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

NCT01942239 | Completed

• 1 other identifier: RT-CGMS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Keywords

hypoglycemia; very low birth weight neonate; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• number of hypoglycemia episodes

  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.

  at the end of the first 3 days of life

Secondary Outcomes (1)

• duration of hypoglycemic episodes

  after their 3 first days of life

Study Arms (2)

CGM-group

ACTIVE COMPARATOR

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

Device: real time continuous glucose monitoring

IGM-group

NO INTERVENTION

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

Interventions

real time continuous glucose monitoring DEVICE

CGM-group

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

UH Tours Clocheville hospital

Tours, 37000, France

Location

Related Publications (1)

• Uettwiller F, Chemin A, Bonnemaison E, Favrais G, Saliba E, Labarthe F. Real-time continuous glucose monitoring reduces the duration of hypoglycemia episodes: a randomized trial in very low birth weight neonates. PLoS One. 2015 Jan 15;10(1):e0116255. doi: 10.1371/journal.pone.0116255. eCollection 2015.

  PMID: 25590334 RESULT

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aude Chemin, MD

  UH Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)