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Post by seanismorris on Jun 5, 2019 13:34:58 GMT -5
IMO a cough is a more likely with pediatric than adult. Kids are just going to breathe in the way they want to breathe. They're also less used to suppressing a cough, or breathing irritating air in general True. But this was the 13-18 age group. I don’t see the younger being better. I have a hard time seeing patients losing interest because of the cough. I tried a cigaret when I was 8, and never tried anything like it again. But, Afrezza is like that...
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Post by seanismorris on Jun 5, 2019 13:37:17 GMT -5
This is the expected experience. That’s why questions, questions...
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Post by awesomo on Jun 5, 2019 13:39:48 GMT -5
So if these are our veins of gold, I guess we need veins of triple platinum using Kendall's scale...
This abstract is going to do absolutely nothing to move the needle.
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Post by sportsrancho on Jun 5, 2019 13:42:53 GMT -5
Could somebody pull up the post while we were talking about the kids not getting to eat for like 20 minutes in the trial I remember we were all discussing it before and I don’t know where it is?
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Post by goyocafe on Jun 5, 2019 13:44:26 GMT -5
Wasn't there a report (rumor) last year that they were dosing these kids and then walking them over to the cafeteria to get food. If I recall, there was a lot of question about the procedures being followed and a lack of training and understanding about how to dose Afrezza in the trial.
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Post by sportsrancho on Jun 5, 2019 13:48:00 GMT -5
Yes Wasn’t it from a mother of one of the kids and she was a little irritated?
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Post by awesomo on Jun 5, 2019 14:00:11 GMT -5
That is beyond embarrassing if true.
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Post by nylefty on Jun 5, 2019 14:10:57 GMT -5
Wasn't there a report (rumor) last year that they were dosing these kids and then walking them over to the cafeteria to get food. If I recall, there was a lot of question about the procedures being followed and a lack of training and understanding about how to dose Afrezza in the trial. mnkd.proboards.com/post/168490/threadFrom the Afrezza Facebook site about the peds trial. It's on the Thompson January 15, 9:39 am thread.
www.facebook.com/groups/1491153011166114/about/
"yes, so UFlorida is one of the sites. The research director said its moving slowly at their location. The protocols were not set up well and needed to be revamped. They didn’t do what they should have and it delayed the process. I don’t know much just that it was not ideal. Also, the instructions were laid out to bolus at the beginning of the meals and kids were coming back with lows of 30. The instructions should have been very clear or changed to bolus mid meal. Kids tend to eat slowly. And some of the nurses who were dosing the kids were doing it before they walked to lunch. Well, that was a disaster! Hopefully they got the kinks worked out."
when I think about it, the care givers didn't know the difference. rapid acting analog say to pre-bolus 20 mins before you eat. So the child is sent to the nurses office and takes the dose. then goes to lunch room and stands in line. then finds a seat. etc, etc. They would need different protocol.
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Post by thekindaguyiyam on Jun 5, 2019 14:43:00 GMT -5
Wasn't there a report (rumor) last year that they were dosing these kids and then walking them over to the cafeteria to get food. If I recall, there was a lot of question about the procedures being followed and a lack of training and understanding about how to dose Afrezza in the trial. mnkd.proboards.com/post/168490/threadFrom the Afrezza Facebook site about the peds trial. It's on the Thompson January 15, 9:39 am thread.
www.facebook.com/groups/1491153011166114/about/
"yes, so UFlorida is one of the sites. The research director said its moving slowly at their location. The protocols were not set up well and needed to be revamped. They didn’t do what they should have and it delayed the process. I don’t know much just that it was not ideal. Also, the instructions were laid out to bolus at the beginning of the meals and kids were coming back with lows of 30. The instructions should have been very clear or changed to bolus mid meal. Kids tend to eat slowly. And some of the nurses who were dosing the kids were doing it before they walked to lunch. Well, that was a disaster! Hopefully they got the kinks worked out."
when I think about it, the care givers didn't know the difference. rapid acting analog say to pre-bolus 20 mins before you eat. So the child is sent to the nurses office and takes the dose. then goes to lunch room and stands in line. then finds a seat. etc, etc. They would need different protocol.
Sounds like they were using the regular protocol for traditional insulin. There's bound to be a learning curve. diatribe.org/switching-afrezza-inhaled-insulin-tips-diabetes-educator
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Post by sportsrancho on Jun 5, 2019 15:06:48 GMT -5
mnholdem Global Moderator ***** Jan 23, 2019 at 2:25pm goyocafe, sportsrancho, and 3 more like this Quote likePost Options Pharmaceutical companies typical place one of their own doctors to coordinate and monitor clinical studies but that doesn’t guarantee that they pay close attention to what’s happening at the trial sites (ie the trial protocols are being strictly adhered to). As critical as this pediatric trial is to the future adoption of Afrezza, CMO David Kendall MD cannot ignore this rumor. He needs to check this out with MannKind’s clinical staff ASAP. As Jerome Pettus graphically illustrated in his recent TCOYD presentation, Afrezza is nothing like injected insulin. It might be difficult for HCPs at the trial site(s) to break decades-old habits for treating diabetes. Read more: mnkd.proboards.com/thread/10859/update-jpm-jan-21st?page=2#ixzz5q0S42W9K
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Post by mango on Jun 5, 2019 15:18:43 GMT -5
Why is so many here bashing these data from this study? Here is what this study was for:
Primary Outcome Measures:
1. Number of patients with adverse events [ Time Frame: Baseline to week 6 ]Number and percentage of patients with any TEAE, any serious TEAE, any severe TEAE, any TEAE leading to treatment discontinuation, or any TEAE leading to death (only if any occurred) will be summarized by age cohort
2. Number of patients with hypoglycemic events [ Time Frame: Baseline to week 6 ]Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.
Nothing bad about these data, except for the 2 participants that withdrew from the study.
😏
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Post by rtmd on Jun 5, 2019 16:29:57 GMT -5
I don't quite understand. It says, "As of August 16, 2018, 15 patients had enrolled in cohort 1, 14 had received at least 1 dose, and 8 completed the titration period." So does that mean the data presented is based only the 8 that completed the titration period?
The thing is, it also says, "Seven patients experienced a total of 41 hypoglycemic events..." If the data is coming from only 8 patients, then that means 88% experienced hypoglycemia.
Also, it says, "Mean postprandial glucose levels decreased within 1-hour postdose for the 8- and 12-unit dose groups." What happened with the 4 unit doses?
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Post by peppy on Jun 5, 2019 16:43:48 GMT -5
I don't quite understand. It says, "As of August 16, 2018, 15 patients had enrolled in cohort 1, 14 had received at least 1 dose, and 8 completed the titration period." So does that mean the data presented is based only the 8 that completed the titration period? The thing is, it also says, "Seven patients experienced a total of 41 hypoglycemic events..." If the data is coming from only 8 patients, then that means 88% experienced hypoglycemia. Also, it says, "Mean postprandial glucose levels decreased within 1-hour postdose for the 8- and 12-unit dose groups." What happened with the 4 unit doses? The investigators did not follow the directions. They had no idea what they were doing. "the care givers didn't know the difference. rapid acting analog say to pre-bolus 20 mins before you eat. So the child is sent to the nurses office and takes the dose. then goes to lunch room and stands in line. then finds a seat. etc, etc. They would need different protocol." VDEX dosing instructions: dosing: www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdf page 22. Comments Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20 minutes after the start of the meal, and then another dose of the same size about 45 minutes later.With very long meals, we have even advised patients to administer two follow-on doses, for very tight control. Starting & Titrating www.afrezza.com/hcp/starting-titrating/Read more: mnkd.proboards.com/thread/7878/afrezza-starting-titrating#ixzz5q0qNHeMl"Honey what happened?"
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Post by awesomo on Jun 5, 2019 17:14:54 GMT -5
Why is so many here bashing these data from this study? Here is what this study was for: Primary Outcome Measures: 1. Number of patients with adverse events [ Time Frame: Baseline to week 6 ]Number and percentage of patients with any TEAE, any serious TEAE, any severe TEAE, any TEAE leading to treatment discontinuation, or any TEAE leading to death (only if any occurred) will be summarized by age cohort
2. Number of patients with hypoglycemic events [ Time Frame: Baseline to week 6 ]Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. Nothing bad about these data, except for the 2 participants that withdrew from the study. 😏 "Nothing bad" isn't good enough when you're trying to change the paradigm of something so entrenched in its ways, especially when involving pediatrics. The data also has a very small sample size, 13.3% of patients dropped out, and sounds like it wasn't even administered properly. If the trial administers aren't dosing properly because they are following standard protocols, it is on MannKind to be aware of this and correct this.
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Post by mango on Jun 5, 2019 17:18:41 GMT -5
Why is so many here bashing these data from this study? Here is what this study was for: Primary Outcome Measures: 1. Number of patients with adverse events [ Time Frame: Baseline to week 6 ]Number and percentage of patients with any TEAE, any serious TEAE, any severe TEAE, any TEAE leading to treatment discontinuation, or any TEAE leading to death (only if any occurred) will be summarized by age cohort
2. Number of patients with hypoglycemic events [ Time Frame: Baseline to week 6 ]Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. Nothing bad about these data, except for the 2 participants that withdrew from the study. 😏 "Nothing bad" isn't good enough when you're trying to change the paradigm of something so entrenched in its ways, especially when involving pediatrics. The data also has a very small sample size, 13.3% of patients dropped out, and sounds like it wasn't even administered properly. If the trial administers aren't dosing properly because they are following standard protocols, it is on MannKind to be aware of this and correct this. I don't disagree that the dosing is an issue, but they have to follow what is on the label. It is what it is. 👍
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