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Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT00717977
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : October 18, 2010
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
JDRF Artificial Pancreas Project
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Without Type 1 Diabetes Device: Continuous glucose monitor Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Overall Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ]
    Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.

  2. Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ]
    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.

  3. Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group [ Time Frame: 48-72 hours ]
    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.

  4. Peak Daytime Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.

  5. Peak Nightime Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ]
    The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.

  6. Daytime Nadir Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ]
    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.

  7. Nighttime Nadir Sensor Glucose Value by Age Group [ Time Frame: 48-72 hours ]
    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.

  8. Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group [ Time Frame: 48-72 hours ]
    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.

  9. Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day [ Time Frame: 48-72 hours ]
  10. Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group [ Time Frame: 48-72 hours ]
  11. Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day [ Time Frame: 48-72 hours ]
  12. Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group [ Time Frame: 48-72 hours ]
  13. Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day [ Time Frame: 48-72 hours ]

    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.


  14. Percentage of Sensor Glucose Levels >120 mg/dL by Age Group [ Time Frame: 48-72 hours ]
  15. Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day [ Time Frame: 48-72 hours ]
  16. Percentage of Sensor Glucose Levels >140 mg/dL by Age Group [ Time Frame: 48-72 hours ]
  17. Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day [ Time Frame: 48-72 hours ]

    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.


  18. Glucose Variability Measure- Standard Deviation by Age Group [ Time Frame: 48-72 hours ]
    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.

  19. Glucose Variability Measure- Standard Deviation by Time of Day [ Time Frame: 48-72 hours ]
    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.

  20. Glucose Variability Measure- Absolute Rate of Change by Age Group [ Time Frame: 48-72 hours ]
  21. Glucose Variability Measure- Absolute Rate of Change by Time of Day [ Time Frame: 48-72 hours ]
  22. Glucose Variability Measure- Coefficient of Variation by Age Group [ Time Frame: 48-72 hours ]
    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.

  23. Glucose Variability Measure- Coefficient of Variation by Time of Day [ Time Frame: 48-72 hours ]
    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.

  24. Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group [ Time Frame: 48-72 hours ]
    The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.

  25. Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day [ Time Frame: 48-72 hours ]
    The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 - Adults
Boston, Massachusetts, United States, 02215
Joslin Diabetes Center - Children
Boston, Massachusetts, United States, 02215
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Jaeb Center for Health Research
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

Publications of Results:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00717977     History of Changes
Other Study ID Numbers: 2008-2403
First Posted: July 18, 2008    Key Record Dates
Results First Posted: October 18, 2010
Last Update Posted: October 19, 2016
Last Verified: September 2016

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