Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Not Applicable

Completed

Conditions: Hyperglycemia
Hypoglycemia
Diabetes Mellitus
Critical Illness

Interventions: Device: Continuous glucose monitoring
Device: Point of care glucose monitoring

Registration Number: NCT05442853

Lead Sponsor: Malcom Randall VA Medical Center

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 target range (blood glucose 70-180 mg/dL).

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring	Continuous 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.
Point of Care Glucose Monitoring	Point 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

Primary Outcome Measures

Name	Time	Method
Time in Target Blood Glucose Range (BG 70-180mg/dL)	For duration of study enrollment (up to 10 days)	Percentage of time within time glucose range based on CGM readings

Secondary Outcome Measures

Name	Time	Method
Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)	For duration of study enrollment (up to 10 days)	Percentage of time with BG less than 54 mg/dl as measured by CGM
Time in Hypoglycemic Range (BG 54-69 mg/dL)	For duration of study enrollment (up to 10 days)	Percentage of time in this glucose range as measured by CGM
Time in Hyperglycemic Range (BG 181-250 mg/dL)	For duration of study enrollment (up to 10 days)	Percentage of time in this glucose range as measured by CGM
Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)	For duration of study enrollment (up to 10 days)	Percentage of time in this glucose range as measured by CGM
ICU Length of Stay	At time of ICU discharge or death (assessed up to 1 month)	Total time (in days or hours) in the intensive care unit
ICU Mortality	At time of ICU discharge or death (assessed up to 1 month)	Death from any cause during ICU stay
30 Day Mortality	At 30 days or time of death	Death from any cause at 30 days after admission to the ICU
Cost Associated With Monitoring	For duration of study enrollment (up to 10 days)	Monetary value assigned to blood glucose monitoring
Mean Blood Glucose	For duration of study enrollment (up to 10 days)	Average blood glucose (\< 180 mg/dl) during the study timeframe
Glucose Variability	For duration of study enrollment (up to 10 days)	a. % coefficient of variation = SD/mean BG\*100%
Patient Satisfaction	Once at completion of study enrollment (at day 10 or sooner)	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.'
New Infection	Assessed daily, For duration of study enrollment (up to 10 days)	Any infection diagnosis that was not present upon admission to the ICU
New Acute Kidney Injury	Assessed daily, For duration of study enrollment (up to 10 days)	New acute kidney injury (based on Acute Kidney Injury Network guideline definitions) not present upon admission to the ICU
ICU Delirium	Assessed daily, For duration of study enrollment (up to 10 days)	Development of ICU delirium, based on Confusion Assessment Method for the ICU (CAM-ICU) score, with any positive score indicating presence of delirium.
Agitation	Assessed daily, For duration of study enrollment (up to 10 days)	Richmond agitation scores (-5 to +4), with scores of +2 or more indicated agitation.
Pain Associated With Glucose Monitoring	Assessed daily, For duration of study enrollment (up to 10 days)	Patient reported pain associated with glucose monitoring