A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 20
- 主要终点
- Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
研究概览
简要总结
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.
详细描述
- After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
- 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.
- Subjects with normal A1c and glucose levels will be provided with an RT-CGM and home glucose meter (HGM)
- An RT-CGM sensor will be inserted and initiated by study personnel.
- Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •History of diabetes or positive islet cell antibody testing
结局指标
主要结局
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
时间窗: 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.
Nighttime Nadir Sensor Glucose Value by Age Group
时间窗: 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.
Overall Mean Sensor Glucose by Age Group
时间窗: 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.
Peak Daytime Sensor Glucose Value by Age Group
时间窗: 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.
Peak Nightime Sensor Glucose Value by Age Group
时间窗: 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.
Daytime Nadir Sensor Glucose Value by Age Group
时间窗: 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.
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group
时间窗: 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.
Glucose Variability Measure- Absolute Rate of Change by Time of Day
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group
时间窗: 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.
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group
时间窗: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day
时间窗: 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.
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day
时间窗: 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.
Glucose Variability Measure- Standard Deviation by Age Group
时间窗: 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.
Glucose Variability Measure- Standard Deviation by Time of Day
时间窗: 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.
Glucose Variability Measure- Absolute Rate of Change by Age Group
时间窗: 48-72 hours
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group
时间窗: 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.
Glucose Variability Measure- Coefficient of Variation by Age Group
时间窗: 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.
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day
时间窗: 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.
Glucose Variability Measure- Coefficient of Variation by Time of Day
时间窗: 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.
次要结局
未报告次要终点