| Trial ID: | L3253 |
| Source ID: | NCT03554486
|
| Associated Drug: |
Fiasp
|
| Title: |
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03554486/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Fiasp|DRUG: Novolog
|
| Outcome Measures: |
Primary: Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl, Measured as percentage of time in range (days)., 7 days (during 2nd half of 2-week intervention period)|Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl, Percentage of time in range (days) as a measure of hypoglycemia., 7 days (during 2nd half of 2-week intervention period) | Secondary: Mean Sensor Glucose in mg/dl, Mean sensor data over the second week of using a randomized, blinded insulin., 7 days (during 2nd half of 2-week intervention period)
|
| Sponsor/Collaborators: |
Sponsor: Stanford University | Collaborators: Medtronic
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-07-23
|
| Completion Date: |
2019-03-30
|
| Results First Posted: |
2021-08-18
|
| Last Update Posted: |
2021-08-18
|
| Locations: |
Stanford University, Palo Alto, California, 94304, United States|Stanford, Palo Alto, California, 94305, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03554486
|
