Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by:
JDRF Artificial Pancreas Project
ClinicalTrials.gov Identifier:
NCT00717977
First received: July 16, 2008
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

The Juvenile Diabetes Research Foundation (JDRF) 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 HbA1c 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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • Overall Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.

  • Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.

  • Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.

  • Peak Daytime Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.

  • Peak Nightime Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.

  • Daytime Nadir Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.

  • Nighttime Nadir Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.

  • Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.

  • Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

    The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.

    Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours.


  • Percentage of Sensor Glucose Levels >120 mg/dL by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels >140 mg/dL by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

    The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.

    Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours.


  • Glucose Variability Measure- Standard Deviation by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.

  • Glucose Variability Measure- Standard Deviation by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.

  • Glucose Variability Measure- Absolute Rate of Change by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Glucose Variability Measure- Absolute Rate of Change by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Glucose Variability Measure- Coefficient of Variation by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.

  • Glucose Variability Measure- Coefficient of Variation by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.

  • Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.

  • Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.


Enrollment: 74
Study Start Date: July 2008
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
    Other Names:
    • Abbott FreeStyle Navigator
    • DexCom SEVEN
    • Medtronic Guardian Clinical
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 HbA1c >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 home glucose meter (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
Kaiser Permanente
San Diego, California, United States, 92111
Stanford University
Stanford, California, United States, 94305
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

Publications:
Responsible Party: Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00717977     History of Changes
Other Study ID Numbers: 2008-2403
Study First Received: July 16, 2008
Results First Received: August 2, 2010
Last Updated: September 30, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014