Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Diabetes Mellitus Clinical Trial

Official title:

Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442853
• Other study ID #: 202201063
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: Malcom Randall VA Medical Center
• Contact: Andrew J Franck, PharmD
• Phone: 3523761611
• Email: Andrew.Franck[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Diabetes Mellitus
• Hyperglycemia
• Hypoglycemia

Intervention

Device:
• 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.
• 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 States.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Malcom Randall VA Medical Center	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in target blood glucose range (BG 70-180mg/dL)	Proportion of time within time glucose range based on CGM readings	For duration of study enrollment (up to 10 days)
Secondary	Time in clinically significant hypoglycemic range (BG < 54 mg/dL)	Proportion of time with BG less than 54 mg/dl as measured by CGM	For duration of study enrollment (up to 10 days)
Secondary	Time in hypoglycemic range (BG 54-69 mg/dL)	Proportion of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
Secondary	Time in hyperglycemic range (BG 181-250 mg/dL)	Proportion of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
Secondary	Time in clinically relevant hyperglycemic range (BG >250 mg/dL)	Proportion of time in this glucose range as measured by CGM	For duration of study enrollment (up to 10 days)
Secondary	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)
Secondary	ICU mortality	Death from any cause during ICU stay	At time of ICU discharge or death (assessed up to 1 month)
Secondary	30 day mortality	Death from any cause at 30 days after admission to the ICU	At 30 days or time of death
Secondary	Cost associated with monitoring	Monetary value assigned to blood glucose monitoring	For duration of study enrollment (up to 10 days)
Secondary	Mean blood glucose	Average blood glucose during the study timeframe	For duration of study enrollment (up to 10 days)
Secondary	Glucose variability	a. % coefficient of variation = SD/mean BG*100%	For duration of study enrollment (up to 10 days)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Pain Score	Pain based on Critical-Care Pain Observation Tool (CPOT) scores (0 to 8) with higher scores indicating more pain; or the Defense & Veterans Pain Rating Scale (DVPRS) score (0 to 10) with higher scores indicating more pain	Assessed daily, For duration of study enrollment (up to 10 days)