Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

Hyperglycemia is one of the most frequently encountered complications of enteral nutrition therapy in the hospital setting.

However, there is no standardized approach directed towards the identification and management of patients who develop hyperglycemia while receiving enteral nutrition.

The study is a phase IV, investigator initiated randomized, parallel group clinical trial.

Potential subjects will include those subjects with written orders for initiation of enteral feedings using a formula containing carbohydrates.

Who Took Part

50 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: Type 2 Diabetes defined according to ADA criteria. Enteral nutrition therapy. Men and women age \>/= 18. Ability for patient or legally authorized representative to understand and sign an informed consent document.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: subjects with conditions that are anticipated to have short term (i.e. \< 2 months survival) based on discussions with the treatment team and attending physician; subjects admitted to the ct icu or any unit with pre-established protocols for glycemic management; subjects with known type 1 diabetes (who will absolutely require a long or intermediate acting insulin preparation).

How the Study Was Run

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

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2005-02 with completion listed for 2006-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to mean 24 hour plasma glucose < [amount hidden]/dl.

It also tracked 8 secondary outcomes, for example Hospital length of stay, Inpatient mortality, Number of days of antibiotic therapy, Number of days with recorded temperature >/= 100.4F, Quality of Life measures using MOS SF 36 General Health Survey and Outpatient glycemic control and self management practices.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 50 people.

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

More context: the Insulin Glargine compound page, all human trials.