Trial Outcomes & Findings for Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. (NCT NCT03668808)
NCT ID: NCT03668808
Last Updated: 2022-11-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
During the initial 24 hours local time and starting within 2 hours after arrival
Results posted on
2022-11-01
Participant Flow
Between 2018-2019, 25 subjects from the local community were screened for eligibility and then randomly assigned to one arm of the study . When the first arm was completed, the subjects crossed over to the other arm of the study.
25 Participants were randomly assigned to one arm and then crossed over to the other arm when the first assignment was completed.
Participant milestones
| Measure |
Insulin Degludec, Then Insulin Glargine
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine.
|
Insulin Glargine U100, Then Insulin Degludec
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec.
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
12
|
|
First Intervention
COMPLETED
|
11
|
10
|
|
First Intervention
NOT COMPLETED
|
2
|
2
|
|
Washout Period
STARTED
|
11
|
10
|
|
Washout Period
COMPLETED
|
11
|
10
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
10
|
|
Second Intervention
COMPLETED
|
11
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Insulin Degludec, Then Insulin Glargine
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine.
|
Insulin Glargine U100, Then Insulin Degludec
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
Subjects with type 1 diabetes and on multiple daily injections will use either basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN or they will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to these arms first or second.
For Insulin Glargine: 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. After a washout period of 2 weeks, subjects crossed over to the other basal insulin, Insulin Degludec.
For Insulin Degludec: 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. After a washout period of 2 weeks, the subjects crossed over to the other basal insulin, Insulin Glargine.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Hypoglycemia awareness
Gold score
|
2.0 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Hypoglycemia awareness
Fear of hypoglycemia scale
|
36.6 units on a scale
STANDARD_DEVIATION 18.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: During the initial 24 hours local time and starting within 2 hours after arrivalPopulation: All participants (n=21) who completed both arms of the study were included in the analysis.
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).
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)
Eastward travel
|
36.3 percentage of Time in Range 70-140mg/dL
Standard Deviation 22.2
|
45.6 percentage of Time in Range 70-140mg/dL
Standard Deviation 21.1
|
|
Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)
Westward travel
|
37.2 percentage of Time in Range 70-140mg/dL
Standard Deviation 22.2
|
43.9 percentage of Time in Range 70-140mg/dL
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: During the initial 24 hours local time and starting within 2 hours after arrivalTime 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).
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)
Eastward travel
|
55.0 percentage of Time in Range 70-180mg/dL
Standard Deviation 21.7
|
62.3 percentage of Time in Range 70-180mg/dL
Standard Deviation 19.3
|
|
Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)
Westward travel
|
54.5 percentage of Time in Range 70-180mg/dL
Standard Deviation 24.7
|
61.2 percentage of Time in Range 70-180mg/dL
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: In flight period of time and for 72 hours at each destinationMean ± standard deviation of CGM glucose (mg/dl) by CGM during the flight and during the 72 hours at the destination
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Mean ± SD CGM Glucose (mg/dl)
In-flight eastward
|
166.3 mg/dL
Standard Deviation 55.2
|
158.8 mg/dL
Standard Deviation 58.9
|
|
Mean ± SD CGM Glucose (mg/dl)
In-flight westward
|
157.0 mg/dL
Standard Deviation 37.5
|
146.1 mg/dL
Standard Deviation 52.3
|
|
Mean ± SD CGM Glucose (mg/dl)
72 hours at destination after eastward travel
|
154.3 mg/dL
Standard Deviation 43.8
|
147.6 mg/dL
Standard Deviation 34.0
|
|
Mean ± SD CGM Glucose (mg/dl)
72 hours at destination after westward travel
|
160.4 mg/dL
Standard Deviation 35.4
|
156.3 mg/dL
Standard Deviation 34.6
|
SECONDARY outcome
Timeframe: In flight period of time and for 72 hours at each destination% time \<70 mg/dl by CGM
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
CGM % Time <70 mg/dl
Eastward travel in flight
|
9.9 percentage of Time below range <70 mg/dL
Standard Deviation 21.5
|
8.9 percentage of Time below range <70 mg/dL
Standard Deviation 13.5
|
|
CGM % Time <70 mg/dl
Westward travel in flight
|
4.1 percentage of Time below range <70 mg/dL
Standard Deviation 7.3
|
9.9 percentage of Time below range <70 mg/dL
Standard Deviation 12.9
|
|
CGM % Time <70 mg/dl
Eastward flight 72 hours at destination
|
10.0 percentage of Time below range <70 mg/dL
Standard Deviation 9.6
|
10.5 percentage of Time below range <70 mg/dL
Standard Deviation 8.6
|
|
CGM % Time <70 mg/dl
Westward flight 72 hours at destination
|
8.4 percentage of Time below range <70 mg/dL
Standard Deviation 6.8
|
8.2 percentage of Time below range <70 mg/dL
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: In flight period of time and for 72 hours at each destination% time 70-180 mg/dl by CGM
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
CGM % Time 70-180 mg/dl
Eastward travel 72 hours at destination
|
58.3 percentage of Time in Range 70-180mg/dL
Standard Deviation 18.8
|
62.0 percentage of Time in Range 70-180mg/dL
Standard Deviation 16.2
|
|
CGM % Time 70-180 mg/dl
Eastward travel in-flight
|
50.5 percentage of Time in Range 70-180mg/dL
Standard Deviation 24.0
|
58.9 percentage of Time in Range 70-180mg/dL
Standard Deviation 30.8
|
|
CGM % Time 70-180 mg/dl
Westward travel in-flight
|
65.1 percentage of Time in Range 70-180mg/dL
Standard Deviation 23.6
|
64.0 percentage of Time in Range 70-180mg/dL
Standard Deviation 21.0
|
|
CGM % Time 70-180 mg/dl
Westward travel 72 hours at destination
|
56.7 percentage of Time in Range 70-180mg/dL
Standard Deviation 18.8
|
59.2 percentage of Time in Range 70-180mg/dL
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: In flight period of time and for 72 hours at each destination% time \>180 mg/dl by CGM
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
CGM % Time >180 mg/dl
In flight Eastward travel %Time above Range >180mg/dL
|
39.5 percentage of Time above Range >180mg/dL
Standard Deviation 27.9
|
32.3 percentage of Time above Range >180mg/dL
Standard Deviation 31.5
|
|
CGM % Time >180 mg/dl
In flight Westward travel %Time above Range >180mg/dL
|
30.8 percentage of Time above Range >180mg/dL
Standard Deviation 25.4
|
26.0 percentage of Time above Range >180mg/dL
Standard Deviation 23.5
|
|
CGM % Time >180 mg/dl
Eastward 72 hours at destination % Time above Range >180mg/dL
|
31.7 percentage of Time above Range >180mg/dL
Standard Deviation 21.3
|
27.6 percentage of Time above Range >180mg/dL
Standard Deviation 17.2
|
|
CGM % Time >180 mg/dl
Westward 72 hours at destination % Time above Range >180mg/dL
|
34.9 percentage of Time above Range >180mg/dL
Standard Deviation 21.9
|
32.7 percentage of Time above Range >180mg/dL
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: In flight period of time and for 72 hours at each destinationCoefficient of variation of CGM values - glycemic variability (CV, %)
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
CGM - Coefficient of Variation (CV)
Eastward In-flight Glycemic variability CV %
|
30.6 percentage of Glycemic Variability %
Standard Deviation 15.9
|
31.0 percentage of Glycemic Variability %
Standard Deviation 14.0
|
|
CGM - Coefficient of Variation (CV)
Westward In-flight Glycemic variability CV %
|
28.2 percentage of Glycemic Variability %
Standard Deviation 8.4
|
33.7 percentage of Glycemic Variability %
Standard Deviation 10.1
|
|
CGM - Coefficient of Variation (CV)
Eastward 72-hours at destination Glycemic variability CV %
|
39.9 percentage of Glycemic Variability %
Standard Deviation 9.3
|
41.0 percentage of Glycemic Variability %
Standard Deviation 10.8
|
|
CGM - Coefficient of Variation (CV)
Westward 72-hours at destination Glycemic variability CV %
|
38.6 percentage of Glycemic Variability %
Standard Deviation 7.4
|
39.5 percentage of Glycemic Variability %
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: At 0600 local time on the morning after arrival at each destinationFasting Blood Glucose (FBG) was determined using CGM at each destination on the morning after arrival.
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
CGM Fasting Blood Glucose (FBG)
After eastward travel
|
143 mg/dL
Standard Deviation 80
|
137 mg/dL
Standard Deviation 60
|
|
CGM Fasting Blood Glucose (FBG)
After westward travel
|
137 mg/dL
Standard Deviation 60
|
140 mg/dL
Standard Deviation 79
|
SECONDARY outcome
Timeframe: After 24 and 48 hours at the destination after arrivalThis 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).
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Liverpool Jet-Lag Questionnaire
Eastward jet lag after 24 hours
|
2.5 score on a scale
Standard Deviation 2.6
|
4.1 score on a scale
Standard Deviation 2.8
|
|
Liverpool Jet-Lag Questionnaire
Eastward jet lag after 48 hours
|
1.6 score on a scale
Standard Deviation 2.7
|
3.8 score on a scale
Standard Deviation 3.4
|
|
Liverpool Jet-Lag Questionnaire
Eastward fatigue after 24 hours
|
0.2 score on a scale
Standard Deviation 1.6
|
0.2 score on a scale
Standard Deviation 2.7
|
|
Liverpool Jet-Lag Questionnaire
Eastward fatigue after 48 hours
|
-0.7 score on a scale
Standard Deviation 1.8
|
-1.5 score on a scale
Standard Deviation 2.3
|
|
Liverpool Jet-Lag Questionnaire
Westward jetlag after 24 hours
|
3.2 score on a scale
Standard Deviation 3.3
|
3.5 score on a scale
Standard Deviation 3.3
|
|
Liverpool Jet-Lag Questionnaire
Westward jetlag after 48 hours
|
3.5 score on a scale
Standard Deviation 2.9
|
2.9 score on a scale
Standard Deviation 3.3
|
|
Liverpool Jet-Lag Questionnaire
Westward fatigue after 24 hours
|
-1.6 score on a scale
Standard Deviation 2.0
|
-1.5 score on a scale
Standard Deviation 2.3
|
|
Liverpool Jet-Lag Questionnaire
Westward fatigue after 48 hours
|
3.5 score on a scale
Standard Deviation 2.9
|
-0.7 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: During 24 hours at each destinationPopulation: The pre-specified intent was to combine insulin arms if there were no differences between insulin arms. Sleep quantity was compared at each destination.
Measurement of sleep duration (TST - Total sleep time in minutes)
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Sleep Quantity Measured by ActiGraph
Total sleep time, minutes in NY
|
489 Minutes
Interval 390.0 to 572.0
|
—
|
|
Sleep Quantity Measured by ActiGraph
Total sleep time, minutes in HI
|
398 Minutes
Interval 337.0 to 422.0
|
—
|
SECONDARY outcome
Timeframe: During 24 hours at each destinationPopulation: The pre-specified intent was to combine insulin arms if there were no differences between insulin arms. Sleep quality/efficiency was compared at each destination.
Measurement of sleep efficiency (SE% - total sleep time in minutes divided by time in bed in minutes)
Outcome measures
| Measure |
Insulin Degludec
n=21 Participants
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
Insulin Degludec: 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.
TRESIBA® FLEXTOUCH®: 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.
|
Insulin Glargine U100
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
Insulin Glargine: 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.
LANTUS® SOLOSTAR® INSULIN PEN: 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.
|
|---|---|---|
|
Sleep Efficiency Measured by ActiGraph
SE% in NY
|
92 percentage of total sleep/time in bed
Interval 90.0 to 95.0
|
—
|
|
Sleep Efficiency Measured by ActiGraph
SE% in HI
|
89 percentage of total sleep/time in bed
Interval 86.0 to 94.0
|
—
|
Adverse Events
Insulin Degludec, Then Insulin Glargine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Glargine U100, Then Insulin Degludec
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place