Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease.

A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar.

Patients with high blood sugar do worse than those with normal blood sugar.

It had 1 arm (groups): Tight glycaemic control (experimental).

Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM.

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

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

Examples of who could join: Physician diagnosis of AECOPD as primary cause for admission. Able to enter study within 24 hours of admission.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: intensive care unit admission; moribund or not for active treatment; admission expected to last \<48 hours.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2008-05 with completion listed for 2009-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate (time frame: During trial).

It also tracked 7 secondary outcomes, for example The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia), The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia), Mean 24 hour capillary glucose concentrations, Proportion of capillary glucose measurements in target range (4.4-6.5mM), Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system and Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Insulin (regular human) in 20 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.