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CompletedNCT01942239Updated Dec 23, 2025

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

An interventional study of real time continuous glucose monitoring in Hypoglycemia, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 1 Hour to 24 Hours. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
1 Hour to 24 Hours
Sex
All
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Study 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.

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Conditions studied

  • Hypoglycemia

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Keywords

  • hypoglycemia
  • very low birth weight neonate
  • continuous glucose monitoring
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 48 is above the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • 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

Interventions

  • Devicereal time continuous glucose monitoring
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What researchers measure

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.

    Time frame: at the end of the first 3 days of life

Secondary outcomes

  1. 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.

    Time frame: after their 3 first days of life

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Study locations

1 site
  • UH Tours Clocheville hospital
    Tours, 37000, France
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References and documents

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. PubMed 25590334 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01942239
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Sep 13, 2013
Start date
Dec 2008
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Dec 23, 2025

Study contacts

Aude Chemin, MD
principal investigator · UH Tours

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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