60
Participants
Start Date
September 30, 2017
Primary Completion Date
December 15, 2017
Study Completion Date
January 31, 2018
Technosphere insulin
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
Barbara Davis Center, Aurora
Collaborators (1)
Atlanta Diabetes Associates
OTHER
University of Southern California
OTHER
Rainier Clinical Research Center
OTHER
Mannkind Corporation
INDUSTRY
University of Colorado, Denver
OTHER