Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home
Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home
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DOI：
10.1111/dom.12663
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发表时间：
2016-07-01
影响因子：
5.8
通讯作者：
DeVries, J. H.
中科院分区：
文献类型：
--
作者：
Blauw, H.;van Bon, A. C.;DeVries, J. H.
目的：评估由一个可穿戴设备和两个无线葡萄糖传感器发射器组成的集成双激素人工胰腺系统在短期日常家庭使用中的性能和安全性。方法：邀请使用胰岛素泵的成年1型糖尿病患者加入这项随机交叉研究。在临床研究中心进行了一天一夜的人工胰腺治疗，随后在家中进行了3天的治疗。对照组在家中进行4天胰岛素泵治疗，并进行盲法连续血糖监测以收集数据。第2-4天预定为分析期，以中位血糖作为主要终点。结果：共有10例患者完成了研究。两组血糖水平的中位数[四分位数间距（IQR）]相似，人工胰腺组为7.3 (7.0-7.6)mmol/l，对照组为7.7 (7.0-9.0)mmol/l；p = 0.123)。在使用人工胰腺期间，血糖（3.9-10 mmol/l）持续时间的中位数（IQR）百分比更长[人工胰腺组为84.7(82.2-87.8)%，对照组为68.5 (57.9-83.6)%；p = 0.007)。降糖时间人工胰腺组为1.3(0.2-3.2)%，对照组为2.4 (0.4-10.3)% （p= 0.139）。白天和夜间的单独分析表明，改善主要是在夜间实现的。结论：这项初步研究的结果表明，我们的综合人工胰腺在1型糖尿病患者家中提供比胰岛素泵治疗更好的血糖控制，并且治疗是安全的。
Aims: To assess the performance and safety of an integrated bihormonal artificial pancreas system consisting of one wearable device and two wireless glucose sensor transmitters during short-term daily use at home.Methods: Adult patients with type 1 diabetes using an insulin pump were invited to enrol in this randomized crossover study. Treatment with the artificial pancreas started with a day and night in the clinical research centre, followed by 3 days at home. The control period consisted of 4 days of insulin pump therapy at home with blinded continuous glucose monitoring for data collection. Days 2-4 were predefined as the analysis period, with median glucose as the primary outcome.Results: A total of 10 patients completed the study. The median [interquartile range (IQR)] glucose level was similar for the two treatments [7.3 (7.0-7.6) mmol/l for the artificial pancreas vs. 7.7 (7.0-9.0) mmol/l for the control; p= 0.123]. The median (IQR) percentage of time spent in euglycaemia (3.9-10 mmol/l) was longer during use of the artificial pancreas [84.7 (82.2-87.8)% for the artificial pancreas vs. 68.5 (57.9-83.6)% for the control; p= 0.007]. Time in hypoglycaemia was 1.3 (0.2-3.2)% for the artificial pancreas and 2.4 (0.4-10.3)% for the control treatment (p= 0.139). Separate analysis of daytime and night-time showed that the improvements were mainly achieved during the night.Conclusions: The results of this pilot study suggest that our integrated artificial pancreas provides better glucose control than insulin pump therapy in patients with type 1 diabetes at home and that the treatment is safe.