DOI: 10.2337/dc06-1361 © 2006 by the American Diabetes Association
Relationship of Fasting and Hourly Blood Glucose Levels to HbA1c ValuesSafety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor
1 Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver and Health Sciences Center, Aurora, Colorado Address correspondence and reprint requests to Satish Garg, MD, Professor of Medicine and Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver and Health Sciences Center, 1775 N. Ursula St. A140, Aurora, CO 80010. E-mail: satish.garg{at}uchsc.edu OBJECTIVEIn this study, we evaluated the safety and efficacy of 7-day transcutaneous, real-time, continuous glucose monitoring (CGM) in subjects with insulin-requiring diabetes. RESEARCH DESIGN AND METHODSEighty-six subjects were enrolled at five U.S. centers. Subjects wore a sensor inserted under the skin of the abdomen for 7 days during each of three consecutive periods. Data were blinded during period 1 and unblinded during periods 2 and 3.
RESULTSOf the 6,811 matched self-monitoring of blood glucose to sensor values prospectively analyzed, 97.2% fell in the Clarke error grid zones A and B, and median absolute relative difference was 11.4%. After unblinding, subjects reduced time spent at <55 mg/dl by 0.3 h/day, reduced time spent at >240 mg/dl by 1.5 h/day, and increased time in the target zone (81140 mg/dl) by 1.4 h/day (P < 0.05 for all three comparisons). Improvements were seen in both types 1 and 2 diabetes and with use of both multiple daily injections and continuous subcutaneous insulin infusion. Modal day graphs were generated in six groups of subjects based on HbA1c (A1C) ( CONCLUSIONSThis is the first report of a real-time, transcutaneous glucose sensor that functioned for 7 days. The use of CGM in the unblinded phase resulted in improvements in target-range glycemia across all A1C values.
Abbreviations: ARD, absolute relative difference CGM, continuous glucose monitoring CSII, continuous subcutaneous insulin infusion MDI, multiple daily injections SMBG, self-monitoring of blood glucose
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