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

September 12, 2013 updated by: University Hospital, Tours

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37000
        • UH Tours Clocheville hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CGM-group
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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of the first 3 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of hypoglycemic episodes
Time Frame: after their 3 first 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.
after their 3 first days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Aude Chemin, MD, UH Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT-CGMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoglycemia

Clinical Trials on real time continuous glucose monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe