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

NCT ID: NCT01942239

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Hypoglycemia

Keywords

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hypoglycemia very low birth weight neonate continuous glucose monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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CGM-group

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

Group Type ACTIVE_COMPARATOR

real time continuous glucose monitoring

Intervention Type DEVICE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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real time continuous glucose monitoring

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aude Chemin, MD

Role: PRINCIPAL_INVESTIGATOR

UH Tours

Locations

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UH Tours Clocheville hospital

Tours, , France

Site Status

Countries

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France

Other Identifiers

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RT-CGMS

Identifier Type: -

Identifier Source: org_study_id