Fast Advanced Closed-Loop Therapy

What Was Tested

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

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Age between 10 and 18 years of age. Type 1 diabetes for at least 6 months. Insulin pump user for at least 3 months. Treated with rapid acting insulin analogue. Subject/carer is willing to perform at least 2 finger-prick blood glucose measurements per day.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: physical or psychological disease likely to interfere with normal conduct of the study; untreated coeliac disease or thyroid disease; current treatment with drugs known to interfere with glucose metabolism.

How the Study Was Run

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

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.

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 2021-04-06 with completion listed for 2021-09-16.

It ran at 2 sites in Austria (1) and Slovenia (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time above range [amount hidden]/dl.

It also tracked 3 secondary outcomes, for example Mean glucose.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 30 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.