Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart.

Faster-acting insulin aspart (FIASP) is a novel formulation of insulin aspart in which two additional excipients (L-arginine and Niacinamide) have been added, resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes after subcutaneous administration using insulin pump.

It had two arms (groups): FIASP + closed loop device (experimental) and Insulin aspart (standard of care insulin) + closed loop device (active comparator).

The registry classes the interventions as device.

More on the Plan

This is an open-label, single-centre, two-period, randomised, cross over study.

The study involves a screening visit to assess participant eligibility and two 24 hour in-patient stays at the clinical research facility during which day and night glucose levels will be controlled by the closed-loop system with either faster-acting insulin aspart or insulin aspart.

Up to 22 adults with type 1 diabetes and treated with continuous subcutaneous insulin infusion will be recruited, aiming for 16 completed participants.

In random order, they will undergo two closed-loop study days using either faster-acting insulin aspart or insulin aspart.

Who Took Part

18 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.

Examples of who could join: The subject is 18 years and older. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative. The subject will have been an insulin pump user for at least 3 months. The subject is treated with any of the rapid acting insulin analogues. The subject is willing to adhere to study procedures.

The full record lists 7 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2020-12-23 with completion listed for 2022-02-24.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Time spent in the target glucose range (time frame: 23 hours).

It also tracked 11 secondary outcomes, for example Time spent in the target glucose range within 4 hours of each meal, Incremental area under the curve of sensor glucose level within 4 hours of each meal, Time spent below target glucose, Time spent above target glucose and Average, coefficient of variation and standard deviation glucose levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 18 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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