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Sponsored by: |
JDRF Artificial Pancreas Project |
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Information provided by: | JDRF Artificial Pancreas Project |
ClinicalTrials.gov Identifier: | NCT00717977 |
The Juvenile Diabetes Research Foundation Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in A1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort.
Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.
Condition | Intervention | Phase |
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Healthy Subjects Without Type 1 Diabetes |
Device: Continuous glucose monitor |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects |
Estimated Enrollment: | 120 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Subjects will have the following tests performed:
Anti-GAD, anti-IA2 and anti-insulin antibodies
Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.
Ages Eligible for Study: | 8 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
Kaiser Permanente | |
San Diego, California, United States, 92111 | |
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 | |
United States, Georgia | |
Atlanta Diabetes Associates | |
Atlanta, Georgia, United States, 30309 | |
United States, Iowa | |
Children's Hospital of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Massachusetts | |
Joslin Diabetes Center - Children | |
Boston, Massachusetts, United States, 02215 | |
Joslin Diabetes Center - Adults | |
Boston, Massachusetts, United States, 02215 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98105 |
Study Director: | Roy W Beck, M.D., Ph.D. | Jaeb Center for Health Research |
Study Chair: | Lori Laffel, M.D. | Joslin Diabetes Center Pediatric Section |
Study Chair: | William Tamborlane, M.D. | Yale University |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D. ) |
Study ID Numbers: | 2008-2403 |
Study First Received: | July 16, 2008 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00717977 History of Changes |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Healthy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |