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Clinical Trial NCT05442853 for Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients 85 Randomized
Clinical Trial NCT05442853 was an interventional study for Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus that is now completed. The study started on April 1, 2023, with plans to enroll 85 participants. Led by Malcom Randall VA Medical Center, the expected completion date was August 1, 2024. The latest data from ClinicalTrials.gov was last updated on April 8, 2025.
Brief 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 ta...Show More
Detailed 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 ant...
Show MoreOfficial Title
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Conditions
HyperglycemiaHypoglycemiaCritical IllnessDiabetes MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 202201063
NCT ID Number
Start Date (Actual)
2023-04-01
Last Update Posted
2025-04-08
Completion Date (Estimated)
2024-08-01
Enrollment (Estimated)
85
Study Type
Interventional
PHASE
N/A
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorContinuous Glucose Monitoring 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. | Continuous glucose monitoring 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. |
Active ComparatorPoint of Care Glucose Monitoring 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 | Point of care glucose monitoring 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 State...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time in Target Blood Glucose Range (BG 70-180mg/dL) | Percentage of time within time glucose range based on CGM readings | For duration of study enrollment (up to 10 days) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL) | Percentage 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) | Percentage 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) | Percentage 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) | Percentage 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 (\< 180 mg/dl) 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 (at day 10 or sooner) |
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 Associated With Glucose Monitoring | Patient reported pain associated with glucose monitoring | Assessed daily, For duration of study enrollment (up to 10 days) |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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)
Malcom Randall VA Medical CenterDexCom, Inc.Study Responsible Party
Andrew Franck, Principal Investigator, Primary Investigator, Malcom Randall VA Medical Center
No contact data.
1 Study Locations in 1 Countries
Florida
North Florida/South Georgia Veterans Health System, Gainesville, Florida, 32608, United States