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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor system | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 CGM - Continues Glucose Monitoring sensor system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose by POC Reading сompared to CGM Reading | Mean daily blood glucose will be calculated | 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 | 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 | During hospital stay (3 days - up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | Mean daily blood glucose will be calculated | 10 days post discharge |
| Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Blood Glucose by POC Reading сompared to CGM Reading | Mean daily blood glucose will be calculated | Posted | Mean | Standard Deviation | mg/dL | During hospital stay (3 days - up to 30 days) |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensor site irritation/bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Umpierrez | Emory University | 404-778-1665 | geumpie@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2019 | Mar 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| POC BG - Point-of-Care Blood Glucose monitoring | Diagnostic Test | Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days. |
|
|
Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
| 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 | 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 | 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 | 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 | 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 | 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. . | 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. . | 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. . | 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. | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 10 days post discharge |
| Glycemic Variability Calculated by Standard Deviation by CGM Reading | Glycemic variability will be calculated using Standard Deviation | 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. | 10 days post discharge |
| Number of Sensor Removal/Failures/Dislodgments | Number of sensor removal/failures/dislodgments will be recorded | 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 | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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.. | 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. | 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.. | 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. | 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. | 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. | During hospital stay (3 days - up to 30 days) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
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| Secondary | Mean Daily Blood Glucose by POC Reading Compared to CGM Reading | Mean daily blood glucose will be calculated | Posted | Mean | Standard Deviation | mg/dL | 10 days post discharge |
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| 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 | Posted | Number | number of events | 10 days post discharge |
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| 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 | Posted | Number | number of events | 10 days post discharge |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Number | number of events | 10 days post discharge |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| Secondary | Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading | Number of of hypoglycemic events < 70mg/dl will be recorded | Posted | Number | number of events | 10 days post discharge |
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| 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. . | Posted | Mean | Standard Deviation | min | During hospital stay (3 days - up to 30 days) |
|
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| 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. . | Posted | Mean | Standard Deviation | min | 10 days post discharge |
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| 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. . | Posted | Mean | Standard Deviation | min | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Mean | Standard Deviation | min | 10 days post discharge |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
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| 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 | Posted | Number | number of events | 10 days post discharge |
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| 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 | Posted | Mean | Standard Deviation | percentage of readings | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Mean | Standard Deviation | percentage of readings | 10 days post discharge |
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| 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. | Posted | Number | percentage of readings | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Number | percentage of patients | 10 days post discharge |
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| 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 | Posted | Number | percentage of patients | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Number | percentage of patients | 10 days post discharge |
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| Secondary | Glycemic Variability Calculated by Standard Deviation by CGM Reading | Glycemic variability will be calculated using Standard Deviation | Posted | Mean | Standard Deviation | mg/dl | During hospital stay (3 days - up to 30 days) |
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| Secondary | Glycemic Variability Calculated by MAGE by CGM Reading | MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold. | Posted | Mean | Standard Deviation | mg/dl | 10 days post discharge |
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| Secondary | Number of Sensor Removal/Failures/Dislodgments | Number of sensor removal/failures/dislodgments will be recorded | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| Secondary | Mean Absolute Relative Difference (MARD) of CGM Compared to POC | Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC | Posted | Mean | Standard Deviation | percent difference | During hospital stay (3 days - up to 30 days) |
|
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
|
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|
| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
|
|
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) measured in arm |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| 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 | Posted | Number | number of events | 10 days post discharge |
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| 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 | Posted | Number | number of events | During hospital stay (3 days - up to 30 days) |
|
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| Secondary | Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading | Number of of hypoglycemic events < 54mg/dl will be recorded | Posted | Number | number of events | 10 days post discharge |
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| 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. | Posted | Number | percentage of patients | During hospital stay (3 days - up to 30 days) |
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| 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 | Posted | Number | percentage of patients | 10 days post discharge |
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| 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 | Posted | Number | percentage of patients | During hospital stay (3 days - up to 30 days) |
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| Secondary | Glycemic Variability Calculated by MAGE by CGM Reading | The average amplitude of glycemic excursions with values exceeding a certain threshold. | Posted | Mean | Standard Deviation | mg/dl | During hospital stay (3 days - up to 30 days) |
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| 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 | Posted | Number | percentage of patients | 10 days post discharge |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| Secondary | Glycemic Variability Calculated by Standard Deviation by CGM Reading | Glycemic variability will be calculated using Standard Deviation | Posted | Mean | Standard Deviation | mg/dl | 10 days post discharge |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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.. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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.. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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| 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. | Posted | Number | percentage of values | During hospital stay (3 days - up to 30 days) |
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