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
Study type: Interventional
Phase: Phase 4

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).
    

Intervention name(s): Insulin Degludec; Insulin Glargine; TRESIBA® FLEXTOUCH®; LANTUS® SOLOSTAR® INSULIN PEN
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): 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.
Other intervention name(s): Tresiba; Lantus; Insulin Degludec; Insulin Glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Long-Acting
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)
Primary purpose: Treatment
Keywords: Insulin Degludec; Insulin Glargine; Air Travel; Continuous Glucose Monitor