We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of accuracy.
Critically ill patients treated with intensive insulin therapy will be monitored for up to 72 hours with the Freestyle Navigator continuous glucose monitor. The device display will be disabled so that continuous glucose monitoring results will not be available to care givers, although low (\<60 mg/dL) and high (\>250 mg/dL) threshold audio alarms will be enabled. Blood glucose monitoring will be performed according to the usual practice for patients treated with intensive insulin therapy in each intensive care unit, except that additional blood glucose measurements will be performed in response to Freestyle Navigator threshold alarm. All blood glucose management decisions will be made according to intensive insulin therapy protocol in each unit. Freestyle Navigator data will be downloaded from the device after each subject has completed the monitoring period. Blood glucose values obtained in the course of usual care, or in response to Freestyle Navigator threshold alarms, will be compared with time-matched Freestyle Navigator values to assess device accuracy and alarm sensitivity and specificity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
76
Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Massachusetts General Hospital
Boston, Massachusetts, United States
Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).
Time frame: 72 hours
Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).
Time frame: 72 hours
Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values
Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values
Time frame: 72 hours
Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)
Time frame: 72 hours
Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)
Time frame: 72 hours
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:
Percentage of readings in different blood sugar ranges as shown by point of care testing: \< 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl \>240 mg/dl
Time frame: 72 hours
Navigator CGM Accuracy by Category
Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)
Time frame: 72 hours
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