Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
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.
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).
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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