Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
JAMA. 2013 Sep 25;310(12):1240-7. doi: 10.1001/jama.2013.277818.
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.
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.
Patients were randomized to insulin pump only or automated insulin suspension for 6 months.
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.
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.
Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes.
anzctr.org.au Identifier: ACTRN12610000024044.
低血糖是 1 型糖尿病患者护理的一个关键障碍。具有自动低血糖胰岛素暂停功能的传感器增强型胰岛素泵有可能降低严重低血糖事件的发生率。
确定与标准胰岛素泵治疗相比，具有低血糖暂停功能的传感器增强型泵治疗时严重和中度低血糖的发生率。
设计、地点和参与者：这是一项随机临床试验，涉及 2009 年 12 月至 2012 年 1 月期间在澳大利亚招募的 95 名 1 型糖尿病患者。
患者被随机分配接受仅胰岛素泵或自动胰岛素暂停治疗 6 个月。
主要结局是严重（低血糖性癫痫或昏迷）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，使用低血糖钳夹技术评估了低血糖时的代偿性激素反应。
在 95 名随机患者中，49 名被分配到标准泵（仅泵）治疗组，46 名被分配到低血糖暂停组。平均（SD）年龄为 18.6（11.8）岁；糖尿病病程为 11.0（8.9）年；泵治疗时间为 4.1（3.4）年。仅泵组的严重和中度低血糖事件基线发生率为 20.7 次/100 患者月，而低血糖暂停组为 129.6 次/100 患者月。治疗 6 个月后，仅泵组的事件发生率从 28 次/100 患者月降至 16 次/100 患者月，而低血糖暂停组从 175 次/100 患者月降至 35 次/100 患者月。调整后的每 100 患者月发病率为 34.2（95%CI，22.0-53.3），低血糖暂停组为 9.5（95%CI，5.2-17.4）。发病率比为 3.6（95%CI，1.7-7.5；P<.001）。两组糖化血红蛋白均无变化：仅泵组为 7.4（95%CI，7.2-7.6）至 7.4（95%CI，7.2-7.7），低血糖暂停组为 7.6（95%CI，7.4-7.9）至 7.5（95%CI，7.3-7.7）。低血糖时的代偿性激素反应没有改变。无糖尿病酮症酸中毒或高血糖伴酮症的发作。
具有自动胰岛素暂停功能的传感器增强型泵治疗可降低 1 型糖尿病患者严重和中度低血糖的综合发生率。
anzctr.org.au 标识符：ACTRN12610000024044。
