Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Degludec; Insulin Glargine; TRESIBA® FLEXTOUCH®; LANTUS® SOLOSTAR® INSULIN PEN
Intervention description: 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.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Long-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Insulin Degludec; Insulin Glargine; Air Travel; Continuous Glucose Monitor

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.
    

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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