Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- number of hypoglycemia episodes
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Hour to 24 Hours (Child)
- Sex
- 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
- •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.
Arms & Interventions
CGM-group
CGM-group: the intervention(s) to be administered is Continuous glucose monitoring with real time glycemia each 5 minutes
Intervention: real time continuous glucose monitoring (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
Outcomes
Primary Outcomes
number of hypoglycemia episodes
Time Frame: at the end of the first 3 days of life
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.
Secondary Outcomes
- duration of hypoglycemic episodes(after their 3 first days of life)