Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) and Insulin Glargine.

It had two arms (groups): Insulin Glargine plus Regular Insulin (experimental) and Control - Regular Insulin (active comparator).

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 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 years. Blood Glucose \>200. Potential of hydrogen (pH) \< 7.3. Bicarbonate \< 18. Ketonemia or Ketonuria.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: age \< 18 years; end state renal disease (esrd); patients in shock or requiring emergency surgery.

How the Study Was Run

The set-up was randomized, single-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

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

Those kept unaware of assignments: participant.

It started in 2012-11 with completion listed for 2013-04.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Anion Gap Closure (time frame: Participants monitored from hospital admission to discharge, an average of 4 days).

It also tracked 4 secondary outcomes, for example Number of Participants Admitted to the ICU, Intensive Care Unit Length of Stay, Hospital Length of Stay and Number of Participants Who Developed Hypoglycemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Glargine in 40 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 and the Insulin Glargine compound page, all human trials.