Full Text View
Tabular View
No Study Results Posted
Related Studies
Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
This study is ongoing, but not recruiting participants.
First Received: July 16, 2008   Last Updated: January 16, 2009   History of Changes
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

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

Resource links provided by NLM:


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
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

Locations
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
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

No publications provided

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

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

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009