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The results of the landmark clinical trial demonstrated that sensor-augmented pump therapy improves glycemic control significantly in adult and pediatric subjects with inadequately controlled type 1 diabetes as compared to insulin therapy.
Panel FCCaCTD. FDA Executive Summary. Dexcom G5 Mobile Continuous Glucose Monitoring System, Dexcom, Inc. July 21, 2016 meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel P120005/S041.
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The randomized clinical multi-center trial results demonstrated the improvement in glycemic control for subjects with T1D using MDI therapy with CGM as compared to no CGM use
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The subgroup analysis from the DIAMOND Trial showed favorable impact of CGM use in improving HbA1c in subjects with T1D and T2D on MDI as compared to non-CGM use while managing diabetes.
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•• Foster NC, Miller KM, Tamborlane WV, Bergenstal RM, Beck RW, TID Exchange Network. Continuous glucose monitoring in patients with type 1 diabetes using insulin injections. Diabetes Care. 2016;39(6):e81–2.
The TIDExchange Registry data suggest that CGM can be beneficial for insulin injection users across all age-groups to achieve optimized metabolic control of TID.
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The study by Garg et al. presents findings from the first FDA approved hybrid closed-loop system in the USA
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The overview of insulin analog use in pumps, findings from the innovative ultra-fast acting insulin analog research and their integration in to the closed-loop system are summarized
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• Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015;38(6):971–8.
The T1D Exchange Registry data by Miller et al. investigated the current status of glycemic control in subjects with T1D in the USA and revealed that 70% of patients have inadequate glycemic control
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