|
|
Post by mango on Jan 21, 2022 16:10:08 GMT -5
The MannKind/One Drop collaborative clinical trial achieved remarkable results. The study demonstrated a significant A1C reduction of -0.93% absolute A1c improvement among people with type 2 diabetes using One Drop's digital therapeutic solution and Afrezza. www.prnewswire.com/news-releases/people-with-diabetes-using-one-drop--afrezza-significantly-lower-a1c-in-3-months-300798843.htmlmichaelcastagna why is MannKind and One Drop silent on these significant findings? Where is the marketing and large scale follow up trial? What happened with this partnership? I find it negligent to sit idle on such significant results such as this and STAT. These are two clinical trials that can be capitalized on yet MannKind does nothing. One Drop has a lot of peer reviewed literature and clinical data supporting is utility and would pair wonderfully with Afrezza and BluHale. I find it odd Jeff Dachis sold us that story at the ASM just to drop off a cliff and never be heard from again after significant clinical trial results are disclosed. MannKind’s ability to successfully achieve and maintain profitability relies heavily on the successful commercialization of Afrezza. |
|
|
|
Post by henry on Jan 21, 2022 16:31:14 GMT -5
.93% is less than 1%.
|
|
|
|
Post by mango on Jan 21, 2022 17:13:50 GMT -5
ATTD19-0096 A PRAGMATIC RANDOMIZED CONTROL TRIAL EVALUATES ONE DROP WITH INHALABLE VS. INJECTABLE INSULINHirsch A.1, Heyman M.1, Raymond J.2, Huddleston B.1, Dachis J.1, Osborn C.1 1One Drop, One Drop, New York, USA 2Children's Hospital of Los Angeles- University of Southern California, Keck School of Medicine, Los Angeles, USA Objective: Digital therapeutics and innovative pharmaceuticals may deliver better outcomes together than alone. We conducted a pragmatic RCT to assess One Drop's digital therapeutics platform ([OD] mobile app, glucometer, and coaching) with Afrezza inhalable insulin vs. OD and injectable insulin. Methods: We randomized 265 adults with type 2 diabetes (T2D) to one of two interventions. Chi-square and Mann-Whitney U tests assessed baseline group differences. Multiple imputation by group corrected for missing data. ANCOVA intent-to-treat (ITT) and per protocol (PP) models tested effects on 3-month A1c. Results: The enrolled sample (n=119) was 50±11 years old, 53% female, 61% White with T2D for 14.5±8 years and an A1c 9.3%±1.6%. Age and days between A1c differed by group and were covariates. Both groups experienced significant A1c improvements (p<.008-04). A significant group by baseline A1c interaction required examining effects by baseline A1c levels. In ITT, a lower baseline A1c was associated with a better effect from OD and Afrezza than OD and injectable insulin. In PP (n=80), 3-month A1c trended lower in OD and Afrezza (MeanDiff -.47% to -.73%; p<.09 to .19) vs. OD and injectable insulin. Conclusion: OD with Afrezza was associated with −.94% absolute A1c improvement; an absolute −.52% better A1c than OD with injectable insulin and an absolute −.39% better A1c than Afrezza without OD (i.e., based on a −.55% A1c effect). While speed and external validity are trial strengths, power to identify group differences was limited. Multiple methods are needed to fully understand the effects of digital therapeutics with pharmaceuticals. www.liebertpub.com/doi/10.1089/dia.2019.2525.abstracts |
|
|
|
Post by beardawg on Jan 26, 2022 12:54:32 GMT -5
I'm guessing it was referring to an absolute change, meaning, for instance, going from 8% to 7.07%, since A1C is measured in percent. |
|
|
|
Post by dh4mizzou on Jan 26, 2022 13:05:39 GMT -5
Which is between 11% and 12% relatively. Is that good?
|
|
|
|
Post by cjm18 on Jan 26, 2022 14:08:27 GMT -5
OD with Afrezza was associated with −.94% absolute A1c improvement; an absolute −.52% better A1c than OD with injectable insulin
Not much difference. 9.3 was avg starting a1c.
|
|
|
|
Post by sayhey24 on Jan 26, 2022 14:12:02 GMT -5
Which is between 11% and 12% relatively. Is that good? Going from 8 to 7.03 is very significant given the fact that these people were already under the One Drop program and had already been optimized under that program. I could never figure Dachis out. He seemed to be married to his chrome glucose meter which comes in the leather pouch rather than switch over to a CGM approach. When I talked with some of his people it seemed like an odd group but maybe it was me. I just could never figure out where One Drop was headed. Another thing to remember is this study was done prior to Mike figuring out how to dose afrezza. While some of us told them to dose more than the label I am pretty sure they did not do that here. They also did not have the real time feedback from the CGM to adjust for meal types and second dosing opportunities. While this study had "significant" results, I am pretty sure they could have had even better results using CGMs and proper dosing. I thought Mike mentioned the study in India is underway and that should be using CGMs and proper dosing. |
|
|
|
Post by beardawg on Jan 26, 2022 14:39:36 GMT -5
Which is between 11% and 12% relatively. Is that good? Well, the range from normal to highest pre-diabetes is 5.7% to 6.4% (a<-above that is diabetic). That 0.7% range is an absolute 12.3% or 10.9% change, depending on if you are going up from 5.7% or coming down from 6.4%. Also, the closer you are to 6.4%, the greater the risk you have of developing Type 2 later. Taking all that into account, I'd say a 0.93% change is significant; it's more than the difference between diabetic and normal - even skipping over pre-diabetic. |
|
|
|
Post by slapshot on Jan 26, 2022 14:44:22 GMT -5
OD with Afrezza was associated with −.94% absolute A1c improvement; an absolute −.52% better A1c than OD with injectable insulin Not much difference. 9.3 was avg starting a1c. Wait, so you are saying that those using Afrezza dropped on average from 9.3 to 9.3 - .94 = 8.36 while those using injectables dropped from 9.3 to 9.3 - .52 = 8.78?
Isn't .94 significantly more than .52? Some may argue that it is about an 80% greater.
You didn't show your work so I'm not sure if this is what you meant as "not much difference"?
|
|
|
|
Post by beardawg on Jan 26, 2022 15:26:20 GMT -5
OD with Afrezza was associated with −.94% absolute A1c improvement; an absolute −.52% better A1c than OD with injectable insulin Not much difference. 9.3 was avg starting a1c. Wait, so you are saying that those using Afrezza dropped on average from 9.3 to 9.3 - .94 = 8.36 while those using injectables dropped from 9.3 to 9.3 - .52 = 8.78?
Isn't .94 significantly more than .52? Some may argue that it is about an 80% greater.
You didn't show your work so I'm not sure if this is what you meant as "not much difference"?
It's even better than that. Injectables dropped from 9.3 to 9.3-(.94 - .52) = 8.88 ..... the actual drop for injectables was .42 It's a 55.3% greater drop than injectables. |
|
|
|
Post by cjm18 on Jan 26, 2022 15:28:55 GMT -5
OD with Afrezza was associated with −.94% absolute A1c improvement; an absolute −.52% better A1c than OD with injectable insulin Not much difference. 9.3 was avg starting a1c. Wait, so you are saying that those using Afrezza dropped on average from 9.3 to 9.3 - .94 = 8.36 while those using injectables dropped from 9.3 to 9.3 - .52 = 8.78?
Isn't .94 significantly more than .52? Some may argue that it is about an 80% greater.
You didn't show your work so I'm not sure if this is what you meant as "not much difference"?
Our math matches. So it’s a matter of opinion. A1c is diabetic after treatment for both. Also this tidbit below. Need a bigger study or longer study. 3-month A1c trended lower in OD and Afrezza (MeanDiff -.47% to -.73%; p<.09 to .19) vs. OD and injectable insulin. |
|
