjustments using Afrezza to compare to the "usual" practice of injecting RAA prandial insulin, whether it's a patient who doesn't inject dose post-meal RAA insulin out of safety concerns or a patient who cannot be bothered, as you suggest.
quote: we can't be bothered and will correct at the next meal. reply: as written, when true, which should show increased compliance with the afrezza arm.
it is all good. it is on camera, CGM. (Diabetes will do, whatever they want to do.)
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Post by compound26 on Nov 14, 2017 12:15:25 GMT -5
Not sure if this has already been posted elsewhere. It appears the completion date has been updated. Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT) This study is ongoing, but not recruiting participants. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center ClinicalTrials.gov Identifier: NCT03143816 First Posted: May 8, 2017 Last Update Posted: November 9, 2017
Estimated Enrollment: 60 Actual Study Start Date: September 30, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure) clinicaltrials.gov/ct2/show/NCT03143816
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