Clinical trial NCT03832907: Dexcom G6 Observational Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Glucose monitoring
POC BG
DexcomG6 CGM
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
Secondary outcomes:
measure: Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
timeFrame: 10 days post discharge
measure: Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
timeFrame: 10 days post discharge
measure: Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading
timeFrame: 10 days post discharge
measure: Glycemic Variability Calculated by Standard Deviation by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Glycemic Variability Calculated by MAGE by CGM Reading
timeFrame: 10 days post discharge
measure: Number of Sensor Removal/Failures/Dislodgments
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Mean Absolute Relative Difference (MARD) of CGM Compared to POC
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm
timeFrame: During hospital stay (3 days - up to 30 days) measured in arm
measure: Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Glycemic Variability Calculated by MAGE by CGM Reading
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Glycemic Variability Calculated by Standard Deviation by CGM Reading
timeFrame: 10 days post discharge
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
timeFrame: During hospital stay (3 days - up to 30 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: