Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

What Was Tested

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

The role of ultralong insulin in the control of the blood glucose level in diabetic patients is well known, the current study will discuss the role of ultralong insulin in controlling of hyperglycaemia in critical illness defined as failure or impending failure of an organ.

It had three arms (groups): group S (active comparator), Group L (active comparator) and Group R (active comparator).

The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale.

The registry classes the interventions as drug.

More on the Plan

The hemodynamic parameters will be recorded every 15 minutes.

The CBC, Kidney function test, liver enzymes, serum creatinine, s.Na+, s.K+ , s.albumin, RBS will be collected on admission and every three days if there is no indication for close monitoring.

Glycated haemoglobin will be collected once.

The blood sugar will be checked hourly using finger prick test and the glucose variabilities will be monitored.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: age less than 18 or greater than 60 years; diabetic ketoacidosis; patients with recurrent episodes of hypoglycaemia-\* stress hyperglycemia.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-12-01 with completion listed for 2024-05-25.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): hyperglycemic control (time frame: 10 days of ICU stay).

It also tracked 1 secondary outcome, for example length of ICU stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Glargine in 90 people.

The trial is marked completed; 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.