Haidar Ahmad, Messier Virginie, Legault Laurent, Ladouceur Martin, Rabasa-Lhoret Rémi
Faculty of Medicine, Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.
Faculty of Medicine, Division of Endocrinology and Metabolism, McGill University, Montréal, Québec, Canada.
Diabetes Obes Metab. 2017 May;19(5):713-720. doi: 10.1111/dom.12880. Epub 2017 Mar 8.
To assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared to the single-hormone (insulin alone) artificial pancreas in outpatient settings during the day and night.
In a randomized, three-way, crossover trial we compared the dual-hormone artificial pancreas, the single-hormone artificial pancreas and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 8 AM Day 1 to 8 PM Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than .017 was regarded as significant.
The median difference between the dual-hormone system and the single-hormone system was -2.3% (P = .072) for time spent below 4.0 mmol/L, -1.3% (P = .017) for time below 3.5 mmol/L, and -0.7% (P = .031) for time below 3.3 mmol/L. Both systems reduced (P < .017) hypoglycaemia below 4.0, 3.5 and 3.3 mmol/L compared to control therapy, but reductions were larger with the dual-hormone system than with the single-hormone system (medians -4.0% vs -3.4% for 4.0 mmol/L; -2.7% vs -2.2% for 3.5 mmol/L; and -2.2% vs -1.2% for 3.3 mmol/L). There were 34 hypoglycaemic events (<3.0 mmol/L for 20 minutes) with control therapy, 14 with the single-hormone system and 6 with the dual-hormone system. These differences in hypoglycaemia were observed while mean glucose level was low and comparable in all interventions (P = NS).
The dual-hormone artificial pancreas had the lowest risk of hypoglycaemia, but the differences were not statistically significant. Larger studies are needed.
评估在门诊环境中，与单激素（仅胰岛素）人工胰腺相比，双激素（胰岛素和胰高血糖素）人工胰腺在白天和夜间是否能降低低血糖发生率。
在一项随机、三臂、交叉试验中，我们比较了双激素人工胰腺、单激素人工胰腺和传感器增强泵疗法（对照）在23例1型糖尿病成年患者中的效果。每种干预措施在门诊自由生活条件下，从第1天上午8点应用至第3天下午8点（60小时）。主要结局指标是传感器血糖水平低于4.0 mmol/L的时间。P值小于0.017被视为具有统计学意义。
双激素系统和单激素系统相比，血糖低于4.0 mmol/L的时间中位数差异为-2.3%（P = 0.072），低于3.5 mmol/L的时间中位数差异为-1.3%（P = 0.017），低于3.3 mmol/L的时间中位数差异为-0.7%（P = 0.031）。与对照疗法相比，两种系统均降低了（P < 0.017）血糖低于4.0、3.5和3.3 mmol/L的低血糖发生率，但双激素系统的降低幅度大于单激素系统（4.0 mmol/L时中位数分别为-4.0%对-3.4%；3.5 mmol/L时为-2.7%对-2.2%；3.3 mmol/L时为-2.2%对-1.2%）。对照疗法有34次低血糖事件（血糖<3.0 mmol/L持续20分钟），单激素系统有14次，双激素系统有6次。在所有干预措施中，低血糖存在这些差异的同时，平均血糖水平较低且相当（P = 无统计学意义）。
双激素人工胰腺发生低血糖的风险最低，但差异无统计学意义。需要开展更大规模的研究。
