Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Last updated: March 21, 2025
Sponsor: Malcom Randall VA Medical Center
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Hormone Deficiencies

Treatment

Continuous glucose monitoring

Point of care glucose monitoring

Clinical Study ID

NCT05442853
202201063
  • Ages 18-89
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients age 18-89

  • Past medical history of any diabetes mellitus OR patients with at least 1 measuredBG of 180 being treated with insulin (subcutaneous or infusion)

  • Enrollment will occur within 72 hours after being admitted to an ICU if history ofdiabetes

  • Enrollment will occur within 72 hours after developing hyperglycemia in ICU if nodiabetes

Exclusion

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 manufacturerspecifications)

  • 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 couldfalsely elevate the sensor readings (if applicable for specific CGM)

Study Design

Total Participants: 85
Treatment Group(s): 2
Primary Treatment: Continuous glucose monitoring
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
August 01, 2024

Study 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.

Connect with a study center

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida 32608
    United States

    Site Not Available

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