Dexcom G6 Observational Study

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03832907
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system; Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring	N/A

Detailed Description

Several studies have shown that the use of a device that can measure blood glucose levels every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point of care (POC)].

This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study
• Actual Study Start Date: Feb 21, 2019
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Dexcom G6 CGM - Continues Glucose Monitoring sensor system The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration. In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital.

Device: 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.; Diagnostic Test: 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.; Other Names: Standard of Care capillary glucose test

Outcome Measures

Primary Outcome Measures

1. Mean Daily Blood Glucose by POC Reading сompared to CGM Reading [During hospital stay (3 days - up to 30 days)]

   Mean daily blood glucose will be calculated

2. Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading [During hospital stay (3 days - up to 30 days)]

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

3. Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading [During hospital stay (3 days - up to 30 days)]

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

Secondary Outcome Measures

1. Mean Daily Blood Glucose by POC Reading Compared to CGM Reading [10 days post discharge]

   Mean daily blood glucose will be calculated

2. Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading [10 days post discharge]

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

3. Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading [10 days post discharge]

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

4. Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading [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

5. Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading [10 days post discharge]

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

6. Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading [During hospital stay (3 days - up to 30 days)]

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

7. Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading [10 days post discharge]

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

8. Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading [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. .

9. Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading [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. .

10. Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading [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. .

11. Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading [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.

12. Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading [During hospital stay (3 days - up to 30 days)]

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

13. Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading [10 days post discharge]

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

14. Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading [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

15. Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading [10 days post discharge]

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

16. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading [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.

17. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading [10 days post discharge]

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

18. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading [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

19. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading [10 days post discharge]

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

20. Glycemic Variability Calculated by Standard Deviation by CGM Reading [During hospital stay (3 days - up to 30 days)]

    Glycemic variability will be calculated using Standard Deviation

21. Glycemic Variability Calculated by MAGE by CGM Reading [10 days post discharge]

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

22. Number of Sensor Removal/Failures/Dislodgments [During hospital stay (3 days - up to 30 days)]

    Number of sensor removal/failures/dislodgments will be recorded

23. Mean Absolute Relative Difference (MARD) of CGM Compared to POC [During hospital stay (3 days - up to 30 days)]

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

24. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG [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.

25. Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen [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.

26. Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm [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.

27. Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading [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

28. Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading [10 days post discharge]

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

29. Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading [During hospital stay (3 days - up to 30 days)]

    Number of of hypoglycemic events < 54 will be recorded

30. Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading [10 days post discharge]

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

31. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading [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.

32. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading [10 days post discharge]

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

33. Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading [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

34. Glycemic Variability Calculated by MAGE by CGM Reading [During hospital stay (3 days - up to 30 days)]

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

35. Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading [10 days post discharge]

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

36. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG [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.

37. Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG [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.

38. Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG [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.

39. Glycemic Variability Calculated by Standard Deviation by CGM Reading [10 days post discharge]

    Glycemic variability will be calculated using Standard Deviation

40. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG [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.

41. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG [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.

42. Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG [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..

43. Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG [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.

44. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG [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..

45. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG [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.

46. Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG [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.

47. Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years admitted to a general medicine or surgical service.

2. Known history of T1D or T2D receiving insulin therapy

3. Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

4. Patients with expected hospital length-of-stay of 3 or more days

Exclusion Criteria:

1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.

2. Patients expected to require MRI procedures during hospitalization.

3. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

4. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 9, 2019

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03832907
• Other Study ID Numbers: IRB00107627
• First Posted: Feb 6, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Guillermo Umpierrez, MD, Professor, Emory University: Glucose monitoring; POC BG; DexcomG6 CGM

Study Results

Participant Flow

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	101
COMPLETED	91
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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 Participants	101
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	75 74.3%
>=65 years	26 25.7%
Sex: Female, Male (Count of Participants)
Female	47 46.5%
Male	54 53.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	85 84.2%
White	13 12.9%
More than one race	0 0%
Unknown or Not Reported	2 2%
Region of Enrollment (participants) [Number]
United States	101 100%

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
Description	Mean daily blood glucose will be calculated
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	175.55 (42.37)
CGM	175.84 (42.35)

2. Primary Outcome

Title	Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Description	Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	9
CGM	60

3. Primary Outcome

Title	Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Description	Number of severe hyperglycemia (>240 mg/dl) events will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	305
CGM	518

4. Secondary Outcome

Title	Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
Description	Mean daily blood glucose will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	175.55 (42.37)
CGM	173.13 (41.77)

5. Secondary Outcome

Title	Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Description	Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	9
CGM (arm)	29

6. Secondary Outcome

Title	Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Description	Number of severe hyperglycemia (>240 mg/dl) events will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	305
CGM	399

7. Secondary Outcome

Title	Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Description	Number of nocturnal hypoglycemic events < 70 mg/dl (between 22:00 and 06:00) will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	1
CGM abdomen	48
CGM arm	34

8. Secondary Outcome

Title	Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Description	Number of nocturnal hypoglycemic events < 70 mg/dl(between 22:00 and 06:00) will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	1
CGM abdomen	22
CGM arm	9

9. Secondary Outcome

Title	Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading
Description	Number of of hypoglycemic events < 70mg/dl will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	36
CGM abdomen	144
CGM arm	115

10. Secondary Outcome

Title	Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
Description	Number of of hypoglycemic events < 70mg/dl will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	10
CGM abdomen	100
CGM arm	48

11. Secondary Outcome

Title	Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
Description	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. .
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen)	119.08 (216.56)
CGM arm	78.63 (135.33)

12. Secondary Outcome

Title	Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
Description	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. .
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	118.70 (217.83)
CGM arm	89.14 (140.16)

13. Secondary Outcome

Title	Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
Description	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. .
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	972.30 (1214.5)
CGM arm	723.23 (1061.4)

14. Secondary Outcome

Title	Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
Description	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.
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	4624.3 (13554)
CGM arm	1706.1 (2255.6)

15. Secondary Outcome

Title	Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Description	Number of hyperglycemic events > 240 mg/dl will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	305
CGM abdomen	518
CGM arm	399

16. Secondary Outcome

Title	Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Description	Number of hyperglycemic events > 240 mg/dl will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	153
CGM abdomen	554
CGM arm	316

17. Secondary Outcome

Title	Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
Description	Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	59.70 (24.73)
CGM (abdomen)	58.91 (26.83)
CGM arm	60.97 (28.56)

18. Secondary Outcome

Title	Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
Description	Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	59.56 (29.31)
CGM abdomen	52.62 (30.64)
CGM arm	51.60 (31.94)

19. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading
Description	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.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM <70 abdomen	10
CGM <70 arm	4.6

20. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time below glucose target <70 mg/dl will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	5.3
CGM arm	2.9

21. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time above glucose target >180 mg/dl will be calculated
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	91
CGM arm	89

22. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time above glucose target >180 will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	89
CGM arm	94

23. Secondary Outcome

Title	Glycemic Variability Calculated by Standard Deviation by CGM Reading
Description	Glycemic variability will be calculated using Standard Deviation
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	46.37 (15.45)
CGM arm	43.37 (15.31)

24. Secondary Outcome

Title	Glycemic Variability Calculated by MAGE by CGM Reading
Description	MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	58.33 (24.43)
CGM arm	55 (23.76)

25. Secondary Outcome

Title	Number of Sensor Removal/Failures/Dislodgments
Description	Number of sensor removal/failures/dislodgments will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
Number [number of events]	31

26. Secondary Outcome

Title	Mean Absolute Relative Difference (MARD) of CGM Compared to POC
Description	Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	12.54 (15.24)
CGM arm	12.22 (15.11)

27. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) meeting %30/30 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	89.3
CGM arm	85.2

28. Secondary Outcome

Title	Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen
Description	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.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
A	82.4
B	16.5
C	0.1
D	1

29. Secondary Outcome

Title	Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm
Description	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.
Time Frame	During hospital stay (3 days - up to 30 days) measured in arm

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
A	81.4
B	17.6
C	0.1
D	0.9

30. Secondary Outcome

Title	Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Description	Number of nocturnal hypoglycemic events < 54 mg/dl (between 22:00 and 06:00) will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	1
CGM abdomen	12
CGM arm	4

31. Secondary Outcome

Title	Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Description	Number of nocturnal hypoglycemic events < 54 mg/dl(between 22:00 and 06:00) will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	0
CGM abdomen	8
CGM arm	3

32. Secondary Outcome

Title	Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading
Description	Number of of hypoglycemic events < 54 will be recorded
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	9
CGM abdomen	60
CGM arm	29

33. Secondary Outcome

Title	Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading
Description	Number of of hypoglycemic events < 54mg/dl will be recorded
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
POC	3
CGM abdomen	48
CGM arm	16

34. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading
Description	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.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM <70 abdomen	3.4
CGM <70 arm	0

35. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time above glucose target >240 will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	56
CGM arm	60

36. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time above glucose target >240 mg/dl will be calculated
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	53
CGM arm	43

37. Secondary Outcome

Title	Glycemic Variability Calculated by MAGE by CGM Reading
Description	The average amplitude of glycemic excursions with values exceeding a certain threshold.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	58.73 (27.87)
CGM arm	56.68 (30.87)

38. Secondary Outcome

Title	Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading
Description	Percentage of patients with greater than 5%-time below glucose target <54 mg/dl will be calculated
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	1.8
CGM arm	2.9

39. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	93.1
CGM arm	92.9

40. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	93.3
CGM arm	94.9

41. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %30/30 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	95.5
CGM arm	94

42. Secondary Outcome

Title	Glycemic Variability Calculated by Standard Deviation by CGM Reading
Description	Glycemic variability will be calculated using Standard Deviation
Time Frame	10 days post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	46.37 (18.17)
CGM arm	43.87 (20.01)

43. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %20/20 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	78.6
CGM arm	74.1

44. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	82.0
CGM arm	82.0

45. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %20/20 accuracy criteria..
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	84.7
CGM arm	81.1

46. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	83.2
CGM arm	83.6

47. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %15/15 accuracy criteria..
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	75.0
CGM arm	66.7

48. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	69.4
CGM arm	70.5

49. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	69.6
CGM arm	73.8

50. Secondary Outcome

Title	Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
Description	Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %15/15 accuracy criteria.
Time Frame	During hospital stay (3 days - up to 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
Measure Participants	91
CGM abdomen	71.0
CGM arm	71.5

Adverse Events

Time Frame	1 month
Arm/Group Title	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
Arm/Group Description	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.
All Cause Mortality
	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
	Affected / at Risk (%)	# Events
Total	0/101 (0%)
Serious Adverse Events
	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
	Affected / at Risk (%)	# Events
Total	0/101 (0%)
Other (Not Including Serious) Adverse Events
	Dexcom G6 CGM - Continues Glucose Monitoring Sensor System
	Affected / at Risk (%)	# Events
Total	4/101 (4%)
Injury, poisoning and procedural complications
Sensor site irritation/bleeding	4/101 (4%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.