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Post by madog365 on Oct 19, 2017 13:28:35 GMT -5
clinicaltrials.gov/ct2/show/NCT03313960?term=one+drop&recrs=ab&draw=1&rank=1Posted today - already underway The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-10.5% already prescribed an injectable rapid-acting insulin. Estimated Enrollment: 400 Actual Study Start Date: October 5, 2017 Estimated Study Completion Date: February 1, 2019 Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
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Post by kc on Oct 19, 2017 13:39:49 GMT -5
Can you say a Paradigm shift in treatment. This trial if they get the 400 enrollment would be great for MannKind. You get some great exposure and tie it together with a cutting edge tool like one drop.
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Post by madog365 on Oct 19, 2017 13:48:58 GMT -5
Can you say a Paradigm shift in treatment. This trial if they get the 400 enrollment would be great for MannKind. You get some great exposure and tie it together with a cutting edge tool like one drop. Yes, 400 new patients on afrezza that have expert coaching from One Drop. My bet is they end up retaining many of these patients. |
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Post by dh4mizzou on Oct 19, 2017 13:52:25 GMT -5
will these 400 count towards scripts or will this be considered cost of business for Mannkind?
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Post by dreamboatcruise on Oct 19, 2017 13:58:19 GMT -5
will these 400 count towards scripts or will this be considered cost of business for Mannkind? I believe they provide drugs directly for clinical trials and thus these would not show up in Symphony or IMS data for retail pharmacy sales. Only half will use Afrezza. |
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Post by porkini on Oct 19, 2017 13:59:56 GMT -5
will these 400 count towards scripts or will this be considered cost of business for Mannkind? I believe they provide drugs directly for clinical trials and thus these would not show up in Symphony or IMS data for retail pharmacy sales. Only half will use Afrezza. Until the study is completed. Then, they will be counted towards scripts if they continue... did I just MOTO?  |
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Post by humann on Oct 19, 2017 14:08:55 GMT -5
I am fairly confident that the results of this trial will look very good for Afrezza. I'm glad it is underway.
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Post by curiousdoc on Oct 19, 2017 15:29:36 GMT -5
THIS. THIS is what MNKD needs. Hopefully they can somehow scrape by and stay alive until at least preliminary results are published (hopefully at the 12 month mark) and they are positive. This is the kind of data that is needed to get this drug the respect is deserves among clinicians.
I would have loved for this to also include patients that are not yet on injectables, but one step at a time.
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Post by boca1girl on Oct 19, 2017 15:29:48 GMT -5
clinicaltrials.gov/ct2/show/NCT03313960?term=one+drop&recrs=ab&draw=1&rank=1Posted today - already underway The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-10.5% already prescribed an injectable rapid-acting insulin. Estimated Enrollment: 400 Actual Study Start Date: October 5, 2017 Estimated Study Completion Date: February 1, 2019 Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure) I sent this info to a T2 family member currently on injections. I hope she signs up and gets accepted. Does anyone know if the study accepts participants nation wide? |
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Post by madog365 on Oct 19, 2017 15:44:13 GMT -5
clinicaltrials.gov/ct2/show/NCT03313960?term=one+drop&recrs=ab&draw=1&rank=1Posted today - already underway The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-10.5% already prescribed an injectable rapid-acting insulin. Estimated Enrollment: 400 Actual Study Start Date: October 5, 2017 Estimated Study Completion Date: February 1, 2019 Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure) I sent this info to a T2 family member currently on injections. I hope she signs up and gets accepted. Does anyone know if the study accepts participants nation wide? Not sure but here is the official link to sign up: www.research.net/r/AOneTrial1All questions can be sent to: Chandra Osborn, PhD, MPH 860-424-2858 chandra@onedrop.today |
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Post by sayhey24 on Oct 19, 2017 18:28:21 GMT -5
I am a bit surprised this is being done against current RAA users and not metformin users. Lets hope the One Drop coaches properly monitor and titrate the new afrezza users. All things equal I would not expect much difference in A1c between afrezza and an RAA. What I would expect would be better time in range and less hypoglycemia. Does the One Drop app support remote monitoring and alerting or it just a phone app taking point in time BG measurements? Have the One Drop coaches read the VDex white paper and are they ready to teach the new afrezza patients as Bill from VDex says "to ride a bike". www.seventhform.com/vdexvids/dr_feelgood.movI hope so but if all they want to show is A1c results and have no idea what the time in range numbers look like "in theory" it should end in a tie with the RAA. I understand they are limited by the finger pokes and are not using a CGM but MNKD cannot afford a tie. |
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Post by chong9 on Nov 9, 2017 0:07:56 GMT -5
Thank you Madog. I acted quick and finally my wife got a pack of afrezza. They said she is the first patient on the trial. For last three years or so, we've been trying to get prescription then pre-authorization which each failed every time. And then saw this trial and got this. We almost cried. Thank you again Madog and every one on the board. Go mannkind, go afrezza. I am 25k long post split,under water. Never give up a single share holding tight without no lending.
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Post by mnkdfann on Nov 9, 2017 0:12:59 GMT -5
Thank you Madog. I acted quick and finally my wife got a pack of afrezza. They said she is the first patient on the trial. She is the FIRST patient on the trial. As of when was this? |
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Post by chong9 on Nov 9, 2017 0:15:36 GMT -5
First with A1 and afrezza as of this past Monday according to the lady who help to set up.
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Post by mnkdfann on Nov 9, 2017 0:20:30 GMT -5
First with A1 and afrezza as of this past Monday according to the lady who help to set up. Thanks. So it took them over a month to recruit one patient, given what was said in the first post: "Actual Study Start Date: October 5, 2017" Hopefully it is faster here on in for the remainder. |
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