Assessing Continuous Glucose Monitors in Healthy Children - Full Text View

Assessing Continuous Glucose Monitors in Healthy Children

This study has been completed.

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00069602

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Device: Continuous Glucose Monitoring System (CGMS) Device: GlucoWatch G2TM Biographer (GW2B)	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Accuracy of the GlucoWatch G2 Biographer and CGMS sensors

Estimated Enrollment:	20
Study Start Date:	August 2002
Estimated Study Completion Date:	November 2002

Detailed Description:

The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069602

Locations


United States, California
	Division of Pediatric Endocrinology and Diabetes, Stanford University
	Stanford, California, United States, 94305-5208

United States, Colorado
	Barbara Davis Center for Childhood Diabetes, University of Colorado
	Denver, Colorado, United States, 80262

United States, Connecticut
	Department of Pediatrics, Yale University School of Medicine
	New Haven, Connecticut, United States, 06519

United States, Florida
	Jaeb Center for Health Research
	Tampa, Florida, United States, 33647
	Nemours Children’s Clinic
	Jacksonville, Florida, United States, 32207

United States, Iowa
	Department of Pediatrics, University of Iowa Carver College of Medicine
	Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Investigators


Study Chair:	William V. Tamborlane, MD	Yale University

More Information

Publications:

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.

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.

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.

Study ID Numbers:	DirecNet 002, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
First Received:	September 29, 2003
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00069602
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Continuous Glucose Monitoring Devices

Blood glucose profiles in normal children

Blood glucose profiles in non-diabetic children

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Healthy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 31, 2008