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Home > "A" Clinical Trials Conditions > Assessing Continuous Glucose Monitors in Healthy Children  Assessing Continuous Glucose Monitors in Healthy Children
Assessing Continuous Glucose Monitors in Healthy Children
For Condition: Diabetes Mellitus
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 7 Years/17 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
WilliamTamborlane, Study Chair, Yale University
Jaeb Center for Health Research
Tampa, Florida, 33647
United States
Nemours Children’s Clinic
Jacksonville, Florida, 32207
United States
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519
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
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: HD041890-02; HD041908-01,HD041918-01,HD041906-01,HD041919-01,HD041915
Study Start Date: August 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069602
Other Diabetes Mellitus Studies:
1. Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes.
2. Effect of AC2993 with or without Immunosuppression on Beta Cell Function in Patients with Type I Diabetes
3. Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients
4. Proactive Diabetes Case Management
5. Vascular Effects of Endothelium-Derived Versus Hemoglobin-Transported Nitric Oxide in Healthy Subjects
Related Studies:
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Assessing Continuous Glucose Monitors in Healthy Children
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