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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942239
• Other study ID #: RT-CGMS
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: September 12, 2013
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2008
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Birth Weight
• Hypoglycemia

Intervention

Device:
• real time continuous glucose monitoring

Locations

Country	Name	City	State
France	UH Tours Clocheville hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No