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Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
This study is currently recruiting participants.
Verified by JDRF Artificial Pancreas Project, July 2008
Sponsored by: JDRF Artificial Pancreas Project
Information provided by: JDRF Artificial Pancreas Project
ClinicalTrials.gov Identifier: NCT00717977
  Purpose

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
Healthy Subjects Without Type 1 Diabetes
Device: Continuous glucose monitor
Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1
Drug Information available for: Dextrose
U.S. FDA Resources
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

Further study details as provided by JDRF Artificial Pancreas Project:

Primary Outcome Measures:
  • Continuous Glucose Monitor Sensor Data [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Device: Continuous glucose monitor
    Daily use of a continuous glucose monitor for 3-7 days
Detailed Description:
  1. After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
  2. Subjects will have the following tests performed:

    • Hemoglobin A1c (using the DCA2000 or equivalent device)
    • Oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels
    • Anti-GAD, anti-IA2 and anti-insulin antibodies

      • Subjects with an A1c >6.0% and/or fasting glucose levels >100 and/or 2 hour glucose levels >140 will be discontinued from the study.
  3. Subjects with normal A1c and glucose levels will be provided with an RT-CGM and HGM
  4. An RT-CGM sensor will be inserted and initiated by study personnel.
  5. Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.
  6. Subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the HGM as needed to calibrate the sensor.
  7. Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.

    • If the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.
  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 8 years
  • Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects
  • No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.

Exclusion Criteria:

  • History of diabetes or positive islet cell antibody testing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717977

Contacts
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

Locations
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            
Sponsors and Collaborators
JDRF Artificial Pancreas Project
Investigators
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
  More Information

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

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009