My biggest concern surrounding the Affinity 1 study was the bridging of the data, and moreso performance, between the Medtone inhaler and the Dreamboat.
After assistance from Brentie, I was feeling better regarding clarity of the parameters of the study, which are:
1. Medtone proving non-inferiority in A1C reduction vs. Lantus / Humalog
2. Dreamboat proving non-inveriority in A1C reduction vs. Lantus / Humalog
3. Lung spiromerty data of Medtone vs. Dreamboat
Regarding proving non-inferiority of the dreamboat vs. the Medtone device, there is a thread on the YMB regarding a "leaked concern" regarding the Dreamboat being outperformed by the Medtone inhaler vs. the Lantus / Humalog arm, centered on the 30% reduction of Afrezza used in the dreamboat inhaler vs. the Medtone inhaler.
Previously, I felt pretty confident after watching the instructional video. via the link below,
http://www.youtube.com/watch?v=Ut7k_IY7ZuU
for the medtone device that showed a requirement of the user to:
1. Insert cartridge
2. Inhale
3. Re-insert cartridge
4. Inhale AGAIN
5. Return the cartridge, with unused powder
While the video helped, after being pointed towards the patent application for the dreamboat inhaler, my concerns were assuaged!
The good news, from page 48 of the patents original document (pg 49 of PDF) from ESPACE patent WO2011163272:
http://wo.espacenet.com/publicationDetails/originalDocument;jsessionid=E44A645C950549995EF59D6392805B2D?CC=WO&NR=2011163272A1&KC=A1&FT=D&ND=4&date=20111229&DB=wo.espacenet.com&locale=en_EP
"The data show that 20 or 22 U using DPI 2 showed similar exposures of insulin and FDKP compared with 30 U insulin administered with Medtone"
This is 30% less powder usage, per their testing, which makes me feel much better, though there is a note that there was some variability among patients in using the device, though I believe this is mitigated by:
1. Training
2. Continued use
3. Titration / treat to target protocol
4. Independent monitoring firm
Bottom line:
I will sleep much better tonight knowing that there was fairly substantial testing done to prove the dosing differences between the dreamboat / medtone inhaler!
Feeling good, my fellow Mannkinders ;-)
Does anyone still have concerns regarding the reduction in dosing between the two devices, and their performance in the Affinity 1 study?
