Healthy Subjects Without Type 1 Diabetes
Conditions
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.
Interventions
DEVICEContinuous glucose monitor
Daily use of a continuous glucose monitor for 3-7 days
Sponsors
JDRF Artificial Pancreas Project
Jaeb Center for Health Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mean Sensor Glucose by Age Group | 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. |
| Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | 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. |
| Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | 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. |
| Peak Daytime Sensor Glucose Value by Age Group | 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 | 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 | 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. |
| Nighttime Nadir Sensor Glucose Value by Age Group | 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. |
| Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | 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. |
| Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day | 48-72 hours | — |
| Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | 48-72 hours | — |
| Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day | 48-72 hours | — |
| Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | 48-72 hours | — |
| Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day | 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 >120 mg/dL by Age Group | 48-72 hours | — |
| Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day | 48-72 hours | — |
| Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | 48-72 hours | — |
| Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day | 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 | 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 | 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 | 48-72 hours | — |
| Glucose Variability Measure- Absolute Rate of Change by Time of Day | 48-72 hours | — |
| Glucose Variability Measure- Coefficient of Variation by Age Group | 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- Coefficient of Variation by Time of Day | 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: Mean Amplitude of Glycemic Excursions by Age Group | 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: Amplitude of Glycemic Excursions by Time of Day | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 10 adult and pediatric diabetes centers, after approval by their institutional review boards. Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an individual with type 1 diabetes.
Participants by arm
| Arm | Count |
|---|---|
| All Non-Diabetic Subjects Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes. | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | All Non-Diabetic Subjects |
|---|---|
| 2-hour post-oral glucose tolerance test (OGTT) | 96 mg/dL STANDARD_DEVIATION 22 |
| Age, Customized 15-<25 years | 17 Participants |
| Age, Customized 25-<45 years | 20 Participants |
| Age, Customized >=45 years | 17 Participants |
| Age, Customized 8-<15 years | 20 Participants |
| Fasting Glucose | 86 mg/dL STANDARD_DEVIATION 8 |
| Hemoglobin A1c 15-<25 years | 5.2 Percent STANDARD_DEVIATION 0.2 |
| Hemoglobin A1c 25-<45 years | 5.2 Percent STANDARD_DEVIATION 0.3 |
| Hemoglobin A1c >=45 years | 5.5 Percent STANDARD_DEVIATION 0.3 |
| Hemoglobin A1c 8-<15 years | 5.3 Percent STANDARD_DEVIATION 0.2 |
| Hemoglobin A1c All | 5.3 Percent STANDARD_DEVIATION 0.3 |
| Race/Ethnicity, Customized African American | 1 Participant |
| Race/Ethnicity, Customized Hispanic | 13 Participant |
| Race/Ethnicity, Customized Non-Hispanic, Caucasian | 55 Participant |
| Race/Ethnicity, Customized Other Race/Ethnicities | 5 Participant |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Non-Diabetic Subjects | Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | All | 99 mg/dL | Standard Deviation 10 |
| All Non-Diabetic Subjects | Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | 8-<15 years | 103 mg/dL | Standard Deviation 10 |
| All Non-Diabetic Subjects | Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | 15-<25 years | 98 mg/dL | Standard Deviation 7 |
| All Non-Diabetic Subjects | Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | 25-<45 years | 97 mg/dL | Standard Deviation 12 |
| All Non-Diabetic Subjects | Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group | >=45 years | 97 mg/dL | Standard Deviation 6 |
Comparison: The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.p-value: 0.04Regression, Linear
Primary
Daytime Nadir Sensor Glucose Value by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Daytime Nadir Sensor Glucose Value by Age Group | All | 73 mg/dL |
| All Non-Diabetic Subjects | Daytime Nadir Sensor Glucose Value by Age Group | 8-<15 Years | 74 mg/dL |
| All Non-Diabetic Subjects | Daytime Nadir Sensor Glucose Value by Age Group | 15-<25 Years | 71 mg/dL |
| All Non-Diabetic Subjects | Daytime Nadir Sensor Glucose Value by Age Group | 25-<45 Years | 75 mg/dL |
| All Non-Diabetic Subjects | Daytime Nadir Sensor Glucose Value by Age Group | >=45 Years | 79 mg/dL |
Primary
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | All | 1.7 Percent |
| All Non-Diabetic Subjects | Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | 8-<15 Years | 1.8 Percent |
| All Non-Diabetic Subjects | Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | 15-<25 Years | 0.6 Percent |
| All Non-Diabetic Subjects | Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | 25-<45 Years | 2.9 Percent |
| All Non-Diabetic Subjects | Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group | >=45 Years | 1.6 Percent |
Primary
Glucose Variability Measure- Absolute Rate of Change by Age Group
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Age Group | All | 0.34 mg/dL/min |
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Age Group | 8-<15 Years | 0.36 mg/dL/min |
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Age Group | 15-<25 Years | 0.34 mg/dL/min |
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Age Group | 25-<45 Years | 0.32 mg/dL/min |
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Age Group | >=45 Years | 0.33 mg/dL/min |
Primary
Glucose Variability Measure- Absolute Rate of Change by Time of Day
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Time of Day | Daytime (6am-midnight) | 0.37 mg/dL/min |
| All Non-Diabetic Subjects | Glucose Variability Measure- Absolute Rate of Change by Time of Day | Nighttime (midnight-6am) | 0.26 mg/dL/min |
Primary
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day | Daytime (6am-midnight) | 28.0 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day | Nighttime (midnight-6am) | 15.8 mg/dL |
Primary
Glucose Variability Measure- Coefficient of Variation by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Age Group | 15-<25 Years | 14 Percent |
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Age Group | 25-<45 Years | 14 Percent |
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Age Group | All | 14 Percent |
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Age Group | 8-<15 Years | 16 Percent |
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Age Group | >=45 Years | 13 Percent |
Primary
Glucose Variability Measure- Coefficient of Variation by Time of Day
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Time of Day | Daytime (6am-midnight) | 14 Percent |
| All Non-Diabetic Subjects | Glucose Variability Measure- Coefficient of Variation by Time of Day | Nighttime (midnight-6am) | 12 Percent |
Primary
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group | All | 27.7 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group | 8-<15 Years | 28.1 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group | 15-<25 Years | 28.3 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group | 25-<45 Years | 25.6 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group | >=45 Years | 26.9 mg/dL |
Primary
Glucose Variability Measure- Standard Deviation by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Age Group | >=45 Years | 12.4 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Age Group | All | 13.7 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Age Group | 8-<15 Years | 16.4 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Age Group | 15-<25 Years | 13.7 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Age Group | 25-<45 Years | 12.6 mg/dL |
Primary
Glucose Variability Measure- Standard Deviation by Time of Day
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Time of Day | Daytime (6am-midnight) | 13.5 mg/dL |
| All Non-Diabetic Subjects | Glucose Variability Measure- Standard Deviation by Time of Day | Nighttime (midnight-6am) | 10.9 mg/dL |
Primary
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Non-Diabetic Subjects | Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | All | 95 mg/dL | Standard Deviation 13 |
| All Non-Diabetic Subjects | Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | 8-<15 years | 101 mg/dL | Standard Deviation 15 |
| All Non-Diabetic Subjects | Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | 15-<25 years | 97 mg/dL | Standard Deviation 11 |
| All Non-Diabetic Subjects | Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | 25-<45 years | 91 mg/dL | Standard Deviation 12 |
| All Non-Diabetic Subjects | Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group | >=45 years | 89 mg/dL | Standard Deviation 11 |
Comparison: The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.p-value: <0.001Regression, Linear
Primary
Nighttime Nadir Sensor Glucose Value by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Nighttime Nadir Sensor Glucose Value by Age Group | All | 80 mg/dL |
| All Non-Diabetic Subjects | Nighttime Nadir Sensor Glucose Value by Age Group | 5-<15 Years | 84 mg/dL |
| All Non-Diabetic Subjects | Nighttime Nadir Sensor Glucose Value by Age Group | 15-<25 Years | 80 mg/dL |
| All Non-Diabetic Subjects | Nighttime Nadir Sensor Glucose Value by Age Group | 25-<45 Years | 77 mg/dL |
| All Non-Diabetic Subjects | Nighttime Nadir Sensor Glucose Value by Age Group | >=45 Years | 78 mg/dL |
Primary
Overall Mean Sensor Glucose by Age Group
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Non-Diabetic Subjects | Overall Mean Sensor Glucose by Age Group | All | 98 mg/dL | Standard Deviation 10 |
| All Non-Diabetic Subjects | Overall Mean Sensor Glucose by Age Group | 8-<15 years | 103 mg/dL | Standard Deviation 11 |
| All Non-Diabetic Subjects | Overall Mean Sensor Glucose by Age Group | 15-<25 years | 97 mg/dL | Standard Deviation 7 |
| All Non-Diabetic Subjects | Overall Mean Sensor Glucose by Age Group | 25-<45 years | 96 mg/dL | Standard Deviation 12 |
| All Non-Diabetic Subjects | Overall Mean Sensor Glucose by Age Group | >=45 years | 95 mg/dL | Standard Deviation 7 |
Comparison: The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.p-value: 0.009Regression, Linear
Primary
Peak Daytime Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Peak Daytime Sensor Glucose Value by Age Group | All | 131 mg/dL |
| All Non-Diabetic Subjects | Peak Daytime Sensor Glucose Value by Age Group | 8-<15 years | 134 mg/dL |
| All Non-Diabetic Subjects | Peak Daytime Sensor Glucose Value by Age Group | 15-<25 years | 135 mg/dL |
| All Non-Diabetic Subjects | Peak Daytime Sensor Glucose Value by Age Group | 25-<45 years | 125 mg/dL |
| All Non-Diabetic Subjects | Peak Daytime Sensor Glucose Value by Age Group | >=45 years | 128 mg/dL |
Primary
Peak Nightime Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Peak Nightime Sensor Glucose Value by Age Group | All | 109 mg/dL |
| All Non-Diabetic Subjects | Peak Nightime Sensor Glucose Value by Age Group | 8-<15 years | 111 mg/dL |
| All Non-Diabetic Subjects | Peak Nightime Sensor Glucose Value by Age Group | 15-<25 years | 111 mg/dL |
| All Non-Diabetic Subjects | Peak Nightime Sensor Glucose Value by Age Group | 25-<45 years | 104 mg/dL |
| All Non-Diabetic Subjects | Peak Nightime Sensor Glucose Value by Age Group | >=45 years | 103 mg/dL |
Primary
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dL by Age Group | All | 5.6 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dL by Age Group | 8-<15 Years | 8.2 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dL by Age Group | 15-<25 Years | 8.3 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dL by Age Group | 25-<45 Years | 4.2 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dL by Age Group | >=45 Years | 4.4 Percent |
Primary
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day | Daytime (6am-midnight) | 5.9 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day | Nighttime (midnight-6am) | 1.1 Percent |
Primary
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | All | 0.4 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | 5-<15 Years | 1.3 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | 15-<25 Years | 0.3 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | 25-<45 Years | 0.3 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dL by Age Group | >=45 Years | 0.0 Percent |
Primary
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day | Daytime (6am-midnight) | 0.5 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day | Nighttime (midnight-6am) | 0.0 Percent |
Primary
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | All | 0.2 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | 8-<15 Years | 0.2 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | 15-<25 Years | 0.0 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | 25-<45 Years | 0.2 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group | >=45 Years | 0.1 Percent |
Primary
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day | Daytime (6am-midnight) | 0.0 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day | Nighttime (midnight-6am) | 0.0 Percent |
Primary
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day | Daytime (6am-midnight) | 1.1 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day | Nighttime (midnight-6am) | 2.2 Percent |
Primary
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day | Daytime (6am-midnight) | 90.4 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day | Nightime (midnight-6am) | 90.3 Percent |
Primary
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group
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.
Time frame: 48-72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | All | 91.0 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | 8-<15 Years | 85.1 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | 15-<25 Years | 87.9 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | 25-<45 Years | 91.4 Percent |
| All Non-Diabetic Subjects | Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group | >=45 Years | 93.7 Percent |