Dexcom G6 Observational Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832907
• Other study ID #: IRB00107627
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Dexcom G6 CGM - Continues Glucose Monitoring sensor system
A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.

Diagnostic Test:
• POC BG - Point-of-Care Blood Glucose monitoring
Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Daily Blood Glucose by POC Reading ?ompared to CGM Reading	Mean daily blood glucose will be calculated	During hospital stay (3 days - up to 30 days)
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	During hospital stay (3 days - up to 30 days)
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	During hospital stay (3 days - up to 30 days)
Secondary	Mean Daily Blood Glucose by POC Reading Compared to CGM Reading	Mean daily blood glucose will be calculated	10 days post discharge
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	10 days post discharge
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
Secondary	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
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. .	During hospital stay (3 days - up to 30 days)
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. .	10 days post discharge
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. .	During hospital stay (3 days - up to 30 days)
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.	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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.	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
Secondary	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)
Secondary	Glycemic Variability Calculated by MAGE by CGM Reading	MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.	10 days post discharge
Secondary	Number of Sensor Removal/Failures/Dislodgments	Number of sensor removal/failures/dislodgments will be recorded	During hospital stay (3 days - up to 30 days)
Secondary	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)
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days) measured in arm
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	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
Secondary	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
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.	During hospital stay (3 days - up to 30 days)
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	10 days post discharge
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	During hospital stay (3 days - up to 30 days)
Secondary	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)
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	10 days post discharge
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
Secondary	Glycemic Variability Calculated by Standard Deviation by CGM Reading	Glycemic variability will be calculated using Standard Deviation	10 days post discharge
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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..	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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..	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)
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.	During hospital stay (3 days - up to 30 days)