Continuous Glucose Monitoring in the Intensive Care Unit

Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation

The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: Dexcom G7 Continuous Glucose Monitor

Detailed Description

The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation).

Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.

• Persons with either type 1 or type 2 diabetes.
• Persons of either sex.
• Persons of any age over 18.
• Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent.
• English or Spanish speaking adults.

Exclusion Criteria:

• Persons unable to provide informed consent.
• Cognitively impaired persons whose LAR declines to provide informed consent.
• Patients receiving hydroxyurea, which interferes with sensor function.
• Patients receiving high dose acetaminophen (> 4 gm/day), which interferes with sensor function.
• Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.
• Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy.
• Persons who are pregnant.
• Prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; All members of the arm will have a CGM place and glucose concentration downloaded.	Diagnostic test: Dexcom G7 Continuous Glucose Monitor; Continuous glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clarke Error Grid	Traditional comparison of glucose concentration results obtained by standard test methods and by newer method	6 months
Mean Absolute Relative Difference (MARD).	Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned event frequency	Number of occurrences per patient of device failure or or unforeseen device removal	6 months
Adverse event nature and frequency	Number of occurrences per patient of device-associated infection, pain, or skin irritation	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: John P Mordes, MD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): July 25, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Hypoglycemia; Accuracy; ICU; CGM; Diabetes mellitus; Intensive care; Continuous glucose monitor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: STUDY00001138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study design and deidentified aggregate glucose concentration data will be shared. No individual patient data will be shared.
• IPD Sharing Time Frame: One year
• IPD Sharing Access Criteria: Publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No