The Landmark JDRF Continuous Glucose Monitoring Randomized Trials: a Look Back at the Accumulated Evidence
Jaeb Center for Health Research, Tampa, FL 33647, USA.Journal of Cardiovascular Translational Research (Impact Factor: 3.02). 04/2012; 5(4):380-7. DOI: 10.1007/s12265-012-9364-9
Despite improvements for management of type 1 diabetes (T1D), patients have difficulty achieving glycated hemoglobin (A1c) levels recommended by the Diabetes Control and Complications Trial (DCCT). Two multicenter randomized trials were conducted to evaluate benefit of using a continuous glucose monitor (CGM) with standard glucose monitoring for T1D management. The primary study evaluated benefits of CGM in 322 patients with A1c >7.0%. The secondary study evaluated 129 patients with A1c <7.0%. In the primary study, CGM resulted in improvements in A1c at 6 m in subjects >25 years, but not those <25. However, all subjects using CGM regularly showed benefit. Improved A1c did not come with increased severe hypoglycemia as seen in the DCCT, and benefit was sustained over 1 year. In the secondary study, CGM use helped subjects maintain target A1c levels with reduced exposure to biochemical hypoglycemia. The data collected allowed for other analyses of important factors in T1D management.
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ABSTRACT: The use of continuous glucose monitoring (CGM) in the pediatric population is not well characterized. We have evaluated the use of CGM over a 12-month interval in youth with type 1 diabetes (TID) and have provided a description of CGM use. Eighty subjects 8-17 years old with T1D and baseline hemoglobin A1c (HbA1c) >or=7.0% used CGM as part of a 6-month randomized trial and subsequent 6-month extension study. Outcomes included frequency of CGM use, HbA1c levels, rate of severe hypoglycemia, and a CGM satisfaction scale. Seventy-six (95%) of 80 subjects were using CGM after 6 months (median use = 5.5 days/week) compared with 67 (84%) after 12 months (median use = 4.0 days/week). The 17 subjects using CGM >or=6 days/week in month 12 had substantially greater improvement from baseline in HbA1c than did the 63 subjects using CGM <6 days/week in month 12 (mean change - 0.8 +/- 0.6% vs. +0.1 +/- 0.7%, P < 0.001). They also reported greater satisfaction with use of CGM (P = 0.001). The incidence of severe hypoglycemic events was low during the 12 months of the study irrespective of the amount of CGM use. In youth with T1D, frequency of use decreases over time. Individuals who use CGM on a near-daily basis can have substantial improvement in glycemic control.
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