Heinemann Lutz, Benesch Carsten, DeVries J Hans
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
J Diabetes Sci Technol. 2016 Jun 28;10(4):950-8. doi: 10.1177/1932296816632002. Print 2016 Jul.
In the past years the development of an artificial pancreas (AP) has made great progress and many activities are ongoing in this area of research. The major step forward made in the last years was moving the evaluation of AP systems from highly controlled experimental conditions to daily life conditions at the home of patients with diabetes; this was also the aim of the European Union-funded AP@home project. Over a time period of 5 years a series of clinical studies were performed that culminated in 2 "final studies" during which an AP system was used by patients in their home environment for 2 or 3 months without supervision by a physician, living their normal lives. Two different versions of the AP system developed within this project were evaluated. A significant improvement in glycated hemoglobin was observed during closed-loop conditions despite the fact that during the control period the patients used the best currently available therapeutic option. In addition, a "single-port AP system" was developed within the project that combines continuous glucose monitoring and insulin infusion at a single tissue site. By using such a combined device the patients not only have to carry one less device around, the number of access points through the skin is also reduced from 2 to 1. In summary, close cooperation of 12 European partners, both academic centers and industry, enabled the development and evaluation of AP systems under daily life conditions. The next step is to develop these into products in cooperation with commercial partners.
在过去几年中,人工胰腺(AP)的发展取得了巨大进展,该研究领域正在开展许多活动。过去几年取得的主要进展是将AP系统的评估从高度受控的实验条件转移到糖尿病患者家中的日常生活条件下;这也是欧盟资助的“AP在家”项目的目标。在5年的时间里进行了一系列临床研究,最终进行了2项“最终研究”,在此期间,AP系统由患者在家庭环境中使用2至3个月,无需医生监督,过着正常生活。对该项目中开发的两种不同版本的AP系统进行了评估。尽管在对照期患者使用了目前可用的最佳治疗方案,但在闭环条件下观察到糖化血红蛋白有显著改善。此外,该项目还开发了一种“单端口AP系统”,该系统在单个组织部位结合了连续血糖监测和胰岛素输注。通过使用这种组合设备,患者不仅携带的设备减少了一个,而且通过皮肤的接入点数量也从2个减少到了1个。总之,12个欧洲合作伙伴(包括学术中心和行业)的密切合作,使得能够在日常生活条件下开发和评估AP系统。下一步是与商业合作伙伴合作将这些系统开发成产品。