Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

What Was Tested

This registered not phased trial tested Insulin (regular human).

Glucontrol is a prospective, randomized, controlled, multi-centric study.

The registry classes the interventions as drug.

More on the Plan

Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications.

However, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management.

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in ICU and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.

Who Took Part

3500 planned participants were the target.

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: All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: absence of the informed consent (as approved by the local ethical committee); life expectancy lower than 24 hours, as estimated upon admission; therapeutic limitation upon admission in icu.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2004-10 with completion listed for 2006-05.

It ran at 11 sites in Belgium (3), France (3), Germany (1), Israel (1), Netherlands (1) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mortality in the Intensive Care Unit (ICU).

It also tracked 10 secondary outcomes, for example Hospital mortality, 28 Day mortality, Length of ICU stay, Length of hospital stay, Number of episodes of hypoglycemia and associated clinical signs and Infectious morbidity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 3500 people.

With 3500 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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