OBJECTIVE We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 ± 2.3 years, HbA1c 7.5 ± 0.5% [58.5 ± 5.5 mmol/mol]) underwent two 27-h inpatient periods with unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals. We compared Faster-CL and Standard-CL in random order. During both interventions, the fuzzy-logic control algorithm DreaMed GlucoSitter was used. Glucose sensor data were analyzed by intention-to-treat principle with the difference (between Faster-CL and Standard-CL) in proportion of time in range 70-180 mg/dL (TIR) over 27 h as the primary end point. RESULTS The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL (P = 0.170). The proportion of time in hypoglycemia <70 mg/dL was 0.0% for both groups. Baseline-adjusted interstitial prandial glucose increments 1 h after meals were greater in Faster-CL compared with Standard-CL (P = 0.017). The gaps between measured plasma insulin and estimated insulin-on-board levels at the beginning, at the end, and 2 h after the exercise were smaller in the Standard-CL group (P = 0.029, P = 0.003, and P = 0.004, respectively). No severe adverse events occurred. CONCLUSIONS Fully closed-loop insulin delivery using either faster or standard insulin aspart was safe and efficient in achieving near-normal glucose concentrations outside postprandial periods. The closed-loop algorithm was better adjusted to the standard insulin aspart.

中文翻译：

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在1型糖尿病的日夜全封闭胰岛素疗法中，与标准的门冬胰岛素相比，速度更快：双盲随机交叉试验。

目的我们评估了使用快速（Faster-CL）与标准门冬胰岛素（Standard-CL）相比，在1型糖尿病青年中使用日夜全闭环胰岛素治疗的安全性和有效性。研究设计和方法在一项双盲，随机，交叉试验中，对20位接受胰岛素泵治疗的1型糖尿病参与者（11名女性，年龄21.3±2.3岁，HbA1c 7.5±0.5％[58.5±5.5 mmol / mol]）进行了研究。在两个27小时的住院期间，进行了不通知的下午中度剧烈运动和不通知/未发现的进餐。我们以随机顺序比较了Faster-CL和Standard-CL。在这两种干预措施中，都使用了模糊逻辑控制算法DreaMed GlucoSitter。通过意向性治疗原理分析葡萄糖传感器数据，以27小时内70-180 mg / dL（TIR）范围内的时间比例（Faster-CL和Standard-CL之间的差异）为主要终点。结果两组的TIR比例相似：在Faster-CL中为53.3％（过夜83％），在Standard-CL中为57.9％（过夜88％）（P = 0.170）。两组<70 mg / dL的低血糖时间比例为0.0％。与标准CL相比，Faster-CL进餐后1小时经基线调整的间质餐中葡萄糖增量更大（P = 0.017）。在标准-CL组中，运动开始，结束和运动后2小时测得的血浆胰岛素与估计的车载胰岛素水平之间的差距较小（P = 0.029，P = 0.003和P = 0.004，分别）。没有发生严重的不良事件。结论使用较快或标准的门冬胰岛素进行全闭环胰岛素输送，可安全，有效地在餐后时段达到接近正常的葡萄糖浓度。更好地将闭环算法调整为标准的门冬胰岛素。