NCT00069602

Brief Summary

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2003

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

First QC Date

September 29, 2003

Last Update Submit

September 2, 2016

Conditions

Diabetes Mellitus

Keywords

Continuous Glucose Monitoring DevicesBlood glucose profiles in normal childrenBlood glucose profiles in non-diabetic children

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the GlucoWatch G2 Biographer and CGMS sensors

Interventions

Continuous Glucose Monitoring System (CGMS)DEVICE
GlucoWatch G2TM Biographer (GW2B)DEVICE

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Weight \>= 16.0 kg (35 lbs)
  • Body mass index between the 10th to 90th percentile for age and sex
  • HbA1c within normal limits
  • Hematocrit within normal limits

You may not qualify if:

  • History of diabetes
  • History of positive islet cell antibody testing
  • Family history of Type 1 or Type 2 diabetes in a sibling or parent
  • Medication use of any type in the 7 days prior to study entry
  • Skin abnormalities contraindicating device use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305-5208, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Denver, Colorado, 80262, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

Related Publications (8)

  • Mauras N, Beck R, Ruedy K, Booth A, Weinzimer S, and the Diabetes Research in Children Network (DirecNet) Study Group. The Physiological Variations of Plasma Glucose Concentrations in Healthy, Non-Diabetic Children: Use of Continuous Glucose Sensors. Pediatr Res 2003 Apr;53(4Pt 2):1A-669A

    BACKGROUND

  • Weinzimer S, Beck R, Ruedy K, Booth A, Boland E, and the Diabetes Research in Children Network (DirecNet) Study Group. Mealtime Glycemic Excursions in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience.Pediatr Res 2003 Apr;53(4Pt2):1A-669A

    BACKGROUND

  • Tsalikian E, Beck R, Ruedy K, Booth A, Tansey M, and the Diabetes Research in Children Network (DirecNet) Study Group. Glycemic Pattern of Insulin Induced Hypoglycemia in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience. Pediatr Res 2003 Apr;53(4Pt2):1A-669A

    BACKGROUND

  • Buckingham B, Beck R, Tamborlane W, Ruedy K, Boland E, Chase P, Wysocki T, Tsalikian E, Wilson D, Mauras N, Weinzimer D, Tansey M, Fiallo-Scharer R, Booth A, Kollman C, and the Diabetes Research In Children Network (DirecNet) Study Group. Diabetes Research in Children Network (DirecNet) Accuracy Study of the Continuous Glucose Monitoring System (CGMS) and GlucoWatch® G2™ Biographer (GWB) in Children with Type 1 Diabetes-A CRC-based Study. Diabetes 2003 Jun;52 Suppl 1:A36.

    BACKGROUND

  • Wilson D, Buckingham B, Beck R, Ruedy K, Kollman C, Tsalikian E, Wysocki T, Weinzimer S, Chase P, and the Diabetes Research in Children Network (DirecNet) Study Group. A 5-center CRC-based Study of the Accuracy of the GlucoWatch®G2™ Biographer in Children and Adolescents with Type 1 Diabetes. Diabetes 2003 Jun;52 Suppl 1:A101.

    BACKGROUND

  • Boland E, Weinzimer S, Beck R, Ruedy K, Kollman C, Buckingham B, Chase P, Tansey M, Mauras N, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in Children with T1DM in the DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A90.

    BACKGROUND

  • Fiallo-Scharer R, Chase P, Beck R, Ruedy K, Booth A, Wysocki T, Boland E, Buckingham B, Tsalikian E, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the One Touch Ultra at Different Glucose Levels in Three Age Groups of Children with T1DM in the CRC-DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A562.

    BACKGROUND

  • Mauras N, Beck RW, Ruedy KJ, Kollman C, Tamborlane WV, Chase HP, Buckingham BA, Tsalikian E, Weinzimer S, Booth AD, Xing D; Diabetes Research in Children Network (DirecNet) Accuracy Study. Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: results of the Diabetes Research in Children Network (DirecNet) accuracy study. J Pediatr. 2004 Jun;144(6):770-5. doi: 10.1016/j.jpeds.2004.03.042.

    PMID: 15192625BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • William V. Tamborlane, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2003

First Posted

September 30, 2003

Study Start

August 1, 2002

Study Completion

November 1, 2002

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

US(6)