Continuous Glucose Monitors for Children With Diabetes Mellitus - Tabular View

Tracking Information

First Received Date ^ICMJE

September 29, 2003

Last Updated Date

September 21, 2005

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Accuracy of the GlucoWatch G2 Biographer and CGMS

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Continuous Glucose Monitors for Children With Diabetes Mellitus

Official Title ^ICMJE

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

Brief Summary

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).

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 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, Insulin-Dependent

Intervention ^ICMJE

Device: The GlucoWatch® G2™ Biographer (GW2B)
Device: The Continuous Glucose Monitoring System (CGMS™)

Study Arms / Comparison Groups

Publications *

* 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

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

Gender

Both

Ages

1 Year to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069537

Responsible Party

Study ID Numbers ^ICMJE

DirecNet 001, 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

September 2005

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