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Continuous Glucose Monitors for Children With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00069537
Recruitment Status : Completed
First Posted : September 30, 2003
Last Update Posted : September 5, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jaeb Center for Health Research

September 29, 2003
September 30, 2003
September 5, 2016
May 2002
Not Provided
Accuracy of the GlucoWatch G2 Biographer and CGMS
Not Provided
Complete list of historical versions of study NCT00069537 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Continuous Glucose Monitors for Children With Diabetes Mellitus
DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes
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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Insulin-Dependent
  • Device: The GlucoWatch® G2™ Biographer (GW2B)
  • Device: The Continuous Glucose Monitoring System (CGMS™)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Same as current
November 2002
Not Provided

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
Sexes Eligible for Study: All
1 Year to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00069537
DirecNet 001
HD041890
HD041919-01
HD041908-01
HD041906-01
HD041918-01
HD041915
Not Provided
Not Provided
Not Provided
Jaeb Center for Health Research
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: William V. Tamborlane, MD Yale University
Jaeb Center for Health Research
September 2016

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