Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had two arms (groups): leuven (active comparator) and glucommander (active comparator).

These subjects had IV insulin controlled by a computer program called the glucommander described by Davidson, P et al Diabetes Care Oct. 2005.

The registry classes the interventions as drug.

More on the Plan

Given the concern of safety while optimizing glycemic control, the researchers investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure.

The researchers will investigate whether a computer-based algorithm for the titration of IV insulin will translate to better clinical outcomes and less hypoglycemia.

Therefore, the researchers will conduct a prospective randomized trial comparing the Glucommander, a computer-based algorithm with their Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or transplant surgery.

This computer based algorithm was invented in 1984 in Atlanta by Dr.

Who Took Part

Enrollment: 93 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: S/p open heart or kidney or liver transplant surgery.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-04 with completion listed for 2006-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent of blood glucose values in the target range [amount hidden]/dl.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 93 people.

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.