Continuous Glucose Monitors for Children With Diabetes Mellitus

September 2, 2016 updated by: Jaeb Center for Health Research

DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes

Good control of blood glucose levels is important in preventing complications from diabetes. This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B), in children with type 1 diabetes mellitus (T1DM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. Intensive therapy has not been systematically evaluated in children less than 13 years of age. This study was conducted by the Diabetes Research in Children Network (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting.

During 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day and night. To assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.

Study Type

Interventional

Enrollment

90

Phase

  • Phase 4

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

  • United States
    • California
      • Stanford, California, United States, 94305-5208
        • Division of Pediatric Endocrinology and Diabetes, Stanford University
    • Colorado
      • Denver, Colorado, United States, 80262
        • Barbara Davis Center for Childhood Diabetes, University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Department of Pediatrics, Yale University School of Medicine
    • Florida
      • Jacksonville,, Florida, United States, 32207
        • Nemours Children's Clinic
      • Tampa, Florida, United States, 33647
        • Jaeb Center for Health Research
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Department of Pediatrics, University of Iowa Carver College of Medicine

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 year to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry
  • For children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender
  • Weight >= 12 kg (26.5 lbs) if < 7 years of age and >= 16 kg (35 lbs) if >7 years of age
  • Normal hematocrit

Exclusion Criteria

  • Current use of glucocorticoids
  • Skin or other medical disorders that would affect completion of the study
  • History of seizures other than those attributable to either hypoglycemia or high fever

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Accuracy of the GlucoWatch G2 Biographer and CGMS

Collaborators and Investigators

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

Sponsor

Jaeb Center for Health Research

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2002

Study Completion

November 1, 2002

Study Registration Dates

First Submitted

September 29, 2003

First Submitted That Met QC Criteria

September 29, 2003

First Posted (ESTIMATE)

September 30, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DirecNet 001
  • HD041890
  • HD041919-01
  • HD041908-01
  • HD041906-01
  • HD041918-01
  • HD041915

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.

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