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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Hypoglycemia

Treatments

Device: real time continuous glucose monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT01942239
RT-CGMS

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

1 to 24 hours old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

CGM-group
Active Comparator group
Description:
CGM-group: the intervention(s) to be administered is Continuous glucose monitoring with real time glycemia each 5 minutes
Treatment:
Device: real time continuous glucose monitoring
IGM-group
No Intervention group
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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