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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
Continuous glucose monitor
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Clarke Error Grid
Traditional comparison of glucose concentration results obtained by standard test methods and by newer method
Time frame: 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
Time frame: 6 months
Unplanned event frequency
Number of occurrences per patient of device failure or or unforeseen device removal
Time frame: 6 months
Adverse event nature and frequency
Number of occurrences per patient of device-associated infection, pain, or skin irritation
Time frame: 6 months
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