OBJECTIVE Perioperative management of glucose levels remains challenging. We aimed to assess whether fully closed-loop subcutaneous insulin delivery would improve glycemic control compared with standard insulin therapy in insulin-requiring patients undergoing elective surgery. RESEARCH DESIGN AND METHODS We performed a single-center, open-label, randomized controlled trial. Patients with diabetes (other than type 1) undergoing elective surgery were recruited from various surgical units and randomly assigned using a minimization schedule (stratified by HbA1c and daily insulin dose) to fully closed-loop insulin delivery with fast-acting insulin aspart (closed-loop group) or standard insulin therapy according to local clinical practice (control group). Study treatment was administered from hospital admission to discharge (for a maximum of 20 days). The primary end point was the proportion of time with sensor glucose in the target range (5.6–10.0 mmol/L). RESULTS Forty-five patients were enrolled and assigned to the closed-loop (n = 23) or the control (n = 22) group. One patient (closed-loop group) withdrew from the study before surgery and was not analyzed. Participants underwent abdominal (57%), vascular (23%), orthopedic (9%), neuro (9%), or thoracic (2%) surgery. The mean proportion of time that sensor glucose was in the target range was 76.7 ± 10.1% in the closed-loop and 54.7 ± 20.8% in the control group (mean difference 22.0 percentage points [95% CI 11.9; 32.0%]; P < 0.001). No episodes of severe hypoglycemia (<3.0 mmol/L) or hyperglycemia with ketonemia or any study-related adverse events occurred in either group. CONCLUSIONS In the context of mixed elective surgery, the use of fully closed-loop subcutaneous insulin delivery improves glucose control without a higher risk of hypoglycemia.

中文翻译：

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择期手术患者围手术期全闭环胰岛素给药：一项开放标签、随机对照试验

目的 围手术期血糖水平管理仍然具有挑战性。我们的目的是评估在接受择期手术的需要胰岛素的患者中，与标准胰岛素治疗相比，完全闭环皮下注射胰岛素是否会改善血糖控制。研究设计和方法 我们进行了一项单中心、开放标签、随机对照试验。接受择期手术的糖尿病患者（1 型除外）从不同的手术单元招募，并使用最小化时间表（按 HbA1c 和每日胰岛素剂量分层）随机分配到使用速效门冬胰岛素的全闭环胰岛素给药组（闭环环组）或根据当地临床实践的标准胰岛素治疗（对照组）。研究治疗从入院到出院进行（最多 20 天）。主要终点是传感器葡萄糖在目标范围内的时间比例（5.6-10.0 mmol/L）。结果 45 名患者入组并分配到闭环组（n = 23）或对照组（n = 22）。一名患者（闭环组）在手术前退出研究，未进行分析。参与者接受了腹部 (57%)、血管 (23%)、骨科 (9%)、神经 (9%) 或胸部 (2%) 手术。传感器葡萄糖在目标范围内的平均时间比例在闭环中为 76.7 ± 10.1%，在对照组中为 54.7 ± 20.8%（平均差 22.0 个百分点 [95% CI 11.9; 32.0%]；P < ; 0.001)。两组均未发生严重低血糖（<3.0 mmol/L）或高血糖伴酮血症或任何与研究相关的不良事件。结论 在混合择期手术的背景下，