Glycemic Control and Variability for Congestive Heart Failure Exacerbation

What Was Tested

This registered phase 1, phase 2 trial tested Insulin (regular human).

It had two arms (groups): Intravenous insulin (experimental) and Subcutaneous Insulin (active comparator).

4 injections of insulin/day.

The registry classes the interventions as drug.

More on the Plan

The researchers will enroll 80 patients with severe heart failure and divide them into 2 groups.

The researchers will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2.

Who Took Part

The registry lists 75 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: Age 18 and above. Admitted (less than 48 hours) to the with worsening heart failure.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: receiving comfort care measures only; hospital stay expected to be less than 2 days; participation in the study on prior hospitalizations.

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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2009-01 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hospital Length of Stay (time frame: participants were followed for the duration of hospital stay, median hospital stay 8 day). Hospital Readmission (time frame: 30 days).

It also tracked 8 secondary outcomes, for example High Frequency Heart Rate Variability, Pre-ejection Period (PEP), High Sensitivity C-reactive Protein (Hs-CRP), Brain Natriuretic Peptide (BNP), Quality of Life and Glycemic Lability Index (GLI).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 75 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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