| Trial ID: | L2172 |
| Source ID: | NCT03987191
|
| Associated Drug: |
Multiple Daily Ijnection Using Insulin Degludec And Insulin Aspart
|
| Title: |
Insulin Pump to Multiple Daily Injection Transition Clinical Trial
|
| Acronym: |
TRANSITION
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03987191/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Multiple daily ijnection using Insulin Degludec and Insulin Aspart
|
| Outcome Measures: |
Primary: Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups, The primary outcome will be time spent in CGM glucose \>180 mg/dL (hyperglycemia) during 7days of randomization period between two groups., 7 days from the randomization | Secondary: Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups, CGM TIR between two groups, 7 days from the randomization|Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups, CGM time below 70 between two groups, 7 days from the randomization|Number of Participants With Severe Hypoglycemia as Defined by the ADA (Severe Cognitive Impairment Requiring External Assistance for Recovery) and Severe Hyperglycemia (BG≥250 Needing Hospitalization) Between Two Groups, Frequency of SH and DKA between two groups, 7 days from the randomization|Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization, no of correction boluses between two groups, 72 hours from the randomization|Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups, PRO between two groups. The Insulin delivery satisfaction survey (IDSS) measures diabetes patients' satisfaction with their insulin delivery system. Possible scores range from 1-5, with higher scores indicating higher satisfaction and a better outcome., 7 days from the randomization|Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups, PRO between two groups, 7 days from the randomization
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-10
|
| Completion Date: |
2020-10-08
|
| Results First Posted: |
2021-09-13
|
| Last Update Posted: |
2021-09-13
|
| Locations: |
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03987191
|
