Trial Outcomes & Findings for Dexcom G6 Intervention Study (NCT NCT03877068)
NCT ID: NCT03877068
Last Updated: 2023-10-24
Results Overview
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
During hospitalization (up to 10 days)
Results posted on
2023-10-24
Participant Flow
Participant milestones
| Measure |
Point-of-Care Blood Glucose Monitoring
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
Began Optional Outpatient Portion of Study
|
52
|
53
|
|
Overall Study
Completed Optional Outpatient Portion of Study
|
41
|
44
|
|
Overall Study
COMPLETED
|
85
|
88
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Point-of-Care Blood Glucose Monitoring
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Overall Study
Physician Decision
|
9
|
3
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Baseline Characteristics
Dexcom G6 Intervention Study
Baseline characteristics by cohort
| Measure |
Point-of-Care Blood Glucose Monitoring
n=85 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 Continuous Glucose Monitoring (CGM) System
n=88 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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Total
n=173 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
55.32 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
57.24 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
56.29 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Diabetes Type
Type 1
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Mean Daily Blood Glucose (BG) Concentration While Hospitalized
|
186.8 mg/dL
Standard Deviation 39
|
183.2 mg/dL
Standard Deviation 40
|
PRIMARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Percent of Time With BG Between 70-180 mg/dL While Hospitalized
|
48.64 percentage of time in range
Standard Deviation 24.25
|
54.51 percentage of time in range
Standard Deviation 27.72
|
PRIMARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Number of Clinically Significant Hypoglycemia Events While Hospitalized
|
0.56 events per participant
Standard Deviation 1.46
|
0.22 events per participant
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant during hospitalization is presented here.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Number of Hypoglycemia Events While Hospitalized
|
1.15 events per participant
Standard Deviation 2.24
|
0.65 events per participant
Standard Deviation 1.26
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SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
The mean number of events of nocturnal hypoglycemia per participant are presented here. Nocturnal hypoglycemia occurs between the hours of 12:00 midnight and 6:00 ante meridiem (AM). Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Number of Nocturnal Hypoglycemia Events While Hospitalized
Hypoglycemia
|
0.34 events per participant
Standard Deviation 0.83
|
0.20 events per participant
Standard Deviation 0.49
|
|
Number of Nocturnal Hypoglycemia Events While Hospitalized
Severe hypoglycemia
|
0.23 events per participant
Standard Deviation 0.72
|
0.08 events per participant
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
The percentage of time spent with BG below the desired range, during the day and night of hospitalization was assessed. Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Percent of Time With Hypoglycemia While Hospitalized
Hypoglycemia (BG < 70 mg/dL)
|
2.15 percentage of time below range
Standard Deviation 5.91
|
0.69 percentage of time below range
Standard Deviation 2.15
|
|
Percent of Time With Hypoglycemia While Hospitalized
Severe hypoglycemia (BG < 54 mg/dL)
|
1.00 percentage of time below range
Standard Deviation 3.74
|
0.32 percentage of time below range
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Percent of Time With Hyperglycemia While Hospitalized
BG > 180mg/dL
|
49.21 percentage of time above range
Standard Deviation 25.50
|
44.80 percentage of time above range
Standard Deviation 27.89
|
|
Percent of Time With Hyperglycemia While Hospitalized
BG > 250mg/dL
|
17.08 percentage of time above range
Standard Deviation 17.59
|
16.24 percentage of time above range
Standard Deviation 19.63
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation of mean glycemia. It is designed to assess major glucose swings and exclude minor ones.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized
|
65.02 mg/dL
Standard Deviation 39.10
|
61.24 mg/dL
Standard Deviation 32.41
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants wearing a CGM device in the indicated bodily location.
The mean absolute relative difference (MARD) reflects accuracy of the CGM glucose reading compared to the reference POC reading. This is the current standard for assessing accuracy of glucometer readings. Lower MARD indicates smaller differences between the CGM and meter value; a higher MARD value indicates larger differences. A three way and direct head-to-head comparison of data from the abdomen, upper arm and POC BG will be compared.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=1391 glucose readings
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=1345 glucose readings
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
|
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
MARD CGM arm vs POC reading
|
13.717 mg/dL
Standard Deviation 11.720
|
12.771 mg/dL
Standard Deviation 12.728
|
|
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
MARD CGM abdomen vs POC reading
|
16.414 mg/dL
Standard Deviation 13.778
|
15.670 mg/dL
Standard Deviation 12.816
|
SECONDARY outcome
Timeframe: During hospitalization (up to 10 days)Population: This analysis includes participants who were hospitalized for at least 24 hours. Six participants in the POC group and 5 participants in the Dexcom G6 CGM group were excluded as they stayed less than 24 hours in the hospital.
Events related to sensor changes (blinded sensor for the POC group or real-time sensor for CGM group), such as removal for procedures or imaging, sensors failures, and sensors dislodgments were recorded.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=79 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=83 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
|
Number of Sensor Changes During Hospitalization
|
1 count of sensor changes
|
13 count of sensor changes
|
SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
|
|---|---|---|
|
Mean Daily BG Concentration After Discharge
|
200.41 mg/dL
Standard Deviation 55.94
|
199.65 mg/dL
Standard Deviation 45.86
|
SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
|
|---|---|---|
|
Percent of Time With BG Between 70-180 mg/dL After Discharge
|
43.42 percentage of time in range
Standard Deviation 30.38
|
42.66 percentage of time in range
Standard Deviation 26.34
|
SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), during the day and night after hospital discharge, per participant is presented here.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycemia Events After Discharge
|
4.41 events per participant
Standard Deviation 6.28
|
2.30 events per participant
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant after hospital discharge is presented here.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
|
|---|---|---|
|
Number of Hypoglycemia Events After Discharge
|
5.20 events per participant
Standard Deviation 7.10
|
3.77 events per participant
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
Hypoglycemia is defined as BG \< 70 mg/dL (\<3.9 mmol/L) and severe hypoglycemia is defined as BG \< 54 mg/dL (\<3.0 mmol/L).
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
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Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Count of Participants With Hypoglycemia After Discharge
Hypoglycemia (BG < 70 mg/dL)
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37 Participants
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42 Participants
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Count of Participants With Hypoglycemia After Discharge
Severe hypoglycemia (BG < 54 mg/dL)
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36 Participants
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38 Participants
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SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
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Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Percent of Time With Hyperglycemia After Discharge
BG > 180mg/dL
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52.35 percentage of time above range
Standard Deviation 30.57
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54.96 percentage of time above range
Standard Deviation 26.52
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Percent of Time With Hyperglycemia After Discharge
BG > 250mg/dL
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26.29 percentage of time above range
Standard Deviation 27.31
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23.03 percentage of time above range
Standard Deviation 26.25
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SECONDARY outcome
Timeframe: After hospital discharge (up to 10 days)Population: This analysis includes participants who completed the outpatient portion of this study.
Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation, is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard of mean glycemia. It is designed to assess major glucose swings and exclude minor ones
Outcome measures
| Measure |
POC Blood Glucose Monitoring
n=41 Participants
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
|
Dexcom G6 CGM System
n=44 Participants
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge
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58.55 mg/dL
Standard Deviation 23.76
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68.35 mg/dL
Standard Deviation 46.68
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Adverse Events
POC Blood Glucose Monitoring
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dexcom G6 CGM System
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
POC Blood Glucose Monitoring
n=85 participants at risk
Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team.
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Dexcom G6 CGM System
n=88 participants at risk
Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm.
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|---|---|---|
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Surgical and medical procedures
Minor bleeding with sensor insertion
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3.5%
3/85 • Information on adverse events was collected from the time consent to participate was given up to 10 days during hospitalization and up to 10 days after discharge (up to 20 days of monitoring).
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2.3%
2/88 • Information on adverse events was collected from the time consent to participate was given up to 10 days during hospitalization and up to 10 days after discharge (up to 20 days of monitoring).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place