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¹ LifeScan data on file: Self-monitoring of blood glucose study number 1: The Ability of People with Diabetes to Use OneTouch® UltraSmart® to Improve Glycemic Control Through Behavioral and Therapeutic Changes (RPT 1039775, Nov. 2004) and Addendum #1 (Nov. 2005). A 20 week, multicenter, randomized clinical trial compared adult and pediatric subjects with type 1 and type 2 diabetes and A1c > 8.0%, followed by a 46 week nonrandomized observational study. Patients were randomized to use the OneTouch® UltraSmart® Meter (n=113) or conventional meters and paper logbooks (n=93). Both groups received monthly counseling from health care providers during the 20 week clinical trial and returned to usual care during the observational follow up. In the 20 week study, both groups saw a reduction in A1c; however, the reduction in the OneTouch® UltraSmart® Group was significantly greater (-0.6 vs. -0.4) (p = 0.03). In the observational study, subjects who chose to continue with the OneTouch® UltraSmart® Meter (n=42) showed a sustained reduction in A1c over subjects who chose to continue with conventional meters and paper logbooks (n=28), (8.47 vs 9.25, p=0.006). The study did not evaluate whether this change in A1c will result in improved health outcomes.
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