Managed Care - August 2008 - (Page 43) dicated that the device was easy to learn (115/130), the glucose alarms were easy to interpret (117/125), and the device helped them to understand their blood sugars (121/129). DISCUSSION This study demonstrated the safe and effective use of the FreeStyle Navigator Continuous Monitoring System by adults with type 1 or type 2 diabetes mellitus in a home-use setting. The participants in the study reported a high level of satisfaction and TABLE 3 Results of subject questionnaire ease of use of the FreeStyle Navigator system and an ability to understand the alarm features. This and other studies show that CGM enables better glycemic control in patients with type 1 or 2 diabetes mellitus who require insulin (Garg 2006, Deiss 2006, DirectNet 2007, Bode 2005, Bode 2004, Hirsch 2007). It is logical to assume that improved glycemic control may result in improved outcomes and the potential for decreased use of medical intervention over the long term. However, in the absence of long-term, large, randomized controlled studies of CGM, clinical and economic benefits must be extrapolated from available data. The potential for economic benefit with use of CGM in carefully selected patient populations is high. Reduced variability in glycemic control may lead to decreased use of acute care services for hypoglycemia in the short-term. In the long term, financial savings may result from improved clinical outcomes and decreased use Questions Overall percent in agreement* n=131 76.3 63.4 73.3 79.4 88.5 88.4 88.5 84.6 90.2 90.3 88.5 93.6 93.8 87.7 46.2 60.0 80.0 53.1 83.2 69.2 91.6 76.3 73.3 96.9 80.2 81.7 Mean score 2.7 3.0 2.8 2.6 2.0 2.0 1.9 2.2 1.9 1.9 2.0 1.7 1.7 1.9 3.6 3.1 2.2 3.5 2.2 2.9 1.9 2.5 2.6 1.6 2.2 2.2 Appearance General appearance of the on-body device is acceptable Overall size of the on-body device is acceptable The receiver size and shape is acceptable Receiver display and function The system is easy to carry around with me The system is easy to learn The receiver display is easy to read The receiver menus are easy to follow The menu choices are satisfactory It is easy to change the settings in the Navigator It is easy to review reports and glucose history It is easy to understand messages and alarms on the receiver It is easy to interpret glucose alarms The information from the system helps understand blood sugars General Blood glucose tests with the FreeStyle test strips in the Navigator are easy Waiting 10 hrs for the system to show real data is acceptable Calibrating the system at 10/12/24/72 hours is acceptable I found insertion site choices acceptable The system performed without errors Adhesive performance The adhesive is comfortable on my skin The adhesive does not peel away from my skin prematurely The adhesive is removed from my skin with minimal pain General wear The transmitter is comfortable during normal activity The transmitter is comfortable during sleep Ease of application The mount is easy to apply to the skin The inserter is no more painful than doing a finger-prick The bleeding from the insertion is acceptable * Response ranked as 1, 2 or 3 on a scale of 1 (strongly agree) to 6 (strongly disagree) AUGUST 2008 / MANAGED CARE 43
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