Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study)

What Was Tested

This registered not phased trial tested Insulin Lispro.

Ultra-rapid acting lispro (Lyumjev) is a novel formulation of insulin lispro in which two additional excipients (citrate and trepostinil) 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): Ultrarapid-acting Lispro (experimental) and Insulin Lispro (active comparator).

Ultrarapid-acting lispro delivered by hybrid closed loop system.

Insulin lispro delivered by hybrid closed loop system.

The registry classes the interventions as drug.

More on the Plan

Study Design An open-label, single-centre, randomised, 2-period cross-over study, in adults (18 years and older) with type 1 diabetes on insulin pump treatment.

It is expected that up to 26 adults with type 1 diabetes will be recruited, aiming for 19 completed participants.

The study flow chart is outlined in Figure 2.

Up to a total of 26 adults aged 18 years and older with type 1 diabetes on insulin pump therapy will be recruited aiming for 19 completed participants.

Who Took Part

The registry lists 26 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

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

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: non-type 1 diabetes mellitus including those secondary to chronic disease; any other physical or psychological disease likely to interfere with the normal conduct of the study; untreated celiac disease or hypothyroidism.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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

It started in 2023-07-21 with completion listed for 2024-05-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in range (time frame: 6 hours).

It also tracked 6 secondary outcomes, for example Area under curve, Time below target, Time above target and Mean glucose and glycaemic variability.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 26 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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