Clinical trial NCT05442853: Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Official title: Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Hypoglycemia
Critical Illness
Diabetes Mellitus
Lead sponsor: Malcom Randall VA Medical Center
Sponsor class: FED
Collaborators: name: DexCom, Inc.
First posted: 2022-07-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time in Target Blood Glucose Range (BG 70-180mg/dL)
timeFrame: For duration of study enrollment (up to 10 days)
Secondary outcomes:
measure: Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)
timeFrame: For duration of study enrollment (up to 10 days)
measure: Time in Hypoglycemic Range (BG 54-69 mg/dL)
timeFrame: For duration of study enrollment (up to 10 days)
measure: Time in Hyperglycemic Range (BG 181-250 mg/dL)
timeFrame: For duration of study enrollment (up to 10 days)
measure: Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)
timeFrame: For duration of study enrollment (up to 10 days)
measure: ICU Length of Stay
timeFrame: At time of ICU discharge or death (assessed up to 1 month)
measure: ICU Mortality
timeFrame: At time of ICU discharge or death (assessed up to 1 month)
measure: 30 Day Mortality
timeFrame: At 30 days or time of death
measure: Cost Associated With Monitoring
timeFrame: For duration of study enrollment (up to 10 days)
measure: Mean Blood Glucose
timeFrame: For duration of study enrollment (up to 10 days)
measure: Glucose Variability
timeFrame: For duration of study enrollment (up to 10 days)
measure: Patient Satisfaction
timeFrame: Once at completion of study enrollment (at day 10 or sooner)
measure: New Infection
timeFrame: Assessed daily, For duration of study enrollment (up to 10 days)
measure: New Acute Kidney Injury
timeFrame: Assessed daily, For duration of study enrollment (up to 10 days)
measure: ICU Delirium
timeFrame: Assessed daily, For duration of study enrollment (up to 10 days)
measure: Agitation
timeFrame: Assessed daily, For duration of study enrollment (up to 10 days)
measure: Pain Associated With Glucose Monitoring
timeFrame: Assessed daily, For duration of study enrollment (up to 10 days)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: US Department of Veterans Affairs
name: Andrew J Franck, PharmD
role: PRINCIPAL_INVESTIGATOR
References: