Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

What Was Tested

This registered not phased trial tested Insulin Aspart.

It had two arms (groups): 1 (active comparator) and 2 (experimental).

Conventional insulin group: In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.

The registry classes the interventions as drug.

More on the Plan

This implies that most severely ill patients with hyperglycemia should be treated with insulin to reach near-normoglycemia.

DESIGN: Randomized, controlled trial with an open intervention.

Patients presenting with hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional treatment (conventional insulin group) or to intensive treatment (intensive insulin group).

Exclusion criteria include severely immunocompromised patients, patients in shock, patients with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.

Who Took Part

The registry lists 130 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.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: patients in shock (defined as hypotension or shock index \> 1 with oliguria, changed mental status and metabolic acidosis); patients with a terminal illness on palliative care; patients with type 1 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2006-12 with completion listed for 2010-04.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in the Glycaemic Target Range ([amount hidden]/l) During the Period of Observation of 48 Hours.

It also tracked 4 secondary outcomes, for example Time to Reach the Target Range, Frequency of Hypoglycemia, Frequency of Severe Hypoglycaemia and Frequency of Hypokalaemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 130 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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