Continuous Glucose Monitoring in the Intensive Care Unit

NCT06190808 | Completed FDA Device

• 1 other identifier: STUDY00001138
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

ICU; CGM; Accuracy; Diabetes; Hypoglycemia; Diabetes mellitus; Continuous glucose monitor; Intensive care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Unplanned event frequency

  6 months

• Adverse event nature and frequency

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

All members of the arm will have a CGM place and glucose concentration downloaded.

Diagnostic Test: Dexcom G7 Continuous Glucose Monitor

Interventions

Dexcom G7 Continuous Glucose Monitor DIAGNOSTIC_TEST

Continuous glucose monitor

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John P Mordes, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Medicine

Model Details: Hyperglycemic patients admitted to an intensive care unit will have blood glucose concentration measured using current standard-of-care tests (fingerstick determinations and laboratory assays). Study participants will bel be asked to volunteer to permit concurrent glucose measurement using a Dexcom G7 continuous glucose monitor in order to determine the accuracy and feasibility of the latter. Only standard glucose measurements will be used for patient management.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: February 20, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year
• Access Criteria: Publication

Locations

US (1)