Trial Outcomes & Findings for Dexcom G6 Observational Study (NCT NCT03832907)

NCT ID: NCT03832907

Last Updated: 2021-08-05

Results Overview

Mean daily blood glucose will be calculated

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: During hospital stay (3 days - up to 30 days)
• Results posted on: 2021-08-05

Participant Flow

Participant milestones

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
Overall Study STARTED	101
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexcom G6 Observational Study

Baseline characteristics by cohort

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=101 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	85 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants

PRIMARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Mean daily blood glucose will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading POC	175.55 mg/dL Standard Deviation 42.37
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading CGM	175.84 mg/dL Standard Deviation 42.35

PRIMARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading POC	9 number of events
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading CGM	60 number of events

PRIMARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of severe hyperglycemia (>240 mg/dl) events will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading POC	305 number of events
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading CGM	518 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Mean daily blood glucose will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading POC	175.55 mg/dL Standard Deviation 42.37
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading CGM	173.13 mg/dL Standard Deviation 41.77

SECONDARY outcome

Timeframe: 10 days post discharge

Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading POC	9 number of events
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading CGM (arm)	29 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of severe hyperglycemia (>240 mg/dl) events will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading POC	305 number of events
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading CGM	399 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of nocturnal hypoglycemic events < 70 mg/dl (between 22:00 and 06:00) will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading POC	1 number of events
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM abdomen	48 number of events
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM arm	34 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of nocturnal hypoglycemic events < 70 mg/dl(between 22:00 and 06:00) will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading POC	1 number of events
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM abdomen	22 number of events
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM arm	9 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of of hypoglycemic events < 70mg/dl will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading POC	36 number of events
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading CGM abdomen	144 number of events
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading CGM arm	115 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of of hypoglycemic events < 70mg/dl will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading POC	10 number of events
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading CGM abdomen	100 number of events
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading CGM arm	48 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading CGM abdomen)	119.08 min Standard Deviation 216.56
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading CGM arm	78.63 min Standard Deviation 135.33

SECONDARY outcome

Timeframe: 10 days post discharge

Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading CGM abdomen	118.70 min Standard Deviation 217.83
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading CGM arm	89.14 min Standard Deviation 140.16

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading CGM abdomen	972.30 min Standard Deviation 1214.5
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading CGM arm	723.23 min Standard Deviation 1061.4

SECONDARY outcome

Timeframe: 10 days post discharge

Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading CGM abdomen	4624.3 min Standard Deviation 13554
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading CGM arm	1706.1 min Standard Deviation 2255.6

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of hyperglycemic events > 240 mg/dl will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading POC	305 number of events
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading CGM abdomen	518 number of events
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading CGM arm	399 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of hyperglycemic events > 240 mg/dl will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading POC	153 number of events
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading CGM abdomen	554 number of events
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading CGM arm	316 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading POC	59.70 percentage of readings Standard Deviation 24.73
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading CGM (abdomen)	58.91 percentage of readings Standard Deviation 26.83
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading CGM arm	60.97 percentage of readings Standard Deviation 28.56

SECONDARY outcome

Timeframe: 10 days post discharge

Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading POC	59.56 percentage of readings Standard Deviation 29.31
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading CGM abdomen	52.62 percentage of readings Standard Deviation 30.64
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading CGM arm	51.60 percentage of readings Standard Deviation 31.94

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of patients with greater than 5%-time below glucose target <70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading CGM <70 abdomen	10 percentage of readings
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading CGM <70 arm	4.6 percentage of readings

SECONDARY outcome

Timeframe: 10 days post discharge

Percentage of patients with greater than 5%-time below glucose target <70 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading CGM abdomen	5.3 percentage of patients
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading CGM arm	2.9 percentage of patients

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of patients with greater than 5%-time above glucose target >180 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading CGM abdomen	91 percentage of patients
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading CGM arm	89 percentage of patients

SECONDARY outcome

Timeframe: 10 days post discharge

Percentage of patients with greater than 5%-time above glucose target >180 will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading CGM abdomen	89 percentage of patients
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading CGM arm	94 percentage of patients

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Glycemic variability will be calculated using Standard Deviation

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Glycemic Variability Calculated by Standard Deviation by CGM Reading CGM abdomen	46.37 mg/dl Standard Deviation 15.45
Glycemic Variability Calculated by Standard Deviation by CGM Reading CGM arm	43.37 mg/dl Standard Deviation 15.31

SECONDARY outcome

Timeframe: 10 days post discharge

MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Glycemic Variability Calculated by MAGE by CGM Reading CGM abdomen	58.33 mg/dl Standard Deviation 24.43
Glycemic Variability Calculated by MAGE by CGM Reading CGM arm	55 mg/dl Standard Deviation 23.76

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of sensor removal/failures/dislodgments will be recorded

Outcome measures

Measure

Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.

Number of Sensor Removal/Failures/Dislodgments

31 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Mean Absolute Relative Difference (MARD) of CGM Compared to POC CGM abdomen	12.54 percent difference Standard Deviation 15.24
Mean Absolute Relative Difference (MARD) of CGM Compared to POC CGM arm	12.22 percent difference Standard Deviation 15.11

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) meeting %30/30 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG CGM abdomen	89.3 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG CGM arm	85.2 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen A	82.4 percentage of values
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen B	16.5 percentage of values
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen C	0.1 percentage of values
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen D	1 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days) measured in arm

Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm A	81.4 percentage of values
Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm B	17.6 percentage of values
Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm C	0.1 percentage of values
Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm D	0.9 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of nocturnal hypoglycemic events < 54 mg/dl (between 22:00 and 06:00) will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading POC	1 number of events
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM abdomen	12 number of events
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM arm	4 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of nocturnal hypoglycemic events < 54 mg/dl(between 22:00 and 06:00) will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading POC	0 number of events
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM abdomen	8 number of events
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading CGM arm	3 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Number of of hypoglycemic events < 54 will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading POC	9 number of events
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading CGM abdomen	60 number of events
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading CGM arm	29 number of events

SECONDARY outcome

Timeframe: 10 days post discharge

Number of of hypoglycemic events < 54mg/dl will be recorded

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading POC	3 number of events
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading CGM abdomen	48 number of events
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading CGM arm	16 number of events

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of patients with greater than 5%-time below glucose target <54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading CGM <70 abdomen	3.4 percentage of patients
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading CGM <70 arm	0 percentage of patients

SECONDARY outcome

Timeframe: 10 days post discharge

Percentage of patients with greater than 5%-time above glucose target >240 will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading CGM abdomen	56 percentage of patients
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading CGM arm	60 percentage of patients

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of patients with greater than 5%-time above glucose target >240 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading CGM abdomen	53 percentage of patients
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading CGM arm	43 percentage of patients

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

The average amplitude of glycemic excursions with values exceeding a certain threshold.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Glycemic Variability Calculated by MAGE by CGM Reading CGM abdomen	58.73 mg/dl Standard Deviation 27.87
Glycemic Variability Calculated by MAGE by CGM Reading CGM arm	56.68 mg/dl Standard Deviation 30.87

SECONDARY outcome

Timeframe: 10 days post discharge

Percentage of patients with greater than 5%-time below glucose target <54 mg/dl will be calculated

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading CGM abdomen	1.8 percentage of patients
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading CGM arm	2.9 percentage of patients

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM abdomen	93.1 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM arm	92.9 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM abdomen	93.3 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM arm	94.9 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %30/30 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM abdomen	95.5 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM arm	94 percentage of values

SECONDARY outcome

Timeframe: 10 days post discharge

Glycemic variability will be calculated using Standard Deviation

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Glycemic Variability Calculated by Standard Deviation by CGM Reading CGM abdomen	46.37 mg/dl Standard Deviation 18.17
Glycemic Variability Calculated by Standard Deviation by CGM Reading CGM arm	43.87 mg/dl Standard Deviation 20.01

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %20/20 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG CGM abdomen	78.6 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG CGM arm	74.1 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM abdomen	82.0 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM arm	82.0 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %20/20 accuracy criteria..

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM abdomen	84.7 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM arm	81.1 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM abdomen	83.2 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM arm	83.6 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %15/15 accuracy criteria..

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG CGM abdomen	75.0 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG CGM arm	66.7 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM abdomen	69.4 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG CGM arm	70.5 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM abdomen	69.6 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG CGM arm	73.8 percentage of values

SECONDARY outcome

Timeframe: During hospital stay (3 days - up to 30 days)

Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %15/15 accuracy criteria.

Outcome measures

Measure	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=91 Participants Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data. POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM abdomen	71.0 percentage of values
Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG CGM arm	71.5 percentage of values

Adverse Events

Dexcom G6 CGM - Continues Glucose Monitoring Sensor System

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Dexcom G6 CGM - Continues Glucose Monitoring Sensor System n=101 participants at risk Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Injury, poisoning and procedural complications Sensor site irritation/bleeding

4.0% 4/101 • Number of events 4 • 1 month

Additional Information

Dr. Umpierrez

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place