Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Conditions
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Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous glucose monitoring
* Device: Point of care glucose monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Glucose Monitoring<br>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. | Device: Continuous glucose monitoring<br>* 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.<br>|
| Active Comparator: Point of Care Glucose Monitoring<br>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 | Device: Point of care glucose monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in target blood glucose range (BG 70-180mg/dL) | Proportion of time within time glucose range based on CGM readings | For duration of study enrollment (up to 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in clinically significant hypoglycemic range (BG < 54 mg/dL) | Proportion 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) | Proportion 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) | Proportion 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) | Proportion 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 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 | 
| 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 Score | Pain based on Critical-Care Pain Observation Tool (CPOT) scores (0 to 8) with higher scores indicating more pain; or the Defense & Veterans Pain Rating Scale (DVPRS) score (0 to 10) with higher scores indicating more pain | Assessed daily, For duration of study enrollment (up to 10 days) |