Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

Previously, the mobile insulin scheme was used for its control.

It had two arms (groups): Umpierrez (active comparator) and Davidson (experimental).

The Umpierrez sensitive correction scheme correction.

Davidson correction factor.

The registry classes the interventions as drug.

More on the Plan

A probabilistic sampling with randomly permuted blocks was performed.

The Umpierrez sensitive correction scheme and the Davidson correction factor were compared by evaluating glycemic control at 2 and 5 hours, and the presence of hypoglycemia.

Who Took Part

Enrollment: 116 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: pregnancy, with acute decompensation of diabetes (diabetic ketoacidosis-hyperosmolar state) or type 1 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 2016-01-01 with completion listed for 2018-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of paticipants with Glicemic control (time frame: 5 hours).

It also tracked 1 secondary outcome, for example Number of participants with hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 116 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.