Evaluation of Fiasp® (Fast Acting Insulin Aspart) in [amount hidden] Hybrid Closed-Loop Therapy

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

It had two arms (groups): Fiasp then Novolog (experimental) and Novolog then Fiasp (experimental).

Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.

Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.

The registry classes the interventions as drug.

More on the Plan

Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study.

They will use their usual home insulin during the optimization phase.

They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 15 inclusion and 16 exclusion criteria; among the exclusions: pregnant or lactating females; no hypoglycemic seizure or loss of consciousness in the past 6 months; severe episode of dka in the 6 months prior to study enrollment that was unrelated to an infusion set failure.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Insulin Aspart 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 Aspart and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2018-07-23 with completion listed for 2019-03-30.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Time in Range: Sensor Glucose Values Between [amount hidden]/dl. Percentage of Time in Range: Sensor Glucose Readings <[amount hidden]/dl.

It also tracked 1 secondary outcome, for example Mean Sensor Glucose in mg/dl.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 27 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 Aspart compound page, all human trials.