Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Glargine.

Short-acting intravenous insulin is often preferred to subcutaneous administration for initial management due to its short half-life and ease of titration, but patients will eventually need to transition to subcutaneous insulin prior to discharge.

It had two arms (groups): Standard of Care (no intervention) and Intervention (active comparator).

Subjects presenting to ED with diagnosis of DKA and receiving intravenous short acting insulin will not have orders for subcutaneous insulin glargine placed for research purposes.

The registry classes the interventions as drug.

More on the Plan

In 2014, there were 168,000 hospitalizations for DKA, and the average length of stay was 3.4 days in 2009.

The estimated annual direct medical expense and indirect cost is 2.4 billion dollars per year.

DKA is a potentially life-threatening condition due to its ability to cause metabolic acidosis, electrolyte imbalances, and dehydration.

While DKA treatment protocols differ from institution to institution, the goals of treatment remain the same --- resolution of acidosis, dehydration, and hyperglycemia.

Who Took Part

Enrollment: 8 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: Presented to Regions Hospital ED for chief complaint of DKA, nausea, vomiting, abdominal pain, hyperglycemia, or similar. Meets all below diagnostic criteria for DKA per the American Diabetes Association:. Arterial or venous pH \</= 7.3. Serum Bicarbonate \</= 18 mEq/L. Ketonuria or ketonemia.

The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: age \< 18; end stage renal disease or hepatic disease; hypotension requiring iv vasopressors or inotropes at any point during admission (i.e. norepinephrine, dobutamine, vasopressin, etc.).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2022-05-31 with completion listed for 2023-02-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Does early administration of insulin glargine result in a change in ICU length of stay when compared to usual care for the treatment of diabetic ketoacidosis? (time frame: Assessed from time of intervention until discharge from ICU to general medical unit or from hospital, up to 12 weeks).

It also tracked 7 secondary outcomes, for example The change in mean blood glucose values in the 24 hours and (separately) 48 hours after IV insulin infusion discontinuation and The change in duration of elevated anion gap when compared to usual care.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 8 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 Glargine compound page, all human trials.