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Post by #NoMoreNeedles on Aug 7, 2017 5:52:08 GMT -5
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Post by uvula on Aug 7, 2017 6:16:33 GMT -5
If I read this correctly they are not comparing afrezza to another insulin or melformin, they are comparing afrezza to nothing. The results won't say anything about the effectiveness of afrezza. The results will merely show that insulin lowers a1c.
They also did not explain how either company will pay for the study.
At least mnkd did not put out bad news. They just had their standard pre-cc fluff statement. Which is what I expected.
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Post by peppy on Aug 7, 2017 6:20:21 GMT -5
Appropriate people with type 2 diabetes who meet inclusion criteria will be randomized to one of two treatment arms: Afrezza® with One Drop | Premium – or – One Drop | Premium alone. Changes in hemoglobin A1C, quality of life, self-care, treatment satisfaction, and other metrics will be assessed. People with type 2 diabetes interested in learning more should email Aone@onedrop.today |
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Post by uvula on Aug 7, 2017 6:43:23 GMT -5
A more useful study would have 3 arms: afrezza with one drop, metformin with one drop, or one drop by itself. Maybe this was too risky because mnkd might not get the results they want.
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Post by tchalaa on Aug 7, 2017 7:03:24 GMT -5
A more useful study would have 3 arms: afrezza with one drop, metformin with one drop, or one drop by itself. Maybe this was too risky because mnkd might not get the results they want. You are overseeing a VERY IMPORTANT thing the fact that one drop is just a monitoring tools for better management of you HA1C; Hence there is no need to mention others insulin type. This trial is Inhaled insulin again the other insulin option. One drop assist a patient in monitoring and the patient need INSULIN. So this trial is design to Compare the use of one-drop with Afrezza or without meaning one-drop with any others form insulin |
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Post by tchalaa on Aug 7, 2017 7:05:05 GMT -5
From management today i still expect a financial solution, not a value-added opportunity
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Post by peppy on Aug 7, 2017 7:06:11 GMT -5
Co-founder of digital marketing agency Razorfish Jeff Dachis has a new app for diabetes called One Drop, which just launched in the App Store today.
Dachis has always been a health-minded individual. He eats well, works out and runs marathons. So, it was a bit of a shock when his doctor told him, at age 47, that he had Type-1 diabetes.
Dachis soon received another shock in dealing with the current healthcare offered to treat the disease. “All I got was a pat on the back and a prescription and sent on my way. I was mad,” Dachis recalled. “I didn’t feel like I was being cared for.” techcrunch.com/2015/04/21/razorfishs-jeff-dachis-launches-one-drop-an-app-for-diabetics-to-log-and-share-info-with-each-other/
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Post by uvula on Aug 7, 2017 7:17:37 GMT -5
A more useful study would have 3 arms: afrezza with one drop, metformin with one drop, or one drop by itself. Maybe this was too risky because mnkd might not get the results they want. You are overseeing a VERY IMPORTANT thing the fact that one drop is just a monitoring tools for better management of you HA1C; Hence there is no need to mention others insulin type. This trial is Inhaled insulin again the other insulin option. One drop assist a patient in monitoring and the patient need INSULIN. So this trial is design to Compare the use of one-drop with Afrezza or without meaning one-drop with any others form insulin You are making an assumption that I think is wrong. "without afrezza" does not necessarily mean "other insulin". This is for a specific group of type 2s. They don't say what the inclusion criteria are. My guess is they are type 2s who are not taking insulin. No where in the press release does it say that the non-afrezza group will be taking insulin or any other medication. It is comparing Afrezza to not taking any diabetes medication. (The press release was not clear so we are both making some assumptions.) |
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Post by agedhippie on Aug 7, 2017 7:24:45 GMT -5
A more useful study would have 3 arms: afrezza with one drop, metformin with one drop, or one drop by itself. Maybe this was too risky because mnkd might not get the results they want. You are overseeing a VERY IMPORTANT thing the fact that one drop is just a monitoring tools for better management of you HA1C; Hence there is no need to mention others insulin type. This trial is Inhaled insulin again the other insulin option. One drop assist a patient in monitoring and the patient need INSULIN. So this trial is design to Compare the use of one-drop with Afrezza or without meaning one-drop with any others form insulin The trial is " Afrezza® with One Drop | Premium – or – One Drop | Premium alone". So it's insulin vs nothing - if we can't win that we really are out of business. It's difficult to say what the studies design is because they don't seem to have given it, and it's not in Clinical Trials (which makes publication later tricky). Questions would be: - Recritment and selection criteria - Randomization into arms - Number of participants - Secondary endpoints (I read the primary endpoint as HbA1c) - Duration Things to watch for include whether the Afrezza arm is all motivated individuals and hence not typical of the wider audience, and whether there is only a small group of participants. On the plus side - anyone who cannot get Afrezza on their insurance should consider joining as supplies are free in trials so it may be worth asking. |
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Post by peppy on Aug 7, 2017 7:38:47 GMT -5
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Post by mnholdem on Aug 7, 2017 7:41:20 GMT -5
Excerpt:
One goal of the collaboration is to identify ways of simplifying the complexity of starting and staying on mealtime insulin along with Customized Coaching to help people achieve their A1C goals.
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Post by uvula on Aug 7, 2017 7:46:48 GMT -5
One drop is NOT a CGM. It is an "old fashioned" meter that uses test strips. The only thing new about it is that it sends the data to your phone.
Would you invest in a web-enabled VCR company when you could invest in a DVD company?
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Post by agedhippie on Aug 7, 2017 7:51:35 GMT -5
Excerpt: One goal of the collaboration is to identify ways of simplifying the complexity of starting and staying on mealtime insulin along with Customized Coaching to help people achieve their A1C goals. So really this is about collecting data on what does and doesn't work in coaching rather than a trial? Trials have fixed protocols to evaluate performance and reduce variability, that excerpt would imply that they were allowing variability to capture the best coaching methods which nullifies it as a trial. Separately from any pretensions to being a trial that data is useful. Edit: To be clear. My objection is the description of this as a trial which it patently is not. A study maybe, but that's pushing the boundaries as well since the details which provide the rigor are missing. |
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Post by mike0475 on Aug 7, 2017 7:51:47 GMT -5
Nothing to see here
Isn't this just the confirmation on this deal that was initially mentioned on prior call
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Post by peppy on Aug 7, 2017 7:52:50 GMT -5
The dvd hasn't been invented.
they just invented the spectacles that sends the data to an iphone.
razorfish, amazon, iphone, strips, data collection, programming tips
titration. and insulin that can be taken with out the fear.
Our target audience?
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