Dexcom G6 Observational Study

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Dexcom G6 CGM - Continues Glucose Monitoring sensor system; Diagnostic Test: POC BG - Point-of-Care Blood Glucose monitoring

• Registration Number: NCT03832907
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-02-21
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Results First Submitted: 2021-03-31
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexcom G6 CGM - Continues Glucose Monitoring sensor system	Dexcom G6 CGM - Continues Glucose Monitoring sensor system	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.
Dexcom G6 CGM - Continues Glucose Monitoring sensor system	POC BG - Point-of-Care Blood Glucose monitoring	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.

Primary Outcome Measures

Name	Time	Method
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
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 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 Outcome Measures

Name	Time	Method
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 >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
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
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 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.
Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading	10 days post discharge	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. .
Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading	10 days post discharge	Number of hyperglycemic events \> 240 mg/dl will be recorded
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.
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
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 Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading	10 days post discharge	Number of nocturnal hypoglycemic events \< 70 mg/dl(between 22:00 and 06:00) 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
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 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
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.
Mean Daily Blood Glucose by POC Reading Compared to CGM Reading	10 days post discharge	Mean daily blood glucose will be calculated
Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading	10 days post discharge	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.
Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading	10 days post discharge	Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading	10 days post discharge	Number of nocturnal hypoglycemic events \< 54 mg/dl(between 22:00 and 06:00) will be recorded
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
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
Glycemic Variability Calculated by Standard Deviation by CGM Reading	10 days post discharge	Glycemic variability will be calculated using Standard Deviation
Glycemic Variability Calculated by MAGE by CGM Reading	During hospital stay (3 days - up to 30 days)	The 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
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.
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
Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading	During hospital stay (3 days - up to 30 days)	Percentage of patients with greater than 5%-time above glucose target \>240 mg/dl will be calculated
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 > 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 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 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 > 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 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 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..
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.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States