Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates

Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01942239

Enrollment

Registered

2013-09-13

Start date

2008-12-31

Completion date

2009-11-30

Last updated

2025-12-23

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

Conditions

Hypoglycemia

Keywords

hypoglycemia, very low birth weight neonate, continuous glucose monitoring

Brief summary

Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.

Interventions

DEVICEreal time continuous glucose monitoring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 24 Hours

Healthy volunteers

Inclusion criteria

* Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours

Exclusion criteria

* a serious congenital abnormality, * a skin condition that contraindicated continuous glucose monitoring, * a transfer toward another hospital during the first days of life * an absence of parental agreement.

Design outcomes

Primary

Measure	Time frame	Description
number of hypoglycemia episodes	at the end of the first 3 days of life	hypoglycemia was defined as interstitial glucose level \<50 mg/dl; consecutive or \<30 min data points \<50 mg/dl were defined as a single episode of low glucose concentration.

Secondary

Measure	Time frame	Description
duration of hypoglycemic episodes	after their 3 first days of life	hypoglycemia was defined as interstitial glucose level \<50 mg/dl. Consecutive or \<30 min data points \<50 mg/dl were defined as a single episode of low glucose concentration.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026