Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

Very low birthweight neonates commonly develop high blood sugar levels.

There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.

There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Clinician decision to start an insulin infusion.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: infants who were moribund and not expected to survive.

How the Study Was Run

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

Being open-label, the Insulin (regular human) study did not mask who received what.

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

It started in 2008-08 with completion listed for 2011-06.

It ran at 1 site in New Zealand.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hypoglycaemia whilst receiving insulin (time frame: Length of hospital stay in NICU which will be from birth to 5 months of age).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) in 30 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.