Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions (AP@Home04_Phase 4)

What Was Tested

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

This is a double-blind, single-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting Humalog or by an automated closed-loop system using ultra-rapid Lispro in random order.

It had two arms (groups): Closed-loop using standard rapid-acting insulin lispro (active comparator) and Closed-loop using ultra-rapid insulin lispro (experimental).

The registry classes the interventions as device.

More on the Plan

Study objectives The study objective is to compare day and night automated closed-loop glucose control using ultra-rapid insulin lispro with closed loop control using standard insulin lispro.

SAFETY: The objective is to evaluate the safety of day and night automated closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.

UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.

Study Design A double-blind, single-centre, randomised, two-period crossover study, contrasting day and night automated closed-loop glucose control applying standard insulin lispro with day and night closed-loop control applying ultra-rapid acting insulin lispro.

Who Took Part

Enrollment: 28 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 has type 1 diabetes as defined by WHO. The subject is 18 years of age or older. The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting. The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine). The subject is willing to wear closed-loop system at home and at work place.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: non-type 1 diabetes mellitus; any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results; known or suspected allergy against insulin or previous reaction to fiasp.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-01-25 with completion listed for 2022-12-28.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time spent in the target glucose range from [amount hidden]/l based on continuous glucose monitoring (CGM).

It also tracked 10 secondary outcomes, for example Average of glucose levels based on continuous glucose monitoring, Standard deviation of glucose levels based on continuous glucose monitoring and Coefficient of variation of glucose levels based on continuous glucose monitoring.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 28 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 Lispro compound page, all human trials.