Dexcom G6 Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study

Conditions
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Diabetes

Intervention / Treatment
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* Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
* Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years admitted to a general medicine or surgical service. Known history of T1D or T2D receiving insulin therapy 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). Patients with expected hospital length-of-stay of 3 or more days Exclusion Criteria: Patients with acute illness admitted to the ICU or expected to require admission to the ICU. Patients expected to require MRI procedures during hospitalization. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom G6 CGM - Continues Glucose Monitoring sensor system<br>The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration. In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. | Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system<br>* 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.<br>Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring<br>* 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.<br>* Other names: Standard of Care capillary glucose test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose monitoring, POC BG, DexcomG6 CGM