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Clinical Trial Details

Trial ID: L4884
Source ID: NCT03668808
Associated Drug: Insulin Degludec
Title: Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Acronym: SafrTravlT1D
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03668808/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Insulin Degludec|DRUG: Insulin Glargine|DEVICE: TRESIBA® FLEXTOUCH®|DEVICE: LANTUS® SOLOSTAR® INSULIN PEN
Outcome Measures: Primary: Continuous Glucose Monitoring - Time in Range (70-140 mg/dl), Time in range (70-140 mg/dl) \[percentage of glucose readings or hours per day\] by continuous glucose monitoring (CGM) during the initial 24 hours local time (starting within 2 hours after arriving) in Newark, NJ after flying 9-10 hours West to East (from Honolulu, HI) and after the return journey from Newark to Honolulu (flying East to West)., During the initial 24 hours local time and starting within 2 hours after arrival | Secondary: Continuous Glucose Monitoring - Time in Range (70-180 mg/dl), Time in range (70-180 mg/dl) \[percentage of glucose readings or hours per day\] by continuous glucose monitoring (CGM) during the first 24 hours after arriving in HNL and EWR (starting within 2 hours after arrival)., During the initial 24 hours local time and starting within 2 hours after arrival|Mean ± SD CGM Glucose (mg/dl), Mean ± standard deviation of CGM glucose (mg/dl) by CGM during the flight and during the 72 hours at the destination, In flight period of time and for 72 hours at each destination|CGM % Time <70 mg/dl, % time \<70 mg/dl by CGM, In flight period of time and for 72 hours at each destination|CGM % Time 70-180 mg/dl, % time 70-180 mg/dl by CGM, In flight period of time and for 72 hours at each destination|CGM % Time >180 mg/dl, % time \>180 mg/dl by CGM, In flight period of time and for 72 hours at each destination|CGM - Coefficient of Variation (CV), Coefficient of variation of CGM values - glycemic variability (CV, %), In flight period of time and for 72 hours at each destination|CGM Fasting Blood Glucose (FBG), Fasting Blood Glucose (FBG) was determined using CGM at each destination on the morning after arrival., At 0600 local time on the morning after arrival at each destination|Liverpool Jet-Lag Questionnaire, This is a Questionnaire about jet-lag and fatigue administered at the destinations after arrival. Jet Lag is rated on a 0-10 scale (0 - insignificant jet lag to 10 - very bad jet lag). Fatigue is rated on a scale of -5 to +5 (more fatigue to less fatigue)., After 24 and 48 hours at the destination after arrival|Sleep Quantity Measured by ActiGraph, Measurement of sleep duration (TST - Total sleep time in minutes), During 24 hours at each destination|Sleep Efficiency Measured by ActiGraph, Measurement of sleep efficiency (SE% - total sleep time in minutes divided by time in bed in minutes), During 24 hours at each destination
Sponsor/Collaborators: Sponsor: Sansum Diabetes Research Institute | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-11-16
Completion Date: 2020-09-19
Results First Posted: 2022-06-02
Last Update Posted: 2022-11-01
Locations: Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States|inControl Diabetes Center, Honolulu, Hawaii, 96814, United States
URL: https://clinicaltrials.gov/show/NCT03668808