Trial Outcomes & Findings for Continuous Glucose Sensor Profiles in Non-Diabetic Subjects (NCT NCT00717977)

Results Overview

Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

74 participants

Primary outcome timeframe

48-72 hours

Results posted on

2016-10-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	74
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Age, Customized 8-<15 years	20 Participants n=5 Participants
Age, Customized 15-<25 years	17 Participants n=5 Participants
Age, Customized 25-<45 years	20 Participants n=5 Participants
Age, Customized >=45 years	17 Participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, Caucasian	55 Participant n=5 Participants
Race/Ethnicity, Customized Hispanic	13 Participant n=5 Participants
Race/Ethnicity, Customized African American	1 Participant n=5 Participants
Race/Ethnicity, Customized Other Race/Ethnicities	5 Participant n=5 Participants
2-hour post-oral glucose tolerance test (OGTT)	96 mg/dL STANDARD_DEVIATION 22 • n=5 Participants
Fasting Glucose	86 mg/dL STANDARD_DEVIATION 8 • n=5 Participants
Hemoglobin A1c All	5.3 Percent STANDARD_DEVIATION 0.3 • n=5 Participants
Hemoglobin A1c 8-<15 years	5.3 Percent STANDARD_DEVIATION 0.2 • n=5 Participants
Hemoglobin A1c 15-<25 years	5.2 Percent STANDARD_DEVIATION 0.2 • n=5 Participants
Hemoglobin A1c 25-<45 years	5.2 Percent STANDARD_DEVIATION 0.3 • n=5 Participants
Hemoglobin A1c >=45 years	5.5 Percent STANDARD_DEVIATION 0.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Overall Mean Sensor Glucose by Age Group All	98 mg/dL Standard Deviation 10
Overall Mean Sensor Glucose by Age Group 8-<15 years	103 mg/dL Standard Deviation 11
Overall Mean Sensor Glucose by Age Group 15-<25 years	97 mg/dL Standard Deviation 7
Overall Mean Sensor Glucose by Age Group 25-<45 years	96 mg/dL Standard Deviation 12
Overall Mean Sensor Glucose by Age Group >=45 years	95 mg/dL Standard Deviation 7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group All	99 mg/dL Standard Deviation 10
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group 8-<15 years	103 mg/dL Standard Deviation 10
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group 15-<25 years	98 mg/dL Standard Deviation 7
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group 25-<45 years	97 mg/dL Standard Deviation 12
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group >=45 years	97 mg/dL Standard Deviation 6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group All	95 mg/dL Standard Deviation 13
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group 8-<15 years	101 mg/dL Standard Deviation 15
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group 15-<25 years	97 mg/dL Standard Deviation 11
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group 25-<45 years	91 mg/dL Standard Deviation 12
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group >=45 years	89 mg/dL Standard Deviation 11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Peak Daytime Sensor Glucose Value by Age Group All	131 mg/dL Interval 121.0 to 140.0
Peak Daytime Sensor Glucose Value by Age Group 8-<15 years	134 mg/dL Interval 128.0 to 145.0
Peak Daytime Sensor Glucose Value by Age Group 15-<25 years	135 mg/dL Interval 119.0 to 144.0
Peak Daytime Sensor Glucose Value by Age Group 25-<45 years	125 mg/dL Interval 118.0 to 134.0
Peak Daytime Sensor Glucose Value by Age Group >=45 years	128 mg/dL Interval 122.0 to 134.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Peak Nightime Sensor Glucose Value by Age Group All	109 mg/dL Interval 99.0 to 118.0
Peak Nightime Sensor Glucose Value by Age Group 8-<15 years	111 mg/dL Interval 108.0 to 120.0
Peak Nightime Sensor Glucose Value by Age Group 15-<25 years	111 mg/dL Interval 106.0 to 118.0
Peak Nightime Sensor Glucose Value by Age Group 25-<45 years	104 mg/dL Interval 95.0 to 111.0
Peak Nightime Sensor Glucose Value by Age Group >=45 years	103 mg/dL Interval 97.0 to 113.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Daytime Nadir Sensor Glucose Value by Age Group All	73 mg/dL Interval 68.0 to 82.0
Daytime Nadir Sensor Glucose Value by Age Group 8-<15 Years	74 mg/dL Interval 68.0 to 86.0
Daytime Nadir Sensor Glucose Value by Age Group 15-<25 Years	71 mg/dL Interval 67.0 to 77.0
Daytime Nadir Sensor Glucose Value by Age Group 25-<45 Years	75 mg/dL Interval 67.0 to 82.0
Daytime Nadir Sensor Glucose Value by Age Group >=45 Years	79 mg/dL Interval 68.0 to 84.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Nighttime Nadir Sensor Glucose Value by Age Group All	80 mg/dL Interval 73.0 to 89.0
Nighttime Nadir Sensor Glucose Value by Age Group 5-<15 Years	84 mg/dL Interval 78.0 to 91.0
Nighttime Nadir Sensor Glucose Value by Age Group 15-<25 Years	80 mg/dL Interval 76.0 to 93.0
Nighttime Nadir Sensor Glucose Value by Age Group 25-<45 Years	77 mg/dL Interval 67.0 to 88.0
Nighttime Nadir Sensor Glucose Value by Age Group >=45 Years	78 mg/dL Interval 78.0 to 86.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group All	91.0 Percent Interval 79.0 to 94.0
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group 8-<15 Years	85.1 Percent Interval 79.0 to 92.0
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group 15-<25 Years	87.9 Percent Interval 76.0 to 96.0
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group 25-<45 Years	91.4 Percent Interval 78.0 to 94.0
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group >=45 Years	93.7 Percent Interval 88.0 to 95.0

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day Daytime (6am-midnight)	90.4 Percent Interval 80.0 to 95.0
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day Nightime (midnight-6am)	90.3 Percent Interval 76.0 to 98.0

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group All	1.7 Percent Interval 0.0 to 7.2
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group 8-<15 Years	1.8 Percent Interval 0.0 to 4.3
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group 15-<25 Years	0.6 Percent Interval 0.0 to 8.1
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group 25-<45 Years	2.9 Percent Interval 0.0 to 8.1
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group >=45 Years	1.6 Percent Interval 0.0 to 6.3

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day Daytime (6am-midnight)	1.1 Percent Interval 0.0 to 5.1
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day Nighttime (midnight-6am)	2.2 Percent Interval 0.0 to 12.0

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group All	0.2 Percent Interval 0.0 to 1.7
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group 8-<15 Years	0.2 Percent Interval 0.0 to 1.8
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group 15-<25 Years	0.0 Percent Interval 0.0 to 3.1
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group 25-<45 Years	0.2 Percent Interval 0.0 to 1.3
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group >=45 Years	0.1 Percent Interval 0.0 to 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day Daytime (6am-midnight)	0.0 Percent Interval 0.0 to 1.2
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day Nighttime (midnight-6am)	0.0 Percent Interval 0.0 to 1.3

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group All	5.6 Percent Interval 2.2 to 9.3
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group 8-<15 Years	8.2 Percent Interval 5.6 to 16.0
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group 15-<25 Years	8.3 Percent Interval 3.1 to 13.0
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group 25-<45 Years	4.2 Percent Interval 1.8 to 7.1
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group >=45 Years	4.4 Percent Interval 1.2 to 5.8

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day Daytime (6am-midnight)	5.9 Percent Interval 2.4 to 11.0
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day Nighttime (midnight-6am)	1.1 Percent Interval 0.0 to 11.0

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group All	0.4 Percent Interval 0.0 to 1.7
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group 5-<15 Years	1.3 Percent Interval 0.3 to 3.7
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group 15-<25 Years	0.3 Percent Interval 0.0 to 1.5
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group 25-<45 Years	0.3 Percent Interval 0.0 to 1.9
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group >=45 Years	0.0 Percent Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day Daytime (6am-midnight)	0.5 Percent Interval 0.0 to 2.3
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day Nighttime (midnight-6am)	0.0 Percent Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Standard Deviation by Age Group All	13.7 mg/dL Interval 11.4 to 18.0
Glucose Variability Measure- Standard Deviation by Age Group 8-<15 Years	16.4 mg/dL Interval 13.2 to 19.1
Glucose Variability Measure- Standard Deviation by Age Group 15-<25 Years	13.7 mg/dL Interval 11.1 to 19.9
Glucose Variability Measure- Standard Deviation by Age Group 25-<45 Years	12.6 mg/dL Interval 12.1 to 16.5
Glucose Variability Measure- Standard Deviation by Age Group >=45 Years	12.4 mg/dL Interval 10.0 to 15.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Standard Deviation by Time of Day Daytime (6am-midnight)	13.5 mg/dL Interval 11.3 to 17.8
Glucose Variability Measure- Standard Deviation by Time of Day Nighttime (midnight-6am)	10.9 mg/dL Interval 8.2 to 16.8

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Absolute Rate of Change by Age Group All	0.34 mg/dL/min Interval 0.3 to 0.41
Glucose Variability Measure- Absolute Rate of Change by Age Group 8-<15 Years	0.36 mg/dL/min Interval 0.36 to 0.46
Glucose Variability Measure- Absolute Rate of Change by Age Group 15-<25 Years	0.34 mg/dL/min Interval 0.3 to 0.39
Glucose Variability Measure- Absolute Rate of Change by Age Group 25-<45 Years	0.32 mg/dL/min Interval 0.28 to 0.37
Glucose Variability Measure- Absolute Rate of Change by Age Group >=45 Years	0.33 mg/dL/min Interval 0.24 to 0.41

PRIMARY outcome

Timeframe: 48-72 hours

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Absolute Rate of Change by Time of Day Daytime (6am-midnight)	0.37 mg/dL/min Interval 0.32 to 0.43
Glucose Variability Measure- Absolute Rate of Change by Time of Day Nighttime (midnight-6am)	0.26 mg/dL/min Interval 0.18 to 0.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Coefficient of Variation by Age Group All	14 Percent Interval 12.0 to 19.0
Glucose Variability Measure- Coefficient of Variation by Age Group 8-<15 Years	16 Percent Interval 13.0 to 19.0
Glucose Variability Measure- Coefficient of Variation by Age Group 15-<25 Years	14 Percent Interval 12.0 to 21.0
Glucose Variability Measure- Coefficient of Variation by Age Group 25-<45 Years	14 Percent Interval 13.0 to 17.0
Glucose Variability Measure- Coefficient of Variation by Age Group >=45 Years	13 Percent Interval 10.0 to 16.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure- Coefficient of Variation by Time of Day Daytime (6am-midnight)	14 Percent Interval 12.0 to 18.0
Glucose Variability Measure- Coefficient of Variation by Time of Day Nighttime (midnight-6am)	12 Percent Interval 9.0 to 19.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group All	27.7 mg/dL Interval 23.1 to 33.1
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group 8-<15 Years	28.1 mg/dL Interval 23.9 to 33.2
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group 15-<25 Years	28.3 mg/dL Interval 25.1 to 33.1
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group 25-<45 Years	25.6 mg/dL Interval 22.8 to 31.4
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group >=45 Years	26.9 mg/dL Interval 21.4 to 34.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Non-Diabetic Subjects n=74 Participants 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.
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day Daytime (6am-midnight)	28.0 mg/dL Interval 23.8 to 31.9
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day Nighttime (midnight-6am)	15.8 mg/dL Interval 12.3 to 20.3

Adverse Events

All Non-Diabetic Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roy W. Beck, M.D., Ph.D.

Jaeb Center for Health Research

Phone: 813-975-8690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60