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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit (ICU) who received continuous glucose monitoring (CGM) vs point of care (POC) glucose monitoring. The study will examine relevant outcomes for patients in the ICU with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).
Study Purpose:
The purpose of this study is to compare the use of continuous glucose monitoring (CGM) versus point of care (POC) glucose monitoring in the intensive care unit (ICU) setting for differences in glycemic control and other important outcomes.
Research Plan:
This will be a prospective, single-center, randomized comparative trial of adult patients at North Florida/South Georgia Veterans Health System anticipated to be admitted to an ICU for a minimum of 48 hours after enrollment. Study participants will be randomly assigned to one of the study groups (CGM or POC) after being found eligible for inclusion and giving consent to participate. The CGM group will receive glycemic management based on CGM readings. The POC group will receive glycemic management based on POC glucose readings.
Study Outcomes:
Groups will be compared for differences in clinical and safety outcomes. The primary outcome will be the proportion of time in target range (BG 70-180mg/dL). Secondary outcomes will include mean glucose, hypoglycemia, hyperglycemia, ICU length of stay, mortality, glucose variability, cost, and patient satisfaction. Safety outcomes will include new infection, acute kidney injury, delirium, agitation, and pain.
Analysis Methods:
Descriptive statistics and inferential statistical methods will be used as appropriate to report findings of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring | Active Comparator | 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. |
|
| Point of Care Glucose Monitoring | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Target Blood Glucose Range (BG 70-180mg/dL) | Percentage of time within time glucose range based on CGM readings | For duration of study enrollment (up to 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | Percentage of time with BG less than 54 mg/dl as measured by CGM | For duration of study enrollment (up to 10 days) |
| Time in Hypoglycemic Range (BG 54-69 mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Franck, PharmD | US Department of Veterans Affairs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39956190 | Derived | Franck AJ, Hendrickson AL, Telford ED, Davids BL, Murray Casanova I, Rosen AN, Hadigal S, Ross RC. Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2025 Aug;168(2):326-335. doi: 10.1016/j.chest.2025.02.006. Epub 2025 Feb 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time in Target Blood Glucose Range (BG 70-180mg/dL) | Percentage of time within time glucose range based on CGM readings | Posted | Mean | Standard Deviation | percentage of time within target range | For duration of study enrollment (up to 10 days) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inability to accurately calibrate CGM | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew J. Franck | Malcom Randall VA Medical Center | 3523761611 | 105771 | Andrew.Franck@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | Feb 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2022 | Feb 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| D016638 | Critical Illness |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Point of care glucose monitoring | Device | 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. |
|
Percentage of time in this glucose range as measured by CGM
| For duration of study enrollment (up to 10 days) |
| Time in Hyperglycemic Range (BG 181-250 mg/dL) | Percentage of time in this glucose range as measured by CGM | For duration of study enrollment (up to 10 days) |
| Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) | Percentage of time in this glucose range as measured by CGM | For duration of study enrollment (up to 10 days) |
| ICU Length of Stay | Total time (in days or hours) in the intensive care unit | At time of ICU discharge or death (assessed up to 1 month) |
| ICU Mortality | Death from any cause during ICU stay | At time of ICU discharge or death (assessed up to 1 month) |
| 30 Day Mortality | Death from any cause at 30 days after admission to the ICU | At 30 days or time of death |
| Cost Associated With Monitoring | Monetary value assigned to blood glucose monitoring | For duration of study enrollment (up to 10 days) |
| Mean Blood Glucose | Average blood glucose (< 180 mg/dl) during the study timeframe | For duration of study enrollment (up to 10 days) |
| Glucose Variability | a. % coefficient of variation = SD/mean BG*100% | For duration of study enrollment (up to 10 days) |
| Patient Satisfaction | 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.' | Once at completion of study enrollment (at day 10 or sooner) |
| New Infection | Any infection diagnosis that was not present upon admission to the ICU | Assessed daily, For duration of study enrollment (up to 10 days) |
| New Acute Kidney Injury | New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU | Assessed daily, For duration of study enrollment (up to 10 days) |
| ICU Delirium | Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium. | Assessed daily, For duration of study enrollment (up to 10 days) |
| Agitation | Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation. | Assessed daily, For duration of study enrollment (up to 10 days) |
| Pain Associated With Glucose Monitoring | Patient reported pain associated with glucose monitoring | Assessed daily, For duration of study enrollment (up to 10 days) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
|
|
| Secondary | Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | Percentage of time with BG less than 54 mg/dl as measured by CGM | Posted | Mean | Standard Deviation | percentage of time | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Time in Hypoglycemic Range (BG 54-69 mg/dL) | Percentage of time in this glucose range as measured by CGM | Posted | Mean | Standard Deviation | percentage of time | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Time in Hyperglycemic Range (BG 181-250 mg/dL) | Percentage of time in this glucose range as measured by CGM | Posted | Mean | Standard Deviation | percentage of time | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) | Percentage of time in this glucose range as measured by CGM | Posted | Mean | Standard Deviation | percentage of time | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | ICU Length of Stay | Total time (in days or hours) in the intensive care unit | Posted | Mean | Standard Deviation | days | At time of ICU discharge or death (assessed up to 1 month) |
|
|
|
| Secondary | ICU Mortality | Death from any cause during ICU stay | Posted | Count of Participants | Participants | At time of ICU discharge or death (assessed up to 1 month) |
|
|
|
| Secondary | 30 Day Mortality | Death from any cause at 30 days after admission to the ICU | Posted | Count of Participants | Participants | At 30 days or time of death |
|
|
|
| Secondary | Cost Associated With Monitoring | Monetary value assigned to blood glucose monitoring | Posted | Number | dollars | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Mean Blood Glucose | Average blood glucose (< 180 mg/dl) during the study timeframe | Posted | Count of Participants | Participants | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Glucose Variability | a. % coefficient of variation = SD/mean BG*100% | Posted | Mean | Standard Deviation | percentage of variability | For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Patient Satisfaction | 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.' | Posted | Median | Inter-Quartile Range | score on a scale | Once at completion of study enrollment (at day 10 or sooner) |
|
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| Secondary | New Infection | Any infection diagnosis that was not present upon admission to the ICU | Posted | Count of Participants | Participants | Assessed daily, For duration of study enrollment (up to 10 days) |
|
|
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| Secondary | New Acute Kidney Injury | New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU | Posted | Count of Participants | Participants | Assessed daily, For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | ICU Delirium | Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium. | Posted | Count of Participants | Participants | Assessed daily, For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Agitation | Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation. | Posted | Count of Participants | Participants | Assessed daily, For duration of study enrollment (up to 10 days) |
|
|
|
| Secondary | Pain Associated With Glucose Monitoring | Patient reported pain associated with glucose monitoring | Posted | Count of Participants | Participants | Assessed daily, For duration of study enrollment (up to 10 days) |
|
|
|
| 8 |
| 43 |
| 0 |
| 43 |
| 2 |
| 43 |
| EG001 | 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. | 2 | 42 | 0 | 42 | 1 | 42 |
| Minor Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |