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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 |
Estimated 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:
Contact: Katrina J Ruedy, M.S.P.H | 813-975-8690 | kruedy@jaeb.org |
Contact: Judy R Jackson, B.S. | 813-975-8690 | jjackson@jaeb.org |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Jennifer Block, RN, CDE 650-736-8948 jblock@stanford.edu | |
Contact: Kari Benassi, RN, NP 650-736-8948 karis@stanford.edu | |
Principal Investigator: Bruce Buckingham, MD | |
Sub-Investigator: Darrell Wilson, MD | |
Kaiser Permanente | Recruiting |
San Diego, California, United States, 92111 | |
Contact: Michelle Maeva, RN 858-573-5440 Michelle.L.Maeva@kp.org | |
Contact: Bonnie Sattler, MS, RD 858-573-5440 Bonnie.J.Sattler@kp.org | |
Principal Investigator: Robert Clemons, MD | |
Sub-Investigator: Jean Lawrence, ScD, MPH, MSSA | |
United States, Colorado | |
University of Colorado | Not yet recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Laurel Messer, RN 303-724-6742 Laurel.Messer@UCHSC.edu | |
Contact: Victoria Gage, RN 303-724-6766 Victoria.Gage@UCHSC.edu | |
Principal Investigator: H. Peter Chase, MD | |
Sub-Investigator: Rosanna Fiallo-Scharer, MD | |
Sub-Investigator: R. Paul Wadwa, MD | |
United States, Connecticut | |
Yale University School of Medicine | Not yet recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Brett Ives, ARNP 203-764-6650 brett.ives@yale.edu | |
Contact: Joan Bosson-Heenan 203-764-8451 joan.heenan@yale.edu | |
Principal Investigator: Stuart Weinzimer, MD | |
Sub-Investigator: William Tamborlane, MD | |
United States, Florida | |
Nemours Children's Clinic | Not yet recruiting |
Jacksonville, Florida, United States, 32207 | |
Contact: Kimberly Englert, RN 904-858-3056 kenglert@nemours.org | |
Contact: Joe Permuy, RN, MSN 904-858-3122 jpermuy@nemours.org | |
Principal Investigator: Tim Wysocki, PhD | |
Principal Investigator: Larry Fox, MD | |
Sub-Investigator: Nelly Mauras, MD | |
Sub-Investigator: J. Atilio Canas, MD | |
Sub-Investigator: Priscilla Gagliardi, MD | |
Sub-Investigator: Robert Olney, MD | |
United States, Georgia | |
Atlanta Diabetes Associates | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Contact: Kelli O'Neil, CDE 404-419-9858 koneil@atlantadiabetes.com | |
Principal Investigator: Bruce Bode, MD | |
Sub-Investigator: Paul Davidson, MD | |
United States, Iowa | |
Children's Hospital of Iowa | Not yet recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Julie Coffey, MSN, ARNP 319-353-6070 julie-coffey@uiowa.edu | |
Contact: Joanne Cabbage 319-353-6070 joanne-cabbage@uiowa.edu | |
Principal Investigator: Eva Tsalikian, MD | |
Sub-Investigator: Michael Tansey, MD | |
United States, Massachusetts | |
Joslin Diabetes Center - Children | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Kerry Milaszewski, RN, CDE 617-732-2603 Kerry.Milaszewski@joslin.harvard.edu | |
Contact: Katherine Pratt 617-732-2603 Katherine.Pratt@joslin.harvard.edu | |
Principal Investigator: Lori Laffel, MD | |
Sub-Investigator: Jamie Redgrave, MD | |
Sub-Investigator: Korey Hood, PhD | |
Joslin Diabetes Center - Adults | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Astrid Atakov-Castillo 617-732-2699 astrid.atakov-castillo@hoslin.harvard.edu | |
Contact: Stacey O'Donnell, RN, CDE 617-732-2699 stacey.o'donnell@joslin.harvard.edu | |
Principal Investigator: Howard Wolpert, MD | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Kathleen Fitzpatrick, RN, MN, CDE 206-598-4882 kfitzpat@u.washington.edu | |
Contact: Dori Khakpour, RD 206-598-4979 dorik@u.washington.edu | |
Principal Investigator: Irl Hirsch, MD | |
Sub-Investigator: Lisa Gilliam, MD, PhD | |
Sub-Investigator: Sayed Sadrzadeh, MD |
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: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00717977 |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |