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

Not Applicable

Completed

• Conditions: Hypoglycemia
• Interventions: Device: real time continuous glucose monitoring

• Registration Number: NCT01942239
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-12
• Study Start: 2008-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UH Tours Clocheville hospital; 🇫🇷 Tours, France