Use of Insulin Glargine to Treat Diabetic Ketoacidosis

What Was Tested

The trial (not phased) is built around Insulin Glargine.

The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

It had two arms (groups): Glargine (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

75 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Established history of insulin dependent diabetes. Chief c/o hyperglycemia or vomiting. Venous pH \< 7.24. Serum Bicarbonate \< 18. Blood glucose \> 150.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: age \< 6y.o; new onset diabetes; received iv insulin bolus prior to arrival to vch emergency room (er).

How the Study Was Run

It was run as a randomized, single-group and triple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2004-08 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time of Acidosis Correction (time frame: Minutes).

It also tracked 2 secondary outcomes, for example Time on Insulin Drip and Total Hospital Stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine 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 Glargine compound page, all human trials.