Diabetes Mellitus, Type 1Phase 4SafrTravlT1DNCT03668808
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
A Phase 4 study testing Insulin Degludec, Insulin Glargine and TRESIBA® FLEXTOUCH® in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin Degludec, Insulin Glargine and TRESIBA® FLEXTOUCH®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2018to 19 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
- -
Who cannot join
- 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.
Show all 10Show fewer
- 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.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
inControl Diabetes Center
Honolulu, Hawaii, 96814
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.
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.
Read the detailed description
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).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin Degludec, Insulin Glargine, TRESIBA® FLEXTOUCH®, LANTUS® SOLOSTAR® INSULIN PEN
- Keywords
- Insulin Degludec, Insulin Glargine, Air Travel, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DegludecDrug
Also called Tresiba
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.
Insulin GlargineDrug
Also called Lantus
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.
TRESIBA® FLEXTOUCH®Device
Also called Insulin Degludec
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.
LANTUS® SOLOSTAR® INSULIN PENDevice
Also called Insulin Glargine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Insulin Glargine; Device: LANTUS® SOLOSTAR® INSULIN PEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the initial 24 hours local time and starting within 2 hours after arrival
Secondary outcomes (10)
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).
Measured: 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
Measured: In flight period of time and for 72 hours at each destination
CGM % Time <70 mg/dl
% time <70 mg/dl by CGM
Measured: 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
Measured: In flight period of time and for 72 hours at each destination
CGM % Time >180 mg/dl
% time >180 mg/dl by CGM
Measured: 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, %)
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: During 24 hours at each destination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start16 Nov 2018
- Primary completion19 Sep 2020
- Study completion19 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will begin in Honolulu, HI (HNL), fly to Newark (EWR) where they will stay for up to 72 hours followed by a return long-haul flight back to Honolulu with up to 72 hours at this destination. This journey will be repeated after a 2 week period when subjects return to their original insulin treatment regimen and then switch to the alternative basal insulin.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- David Kerr, M.D., Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668808
- Sponsor's protocol ID
- ISS-001227
- Other IDs
- U1111-1210-7350
- Acronym
- SafrTravlT1D
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2018
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided to whether to make individual participant data available.
Publications
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.
PubMed 34716211
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03668808
- Acronym / sponsor ID
- SafrTravlT1D / ISS-001227
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Insulin Degludec, Insulin Glargine, Air Travel, Continuous Glucose Monitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 19 Sep 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will begin in Honolulu, HI (HNL), fly to Newark (EWR) where they will stay for up to 72 hours followed by a return long-haul flight back to Honolulu with up to 72 hours at this destination. This journey will be repeated after a 2 week period when subjects return to their original insulin treatment regimen and then switch to the alternative basal insulin.
| Arm | Type | Receives |
|---|---|---|
| Insulin Degludec | Experimental | Drug: Insulin Degludec, Device: TRESIBA® FLEXTOUCH®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 Glargine U100 | Active comparator | Drug: Insulin Glargine, Device: LANTUS® SOLOSTAR® INSULIN PENSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin DegludecAlso: TresibaSubjects 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. | Drug | Insulin Degludec |
| Insulin GlargineAlso: LantusSubjects 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. | Drug | Insulin Glargine U100 |
| TRESIBA® FLEXTOUCH®Also: Insulin DegludecSubjects 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. | Device | Insulin Degludec |
| LANTUS® SOLOSTAR® INSULIN PENAlso: Insulin GlargineSubjects 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. | Device | Insulin Glargine U100 |
Primary outcome
Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)
Time frame: During the initial 24 hours local time and starting within 2 hours after arrival
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).
10 secondary outcomes
Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)
Time frame: During the initial 24 hours local time and starting within 2 hours after arrival
Mean ± SD CGM Glucose (mg/dl)
Time frame: In flight period of time and for 72 hours at each destination
CGM % Time <70 mg/dl
Time frame: In flight period of time and for 72 hours at each destination
CGM % Time 70-180 mg/dl
Time frame: In flight period of time and for 72 hours at each destination
CGM % Time >180 mg/dl
Time frame: In flight period of time and for 72 hours at each destination
CGM - Coefficient of Variation (CV)
Time frame: In flight period of time and for 72 hours at each destination
CGM Fasting Blood Glucose (FBG)
Time frame: At 0600 local time on the morning after arrival at each destination
Liverpool Jet-Lag Questionnaire
Time frame: After 24 and 48 hours at the destination after arrival
Sleep Quantity Measured by ActiGraph
Time frame: During 24 hours at each destination
Sleep Efficiency Measured by ActiGraph
Time frame: During 24 hours at each destination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34716211Bevier 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.
- Individual participant dataSharing planned: Undecided. Undecided to whether to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kerr, M.D. principal investigator
Sansum Diabetes Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec, Insulin Glargine and TRESIBA® FLEXTOUCH® in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Glucose Monitoring - Time in Range (70-140 mg/dl) (time frame: During the initial 24 hours local time and starting within 2 hours after arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.