NCT01942239

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	real time continuous glucose monitoring

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2013-09-13
• Last updated: 2025-12-23

Locations

1 site across 1 country: France