Comparison of the Clinical Information Provided by the FreeStyle Navigator Continuous Interstitial Glucose Monitor Versus Traditional Blood Glucose Readings

Background: The purpose of the analysis was to compare the clinical utility of data from traditional self-monitoring of blood glucose (SMBG) to that of continuous glucose monitoring (CGM). Methods: A clinical study of the clinical accuracy of the FreeStyle Navigator (R) CGM System (Abbott Diabetes Care, Alameda, CA), which includes SMBG capabilities, was conducted by comparison to the YSI blood glucose analyzer (YSI Inc., Yellow Springs, OH) using 58 subjects with type 1 diabetes. The Continuous Glucose-Error Grid Analysis (CG-EGA) was used as the analytical tool. Results: Using CG-EGA, the "clinically accurate,'' "benign errors,'' and "clinical errors'' were 86.8%, 8.7%, and 4.5% for SMBG and 92.7%, 3.7%, and 3.6% for CGM, respectively. If blood glucose is viewed as a process in time, SMBG would provide accurate information about this process 86.8% of the time, whereas CGM would provide accurate information about this process 92.7% of the time (P<0.0001). In the hypoglycemic range, however, SMBG is more accurate as the "clinically accurate,'' "benign errors,'' and "clinical errors'' were 83.5%, 6.4%, and 10.1% for SMBG and 57.1%, 8.4%, and 34.5% (P<0.0001) for CGM, respectively. Conclusions: While SMBG produces more accurate instantaneous glucose values than CGM, control of blood glucose involves a system in flux, and CGM provides more detailed insight into the dynamics of that system. In the normal and elevated glucose ranges, the additional information about the direction and rate of glucose change provided by the FreeStyle Navigator CGM System increases the ability to make correct clinical decisions when compared to episodic SMBG tests.