Diabetes Mellitus
Conditions
Keywords
Glycemic control, Bedside point-of-care capillary glucose monitoring, Dexcom, Continuous glucose monitoring, Hyperglycemia, Inpatient
Brief summary
The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).
Detailed description
Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality. Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if CGM represents a better tool to guide healthcare providers in adjusting insulin therapy by providing a more complete 24-hour assessment of glucose values compared to POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D. Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.
Interventions
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 up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.
DIAGNOSTIC_TESTPOC 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 up to 10 days.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females ≥ 18 years admitted to a general medicine or surgical services. 2. History of T1D or T2D receiving insulin therapy during hospital admission. 3. Subjects must have a randomization BG \<400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones). 4. Patients with expected hospital length-of-stay of 2 or more day
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. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema). 4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study. 6. Coronavirus Disease 2019 (COVID-19) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Blood Glucose (BG) Concentration While Hospitalized | During hospitalization (up to 10 days) | 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. |
| Percent of Time With BG Between 70-180 mg/dL While Hospitalized | During hospitalization (up to 10 days) | Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL. |
| Number of Clinically Significant Hypoglycemia Events While Hospitalized | During hospitalization (up to 10 days) | The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time With Hyperglycemia While Hospitalized | During hospitalization (up to 10 days) | The percentage of time above the desired BG range, during the day and night while hospitalized was assessed. |
| Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized | During hospitalization (up to 10 days) | 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. |
| Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized | During hospitalization (up to 10 days) | 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. |
| Number of Sensor Changes During Hospitalization | During hospitalization (up to 10 days) | 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. |
| Percent of Time With Hyperglycemia After Discharge | After hospital discharge (up to 10 days) | The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed. |
| Number of Hypoglycemia Events While Hospitalized | During hospitalization (up to 10 days) | The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant during hospitalization is presented here. |
| Percent of Time With BG Between 70-180 mg/dL After Discharge | After hospital discharge (up to 10 days) | Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL. |
| Number of Clinically Significant Hypoglycemia Events After Discharge | After hospital discharge (up to 10 days) | 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. |
| Number of Hypoglycemia Events After Discharge | After hospital discharge (up to 10 days) | The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant after hospital discharge is presented here. |
| Count of Participants With Hypoglycemia After Discharge | After hospital discharge (up to 10 days) | 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). |
| Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge | After hospital discharge (up to 10 days) | 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 |
| Mean Daily BG Concentration After Discharge | After hospital discharge (up to 10 days) | 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. |
| Number of Nocturnal Hypoglycemia Events While Hospitalized | During hospitalization (up to 10 days) | 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). |
| Percent of Time With Hypoglycemia While Hospitalized | During hospitalization (up to 10 days) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 88 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 9 | 3 |
Baseline characteristics
| Characteristic | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Total | Point-of-Care Blood Glucose Monitoring |
|---|---|---|---|
| Age, Continuous | 57.24 years STANDARD_DEVIATION 12.45 | 56.29 years STANDARD_DEVIATION 11.11 | 55.32 years STANDARD_DEVIATION 9.5 |
| Diabetes Type Type 1 | 11 Participants | 18 Participants | 7 Participants |
| Diabetes Type Type 2 | 77 Participants | 155 Participants | 78 Participants |
| Race/Ethnicity, Customized Black | 57 Participants | 115 Participants | 58 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 43 Participants | 19 Participants |
| Region of Enrollment United States | 88 Participants | 173 Participants | 85 Participants |
| Sex: Female, Male Female | 37 Participants | 68 Participants | 31 Participants |
| Sex: Female, Male Male | 51 Participants | 105 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 88 |
| other Total, other adverse events | 3 / 85 | 2 / 88 |
| serious Total, serious adverse events | 0 / 85 | 0 / 88 |
Outcome results
Primary
Mean Daily Blood Glucose (BG) Concentration While Hospitalized
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Mean Daily Blood Glucose (BG) Concentration While Hospitalized | 186.8 mg/dL | Standard Deviation 39 |
| Dexcom G6 CGM System | Mean Daily Blood Glucose (BG) Concentration While Hospitalized | 183.2 mg/dL | Standard Deviation 40 |
Primary
Number of Clinically Significant Hypoglycemia Events While Hospitalized
The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Number of Clinically Significant Hypoglycemia Events While Hospitalized | 0.56 events per participant | Standard Deviation 1.46 |
| Dexcom G6 CGM System | Number of Clinically Significant Hypoglycemia Events While Hospitalized | 0.22 events per participant | Standard Deviation 0.59 |
Primary
Percent of Time With BG Between 70-180 mg/dL While Hospitalized
Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Percent of Time With BG Between 70-180 mg/dL While Hospitalized | 48.64 percentage of time in range | Standard Deviation 24.25 |
| Dexcom G6 CGM System | Percent of Time With BG Between 70-180 mg/dL While Hospitalized | 54.51 percentage of time in range | Standard Deviation 27.72 |
Secondary
Count of Participants With Hypoglycemia After Discharge
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).
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POC Blood Glucose Monitoring | Count of Participants With Hypoglycemia After Discharge | Hypoglycemia (BG < 70 mg/dL) | 37 Participants |
| POC Blood Glucose Monitoring | Count of Participants With Hypoglycemia After Discharge | Severe hypoglycemia (BG < 54 mg/dL) | 36 Participants |
| Dexcom G6 CGM System | Count of Participants With Hypoglycemia After Discharge | Hypoglycemia (BG < 70 mg/dL) | 42 Participants |
| Dexcom G6 CGM System | Count of Participants With Hypoglycemia After Discharge | Severe hypoglycemia (BG < 54 mg/dL) | 38 Participants |
Secondary
Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized
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.
Time frame: During hospitalization (up to 10 days)
Population: This analysis includes participants wearing a CGM device in the indicated bodily location.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC Blood Glucose Monitoring | 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 11.72 |
| POC Blood Glucose Monitoring | 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 |
| Dexcom G6 CGM System | Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized | MARD CGM arm vs POC reading | 12.771 mg/dL | Standard Deviation 12.728 |
| Dexcom G6 CGM System | Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized | MARD CGM abdomen vs POC reading | 15.670 mg/dL | Standard Deviation 12.816 |
Secondary
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge
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
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge | 58.55 mg/dL | Standard Deviation 23.76 |
| Dexcom G6 CGM System | Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge | 68.35 mg/dL | Standard Deviation 46.68 |
Secondary
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized | 65.02 mg/dL | Standard Deviation 39.1 |
| Dexcom G6 CGM System | Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized | 61.24 mg/dL | Standard Deviation 32.41 |
Secondary
Mean Daily BG Concentration After Discharge
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.
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Mean Daily BG Concentration After Discharge | 200.41 mg/dL | Standard Deviation 55.94 |
| Dexcom G6 CGM System | Mean Daily BG Concentration After Discharge | 199.65 mg/dL | Standard Deviation 45.86 |
Secondary
Number of Clinically Significant Hypoglycemia Events After Discharge
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.
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Number of Clinically Significant Hypoglycemia Events After Discharge | 4.41 events per participant | Standard Deviation 6.28 |
| Dexcom G6 CGM System | Number of Clinically Significant Hypoglycemia Events After Discharge | 2.30 events per participant | Standard Deviation 1.95 |
Secondary
Number of Hypoglycemia Events After Discharge
The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant after hospital discharge is presented here.
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Number of Hypoglycemia Events After Discharge | 5.20 events per participant | Standard Deviation 7.1 |
| Dexcom G6 CGM System | Number of Hypoglycemia Events After Discharge | 3.77 events per participant | Standard Deviation 3.73 |
Secondary
Number of Hypoglycemia Events While Hospitalized
The mean number of hypoglycemia events, defined as BG \< 70 (\<3.9 mmol/L), per participant during hospitalization is presented here.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Number of Hypoglycemia Events While Hospitalized | 1.15 events per participant | Standard Deviation 2.24 |
| Dexcom G6 CGM System | Number of Hypoglycemia Events While Hospitalized | 0.65 events per participant | Standard Deviation 1.26 |
Secondary
Number of Nocturnal Hypoglycemia Events While Hospitalized
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC Blood Glucose Monitoring | Number of Nocturnal Hypoglycemia Events While Hospitalized | Hypoglycemia | 0.34 events per participant | Standard Deviation 0.83 |
| POC Blood Glucose Monitoring | Number of Nocturnal Hypoglycemia Events While Hospitalized | Severe hypoglycemia | 0.23 events per participant | Standard Deviation 0.72 |
| Dexcom G6 CGM System | Number of Nocturnal Hypoglycemia Events While Hospitalized | Hypoglycemia | 0.20 events per participant | Standard Deviation 0.49 |
| Dexcom G6 CGM System | Number of Nocturnal Hypoglycemia Events While Hospitalized | Severe hypoglycemia | 0.08 events per participant | Standard Deviation 0.36 |
Secondary
Number of Sensor Changes During Hospitalization
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POC Blood Glucose Monitoring | Number of Sensor Changes During Hospitalization | 1 count of sensor changes |
| Dexcom G6 CGM System | Number of Sensor Changes During Hospitalization | 13 count of sensor changes |
Secondary
Percent of Time With BG Between 70-180 mg/dL After Discharge
Glycemic control after hospital discharge is measured by the percent of time with BG in the range of 70-180 mg/dL.
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POC Blood Glucose Monitoring | Percent of Time With BG Between 70-180 mg/dL After Discharge | 43.42 percentage of time in range | Standard Deviation 30.38 |
| Dexcom G6 CGM System | Percent of Time With BG Between 70-180 mg/dL After Discharge | 42.66 percentage of time in range | Standard Deviation 26.34 |
Secondary
Percent of Time With Hyperglycemia After Discharge
The percentage of time above the desired BG range, during the day and night after hospital discharge was assessed.
Time frame: After hospital discharge (up to 10 days)
Population: This analysis includes participants who completed the outpatient portion of this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC Blood Glucose Monitoring | Percent of Time With Hyperglycemia After Discharge | BG > 180mg/dL | 52.35 percentage of time above range | Standard Deviation 30.57 |
| POC Blood Glucose Monitoring | Percent of Time With Hyperglycemia After Discharge | BG > 250mg/dL | 26.29 percentage of time above range | Standard Deviation 27.31 |
| Dexcom G6 CGM System | Percent of Time With Hyperglycemia After Discharge | BG > 180mg/dL | 54.96 percentage of time above range | Standard Deviation 26.52 |
| Dexcom G6 CGM System | Percent of Time With Hyperglycemia After Discharge | BG > 250mg/dL | 23.03 percentage of time above range | Standard Deviation 26.25 |
Secondary
Percent of Time With Hyperglycemia While Hospitalized
The percentage of time above the desired BG range, during the day and night while hospitalized was assessed.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC Blood Glucose Monitoring | Percent of Time With Hyperglycemia While Hospitalized | BG > 180mg/dL | 49.21 percentage of time above range | Standard Deviation 25.5 |
| POC Blood Glucose Monitoring | Percent of Time With Hyperglycemia While Hospitalized | BG > 250mg/dL | 17.08 percentage of time above range | Standard Deviation 17.59 |
| Dexcom G6 CGM System | Percent of Time With Hyperglycemia While Hospitalized | BG > 180mg/dL | 44.80 percentage of time above range | Standard Deviation 27.89 |
| Dexcom G6 CGM System | Percent of Time With Hyperglycemia While Hospitalized | BG > 250mg/dL | 16.24 percentage of time above range | Standard Deviation 19.63 |
Secondary
Percent of Time With Hypoglycemia While Hospitalized
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC Blood Glucose Monitoring | Percent of Time With Hypoglycemia While Hospitalized | Hypoglycemia (BG < 70 mg/dL) | 2.15 percentage of time below range | Standard Deviation 5.91 |
| POC Blood Glucose Monitoring | Percent of Time With Hypoglycemia While Hospitalized | Severe hypoglycemia (BG < 54 mg/dL) | 1.00 percentage of time below range | Standard Deviation 3.74 |
| Dexcom G6 CGM System | Percent of Time With Hypoglycemia While Hospitalized | Hypoglycemia (BG < 70 mg/dL) | 0.69 percentage of time below range | Standard Deviation 2.15 |
| Dexcom G6 CGM System | Percent of Time With Hypoglycemia While Hospitalized | Severe hypoglycemia (BG < 54 mg/dL) | 0.32 percentage of time below range | Standard Deviation 1.33 |