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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Hypoglycemia

Treatments: Device: real time continuous glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01942239

RT-CGMS

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

CGM-group

Active Comparator group

Description:

CGM-group: the intervention(s) to be administered is Continuous glucose monitoring with real time glycemia each 5 minutes

Treatment:

Device: real time continuous glucose monitoring

IGM-group

No Intervention group

Description:

IGM-group: the intervention(s) to be administered is intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia