Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Tight glucose control (experimental) and Liberal glucose control (active comparator).

The registry classes the interventions as drug.

Who Took Part

9230 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.

The full record lists 0 inclusion and 13 exclusion criteria; among the exclusions: patients with a do not resuscitate (dnr) order at the time of icu admission; patients expected to die within 12 hours after icu admission (= moribund patients); patients able to receive oral feeding (not critically ill).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2018-09-18 with completion listed for 2022-11-30.

It ran at 4 sites in Belgium (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Duration of ICU dependency (time frame: up to 1 year after randomization).

It also tracked 35 secondary outcomes, for example ICU Mortality, Hospital Mortality, 90-day mortality, Blood glucose concentrations in ICU, Duration of ICU dependency and Length of stay in hospital.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 9230 people.

With 9230 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.