Diabetes
Conditions
Keywords
Glucose monitoring, POC BG, DexcomG6 CGM
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.
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.
Interventions
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_TESTPOC 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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. . |
| 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. . |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| Glycemic Variability Calculated by MAGE by CGM Reading | 10 days post discharge | MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold. |
| Number of Sensor Removal/Failures/Dislodgments | During hospital stay (3 days - up to 30 days) | Number of sensor removal/failures/dislodgments will be recorded |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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.. |
| 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. |
| 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.. |
| Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | 10 days post discharge | Mean daily blood glucose will be calculated |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Dexcom G6 CGM - Continues Glucose Monitoring Sensor System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 85 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 4 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
Mean daily blood glucose will be calculated
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Daily Blood Glucose by POC Reading сompared to CGM Reading | POC | 175.55 mg/dL | Standard Deviation 42.37 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Daily Blood Glucose by POC Reading сompared to CGM Reading | CGM | 175.84 mg/dL | Standard Deviation 42.35 |
Primary
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | POC | 9 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | CGM | 60 number of events |
Primary
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Number of severe hyperglycemia (\>240 mg/dl) events will be recorded
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | POC | 305 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | CGM | 518 number of events |
Secondary
Glycemic Variability Calculated by MAGE by CGM Reading
The average amplitude of glycemic excursions with values exceeding a certain threshold.
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by MAGE by CGM Reading | CGM abdomen | 58.73 mg/dl | Standard Deviation 27.87 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by MAGE by CGM Reading | CGM arm | 56.68 mg/dl | Standard Deviation 30.87 |
Secondary
Glycemic Variability Calculated by MAGE by CGM Reading
MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by MAGE by CGM Reading | CGM abdomen | 58.33 mg/dl | Standard Deviation 24.43 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by MAGE by CGM Reading | CGM arm | 55 mg/dl | Standard Deviation 23.76 |
Secondary
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Glycemic variability will be calculated using Standard Deviation
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by Standard Deviation by CGM Reading | CGM abdomen | 46.37 mg/dl | Standard Deviation 15.45 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by Standard Deviation by CGM Reading | CGM arm | 43.37 mg/dl | Standard Deviation 15.31 |
Secondary
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Glycemic variability will be calculated using Standard Deviation
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by Standard Deviation by CGM Reading | CGM abdomen | 46.37 mg/dl | Standard Deviation 18.17 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Glycemic Variability Calculated by Standard Deviation by CGM Reading | CGM arm | 43.87 mg/dl | Standard Deviation 20.01 |
Secondary
Mean Absolute Relative Difference (MARD) of CGM Compared to POC
Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Absolute Relative Difference (MARD) of CGM Compared to POC | CGM abdomen | 12.54 percent difference | Standard Deviation 15.24 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Absolute Relative Difference (MARD) of CGM Compared to POC | CGM arm | 12.22 percent difference | Standard Deviation 15.11 |
Secondary
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
Mean daily blood glucose will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | POC | 175.55 mg/dL | Standard Deviation 42.37 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | CGM | 173.13 mg/dL | Standard Deviation 41.77 |
Secondary
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | POC | 9 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading | CGM (arm) | 29 number of events |
Secondary
Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
Number of severe hyperglycemia (\>240 mg/dl) events will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | POC | 305 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading | CGM | 399 number of events |
Secondary
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Number of hyperglycemic events \> 240 mg/dl will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | POC | 153 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | CGM abdomen | 554 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | CGM arm | 316 number of events |
Secondary
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
Number of hyperglycemic events \> 240 mg/dl will be recorded
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | POC | 305 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | CGM abdomen | 518 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading | CGM arm | 399 number of events |
Secondary
Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading
Number of of hypoglycemic events \< 54mg/dl will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading | POC | 3 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading | CGM abdomen | 48 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading | CGM arm | 16 number of events |
Secondary
Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
Number of of hypoglycemic events \< 70mg/dl will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading | POC | 10 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading | CGM abdomen | 100 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading | CGM arm | 48 number of events |
Secondary
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events \< 54 mg/dl(between 22:00 and 06:00) will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
Number of nocturnal hypoglycemic events \< 70 mg/dl(between 22:00 and 06:00) will be recorded
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading
Number of of hypoglycemic events \< 54 will be recorded
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading | POC | 9 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading | CGM abdomen | 60 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading | CGM arm | 29 number of events |
Secondary
Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading
Number of of hypoglycemic events \< 70mg/dl will be recorded
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading | POC | 36 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading | CGM abdomen | 144 number of events |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading | CGM arm | 115 number of events |
Secondary
Number of Sensor Removal/Failures/Dislodgments
Number of sensor removal/failures/dislodgments will be recorded
Time frame: During hospital stay (3 days - up to 30 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Number of Sensor Removal/Failures/Dislodgments | 31 number of events |
Secondary
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
Secondary
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
Secondary
Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target \>180 will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading | CGM abdomen | 89 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading | CGM arm | 94 percentage of patients |
Secondary
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading | CGM abdomen | 91 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading | CGM arm | 89 percentage of patients |
Secondary
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time above glucose target \>240 will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | CGM abdomen | 56 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | CGM arm | 60 percentage of patients |
Secondary
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | CGM abdomen | 53 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading | CGM arm | 43 percentage of patients |
Secondary
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time below glucose target \<54 mg/dl will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading | CGM abdomen | 1.8 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading | CGM <70 abdomen | 3.4 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading | CGM <70 arm | 0 percentage of patients |
Secondary
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading
Percentage of patients with greater than 5%-time below glucose target \<70 mg/dl will be calculated
Time frame: 10 days post discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading | CGM abdomen | 5.3 percentage of patients |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading | CGM <70 abdomen | 10 percentage of readings |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen | A | 82.4 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen | B | 16.5 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen | C | 0.1 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen | D | 1 percentage of values |
Secondary
Percentage of Values Within Zone A, B, C of the Clarke Error Grid 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.
Time frame: During hospital stay (3 days - up to 30 days) measured in arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm | A | 81.4 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm | B | 17.6 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm | C | 0.1 percentage of values |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm | D | 0.9 percentage of values |
Secondary
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading | CGM abdomen | 4624.3 min | Standard Deviation 13554 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading | CGM abdomen | 972.30 min | Standard Deviation 1214.5 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | 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
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | CGM abdomen | 118.70 min | Standard Deviation 217.83 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | CGM arm | 89.14 min | Standard Deviation 140.16 |
Secondary
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | CGM abdomen) | 119.08 min | Standard Deviation 216.56 |
| Dexcom G6 CGM - Continues Glucose Monitoring Sensor System | Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading | CGM arm | 78.63 min | Standard Deviation 135.33 |