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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
101
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.
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.
Emory University
Atlanta, Georgia, United States
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)
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)
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)
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
Mean daily blood glucose will be calculated
Time frame: 10 days post discharge
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
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
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
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Time frame: During hospital stay (3 days - up to 30 days)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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)
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)
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)
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
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)
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
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)
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
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)
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
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)
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)
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
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)
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)
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)
Glycemic Variability Calculated by Standard Deviation by CGM Reading
Glycemic variability will be calculated using Standard Deviation
Time frame: 10 days post discharge
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)
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)
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)
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)
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)
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)
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)
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)