Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Completed · Not applicable
Conditions studied: Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus
In brief
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).
Key facts
- Study ID
- NCT05442853
- Run by
- Malcom Randall VA Medical Center
- People needed
- 85
- Starts
- 2023-04-01
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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