Clinical trial NCT00717977: Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
Official title: A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects Without Type 1 Diabetes
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: JDRF Artificial Pancreas Project
First posted: 2008-07-18
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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 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

Primary outcomes:
measure: Overall Mean Sensor Glucose by Age Group
timeFrame: 48-72 hours
measure: Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group
timeFrame: 48-72 hours
measure: Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
timeFrame: 48-72 hours
measure: Peak Daytime Sensor Glucose Value by Age Group
timeFrame: 48-72 hours
measure: Peak Nightime Sensor Glucose Value by Age Group
timeFrame: 48-72 hours
measure: Daytime Nadir Sensor Glucose Value by Age Group
timeFrame: 48-72 hours
measure: Nighttime Nadir Sensor Glucose Value by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day
timeFrame: 48-72 hours
measure: Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels >120 mg/dL by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels >140 mg/dL by Age Group
timeFrame: 48-72 hours
measure: Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Standard Deviation by Age Group
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Standard Deviation by Time of Day
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Absolute Rate of Change by Age Group
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Absolute Rate of Change by Time of Day
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Coefficient of Variation by Age Group
timeFrame: 48-72 hours
measure: Glucose Variability Measure- Coefficient of Variation by Time of Day
timeFrame: 48-72 hours
measure: Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group
timeFrame: 48-72 hours
measure: Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Iowa City
country: United States
facility: Children's Hospital of Iowa
state: Iowa
city: Boston
country: United States
facility: Joslin Diabetes Center - Adults
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center - Children
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Jaeb Center for Health Research
name: Roy W Beck, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Joslin Diabetes Center Pediatric Section
name: Lori Laffel, M.D.
role: STUDY_CHAIR
affiliation: Yale University
name: William Tamborlane, M.D.
role: STUDY_CHAIR
References:
citation: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.