葡萄糖反应性胰岛素和胰高血糖素递送（双激素人工胰腺）在 1 型糖尿病成人中的随机交叉对照试验。
Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial.
机构信息
Institut de Recherches Cliniques de Montréal, Montréal, Que.
出版信息
CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28.
BACKGROUND
Most patients with type 1 diabetes do not achieve their glycemic targets. We aimed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes.
METHODS
We conducted a randomized crossover trial involving 15 adults with type 1 diabetes, comparing standard insulin-pump therapy with dual-hormone, closed-loop delivery. Patients were admitted twice to a clinical research facility and received, in random order, both treatments. Each 15-hour visit (from 1600 to 0700) included an evening exercise session, followed by a medium-sized meal, a bedtime snack and an overnight stay. During visits that involved closed-loop delivery, basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals. During visits involving standard insulin-pump therapy (control visits), patients used conventional treatment.
RESULTS
Dual-hormone closed-loop delivery increased the percentage of time for which patients' plasma glucose levels were in the target range (median 70.7% [interquartile range (IQR) 46.1%-88.4%] for closed-loop delivery v. 57.3% [IQR 25.2%-71.8%] for control, p = 0.003) and decreased the percentage of time for which plasma glucose levels were in the low range (bottom of target range [< 4.0 mmol/L], 0.0% [IQR 0.0%-3.0%] for closed-loop delivery v. 10.2% [IQR 0.0%-13.0%] for control, p = 0.01; hypoglycemia threshold [< 3.3 mmol/L], 0.0% [IQR 0.0%-0.0%] for closed-loop delivery v. 2.8% [IQR 0.0%-5.9%] for control, p = 0.006). Eight participants (53%) had at least 1 hypoglycemic event (plasma glucose < 3.0 mmol/L) during standard treatment, compared with just 1 participant (7%) during closed-loop treatment (p = 0.02).
INTERPRETATION
Dual-hormone, closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of hypoglycemia in a group of 15 adults with type 1 diabetes.
TRIAL REGISTRATION
ClinicalTrials.gov, no. NCT01297946.
背景
大多数 1 型糖尿病患者无法达到血糖目标。我们旨在评估葡萄糖反应性胰岛素和胰高血糖素闭环输送在控制 1 型糖尿病成人血糖水平方面的疗效。
方法
我们进行了一项随机交叉试验，涉及 15 名 1 型糖尿病成人，比较标准胰岛素泵治疗与双激素闭环输送。患者两次住院到临床研究机构，并随机接受两种治疗。每次 15 小时的就诊（从 1600 到 0700）包括一次晚间运动，然后是一顿中等大小的餐食、睡前小吃和过夜。在闭环输送就诊期间，根据基于血糖传感器读数和预测剂量算法的建议，每 10 分钟输送一次基础胰岛素和胰高血糖素小剂量。在涉及标准胰岛素泵治疗（对照就诊）的就诊期间，患者使用常规治疗。
结果
双激素闭环输送增加了患者血糖处于目标范围的时间百分比（闭环输送时为 70.7%[四分位距 46.1%-88.4%]，而对照时为 57.3%[四分位距 25.2%-71.8%]，p = 0.003），并降低了血糖处于低范围的时间百分比（目标范围下限 [<4.0mmol/L]，闭环输送时为 0.0%[四分位距 0.0%-3.0%]，而对照时为 10.2%[四分位距 0.0%-13.0%]，p = 0.01；低血糖阈值 [<3.3mmol/L]，闭环输送时为 0.0%[四分位距 0.0%-0.0%]，而对照时为 2.8%[四分位距 0.0%-5.9%]，p = 0.006）。与标准治疗时 8 名参与者（53%）至少发生 1 次低血糖事件（血糖 <3.0mmol/L）相比，闭环治疗时仅有 1 名参与者（7%）发生低血糖事件（p = 0.02）。
结论
在一组 15 名 1 型糖尿病成人中，基于先进算法的双激素闭环输送改善了短期血糖控制并降低了低血糖风险。
试验注册
ClinicalTrials.gov，编号 NCT01297946。
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