Comparison of Insulin Degludec With Insulin Glargine U100... | NCT03668808

NCT03668808

ID	Type	Description	Link
U1111-1210-7350	Registry Identifier	Universal Trial Number - World Health Organization (WHO)

Status Module

Sponsor/Collaborators Module

Name	Class
Novo Nordisk A/S	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin Degludec	Experimental	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.	Drug: Insulin Degludec Device: TRESIBA® FLEXTOUCH®
Insulin Glargine U100	Active Comparator	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.	Drug: Insulin Glargine Device: LANTUS® SOLOSTAR® INSULIN PEN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Degludec	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females ≥18 and ≤65 years of age.
Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months.
HbA1c <10% within 30 days of being enrolled in the study
Current treatment with any basal insulin analogue as the once daily basal insulin given in the evening (22) and no fewer than three injections with rapid acting bolus insulin (e.g. insulin aspart, insulin lispro, or insulin glulisine) as mealtime bolus insulin therapy.
No contraindication to long-haul travel.
No recurrent severe hypoglycemia (more than 1 severe hypoglycemic event requiring hospitalization during the last 12 months), or hypoglycemia unawareness as judged by a score of >4 on the Gold score (23), or hospitalization for diabetic ketoacidosis during the previous 6 months.
Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).
Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening.
Ability and willingness to adhere to the protocol, including performance of self-monitored blood glucose (SMBG) readings and self-adjustment of insulin doses according to protocol.

-

Exclusion Criteria:

Current use of an insulin pump.
Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin.
Initiation or significant change of any systemic treatment which, in the investigator's opinion, could interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers or monoamine oxidase inhibitors (inhaled corticosteroids allowed).
Proliferative retinopathy or maculopathy requiring treatment, according to the investigator.
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial.
Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or cooperation, including subjects not able to read or write, and known or suspected abuse of alcohol, narcotics, or illicit drugs.
Known or suspected allergy to any of the trial products or related products.
Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1.

-

Contacts/Locations Module

Name	Affiliation	Role
David Kerr, M.D.	Sansum Diabetes Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sansum Diabetes Research Institute		Santa Barbara	California	93105	United States
inControl Diabetes Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34716211	Derived	Bevier WC, Castorino KN, Axelrod C, Haroush G, Farfan CC, Shelton N, Nelson K, Spink LA, Liu H, Kerr D. Traveling Across Time Zones With Type 1 Diabetes: A Pilot Study Comparing Insulin Degludec With Insulin Glargine U100. Diabetes Care. 2022 Jan 1;45(1):67-73. doi: 10.2337/dc21-1524.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 18, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Subjects randomly assigned to one arm and then crossed over to the other arm when the first was completed.

Arm/Group Information

ID	Title	Description
BG000	All Study 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.

Units	Counts
Participants	BG00025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG00025
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00035± 14.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014
Male	BG00011

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003
Not Hispanic or Latino	BG00022

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0001

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00025

Hypoglycemia awareness

Hypoglycemia awareness - ability to perceive onset of hypoglycemia in patients who use insulin to treat diabetes.

"Gold Score" poses the question: "Do you know when your hypos are commencing?". Patients complete a 7 point Likert scale from 1 "always aware" to 7 "never aware." "Fear of Hypoglycemia scale" - a 33 question survey describing behaviors and worry about hypoglycemia. Questions are answered with 0 never, 1 rarely, 2 sometimes, 3 often, 4 almost always. Total range is 0 minimum to 132 maximum. Total scores (>50) indicate more fear of hypoglycemia.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Gold score

Title	Measurements
	BG0002.0± 1.2

Fear of hypoglycemia scale

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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).

All participants (n=21) who completed both arms of the study were included in the analysis.

Posted

Mean

Standard Deviation

percentage of Time in Range 70-140mg/dL

During the initial 24 hours local time and starting within 2 hours after arrival

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Units	Counts
Participants	OG00021 OG00121

Title

Denominators

Categories

Eastward travel

Title	Measurements
	OG00036.3± 22.2 OG00145.6± 21.1

Westward travel

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec & Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is <106 minutes.	t-test, 2 sided		<0.05	The threshold for statistical significance was p=0.05.													Superiority

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).

Posted

Mean

Standard Deviation

percentage of Time in Range 70-180mg/dL

During the initial 24 hours local time and starting within 2 hours after arrival

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

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

Posted

Mean

Standard Deviation

mg/dL

In flight period of time and for 72 hours at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

CGM % Time <70 mg/dl

% time <70 mg/dl by CGM

Posted

Mean

Standard Deviation

percentage of Time below range <70 mg/dL

In flight period of time and for 72 hours at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

CGM % Time 70-180 mg/dl

% time 70-180 mg/dl by CGM

Posted

Mean

Standard Deviation

percentage of Time in Range 70-180mg/dL

In flight period of time and for 72 hours at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

CGM % Time >180 mg/dl

% time >180 mg/dl by CGM

Posted

Mean

Standard Deviation

percentage of Time above Range >180mg/dL

In flight period of time and for 72 hours at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

CGM - Coefficient of Variation (CV)

Coefficient of variation of CGM values - glycemic variability (CV, %)

Posted

Mean

Standard Deviation

percentage of Glycemic Variability %

In flight period of time and for 72 hours at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

CGM Fasting Blood Glucose (FBG)

Fasting Blood Glucose (FBG) was determined using CGM at each destination on the morning after arrival.

Posted

Mean

Standard Deviation

mg/dL

At 0600 local time on the morning after arrival at each destination

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

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).

Posted

Mean

Standard Deviation

score on a scale

After 24 and 48 hours at the destination after arrival

ID	Title	Description
OG000	Insulin Degludec	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.
OG001	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.

Secondary

Sleep Quantity Measured by ActiGraph

Measurement of sleep duration (TST - Total sleep time in minutes)

The pre-specified intent was to combine insulin arms if there were no differences between insulin arms. Sleep quantity was compared at each destination.

Posted

Median

Inter-Quartile Range

Minutes

During 24 hours at each destination

ID	Title	Description
OG000	Sleep at Each Destination	Sleep quantity at each destination, either New York or Hawaii.

Units	Counts
Participants	OG00021

Secondary

Sleep Efficiency Measured by ActiGraph

Measurement of sleep efficiency (SE% - total sleep time in minutes divided by time in bed in minutes)

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.

Posted

Median

Inter-Quartile Range

percentage of total sleep/time in bed

During 24 hours at each destination

ID	Title	Description
OG000	Sleep at Each Destination	Sleep quality/efficiency at each destination, either New York or Hawaii.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	21	0	21	0	21
EG001	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.	0	21	0	21	0	21

First MCP Posted Date

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C571886	insulin degludec
D000069036	Insulin Glargine

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Title	Measurements
	BG00036.6± 18.1

Title

Denominators

Categories

Total sleep time, minutes in NY

Title	Measurements
	OG000489(390 to 572)

Total sleep time, minutes in HI

Title	Measurements
	OG000398(337 to 422)