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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
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Hour - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

First Posted
September 10, 2013
Last Updated
September 12, 2013
Sponsor
University Hospital, Tours
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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

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

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