FASter Insulin in Closed-loop Technology in Children

What Was Tested

This registered not phased trial tested Insulin Aspart.

The closed-loop system consists of three components: the continuous glucose monitor (CGM), the insulin pump and a smartphone Application, or App, that translates, in real-time, sensor glucose levels received from the glucose monitoring device and calculates the amount of insulin to be delivered by the coupled insulin pump.

This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two 8-week study periods during which glucose levels will be controlled by a hybrid closed-loop system using either standard insulin aspart or faster insulin aspart in random order.

It had two arms (groups): Faster insulin aspart with hybrid closed-loop insulin delivery (active comparator) and Standard insulin aspart with hybrid closed-loop insulin delivery (active comparator).

Unsupervised home use of hybrid closed-loop insulin delivery with faster insulin aspart for 8 weeks. Intervention: Use of faster insulin aspart with hybrid closed-loop insulin delivery.

Unsupervised home use of hybrid closed-loop insulin delivery with standard insulin aspart for 8 weeks. Intervention: Use of standard insulin aspart with hybrid closed-loop insulin delivery.

The registry classes the interventions as device.

More on the Plan

Purpose of clinical trial: To compare hybrid closed-loop applying faster insulin aspart to hybrid closed-loop applying standard insulin aspart over 8 weeks.

SAFETY: The objective is to evaluate the safety of closed-loop glucose control using faster insulin aspart compared to standard insulin aspart in terms of episodes and severity of hypoglycaemia, frequency of diabetic ketoacidosis (DKA) and nature and severity of other adverse events. 3.

UTILITY: The objective is to determine the acceptability and duration of use of the closed-loop system. 4.

HUMAN FACTORS: The objective is to assess emotional and behavioural characteristics of parents/guardians and their response to the closed-loop system and clinical trial using validated surveys.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to people of any sex aged from 2 years up to 6 years.

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

Examples of who could join: Age between 2 and 6 years (inclusive). Treated with U-100 rapid or ultra-rapid acting insulin analogue. Able to wear glucose sensor. Able to wear closed-loop system 24/7. The parent/guardian is willing to follow study specific instructions.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator; untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment; current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids.

How the Study Was Run

The set-up was randomized, crossover and triple-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.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2021-03-12 with completion listed for 2022-09-14.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in target ([amount hidden]/L) ([amount hidden]/dL).

It also tracked 15 secondary outcomes, for example Mean glucose, Standard deviation of glucose, Coefficient of variation of glucose, BMI SDS, Number of episodes of severe hypoglycaemia and Frequency of diabetic ketoacidosis.

What This Means in Plain Language

Put simply, this is a not phased, 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; no results are posted to the registry yet, so nothing here describes outcomes.

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