Critical Illness, Diabetes Mellitus, Hyperglycemia, Hypoglycemia
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEContinuous 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.
DEVICEPoint 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.
Sponsors
DexCom, Inc.
Malcom Randall VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients age 18-89 * Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion) * Enrollment will occur within 72 hours after being admitted to an ICU if history of diabetes * Enrollment will occur within 72 hours after developing hyperglycemia in ICU if no diabetes
Exclusion criteria
* Pregnant patients * Patients using CGMs in the outpatient setting * Diagnosis of diabetic ketoacidosis (DKA) * Diagnosis of hyperosmolar hyperglycemic state (HHS) * Anticipated to require prone positioning while on insulin therapy * Any contraindications to CGMs based on manufacturer labeling * BG above maximum reading for CGM (e.g. greater than 400 mg/dL) * Receiving medication that could interfere with CGM readings (based on manufacturer specifications) * Receiving any dose of hydroxyurea as this could falsely elevate the sensor readings (if applicable for specific CGM) * Receiving greater than 1,000mg acetaminophen every 6 hours in any form as this could falsely elevate the sensor readings (if applicable for specific CGM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Target Blood Glucose Range (BG 70-180mg/dL) | For duration of study enrollment (up to 10 days) | Percentage of time within time glucose range based on CGM readings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | For duration of study enrollment (up to 10 days) | Percentage of time with BG less than 54 mg/dl as measured by CGM |
| Time in Hypoglycemic Range (BG 54-69 mg/dL) | For duration of study enrollment (up to 10 days) | Percentage of time in this glucose range as measured by CGM |
| Time in Hyperglycemic Range (BG 181-250 mg/dL) | For duration of study enrollment (up to 10 days) | Percentage of time in this glucose range as measured by CGM |
| Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) | For duration of study enrollment (up to 10 days) | Percentage of time in this glucose range as measured by CGM |
| ICU Length of Stay | At time of ICU discharge or death (assessed up to 1 month) | Total time (in days or hours) in the intensive care unit |
| ICU Mortality | At time of ICU discharge or death (assessed up to 1 month) | Death from any cause during ICU stay |
| 30 Day Mortality | At 30 days or time of death | Death from any cause at 30 days after admission to the ICU |
| ICU Delirium | 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. |
| Mean Blood Glucose | For duration of study enrollment (up to 10 days) | Average blood glucose (\< 180 mg/dl) during the study timeframe |
| Glucose Variability | For duration of study enrollment (up to 10 days) | a. % coefficient of variation = SD/mean BG\*100% |
| Patient Satisfaction | 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.' |
| New Infection | Assessed daily, For duration of study enrollment (up to 10 days) | Any infection diagnosis that was not present upon admission to the ICU |
| New Acute Kidney Injury | 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 |
| Agitation | 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. |
| Pain Associated With Glucose Monitoring | Assessed daily, For duration of study enrollment (up to 10 days) | Patient reported pain associated with glucose monitoring |
| Cost Associated With Monitoring | For duration of study enrollment (up to 10 days) | Monetary value assigned to blood glucose monitoring |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 42 |
| Total | 85 |
Baseline characteristics
| Characteristic | Point of Care Glucose Monitoring | Total | Continuous Glucose Monitoring |
|---|---|---|---|
| Age, Continuous | 72 years | 74 years | 75 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 84 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 32 Participants | 70 Participants | 38 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 42 Participants | 85 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 43 | 2 / 42 |
| other Total, other adverse events | 2 / 43 | 1 / 42 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 |
Outcome results
Primary
Time in Target Blood Glucose Range (BG 70-180mg/dL)
Percentage of time within time glucose range based on CGM readings
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Time in Target Blood Glucose Range (BG 70-180mg/dL) | 60.5 percentage of time within target range | Standard Deviation 30.5 |
| Point of Care Glucose Monitoring | Time in Target Blood Glucose Range (BG 70-180mg/dL) | 61.4 percentage of time within target range | Standard Deviation 28.3 |
Secondary
30 Day Mortality
Death from any cause at 30 days after admission to the ICU
Time frame: At 30 days or time of death
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | 30 Day Mortality | 8 Participants |
| Point of Care Glucose Monitoring | 30 Day Mortality | 2 Participants |
Secondary
Agitation
Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation.
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Agitation | 2 Participants |
| Point of Care Glucose Monitoring | Agitation | 1 Participants |
Secondary
Cost Associated With Monitoring
Monetary value assigned to blood glucose monitoring
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Monitoring | Cost Associated With Monitoring | 0 dollars |
| Point of Care Glucose Monitoring | Cost Associated With Monitoring | 0 dollars |
Secondary
Glucose Variability
a. % coefficient of variation = SD/mean BG\*100%
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Glucose Variability | 21.0 percentage of variability | Standard Deviation 6.9 |
| Point of Care Glucose Monitoring | Glucose Variability | 22.3 percentage of variability | Standard Deviation 7.2 |
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.
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | ICU Delirium | 1 Participants |
| Point of Care Glucose Monitoring | ICU Delirium | 1 Participants |
Secondary
ICU Length of Stay
Total time (in days or hours) in the intensive care unit
Time frame: At time of ICU discharge or death (assessed up to 1 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | ICU Length of Stay | 3.9 days | Standard Deviation 2.8 |
| Point of Care Glucose Monitoring | ICU Length of Stay | 4.6 days | Standard Deviation 3.8 |
Secondary
ICU Mortality
Death from any cause during ICU stay
Time frame: At time of ICU discharge or death (assessed up to 1 month)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | ICU Mortality | 3 Participants |
| Point of Care Glucose Monitoring | ICU Mortality | 2 Participants |
Secondary
Mean Blood Glucose
Average blood glucose (\< 180 mg/dl) during the study timeframe
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Mean Blood Glucose | 28 Participants |
| Point of Care Glucose Monitoring | Mean Blood Glucose | 27 Participants |
Secondary
New Acute Kidney Injury
New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | New Acute Kidney Injury | 6 Participants |
| Point of Care Glucose Monitoring | New Acute Kidney Injury | 4 Participants |
Secondary
New Infection
Any infection diagnosis that was not present upon admission to the ICU
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | New Infection | 2 Participants |
| Point of Care Glucose Monitoring | New Infection | 2 Participants |
Secondary
Pain Associated With Glucose Monitoring
Patient reported pain associated with glucose monitoring
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Pain Associated With Glucose Monitoring | 1 Participants |
| Point of Care Glucose Monitoring | Pain Associated With Glucose Monitoring | 4 Participants |
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.'
Time frame: Once at completion of study enrollment (at day 10 or sooner)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Monitoring | Patient Satisfaction | 5 score on a scale |
| Point of Care Glucose Monitoring | Patient Satisfaction | 4 score on a scale |
Secondary
Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)
Percentage of time in this glucose range as measured by CGM
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) | 8.0 percentage of time | Standard Deviation 14.6 |
| Point of Care Glucose Monitoring | Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL) | 11.0 percentage of time | Standard Deviation 18.4 |
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
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | 0.2 percentage of time | Standard Deviation 1 |
| Point of Care Glucose Monitoring | Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | 1.1 percentage of time | Standard Deviation 3.1 |
Secondary
Time in Hyperglycemic Range (BG 181-250 mg/dL)
Percentage of time in this glucose range as measured by CGM
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Time in Hyperglycemic Range (BG 181-250 mg/dL) | 29.6 percentage of time | Standard Deviation 24.4 |
| Point of Care Glucose Monitoring | Time in Hyperglycemic Range (BG 181-250 mg/dL) | 25.6 percentage of time | Standard Deviation 17 |
Secondary
Time in Hypoglycemic Range (BG 54-69 mg/dL)
Percentage of time in this glucose range as measured by CGM
Time frame: For duration of study enrollment (up to 10 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Time in Hypoglycemic Range (BG 54-69 mg/dL) | 1.4 percentage of time | Standard Deviation 6.8 |
| Point of Care Glucose Monitoring | Time in Hypoglycemic Range (BG 54-69 mg/dL) | 0.9 percentage of time | Standard Deviation 2 |