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

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): Insulin Degludec (experimental) and Insulin Glargine U100 (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

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.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females ≥18 and ≤65 years of age. No contraindication to long-haul travel. Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: current use of an insulin pump; use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin; proliferative retinopathy or maculopathy requiring treatment, according to the investigator.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2018-11-16 with completion listed for 2020-09-19.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Continuous Glucose Monitoring - Time in Range ([amount hidden]/dl).

It also tracked 10 secondary outcomes, for example Mean ± SD CGM Glucose (mg/dl), CGM - Coefficient of Variation (CV), CGM Fasting Blood Glucose (FBG), Liverpool Jet-Lag Questionnaire, Sleep Quantity Measured by ActiGraph and Sleep Efficiency Measured by ActiGraph.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.