Intensive Insulin Therapy as Therapeutic Strategy for Non-diabetic Hyperglycemia After Surgery in ICU

What Was Tested

The trial (not phased) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

It had two arms (groups): Conventional Insulin Therapy (active comparator) and Intensive Insulin Therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

All postoperative patients who will be admitted to surgical ICU and develop (PSH) will be eligible for evaluation for inclusion and exclusion criteria.

Prior to initiation of IV-IT (insulin therapy), blood samples will be obtained to estimate base-line Blood Glucose level (BG).

BG will be estimated hourly during IV-IT to guard against development of hypoglycemic episodes.

The assigned IV-IT will continue till reaching the target BG for each group and then will be stopped and patients will be shifted to subcutaneous (sc)-IT.

Who Took Part

Enrollment: 86 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: All postoperative patients who will be admitted to surgical ICU and developed Post Surgical Hyperglycemia will be eligible for evaluation for inclusion and.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2017-09-14 with completion listed for 2018-03-03.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The number of IV-Insulin Therapy sessions required till stabilization of the targeted Blood Glucose level (time frame: 180 days).

It also tracked 3 secondary outcomes, for example Duration to control hyperglycemia, 28-day ICU morbidity and 28 - day ICU mortality.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 86 people with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.