Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Malcom Randall VA Medical Center

Status: Enrolling

Conditions: Hypoglycemia; Hyperglycemia; Diabetes Mellitus; Critical Illness

Treatments: Device: Point of care glucose monitoring; Device: Continuous glucose monitoring

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT05442853

202201063

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Continuous Glucose Monitoring

Active Comparator group

Description:

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.

Treatment:

Device: Continuous glucose monitoring

Point of Care Glucose Monitoring

Active Comparator group

Description:

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

Treatment:

Device: Point of care glucose monitoring