人工胰腺系统在2型糖尿病患者中的试验

Iskandar Idris
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引用次数: 0

摘要

在输送胰岛素和持续监测1型糖尿病患者血糖水平的技术领域已经取得了重大进展。这些发展中的许多已经导致了闭环系统(简称为人工胰腺),该系统同时监测葡萄糖水平并输送最佳量的胰岛素,以实现稳定的葡萄糖水平。剑桥大学威康医学研究中心代谢科学研究所的研究人员最近在《自然医学》杂志上发表了一项研究,研究了该系统在2型糖尿病患者中的使用和疗效。他们研究中使用的设备将现成的葡萄糖监测仪和胰岛素泵与该团队开发的应用程序CamAPS HX相结合。该应用程序由一种算法运行,该算法预测将葡萄糖水平维持在目标范围内需要多少胰岛素。先前的研究表明,由类似算法运行的人工胰腺对1型糖尿病患者和需要肾透析的2型糖尿病患者都是有效的。与他们之前研究中使用的人工胰腺不同,这种新版本是一个完全闭环系统,即患者不需要注射胰岛素来适应食物。在这项研究中,从初级和二级护理招募的26名接受胰岛素治疗的2型糖尿病患者被随机分配到人工胰腺试验中,为期8周,然后转向每天多次注射胰岛素的标准治疗;或者先接受这种标准治疗,八周后改用人工胰腺。他们发现,使用人工胰腺的患者有三分之二(66%)的时间在目标范围内(3.9至10.0 mmol/L),而在标准治疗中为32%。此外,接受标准治疗的患者67%的时间经历了高血糖水平(>;10 mmol/L)时降低到33%。平均血糖水平从12.6下降 mmol/L时服用对照治疗至9.2 mmol/L。使用人工胰腺后的HbA1c水平为7.3%,而标准治疗时为8.7%。令人放心的是,尽管血糖控制严格,但在研究期间没有患者出现低血糖。一名患者在使用人工胰腺时因泵套管部位脓肿入院。来自参与者的反馈表明,参与者很乐意让系统自动控制他们的血糖水平,十分之九(89%)的人报告说,总体而言,他们花在管理糖尿病上的时间更少。虽然大多数2型糖尿病患者应该而且仍将通过药物治疗进行治疗,但对于一些需要多次注射胰岛素的2型糖尿病病人来说,使用人工胰腺技术将提高他们的血糖水平,降低长期并发症的风险,并提高生活质量。这项研究为一项更大规模的多中心研究奠定了基础。该团队还将该设备提交给了监管部门批准,以期使其可用于2型糖尿病门诊患者。这项研究得到了国家卫生与保健研究所(NIHR)剑桥生物医学研究中心的支持。
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Artificial pancreas system trialled in patients with type 2 diabetes

Significant advances have been made in the field of technology to deliver insulin and to continuously monitor glucose levels in patients with type 1 diabetes. Much of these developments have led to the close-loop system (simply known as the artificial pancreas) which simultaneously monitor glucose levels and deliver the optimal amount of insulin in order to achieve a stable glucose levels. A recent study published in the journal Nature Medicine conducted by researchers from the Wellcome-MRC Institute of Metabolic Science at the University of Cambridge looked at the use and efficacy of this system in people with type 2 diabetes. The device used in their study combines an off-the-shelf glucose monitor and insulin pump with an app developed by the team, known as CamAPS HX. This app is run by an algorithm that predicts how much insulin is required to maintain glucose levels in the target range. Previous studies have shown that an artificial pancreas run by a similar algorithm is effective for patients living with type 1 diabetes as well as in patients with type 2 diabetes who require kidney dialysis. Unlike the artificial pancreas used in their previous studies, this new version is a fully closed loop system – i.e. patients do not need to bolus their insulin to adjust for their food.

In this study, 26 patients insulin treated patients with Type 2 diabetes recruited from the primary and secondary care were randomly allocated to a trial of the artificial pancreas for eight weeks and then switch to the standard therapy of multiple daily insulin injections; or to take this standard therapy first and then switch to the artificial pancreas after eight weeks.

They found that patients using the artificial pancreas spent two-thirds (66%) of their time within the target range (between 3.9 and 10.0 mmol/L) compared with 32% in the standard therapy. Furthermore, patients receiving standard therapy experienced 67% of their time with high glucose levels (>10 mmol/L), which was reduced to 33% when using the artificial pancreas. Average glucose levels fell - from 12.6 mmol/L when taking the control therapy to 9.2 mmol/L while using the artificial pancreas. HbA1c level after using the artificial pancreas was 7.3% compared with 8.7% in the standard therapy. Reassuringly, despite tight glucose control, no patients experienced hypoglycaemia during the study. One patient was admitted to hospital while using the artificial pancreas, due to an abscess at the site of the pump cannula. Feedback from participants suggested that participants were happy to have their glucose levels controlled automatically by the system, and nine out of ten (89%) reported spending less time managing their diabetes overall.

While the majority of patients with type 2 diabetes should be and will still be managed by drug therapies, for some patients with type 2 diabetes who requires multiple insulin injection, the use of artificial pancreas technology will improve their glucose levels, reduce risks of long-term complications and improve quality of life. This study forms a basis for a much larger multicentre study to build on their findings. The team have also submitted the device for regulatory approval with a view to making it commercially available for outpatients with type 2 diabetes.

The research was supported by the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.

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