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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419873

Enrollment

Registered

2011-08-18

Start date

2008-08-31

Completion date

2011-06-30

Last updated

2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycaemia

Keywords

Hyperglycaemia, Very low birthweight infants, Insulin

Brief summary

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. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia. This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.

Interventions

DRUGActrapid Human Insulin

Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Birthweight \<1500g * Blood sugar \>/= 10mmol/L * Clinician decision to start an insulin infusion

Exclusion criteria

* Infants who were moribund and not expected to survive

Design outcomes

Primary

Measure	Time frame	Description
Hypoglycaemia whilst receiving insulin	Length of hospital stay in NICU which will be from birth to 5 months of age	Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026