Assessing Continuous Glucose Monitors in Healthy Children - Tabular View

Tracking Information

First Received Date ^ICMJE

September 29, 2003

Last Updated Date

November 29, 2005

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Accuracy of the GlucoWatch G2 Biographer and CGMS sensors

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069602 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessing Continuous Glucose Monitors in Healthy Children

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Device: Continuous Glucose Monitoring System (CGMS)
Device: GlucoWatch G2TM Biographer (GW2B)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069602

Responsible Party

Study ID Numbers ^ICMJE

DirecNet 002, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

William V. Tamborlane, MD

Yale University

Information Provided By

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

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP