Herzig David, Suhner Simon, Roos Jonathan, Schürch Daniel, Cecchini Luca, Nakas Christos T, Weiss Salome, Kadner Alexander, Kocher Gregor J, Guensch Dominik P, Wilinska Malgorzata E, Raabe Andreas, Siebenrock Klaus A, Beldi Guido, Gloor Beat, Hovorka Roman, Vogt Andreas P, Bally Lia
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, University Hospital of Bern, Bern, Switzerland.
Department of Anaesthesiology and Pain Medicine, University Hospital of Bern, Bern, Switzerland.
Diabetes Care. 2022 Sep 1;45(9):2076-2083. doi: 10.2337/dc22-0438.
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.
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).
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.
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.
围手术期血糖水平的管理仍然具有挑战性。我们旨在评估在接受择期手术的胰岛素依赖患者中，与标准胰岛素治疗相比，完全闭环皮下胰岛素输注是否能改善血糖控制。
我们进行了一项单中心、开放标签、随机对照试验。从各个外科科室招募接受择期手术的非1型糖尿病患者，并根据最小化方案（按糖化血红蛋白和每日胰岛素剂量分层）随机分配至使用速效门冬胰岛素进行完全闭环胰岛素输注组（闭环组）或根据当地临床实践进行标准胰岛素治疗组（对照组）。研究治疗从入院至出院（最长20天）。主要终点是传感器葡萄糖处于目标范围（5.6 - 10.0 mmol/L）的时间比例。
45例患者入组并被分配至闭环组（n = 23）或对照组（n = 22）。1例患者（闭环组）在手术前退出研究，未纳入分析。参与者接受腹部手术（57%）、血管手术（23%）、骨科手术（9%）、神经外科手术（9%）或胸科手术（2%）。闭环组传感器葡萄糖处于目标范围的平均时间比例为76.7 ± 10.1%，对照组为54.7 ± 20.8%（平均差值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）或伴有酮血症的高血糖事件或任何与研究相关的不良事件。
在混合择期手术的背景下，使用完全闭环皮下胰岛素输注可改善血糖控制，且低血糖风险未增加。
