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

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.

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.