Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

NCT05442853 | Completed Results FDA Device

• 1 other identifier: 202201063
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperglycemia; Hypoglycemia; Critical Illness; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (16)

• Time in Clinically Significant Hypoglycemic Range (BG < 54 mg/dL)

  For duration of study enrollment (up to 10 days)

• Time in Hypoglycemic Range (BG 54-69 mg/dL)

  For duration of study enrollment (up to 10 days)

• Time in Hyperglycemic Range (BG 181-250 mg/dL)

  For duration of study enrollment (up to 10 days)

• Time in Clinically Relevant Hyperglycemic Range (BG >250 mg/dL)

  For duration of study enrollment (up to 10 days)

• ICU Length of Stay

  At time of ICU discharge or death (assessed up to 1 month)

Study Arms (2)

Continuous Glucose Monitoring

ACTIVE COMPARATOR

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.

Device: Continuous glucose monitoring

Point of Care Glucose Monitoring

ACTIVE COMPARATOR

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

Device: Point of care glucose monitoring

Interventions

Continuous glucose monitoring DEVICE

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.

Continuous Glucose Monitoring

Point of care glucose monitoring DEVICE

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.

Point of Care Glucose Monitoring

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Malcom Randall VA Medical Center: lead
• DexCom, Inc.: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Franck AJ, Hendrickson AL, Telford ED, Davids BL, Murray Casanova I, Rosen AN, Hadigal S, Ross RC. Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2025 Aug;168(2):326-335. doi: 10.1016/j.chest.2025.02.006. Epub 2025 Feb 15.

  PMID: 39956190 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia; Critical Illness; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Andrew J. Franck
• Organization: Malcom Randall VA Medical Center

Andrew.Franck@va.gov

3523761611

Study Officials

• Andrew J Franck, PharmD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 5, 2022
• Study Start: April 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)