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首页> 外文期刊>JAMA: the Journal of the American Medical Association >Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: A randomized clinical trial
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Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: A randomized clinical trial

机译：传感器增强型胰岛素泵治疗和自动胰岛素悬架对比标准胰岛素泵治疗对1型糖尿病患者低血糖的影响：一项随机临床试验

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IMPORTANCE: Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes. Sensor-augmented insulin pump with automated low-glucose insulin suspension has the potential to reduce the incidence of major hypoglycemic events. OBJECTIVE: To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial involving 95 patients with type 1 diabetes, recruited from December 2009 to January 2012 in Australia. INTERVENTIONS: Patients were randomized to insulin pump only or automated insulin suspension for 6 months. MAIN OUTCOMES AND MEASURES: The primary outcome was the combined incidence of severe (hypoglycemic seizure or coma) and moderate hypoglycemia (an event requiring assistance for treatment). In a subgroup, counterregulatory hormone responses to hypoglycemia were assessed using the hypoglycemic clamp technique. RESULTS: Of the 95 patients randomized, 49 were assigned to the standard-pump (pump-only) therapy and 46 to the low-glucose suspension group. The mean (SD) age was 18.6 (11.8) years; duration of diabetes, 11.0 (8.9) years; and duration of pump therapy, 4.1 (3.4) years. The baseline rate of severe and moderate hypoglycemic events in the pump-only group was 20.7 vs 129.6 events per 100 patient months in the low-glucose suspension group. After 6 months of treatment, the event rates decreased from 28 to 16 in the pump-only group vs 175 to 35 in the low-glucose suspension group. The adjusted incidence rate per 100 patient-months was 34.2 (95% CI, 22.0-53.3) for the pump-only group vs 9.5 (95% CI, 5.2-17.4) for the low-glucose suspension group. The incidence rate ratio was 3.6 (95% CI, 1.7-7.5; P <.001). There was no change in glycated hemoglobin in either group: mean, 7.4 (95% CI, 7.2-7.6) to 7.4 (95% CI, 7.2-7.7) in the pump-only group vs mean, 7.6 (95%, CI, 7.4-7.9) to 7.5 (95% CI, 7.3-7.7) in the low-glucose suspension group. Counterregulatory hormone responses to hypoglycemia were not changed. There were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis. CONCLUSIONS AND RELEVANCE: Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000024044.
机译：重要提示：低血糖症是1型糖尿病患者护理的关键障碍。具有自动低葡萄糖胰岛素悬浮液的传感器增强型胰岛素泵具有降低主要降血糖事件发生率的潜力。目的：确定与标准胰岛素泵疗法相比，低糖悬浮液传感器增强型泵严重和中度低血糖的发生率。设计，地点和参与者：2009年12月至2012年1月在澳大利亚进行的一项随机临床试验，涉及95名1型糖尿病患者。干预措施：将患者随机分为仅使用胰岛素泵或自动胰岛素悬浮液治疗6个月。主要结果和措施：主要结果是严重（低血糖发作或昏迷）和中度低血糖（需要协助治疗的事件）的合并发生率。在一个亚组中，使用降血糖钳技术评估了对低血糖的反调节激素反应。结果：在随机分组的95例患者中，有49例被分配为标准泵（仅泵）治疗，而46例被分配为低糖悬液治疗组。平均（SD）年龄为18.6（11.8）岁;糖尿病持续时间11.0（8.9）年;和泵浦疗法的持续时间为4.1（3.4）年。单纯抽血组的严重和中度降血糖事件的基线发生率为20.7，而低糖悬浮液组为每100个患者月129.6事件。治疗6个月后，单纯抽血组的发生率从28降至16，而低糖悬浮液组的发生率从175降至35。单纯泵组的调整后发病率是每100个患者月34.2（95％CI，22.0-53.3），而低糖混悬液组为9.5（95％CI，5.2-17.4）。发生率为3.6（95％CI，1.7-7.5; P <.001）。两组糖化血红蛋白均无变化：仅泵组的平均值为7.4（95％CI，7.2-7.6）至7.4（95％CI，7.2-7.7），而平均值为7.6（95％CI，7.2-7.6），低糖悬浮液组中的7.4-7.9）至7.5（95％CI，7.3-7.7）。对低血糖的反调节激素反应未改变。没有糖尿病酮症酸中毒或高血糖合并酮症的发作。结论和相关性：传感器增强的泵治疗与自动胰岛素悬浮液可降低1型糖尿病患者重度和中度低血糖的综合发生率。试用注册：anzctr.org.au标识符：ACTRN12610000024044。

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