OBJECTIVE To assess the efficacy and safety of fully closed-loop (FCL) compared with usual care (UC) glucose control in patients experiencing major abdominal surgery-related stress hyperglycaemia. SUMMARY BACKGROUND DATA Major abdominal surgery-related stress and periprocedural interventions predispose to perioperative hyperglycaemia, both in diabetes and non-diabetes patients. Insulin corrects hyperglycaemia effectively, but its safe use remains challenging. METHODS In this two-centre randomised controlled trial, we contrasted subcutaneous FCL with UC glucose management in patients undergoing major abdominal surgery anticipated to experience prolonged hyperglycaemia. FCL (CamAPS HX, Dexcom G6, mylife YpsoPump 1.5x) or UC treatment was used from hospital admission to discharge (max 20 d). Glucose control was assessed using continuous glucose monitoring (masked in the UC group). The primary outcome was the proportion of time with sensor glucose values in target range 5.6-10.0 mmol/L. RESULTS Thirty-seven surgical patients (54% pancreas, 22% liver, 19% upper gastrointestinal, 5% lower gastrointestinal), of whom 18 received FCL and 19 UC glucose management, were included in the analysis. Mean±SD percentage time with sensor glucose in target range was 80.1±10.0% in the FCL and 53.7±19.7% in the UC group (P<0.001). Mean±SD glucose was 7.5±0.5 mmol/L in the FCL and 9.1±2.4 mmol/L in the UC group (P=0.015). Time in hypoglycaemia (<3.0 mmol/L) was low in either group. No study-related serious adverse events occurred. CONCLUSIONS The FCL approach resulted in significantly better glycaemic control compared to UC management, without increasing the risk of hypoglycaemia. Automated glucose-responsive insulin delivery is a safe and effective strategy to minimise hyperglycaemia in complex surgical populations.

中文翻译：

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接受腹部大手术的成人围手术期全闭环与常规护理血糖管理 - 一项双中心随机对照试验。


目的 评估完全闭环 （FCL） 与常规护理 （UC） 血糖控制相比对腹部大手术相关应激性高血糖患者的疗效和安全性。摘要 背景数据 与腹部手术相关的主要压力和围手术期干预易导致围手术期高血糖，无论是在糖尿病患者还是在非糖尿病患者中。胰岛素可有效纠正高血糖，但其安全使用仍具有挑战性。方法 在这项双中心随机对照试验中，我们对比了接受腹部大手术预期会出现长期高血糖的患者的皮下 FCL 与 UC 葡萄糖管理。从入院到出院 （最大 20 d） 使用 FCL （CamAPS HX， Dexcom G6， mylife YpsoPump 1.5x） 或 UC 治疗。使用连续血糖监测评估血糖控制 （在 UC 组中设盲）。主要结局是传感器葡萄糖值在目标范围 5.6-10.0 mmol/L 的时间比例。结果 37 例手术患者 （54% 胰腺，22% 肝脏，19% 上消化道，5% 下消化道），其中 18 例接受 FCL 和 19 例 UC 葡萄糖管理，被纳入分析。FCL ±传感器葡萄糖在目标范围内的平均 SD 百分比时间为 80.1±10.0%，UC 组为 53.7±19.7% （P<0.001）。FCL 平均 ±SD 葡萄糖为 7.5±0.5 mmol/L，UC 组为 9.1±2.4 mmol/L （P=0.015）。两组低血糖时间 （<3.0 mmol/L） 均较短。未发生与研究相关的严重不良事件。结论与 UC 管理相比，FCL 方法的血糖控制明显更好，而不会增加低血糖的风险。 自动葡萄糖反应胰岛素输送是一种安全有效的策略，可最大限度地减少复杂手术人群的高血糖。