| Trial ID: | L4136 |
| Source ID: | NCT03143816
|
| Associated Drug: |
Technosphere Insulin
|
| Title: |
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
| Acronym: |
STAT
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03143816/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Technosphere insulin
|
| Outcome Measures: |
Primary: Change in Time in Range (%) (70-180 mg/dl) With TI on CGM, Difference between Time in range for TI group (treatment) and for Aspart group (control), 4 weeks | Secondary: Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI, Difference in postprandial blood glucose between treatment and control group, 4 weeks|Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation), Difference of glucose variability metrics between treatment and control groups, 4 weeks|The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,, Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration), 0, 1, 2, 3, 4 hours post-dose at 4 weeks|Change in HbA1c (%) in One-month Treatment, Difference in HbA1c between treatment and control group, 4 weeks|Change in Above the Target Time (%) (>180 mg/dl) on CGM, Difference of time above range between treatment and control group, 4 weeks|Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM, Difference of hypoglycemia frequency between treatment and control groups., 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: Atlanta Diabetes Associates|University of Southern California|Rainier Clinical Research Center|Mannkind Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-30
|
| Completion Date: |
2018-01-31
|
| Results First Posted: |
2022-02-22
|
| Last Update Posted: |
2022-02-22
|
| Locations: |
Barbara Davis Center, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03143816
|
