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Home > "C" Clinical Trials Conditions > Continuous Glucose Monitors for Children With Diabetes Mellitus  Continuous Glucose Monitors for Children With Diabetes Mellitus
Continuous Glucose Monitors for Children With Diabetes Mellitus
For Condition: Diabetes Mellitus, Insulin-Dependent
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Synopsis: 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).
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 1 Year/17 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
WilliamTamborlane, Study Chair, Yale University
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519
United States
Jaeb Center for Health Research
Tampa, Florida, 33647
United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, 80262
United States
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
United States
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, 94305-5208
United States
Nemours Children’s Clinic
Jacksonville, Florida, 32207
United States
Additional Information:
Study ID Numbers: HD041890-01; HD041906-01,HD041915,HD041908-01,HD041918-01,HD041919-01
Study Start Date: May 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069537
Other Diabetes Mellitus, Insulin-Dependent Studies:
1. The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
2. Safety and Efficacy of INGAP-Peptide in Patients with Type 1 Diabetes
3. Islet Cell Transplants for Diabetes
4. LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes.
5. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure
Related Studies:
Other Diabetes Mellitus, Insulin-Dependent Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
Continuous Glucose Monitors for Children With Diabetes Mellitus
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