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Continuous Glucose Monitors for Children With Diabetes Mellitus
This study has been completed.
First Received: September 29, 2003   Last Updated: September 21, 2005   History of Changes
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: NCT00069537
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Device: The GlucoWatch® G2™ Biographer (GW2B)
Device: The Continuous Glucose Monitoring System (CGMS™)
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes

Resource links provided by NLM:


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

Estimated Enrollment: 90
Study Start Date: May 2002
Estimated Study Completion Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069537

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
Investigators
Study Chair: William V. Tamborlane, MD Yale University
  More Information

Publications:
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.
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.
Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the GlucoWatch G2 biographer in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):791-800.
Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):781-9.
The Diabetes Research In Children Network (Direcnet) Study Group. A multicenter study of the accuracy of the One Touch Ultra home glucose meter in children with type 1 diabetes. Diabetes Technol Ther. 2003;5(6):933-41.
Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the GlucoWatch G2 Biographer and the continuous glucose monitoring system during hypoglycemia: experience of the Diabetes Research in Children Network. Diabetes Care. 2004 Mar;27(3):722-6.
Tsalikian E, Kollman C, Mauras N, Weinzimer S, Buckingham B, Xing D, Beck R, Ruedy K, Tamborlane W, Fiallo-Scharer R; Diabetes Research in Children Network (DirecNet) Study Group. GlucoWatch G2 Biographer alarm reliability during hypoglycemia in children. Diabetes Technol Ther. 2004 Oct;6(5):559-66.
Tsalikian E, Beck RW, Kalajian A, Janz KF, Tansey MJ; Diabetes Research in Children Network (DirecNet) Study Group. Function of the GlucoWatch G2 Biographer during exercise. Diabetes Technol Ther. 2005 Feb;7(1):230. No abstract available.
Buckingham B, Block J, Burdick J, Kalajian A, Kollman C, Choy M, Wilson DM, Chase P; Diabetes Research in Children Network. Response to nocturnal alarms using a real-time glucose sensor. Diabetes Technol Ther. 2005 Jun;7(3):440-7.

Study ID Numbers: DirecNet 001, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
Study First Received: September 29, 2003
Last Updated: September 21, 2005
ClinicalTrials.gov Identifier: NCT00069537     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Diabetes in Children
Continuous Glucose Monitoring Devices

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009