Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
Primary Purpose
Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
real time continuous glucose monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypoglycemia focused on measuring hypoglycemia, very low birth weight neonate, continuous glucose monitoring
Eligibility Criteria
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.
Sites / Locations
- UH Tours Clocheville hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CGM-group
IGM-group
Arm Description
CGM-group: the intervention(s) to be administered is Continuous glucose monitoring with real time glycemia each 5 minutes
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 Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01942239
First Posted
September 10, 2013
Last Updated
September 12, 2013
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT01942239
Brief Title
Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
Official Title
Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
hypoglycemia, very low birth weight neonate, continuous glucose monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGM-group
Arm Type
Active Comparator
Arm Description
CGM-group: the intervention(s) to be administered is Continuous glucose monitoring with real time glycemia each 5 minutes
Arm Title
IGM-group
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
real time continuous glucose monitoring
Primary Outcome Measure Information:
Title
number of hypoglycemia episodes
Description
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.
Time Frame
at the end of the first 3 days of life
Secondary Outcome Measure Information:
Title
duration of hypoglycemic episodes
Description
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.
Time Frame
after their 3 first days of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aude Chemin, MD
Organizational Affiliation
UH Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Tours Clocheville hospital
City
Tours
ZIP/Postal Code
37000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
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