One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System
One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System
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DOI：
10.2337/dc19-0855
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发表时间：
2019-12-01
期刊：
影响因子：
16.2
通讯作者：
Wilson, Darrell M.
中科院分区：
文献类型：
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作者：
Lal, Rayhan A.;Basina, Marina;Wilson, Darrell M.
2016年9月，美国食品药品监督管理局批准了美敦力670G“混合”闭环系统。在Auto模式下，系统根据连续的血糖监测数据自动控制基础胰岛素的输送，但需要用户输入碳水化合物和血糖。为了追踪这首个商用闭环设备的真实体验，我们前瞻性地跟踪了启动670G系统的儿童和成人患者。研究设计和方法：本研究是一项为期1年的前瞻性观察性研究，研究对象为2017年5月至2018年5月在临床中开始使用670G系统的1型糖尿病患者。在接受670G治疗并同意的84例患者中，5例患者未返回随访，79例（年龄9-61岁）在Auto Mode启动后1周、3、6、9和/或12个月提供数据。对于86%（79人中有68人）的1周数据，99%（68人中有67人）成功启动。3个月后，至少28%（79人中有22人）停止使用自动模式；6个月时，34%（79人中有27人）；9个月时，35%（79人中有28人）；12个月后，33%（79人中的26人）。继续使用自动模式的主要原因是希望增加在范围内的时间。停药的原因包括62%（16 / 26）的传感器问题，12%（3 / 26）的患者无法获得药物供应，12%（3 / 26）的患者害怕低血糖，8%（2 / 26）的患者偏好每日多次注射，8%（2 / 26）的患者喜欢运动。在所有访问中，血红蛋白a (1c) （HbA(1c)）与自动模式利用率之间存在显著相关性。结论：虽然自动模式的使用与血糖控制的改善相关，但需要关注可用性和人为因素，以确保自动模式的使用。警报和传感器校准是患者关注的主要问题，未来的技术应该会缓解这一问题。
OBJECTIVE In September 2016, the U.S. Food and Drug Administration approved the Medtronic 670G "hybrid" closed-loop system. In Auto Mode, this system automatically controls basal insulin delivery based on continuous glucose monitoring data but requires users to enter carbohydrates and blood glucose for boluses. To track real-world experience with this first commercial closed-loop device, we prospectively followed pediatric and adult patients starting the 670G system. RESEARCH DESIGN AND METHODS This was a 1-year prospective observational study of patients with type 1 diabetes starting the 670G system between May 2017 and May 2018 in clinic. RESULTS Of the total of 84 patients who received 670G and consented, 5 never returned for follow-up, with 79 (aged 9-61 years) providing data at 1 week and 3, 6, 9, and/or 12 months after Auto Mode initiation. For the 86% (68 out of 79) with 1-week data, 99% (67 out of 68) successfully started. By 3 months, at least 28% (22 out of 79) had stopped using Auto Mode; at 6 months, 34% (27 out of 79); at 9 months, 35% (28 out of 79); and by 12 months, 33% (26 out of 79). The primary reason for continuing Auto Mode was desire for increased time in range. Reasons for discontinuation included sensor issues in 62% (16 out of 26), problems obtaining supplies in 12% (3 out of 26), hypoglycemia fear in 12% (3 out of 26), multiple daily injection preference in 8% (2 out of 26), and sports in 8% (2 out of 26). At all visits, there was a significant correlation between hemoglobin A(1c) (HbA(1c)) and Auto Mode utilization. CONCLUSIONS While Auto Mode utilization correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure use of Auto Mode. Alarms and sensor calibration are a major patient concern, which future technology should alleviate.