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[NEJM最新论文]:闭环胰岛素治疗控制非重症患者血糖
2018年08月15日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care

Lia Bally, Hood Thabit, Sara Hartnell, et al

N Engl J Med 2018; 379:547-556

DOI: 10.1056/NEJMoa1805233

Abstract

BACKGROUND 背景

In patients with diabetes, hospitalization can complicate the achievement of recommended glycemic targets. There is increasing evidence that a closed-loop delivery system (artificial pancreas) can improve glucose control in patients with type 1 diabetes. We wanted to investigate whether a closed-loop system could also improve glycemic control in patients with type 2 diabetes who were receiving noncritical care.

对于糖尿病患者,住院治疗可能影响达到推荐血糖目标。越来越多的证据显示,闭环胰岛素治疗(人工胰腺)能够改善1型糖尿病患者的血糖控制。我们希望研究闭环系统能否改善非重症2型糖尿病患者的血糖控制。

METHODS 方法

In this randomized, open-label trial conducted on general wards in two tertiary hospitals located in the United Kingdom and Switzerland, we assigned 136 adults with type 2 diabetes who required subcutaneous insulin therapy to receive either closed-loop insulin delivery (70 patients) or conventional subcutaneous insulin therapy, according to local clinical practice (66 patients). The primary end point was the percentage of time that the sensor glucose measurement was within the target range of 100 to 180 mg per deciliter (5.6 to 10.0 mmol per liter) for up to 15 days or until hospital discharge.

这项随机、开放标签临床试验在英国和瑞士的2所三级医院的普通病房进行。我们将需要皮下注射胰岛素的136名成年2型糖尿病患者随机分为闭环胰岛素治疗(70例患者)或根据本地临床实践进行传统皮下胰岛素治疗组(66名患者)。主要预后终点为在15天或直至出院时,传感器血糖测定水平在目标范围(100-180 mg/dl,或5.6-10.0 mmol/L)的时间百分比。

RESULTS 结果

The mean (±SD) percentage of time that the sensor glucose measurement was in the target range was 65.8±16.8% in the closed-loop group and 41.5±16.9% in the control group, a difference of 24.3±2.9 percentage points (95% confidence interval [CI], 18.6 to 30.0; P<0.001); values above the target range were found in 23.6±16.6% and 49.5±22.8% of the patients, respectively, a difference of 25.9±3.4 percentage points (95% CI, 19.2 to 32.7; P<0.001). The mean glucose level was 154 mg per deciliter (8.5 mmol per liter) in the closed-loop group and 188 mg per deciliter (10.4 mmol per liter) in the control group (P<0.001). There was no significant between-group difference in the duration of hypoglycemia (as defined by a sensor glucose measurement of <54 mg per deciliter; P=0.80) or in the amount of insulin that was delivered (median dose, 44.4 U and 40.2 U, respectively; P=0.50). No episode of severe hypoglycemia or clinically significant hyperglycemia with ketonemia occurred in either trial group.

传感器血糖测定水平在目标范围内的平均(±SD)百分比,闭环治疗组为65.8±16.8%,对照组为41.5±16.9%,差异为24.3±2.9个百分点(95%可信区间 [CI], 18.6 to 30.0; P<0.001);两组患者分别有23.6±16.6% 和 49.5±22.8% 的患者血糖水平高于目标范围,差异为25.9±3.4 个百分点 (95% CI, 19.2 to 32.7; P<0.001)。闭环治疗组平均血糖水平为154 mg/dl (8.5 mmol/L),对照组为188 mg/dl (10.4 mmol/L) (P<0.001)。两组间低血糖(定义为传感器血糖测定值< 54 mg/dl)持续时间没有显著差异(P=0.80),胰岛素用量也无差异(中位剂量分别为44.4 U 和 40.2 U;P=0.50)。两组患者均未发生严重低血糖或伴酮症的严重高血糖。

CONCLUSIONS 结论

Among inpatients with type 2 diabetes receiving noncritical care, the use of an automated, closed-loop insulin-delivery system resulted in significantly better glycemic control than conventional subcutaneous insulin therapy, without a higher risk of hypoglycemia.

对于住院治疗的非重症2型糖尿病患者,与传统皮下胰岛素治疗相比,自动化闭环胰岛素治疗系统能够更好控制血糖,且不增加低血糖风险。

(Funded by Diabetes UK and others; ClinicalTrials.gov number, NCT01774565.)

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