Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.
BACKGROUND: Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital. METHODS: In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients. RESULTS: On nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported. CONCLUSIONS: Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.).
背景：最近的研究表明，人工胰腺系统可以改善血糖控制并减少夜间低血糖。但是，尚不清楚这些结果是否可以在医院以外的环境中得到复制。
方法：在这项多中心、多国、随机、交叉试验中，我们评估了人工胰腺系统在糖尿病营地中控制 10 至 18 岁 1 型糖尿病患者夜间血糖水平的短期安全性和疗效。在两个连续的夜间，我们随机将 56 名患者分配到第一晚接受人工胰腺治疗，第二晚接受传感器增强型胰岛素泵（对照）治疗，或在第一晚和第二晚以相反的顺序接受治疗。因此，所有患者均以随机分配的顺序接受每种治疗。主要终点是低血糖事件的数量（定义为传感器血糖值低于 63mg/dL[3.5mmol/L]至少 10 分钟）、血糖水平低于 60mg/dL（3.3mmol/L）的时间以及每位患者的平均夜间血糖水平。
结果：与使用传感器增强型胰岛素泵的夜晚相比，使用人工胰腺的夜晚夜间血糖水平低于 63mg/dL（7 次与 22 次）的次数明显减少，血糖水平低于 60mg/dL（P=0.003 和 P=0.02，分别在多重调整后）的时间段明显缩短。个体平均夜间血糖水平的中位数分别为 126.4mg/dL（四分位距，115.7 至 139.1[7.0mmol/L；四分位距，6.4 至 7.7]），人工胰腺为 140.4mg/dL（四分位距，105.7 至 167.4[7.8mmol/L；四分位距，5.9 至 9.3]）与传感器增强型泵。未报告严重不良事件。
结论：在糖尿病营地中接受人工胰腺系统治疗的患者夜间低血糖发生率较低，血糖控制较使用传感器增强型胰岛素泵更为严格。（由 Sanofi 等人资助；ClinicalTrials.gov 编号，NCT01238406。）
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