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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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 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.
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
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)
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)
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)
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)
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)
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)
ICU Mortality
Death from any cause during ICU stay
Time frame: 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
Time frame: At 30 days or time of death
Cost Associated With Monitoring
Monetary value assigned to blood glucose monitoring
Time frame: For duration of study enrollment (up to 10 days)
Mean Blood Glucose
Average blood glucose (\< 180 mg/dl) during the study timeframe
Time frame: For duration of study enrollment (up to 10 days)
Glucose Variability
a. % coefficient of variation = SD/mean BG\*100%
Time frame: 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.'
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Assessed daily, For duration of study enrollment (up to 10 days)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.