The purpose of the proposed study is to compare insulin Degludec \[TRESIBA® (insulin degludec injection)\] with insulin Glargine U100 \[Lantus® (insulin glargine injection)\] to determine the basal insulin of choice for adults with type 1 diabetes (T1D) who fly non-stop across multiple time zones. With the introduction of Degludec as basal insulin for T1D and the opportunity to vary time of injection between 8 and 40 hours, the use of Degludec as a basal insulin may make it easier for both people living with T1D and diabetologists to plan long-haul travel compared to the use of existing basal insulins when crossing multiple time zones.The study hypothesis is that once daily Degludec as the basal insulin will provide better glycemic control for people with type 1 diabetes on multiple daily injections who are traveling non-stop across multiple time zones than once daily Glargine U100.
This study will be an open-label, single center, pilot study. Participants will be randomized to either Glargine U100 or Degludec as the basal insulin, then a 2 week break, and followed by a cross-over to the other insulin. Each study period will begin in Honolulu, Hawaii (HI) (airport code HNL) with a non-stop flight to Newark, New Jersey (NJ) (EWR) lasting approximately 10 hours with a 6 hour time difference between destinations. After up to 72 hours in EWR, participants will return to Honolulu and spend up to 72 hours at that destination. Investigators plan to recruit 25 adults with established T1D currently being treated with multiple daily injections of insulin (MDI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
Subjects will use Tresiba FlexTouch pens when using Tresiba as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
Subjects will use Lantus SoloStar insulin pens when using Lantus as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
inControl Diabetes Center
Honolulu, Hawaii, United States
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).
Time frame: During the initial 24 hours local time and starting within 2 hours after arrival
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).
Time frame: 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
Time frame: In flight period of time and for 72 hours at each destination
CGM % Time <70 mg/dl
% time \<70 mg/dl by CGM
Time frame: 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
Time frame: In flight period of time and for 72 hours at each destination
CGM % Time >180 mg/dl
% time \>180 mg/dl by CGM
Time frame: 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, %)
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: During 24 hours at each destination
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