Trial Outcomes & Findings for Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients (NCT NCT05442853)
NCT ID: NCT05442853
Last Updated: 2025-04-08
Results Overview
Percentage of time within time glucose range based on CGM readings
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
For duration of study enrollment (up to 10 days)
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Continuous Glucose Monitoring
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Baseline characteristics by cohort
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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Total
n=85 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
75 years
n=93 Participants
|
72 years
n=4 Participants
|
74 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Percentage of time within time glucose range based on CGM readings
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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Time in Target Blood Glucose Range (BG 70-180mg/dL)
|
60.5 percentage of time within target range
Standard Deviation 30.5
|
61.4 percentage of time within target range
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Percentage of time with BG less than 54 mg/dl as measured by CGM
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)
|
0.2 percentage of time
Standard Deviation 1.0
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1.1 percentage of time
Standard Deviation 3.1
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SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Percentage of time in this glucose range as measured by CGM
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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Time in Hypoglycemic Range (BG 54-69 mg/dL)
|
1.4 percentage of time
Standard Deviation 6.8
|
0.9 percentage of time
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Percentage of time in this glucose range as measured by CGM
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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Time in Hyperglycemic Range (BG 181-250 mg/dL)
|
29.6 percentage of time
Standard Deviation 24.4
|
25.6 percentage of time
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Percentage of time in this glucose range as measured by CGM
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
|
Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)
|
8.0 percentage of time
Standard Deviation 14.6
|
11.0 percentage of time
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: At time of ICU discharge or death (assessed up to 1 month)Total time (in days or hours) in the intensive care unit
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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ICU Length of Stay
|
3.9 days
Standard Deviation 2.8
|
4.6 days
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: At time of ICU discharge or death (assessed up to 1 month)Death from any cause during ICU stay
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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ICU Mortality
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 30 days or time of deathDeath from any cause at 30 days after admission to the ICU
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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30 Day Mortality
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Monetary value assigned to blood glucose monitoring
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
|
Cost Associated With Monitoring
|
0 dollars
|
0 dollars
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)Average blood glucose (\< 180 mg/dl) during the study timeframe
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
|
Mean Blood Glucose
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: For duration of study enrollment (up to 10 days)a. % coefficient of variation = SD/mean BG\*100%
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
Glucose Variability
|
21.0 percentage of variability
Standard Deviation 6.9
|
22.3 percentage of variability
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Once at completion of study enrollment (at day 10 or sooner)Patient satisfaction with glucose monitoring as assessed by survey on Likert Scale (1-5). Score of 1 being 'very dissatisfied' to score of 5 being 'very satisfied.'
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
Patient Satisfaction
|
5 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Assessed daily, For duration of study enrollment (up to 10 days)Any infection diagnosis that was not present upon admission to the ICU
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
New Infection
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed daily, For duration of study enrollment (up to 10 days)New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
New Acute Kidney Injury
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Assessed daily, For duration of study enrollment (up to 10 days)Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium.
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
ICU Delirium
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed daily, For duration of study enrollment (up to 10 days)Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation.
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
|
|---|---|---|
|
Agitation
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed daily, For duration of study enrollment (up to 10 days)Patient reported pain associated with glucose monitoring
Outcome measures
| Measure |
Continuous Glucose Monitoring
n=43 Participants
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
|
Point of Care Glucose Monitoring
n=42 Participants
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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Pain Associated With Glucose Monitoring
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1 Participants
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4 Participants
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Adverse Events
Continuous Glucose Monitoring
Serious events: 0 serious events
Other events: 2 other events
Deaths: 8 deaths
Point of Care Glucose Monitoring
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Glucose Monitoring
n=43 participants at risk
Study subjects in this arm will receive glycemic management based on continuous glucose monitoring with CGM device. CGM readings will be available to patients, nurses, and the treating team. All treatment decisions for this group will be based on CGM readings, confirmatory POC readings (as necessary), and venipuncture.
Continuous glucose monitoring: Continuous glucose monitoring involves a wearable device that measures glucose with a sensor that is inserted subcutaneously. The sensor transmits data to receiving device that displays the glucose values.
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Point of Care Glucose Monitoring
n=42 participants at risk
Study subjects in this arm will receive glycemic management based on point of care blood glucose readings. CGM will be placed in blinded mode and used for study comparison only. Patients, nurses, and other treatment team will be blinded to the CGM readings. All treatment decisions for this group will be based on POC readings and venipuncture
Point of care glucose monitoring: Point of care glucose monitoring involves use of an external device that can provide glucose readings at a patient's bedside. These devices require a small blood sample from venous, arterial, or capillary fingerstick blood. The blood sample is analyzed by the device and reports a glucose value within 5 minutes. This method of glucose monitoring is a mainstay and standard of care for most hospitals in the United States.
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|---|---|---|
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Product Issues
Inability to accurately calibrate CGM
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4.7%
2/43 • Number of events 2 • All-Cause Mortality: up to 30 days after admission to the ICU. Serious and Other Adverse Events: for duration of study enrollment (up to 10 days)
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0.00%
0/42 • All-Cause Mortality: up to 30 days after admission to the ICU. Serious and Other Adverse Events: for duration of study enrollment (up to 10 days)
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Blood and lymphatic system disorders
Minor Bleeding
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0.00%
0/43 • All-Cause Mortality: up to 30 days after admission to the ICU. Serious and Other Adverse Events: for duration of study enrollment (up to 10 days)
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2.4%
1/42 • Number of events 1 • All-Cause Mortality: up to 30 days after admission to the ICU. Serious and Other Adverse Events: for duration of study enrollment (up to 10 days)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place