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持续葡萄糖监测、未来产品及全球人工胰腺项目进展

Continuous Glucose Monitoring, Future Products, and Update on Worldwide Artificial Pancreas Projects.

作者信息

Kropff Jort, DeVries J Hans

机构信息

Department of Endocrinology, Academic Medical Center at the University of Amsterdam , Amsterdam, The Netherlands .

出版信息

Diabetes Technol Ther. 2016 Feb;18 Suppl 2(Suppl 2):S253-63. doi: 10.1089/dia.2015.0345.

Abstract

The development of accurate and easy-to-use continuous glucose monitoring (CGM) improved diabetes treatment by providing additional temporal information on glycemia and glucose trends to patient and physician. Although CGM enables users to lower their average glucose level without an increased incidence of hypoglycemia, this comes at the price of additional patient effort. Automation of insulin administration, also known as closed-loop (CL) or artificial pancreas treatment, has the promise to reduce patient effort and improve glycemic control. CGM data serve as the conditional input for insulin automation devices. The first commercial product for partial automation of insulin administration used insulin delivery shutoff at a predefined glucose level. These systems showed a reduction in hypoglycemia. Insulin-only CL devices show increased time spent in euglycemia and a reduction of hypo- and hyperglycemia. Improved glycemic control, coinciding with a minor decrease in hemoglobin A1c level, was confirmed in recent long-term home studies investigating these devices, paving the way for pivotal studies for commercialization of the artificial pancreas. Although the first results from dual-hormone CL systems are promising, because of increased cost of consumables of these systems, long-term head-to-head studies will have to prove superiority over insulin-only approaches. Now CL glucose control for daily use might finally become reality. Improved continuous glucose sensing technology, miniaturization of electrical devices, and development of algorithms were key in making this possible. Clinical adoption challenges, including device usability and reimbursement, need to be addressed. Time will tell for which patient groups CL systems will be reimbursed and whether these devices can deliver the promise that they hold.

摘要

准确且易于使用的连续血糖监测(CGM)技术的发展,通过向患者和医生提供有关血糖水平及血糖变化趋势的额外时间信息,改善了糖尿病治疗。尽管CGM能使使用者在不增加低血糖发生率的情况下降低平均血糖水平,但这是以患者付出更多努力为代价的。胰岛素给药自动化,也称为闭环(CL)或人工胰腺治疗,有望减少患者的努力并改善血糖控制。CGM数据作为胰岛素自动化设备的条件输入。首个用于胰岛素给药部分自动化的商业产品在预定义的血糖水平时停止胰岛素输注。这些系统显示低血糖情况有所减少。仅使用胰岛素的CL设备显示血糖正常的时间增加,低血糖和高血糖情况减少。在最近针对这些设备的长期家庭研究中证实,血糖控制得到改善,同时糖化血红蛋白水平略有下降,这为人工胰腺商业化的关键研究铺平了道路。尽管双激素CL系统的初步结果很有前景,但由于这些系统耗材成本增加,长期的直接比较研究将必须证明其优于仅使用胰岛素的方法。现在,日常使用的CL血糖控制最终可能成为现实。改进的连续血糖传感技术、电子设备的小型化以及算法的开发是实现这一目标的关键。临床应用面临的挑战,包括设备的易用性和报销问题,都需要得到解决。时间将证明哪些患者群体的CL系统能够获得报销,以及这些设备是否能够兑现它们所承载的承诺。

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