Aims/hypothesis

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP).

Methods

This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19–69 years with type 1 diabetes who had HbA_1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates.

Results

A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA_1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: −0.7 mmol/mol [95% CI −2.0, 0.8 mmol/mol] (−0.1% [95% CI −0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group.

Conclusions/interpretation

The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP.

Trial registration

Clinical Research Information Service (CRIS) KCT0008398

Funding

The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Graphical Abstract

中文翻译：

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无管体内自动胰岛素输送系统与无管体内传感器增强泵在 1 型糖尿病治疗中的比较：一项多中心随机对照试验

目标/假设

本研究比较了无管体内自动胰岛素输送 (AID) 系统与无管体内传感器增强泵 (SAP) 的功效和安全性。

方法

这项多中心、平行组随机对照试验在韩国 13 个三级医疗中心进行。 19-69 岁患有 1 型糖尿病且 HbA _1c水平 <85.8 mmol/mol (<10.0%) 的成年人符合资格。参与者按照 1:1 的比例分配接受无内胎植入式 AID 系统（干预组）或无内胎植入式 SAP（对照组），为期 12 周。分层分组随机化由独立统计学家进行。由于干预的性质，不可能实施盲法。主要结果是通过连续血糖监测测量的范围时间百分比 (TIR)、血糖在 3.9 至 10.0 mmol/l 之间。以基线值和研究中心作为协变量进行ANCOVA。

结果

共有 104 名参与者接受了随机分组，其中干预组 53 人，对照组 51 人。参与者的平均 (±SD) 年龄为 40±11 岁。干预组的平均 (±SD) TIR 从基线时的 62.1±17.1% 增加到 12 周试验期间的 71.5±10.7%，对照组从 64.7±17.0% 增加到 66.9±15.0%（调整后的差异）平均值：6.5% [95% CI 3.6%, 9.4%]，p <0.001）。与对照组相比，干预组低于范围的时间、高于范围的时间、CV 和平均血糖水平也明显更好。干预组的HbA _1c从基线时的 50.9±9.9 mmol/mol (6.8±0.9%) 降至 12 周后的 45.9±7.4 mmol/mol (6.4±0.7%)，并从 48.7±9.1 mmol/mol (6.6±0.8 %) 至对照组的 45.7±7.5 mmol/mol (6.3±0.7%)（调整后平均值之间的差异：-0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p =0.366)。两组均未发生糖尿病酮症酸中毒或严重低血糖事件。

结论/解释

与使用无管体内 SAP 相比，使用无管体内 AID 系统是安全的，并且具有更好的血糖曲线，包括 TIR、低于范围的时间、高于范围的时间和 CV。

试用注册

临床研究信息服务 (CRIS) KCT0008398

资金

该研究由韩国科学和信息通信技术部支持的韩国医疗器械发展基金资助；产业通商资源部；卫生和福利部；食品药品安全部（授权号：RS-2020-KD000056）。

图形概要