Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

What Was Tested

The trial (phase 2) is built around Insulin Glargine.

It had two arms (groups): basal insulin and insulin pump (experimental) and insulin pump (no intervention).

Patients in the control group did not receive placebo injections.

The registry classes the interventions as drug.

More on the Plan

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities.

Hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone.

Glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities.

Who Took Part

The registry lists 70 planned participants were the target.

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: Patients with hyperglycemic crisis(DKA, HHS or mixing type) receiving iv insulin infusion.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: age under 18 years old.

How the Study Was Run

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

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Insulin Glargine was given.

Those kept unaware of assignments: participant.

It started in 2022-03-01 with completion listed for 2024-01.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the rates of rebound hyperglycemia (time frame: "the next 12 hours" after ceasing insulin infusion). the rates of hypoglycemia (time frame: "the next 12 hours" after ceasing insulin infusion).

It also tracked 4 secondary outcomes, for example insulin infusion time, ICU length of stay, ventilator use days and ICU Mortality rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 70 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.