Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

What Was Tested

This registered not phased trial tested Insulin (regular human) and Insulin Glargine.

The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient.

Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized.

Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen.

It had two arms (groups): Control Group (placebo comparator) and Treatment Group (experimental).

The control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection.

The study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 17 actual participants took part.

It was open to people of any sex aged from 1 Year up to 21 years.

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

Examples of who could join: PH \< 7.3. Admission to PICU (Pediatric Intensive Care Unit). Ages 1-21 years.

The full record lists 9 inclusion and 2 exclusion criteria; among the exclusions: patients who received glargine within the last 24 hours; patients with sepsis.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

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

It started in 2015-11 with completion listed for 2019-02-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood glucose (time frame: Within 3 hrs of arrival).

It also tracked 7 secondary outcomes, for example Blood glucose, blood pH, blood pH, blood bicarbonate level, blood bicarbonate level and Urinalysis for levels of ketones & glucosuria.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Glargine in 17 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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