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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) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00166673 |
This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help prevent low blood sugar events. This study has three basic parts: Use of the Navigator at home for one week without being able to see the blood sugar readings; a Baseline visit or a 24-hour admission to a research unit of the hospital to find out how well the Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid to diabetes care.
Condition | Intervention | Phase |
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Diabetes Mellitus, Insulin-Dependent |
Device: FreeStyle Navigator Continuous Glucose Monitoring System |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study to Evaluate the Navigator Continuous Glucose Sensor in the Management of Type 1 Diabetes in Children |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 3 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following diseases:
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 | |
Aurora, Colorado, United States, 80010 | |
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 |
Study Chair: | William V Tamborlane, M.D. | Yale University |
Study ID Numbers: | DirecNet 006, HD041890, HD041919, HD041908, HD041906, HD041918, HD041915 |
Study First Received: | September 9, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00166673 |
Health Authority: | United States: Federal Government |
Diabetes Mellitus, Insulin-Dependent Type 1 Diabetes Continuous Glucose Monitoring Devices Electronic Data Collection |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |