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首页> 外文OA文献 >The SWITCH study (sensing with insulin pump therapy to control HbA 1c): Design and methods of a randomized controlled crossover trial on sensor-augmented insulin pump efficacy in type 1 diabetes suboptimally controlled with pump therapy
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The SWITCH study (sensing with insulin pump therapy to control HbA 1c): Design and methods of a randomized controlled crossover trial on sensor-augmented insulin pump efficacy in type 1 diabetes suboptimally controlled with pump therapy

机译：SWITCH研究（用胰岛素泵治疗控制HbA 1c的传感）：在泵治疗未达到最佳控制的1型糖尿病患者中，通过传感器增强的胰岛素泵疗效的随机对照试验的设计和方法

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Background: Studies investigating the effect of real-time continuous glucose monitoring (CGM) combined with pump therapy on glycemic outcomes in type 1 diabetes are increasing. Pump therapy is well established as a "gold standard" for insulin delivery, offering improvements over multiple daily insulin injections. However, there is still a proportion of subjects using continuous subcutaneous insulin infusion in whom goals for metabolic control are far from achieved or benefits of this type of insulin therapy are transient. The SWITCH (Sensing With Insulin pump Therapy to Control HbA1c [hemoglobin A1c]) study is a multicenter, randomized, controlled, crossover study to evaluate if adding CGM to experienced pump patients with suboptimal metabolic control will provide additional insight enabling clinical and therapeutic benefit. Methods: Subjects meeting the inclusion criteria were randomized to Sensor On or Sensor Off arms for 6 months, after a 1-month run-in period. Following a 4-month washout period, the subjects crossed over to the other study arm for 6 months. The primary end point was the between arm difference in HbA1c levels. Among others, additional end points include time spent in different glycemic ranges, percentage of patients with HbA1c <7%, number of hypoglycemic events, glucose variability parameters, safety outcomes, treatment satisfaction, and quality of life. Results: Recruitment occurred between January 2008 and February 2009. A total of 153 patients were randomized. Study completion is anticipated in July 2010. Conclusions: The results will establish if adding CGM to existing, capable, insulin pump users can enable better metabolic control. © Copyright 2011, Mary Ann Liebert, Inc. 2011.
机译：背景：有关实时连续血糖监测（CGM）结合泵浦疗法对1型糖尿病血糖预后的影响的研究正在增加。泵疗法已被公认是胰岛素输送的“黄金标准”，与每日多次胰岛素注射相比已有改善。然而，仍然有一部分受试者使用连续皮下胰岛素输注，但其代谢控制目标仍未实现，或者这种胰岛素治疗的益处是短暂的。 SWITCH（使用胰岛素泵疗法控制HbA1c [血红蛋白A1c]的传感）研究是一项多中心，随机，对照，交叉研究，旨在评估是否将CGM添加到代谢控制不佳的经验丰富的泵患者中是否将提供更多见识，从而带来临床和治疗益处。方法：经过1个月的磨合期后，将符合纳入标准的受试者随机分配到Sensor On（传感器打开）或Sensor Off（传感器关闭）两个月。经过4个月的冲洗期后，受试者跨到另一个研究组接受了6个月的治疗。主要终点是HbA1c水平之间的差异。除其他外，其他终点包括花费在不同血糖范围内的时间，HbA1c <7％的患者百分比，降血糖事件的数量，葡萄糖变异性参数，安全性结果，治疗满意度和生活质量。结果：招募发生在2008年1月至2009年2月。总共153例患者被随机分组​​。预计将于2010年7月完成研究。结论：将确定是否将CGM添加到现有的有能力的胰岛素泵使用者中，从而能够更好地控制代谢。 ©版权所有2011，Mary Ann Liebert，Inc. 2011。

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