UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
NCT Number: NCT06190808
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01605, United States
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
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.
Exclusion criteria
Continuous glucose monitor
Time frame: 6 months
Traditional comparison of glucose concentration results obtained by standard test methods and by newer method
Time frame: 6 months
Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device
Time frame: 6 months
Number of occurrences per patient of device failure or or unforeseen device removal
Time frame: 6 months
Number of occurrences per patient of device-associated infection, pain, or skin irritation
University of Massachusetts, Worcester
Other
Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation
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