AIMS To compare closed-loop (CL) and open-loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real-life challenging situations (gastronomic dinners or sustained physical exercise). METHODS Thirty-eight adult patients with T1D were included in a three-armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72-hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4-7.8 mmol/L and 3.9-10.0 mmol/L, and time in hypo- and hyperglycaemia. RESULTS Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups. CONCLUSIONS The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.

中文翻译：

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Diabeloop闭环系统可改善患有美食晚餐或持续体育锻炼的1型糖尿病患者的血糖控制效果。

目的比较暴露于现实生活中极富挑战性情况（美食晚餐或持续体育锻炼）的1型糖尿病（T1D）患者的血糖控制的闭环（CL）和开环（OL）系统。方法在三组随机先导试验（Diabeloop WP6.2试验）中纳入三十八名成人T1D患者，比较三组中的一组在两个交叉72小时内使用CL系统和OL装置进行血糖控制的情况。以下情况：丰盛的（美食）晚餐；持续反复进行体育锻炼（食物摄入不受控制）；或控制（休息条件）。结果包括花费在4.4-7.8 mmol / L和3.9-10.0 mmol / L的葡萄糖范围内的时间，以及低血糖和高血糖的时间。结果过夜花费的时间介于4.4到7之间。CL时为8 mmol / L更长（平均值：63.2％，而OL为40.9％； P≤.0001）。对于CL而言，白天花费的时间在3.9至10.0 mmol / L范围内也更长（OL为79.4％，OL为64.1％； P≤.0001）。与使用OL系统的参与者相比，使用CL系统的参与者在白天进行高血糖游览（葡萄糖> 10.0 mmol / L）的时间要短于使用OL系统的参与者（17.9％vs 31.9％; P≤.0001），并且美食晚餐和体育锻炼亚组中使用CL系统的患者发生高血糖偏移的当天与对照组亚组的发生幅度相似（分别为18.1±6.3％，17.2±8.1％和18.4±12.5％）。最后，在低血糖症患者中花费的时间很短，两组之间没有显着差异。