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Completed

NCT Number: NCT06190808

Continuous Glucose Monitoring in the Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom G7 Continuous Glucose Monitor

Diagnostic Test

Continuous glucose monitor

Primary outcomes

  1. Clarke Error Grid

    Time frame: 6 months

    Traditional comparison of glucose concentration results obtained by standard test methods and by newer method

  2. Mean Absolute Relative Difference (MARD).

    Time frame: 6 months

    Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device

Secondary outcomes

  1. Unplanned event frequency

    Time frame: 6 months

    Number of occurrences per patient of device failure or or unforeseen device removal

  2. Adverse event nature and frequency

    Time frame: 6 months

    Number of occurrences per patient of device-associated infection, pain, or skin irritation

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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