Introduction: Multiple daily injection insulin therapy frequently fails to meet hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery (AID) with remote glucose monitoring offers a solution to these shortcomings. Research Design and Methods: In a single-arm multicenter pilot trial, we tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized patients with insulin-requiring diabetes on nonintensive care unit medical-surgical units. Primary endpoints included the proportion of time in automated mode and percent time-in-range (TIR 70-180 mg/dL) among participants with >48 h of CGM data. Safety endpoints included incidence of severe hypoglycemia and diabetes-related ketoacidosis (DKA). Additional glycemic endpoints, CGM accuracy, and patient satisfaction were also explored. Results: Twenty-two participants were enrolled; 18 used the system for a total of 96 days (mean 5.3 ± 3.1 days per patient), and 16 had sufficient CGM data required for analysis. Median percent time in automated mode was 95% (interquartile range 92%-98%) for the 18 system users, and the 16 participants with >48 h of CGM data achieved an overall TIR of 68% ± 16%, with 0.17% ± 0.3% time <70 mg/dL and 0.06% ± 0.2% time <54 mg/dL. Sensor mean glucose was 167 ± 21 mg/dL. There were no DKA or severe hypoglycemic events. All participants reported satisfaction with the system at study end. Conclusions: The use of AID with a disposable tubeless patch-pump along with remote real-time CGM is feasible in the hospital setting. These results warrant further investigation in randomized trials.

中文翻译：

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为住院糖尿病患者提供远程实时连续血糖自动胰岛素输送：多中心、单臂可行性试验。

简介：每日多次注射胰岛素治疗经常无法达到医院的血糖目标，并且容易发生低血糖。具有远程血糖监测功能的自动胰岛素输送 (AID) 为这些缺点提供了解决方案。研究设计和方法：在一项单臂多中心试点试验中，我们测试了 Omnipod 5 AID 系统的可行性、安全性和有效性，该系统具有实时连续血糖监测 (CGM)，对住院患者使用胰岛素进行长达 10 天的监测。需要在非重症监护病房内科手术病房治疗糖尿病。主要终点包括具有 >48 小时 CGM 数据的参与者中处于自动模式的时间比例和范围内时间百分比 (TIR 70-180 mg/dL)。安全性终点包括严重低血糖和糖尿病相关酮症酸中毒（DKA）的发生率。还探讨了其他血糖终点、CGM 准确性和患者满意度。结果：22 名参与者入组；18 名患者总共使用该系统 96 天（每位患者平均 5.3 ± 3.1 天），16 名患者拥有足够的 CGM 数据进行分析。对于 18 名系统用户，自动模式下的中位时间百分比为 95%（四分位距 92%-98%），并且具有 >48 小时 CGM 数据的 16 名参与者的总体 TIR 为 68% ± 16%，其中 0.17% ± 0.3% 时间<70 mg/dL，0.06% ± 0.2% 时间<54 mg/dL。传感器平均葡萄糖为 167 ± 21 mg/dL。没有发生 DKA 或严重低血糖事件。所有参与者在研究结束时均表示对该系统感到满意。结论：在医院环境中使用带有一次性无管贴片泵的 AID 以及远程实时 CGM 是可行的。这些结果值得在随机试验中进一步研究。