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

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia
• Intervention / Treatment: Device: real time continuous glucose monitoring

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • UH Tours Clocheville hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CGM-group; 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
No Intervention: IGM-group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of hypoglycemic 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.	after their 3 first days of life

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Aude Chemin, MD, UH Tours

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimated): September 13, 2013

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: hypoglycemia; very low birth weight neonate; continuous glucose monitoring
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: RT-CGMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No