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优化使用 MiniMed 670G 系统的青少年和青年成年人的混合闭环治疗。

Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System.

机构信息

Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO

Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.

出版信息

Diabetes Care. 2018 Apr;41(4):789-796. doi: 10.2337/dc17-1682. Epub 2018 Feb 14.

Abstract

OBJECTIVE

The MiniMed 670G System is the first commercial hybrid closed-loop (HCL) system for management of type 1 diabetes. Using data from adolescent and young adult participants, we compared insulin delivery patterns and time-in-range metrics in HCL (Auto Mode) and open loop (OL). System alerts, usage profiles, and operational parameters were examined to provide suggestions for optimal clinical use of the system.

RESEARCH DESIGN AND METHODS

Data from 31 adolescent and young adult participants (14-26 years old) at three clinical sites in the 670G pivotal trial were analyzed. Participants had a 2-week run-in period in OL, followed by a 3-month in-home study phase with HCL functionality enabled. Data were compared between baseline OL and HCL use after 1 week, 1 month, 2 months, and 3 months.

RESULTS

Carbohydrate-to-insulin (C-to-I) ratios were more aggressive for all meals with HCL compared with baseline OL. Total daily insulin dose and basal-to-bolus ratio did not change during the trial. Time in range increased 14% with use of Auto Mode after 3 months ( < 0.001), and HbA decreased 0.75%. Auto Mode exits were primarily due to sensor/insulin delivery alerts and hyperglycemia. The percentage of time in Auto Mode gradually declined from 87%, with a final use rate of 72% (-15%).

CONCLUSIONS

In transitioning young patients to the 670G system, providers should anticipate immediate C-to-I ratio adjustments while also assessing active insulin time. Users should anticipate occasional Auto Mode exits, which can be reduced by following system instructions and reliably bolusing for meals. Unique 670G system functionality requires ongoing clinical guidance and education from providers.

摘要

目的

美敦力 670G 系统是首个用于 1 型糖尿病管理的商业化混合闭环(HCL)系统。我们使用青少年和年轻成年参与者的数据,比较了 HCL(自动模式)和开放回路(OL)中的胰岛素输送模式和达标时间(TIR)指标。检查了系统警报、使用情况概况和操作参数,以提供系统最佳临床使用的建议。

研究设计和方法

对来自三个临床中心的 670G 关键试验的 31 名青少年和年轻成年参与者(14-26 岁)的数据进行了分析。参与者在 OL 进行了 2 周的适应期,然后在启用 HCL 功能的家庭研究阶段进行了 3 个月的研究。在启用 HCL 后的第 1 周、第 1 个月、第 2 个月和第 3 个月,比较了基线 OL 和 HCL 使用之间的数据。

结果

与基线 OL 相比,HCL 时所有餐时的碳水化合物与胰岛素比值(C-to-I)更积极。试验期间,总日胰岛素剂量和基础-餐时胰岛素比值没有变化。启用 Auto Mode 3 个月后,TIR 增加了 14%(<0.001),HbA 降低了 0.75%。Auto Mode 退出主要是由于传感器/胰岛素输送警报和高血糖。Auto Mode 的使用百分比逐渐从 87%下降,最终使用率为 72%(-15%)。

结论

在向年轻患者过渡到 670G 系统时,提供者应预期 C-to-I 比值的立即调整,同时评估活性胰岛素时间。使用者应预期偶尔会出现 Auto Mode 退出,遵循系统说明并可靠地为餐时注射胰岛素可以减少退出。670G 系统独特的功能需要提供者提供持续的临床指导和教育。

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