Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
NCT05442853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2025-04-08
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
Interventions
- 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.
- DEVICE
-
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.
Sponsors & Collaborators
-
DexCom, Inc.
collaborator INDUSTRY -
Malcom Randall VA Medical Center
lead FED
Principal Investigators
-
Andrew J Franck, PharmD · US Department of Veterans Affairs
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2024-06-30
- Completion
- 2024-08-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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