Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.
Lancet Diabetes Endocrinol. 2019 May;7(5):368-377. doi: 10.1016/S2213-8587(19)30061-0. Epub 2019 Mar 29.
Glucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both.
We did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6-10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565.
Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5-45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group.
Closed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital.
Diabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes.
在需要医院营养支持的患者中，血糖管理极具挑战。我们旨在评估全闭环胰岛素输注与常规皮下胰岛素治疗相比，在接受肠内或肠外营养或两者联合治疗的住院患者中是否能改善血糖控制。
我们在英国和瑞士的两家中心进行了一项开放标签、随机对照试验，纳入了需要皮下胰岛素治疗且接受肠内或肠外营养（或两者联合）的成年住院患者。从非重症监护外科和内科病房招募的患者，按照计算机生成的最小化方案（按营养支持类型[肠外营养有或无]和研究前每日总胰岛素剂量[<50 或≥50 单位]分层）进行 1:1 随机分组，分别接受速效门冬胰岛素的全闭环胰岛素输注（闭环组）或根据当地临床实践进行常规皮下胰岛素治疗（对照组）。对照组中的连续血糖监测对患者、病房工作人员和研究者均设盲。患者的随访时间最长为 15 天或直至出院。主要终点是传感器葡萄糖浓度处于目标范围内的时间比例（5.6-10.0mmol/L），在意向治疗人群中进行评估。这项试验在 ClinicalTrials.gov 注册，编号为 NCT01774565。
2018 年 2 月 8 日至 2018 年 9 月 21 日，共有 90 名患者接受了入组评估，其中 43 名符合条件并被纳入研究，随机分配至闭环组（n=21）或对照组（n=22）。闭环组传感器葡萄糖处于目标范围内的时间比例为 68.4%[标准差 15.5]，对照组为 36.4%[26.6]（差值为 32.0 个百分点[95%CI 18.5-45.5；p<0.0001]）。两组各有 1 例严重不良事件（对照组 1 例心脏骤停，闭环组 1 例急性呼吸衰竭），均与研究干预无关。两组均无与研究干预相关的不良事件。两组均未发生严重低血糖或高血糖伴酮血症。
闭环胰岛素输注是改善接受医院营养支持患者血糖控制的有效治疗选择。
英国糖尿病协会、瑞士国家科学基金会、英国国家卫生研究院剑桥生物医学研究中心、惠康基金会和欧洲糖尿病研究基金会。
