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

Study Overview
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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.

Official Title
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Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates

Conditions
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Hypoglycemia

Intervention / Treatment
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* Device: real time continuous glucose monitoring


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM-group<br>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<br> <br> |
| No Intervention: IGM-group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoglycemia, very low birth weight neonate, continuous glucose monitoring