Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients (NCT05442853) | Clinical Trial Compass
CompletedNot Applicable
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
United States85 participantsStarted 2023-04-01
Plain-language 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).
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in Target Blood Glucose Range (BG 70-180mg/dL)
Timeframe: For duration of study enrollment (up to 10 days)