Clinical trial NCT03668808: Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Official title: Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: Insulin Degludec
Insulin Glargine
Air Travel
Continuous Glucose Monitor
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2018-09-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

1. Males or females ≥18 and ≤65 years of age.
2. Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months.
3. HbA1c \<10% within 30 days of being enrolled in the study
4. 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.
5. No contraindication to long-haul travel.
6. 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.
7. Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).
8. Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening.
9. 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.

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Exclusion Criteria:

1. Current use of an insulin pump.
2. Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin.
3. 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).
4. Proliferative retinopathy or maculopathy requiring treatment, according to the investigator.
5. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
6. Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial.
7. 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.
8. Known or suspected allergy to any of the trial products or related products.
9. Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1.

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Primary outcomes:
measure: Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)
timeFrame: During the initial 24 hours local time and starting within 2 hours after arrival
Secondary outcomes:
measure: Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)
timeFrame: During the initial 24 hours local time and starting within 2 hours after arrival
measure: Mean ± SD CGM Glucose (mg/dl)
timeFrame: In flight period of time and for 72 hours at each destination
measure: CGM % Time <70 mg/dl
timeFrame: In flight period of time and for 72 hours at each destination
measure: CGM % Time 70-180 mg/dl
timeFrame: In flight period of time and for 72 hours at each destination
measure: CGM % Time >180 mg/dl
timeFrame: In flight period of time and for 72 hours at each destination
measure: CGM - Coefficient of Variation (CV)
timeFrame: In flight period of time and for 72 hours at each destination
measure: CGM Fasting Blood Glucose (FBG)
timeFrame: At 0600 local time on the morning after arrival at each destination
measure: Liverpool Jet-Lag Questionnaire
timeFrame: After 24 and 48 hours at the destination after arrival
measure: Sleep Quantity Measured by ActiGraph
timeFrame: During 24 hours at each destination
measure: Sleep Efficiency Measured by ActiGraph
timeFrame: During 24 hours at each destination
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Honolulu
country: United States
facility: inControl Diabetes Center
state: Hawaii
Study officials:
affiliation: Sansum Diabetes Research Institute
name: David Kerr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.