Wang Yaxin, Lu Jingyi, Wang Ming, Ni Jiaying, Yu Jiamin, Wang Shiyun, Wu Liang, Lu Wei, Zhu Wei, Guo Jingyi, Yu Xiangtian, Bao Yuqian, Zhou Jian
Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Shanghai Clinical Center for Diabetes; Shanghai Diabetes Institute; Shanghai Key Laboratory of Diabetes Mellitus, China.
Clinical Research Center, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.
Lancet Reg Health West Pac. 2024 Jul 21;48:101067. doi: 10.1016/j.lanwpc.2024.101067. eCollection 2024 Jul.
The use of real-time continuous glucose monitoring (rtCGM) technology remains largely investigational in the hospital setting. The current study aimed to evaluate the effectiveness of rtCGM in inpatients with diabetes who were treated with short-term continuous subcutaneous insulin infusion (CSII).
In this randomized, parallel controlled trial conducted on the endocrinology wards in a tertiary hospital located in Shanghai, adults with type 1 and type 2 diabetes who required short-term CSII during hospitalization were randomly assigned (1:1) to receive either rtCGM-based glucose monitoring and management program or point-of-care (POC) standard of care (8 times/day) with blinded CGM. Primary outcome measure was the difference in the percentage of time within the target glucose range of 3.9-10 mmol/L (TIR, %). This study was registered at www.chictr.org.cn (ChiCTR2300068933).
Among the 475 randomized participants (237 in the rtCGM group and 238 in the POC group), the mean age of was 60 ± 13 years, and the mean baseline glycated hemoglobin level was 9.4 ± 1.8%. The CGM-recorded mean TIR was 71.1 ± 15.8% in the rtCGM group and 62.9 ± 18.9% in the POC group, with a mean difference of 8.2% (95% confidence interval [CI]: 5.1-11.4%, P < 0.001). The mean time above range >10 mmol/L was significantly lower in the rtCGM group than in the POC group (28.3 ± 15.8% vs. 36.6 ± 19.0%, P < 0.001), whereas there was no significant between-group difference in the time below range <3.9 mmol/L (P = 0.11). Moreover, the time to reach target glucose was significantly shorter in the rtCGM group than in the POC group (2.0 [1.0-4.0] days vs. 4.0 [2.0-5.0] days, P < 0.001). There were no serious adverse events in both groups.
In patients with diabetes who received short-term CSII during hospitalization, the rtCGM program resulted in better glucose control than the POC standard of care, without increasing the risk of hypoglycemia.
The Program of Shanghai Academic Research Leader (22XD1402300), Shanghai Oriental Talent Program (Youth Project) (No. NA), the Shanghai "Rising Stars of Medical Talent" Youth Development Program-Outstanding Youth Medical Talents (SHWSRS(2021)_099), and the Shanghai Research Center for Endocrine and Metabolic Diseases (2022ZZ01002).
在医院环境中，实时连续血糖监测（rtCGM）技术的应用在很大程度上仍处于研究阶段。本研究旨在评估rtCGM在接受短期持续皮下胰岛素输注（CSII）治疗的糖尿病住院患者中的有效性。
在上海一家三级医院的内分泌病房进行的这项随机、平行对照试验中，将住院期间需要短期CSII的1型和2型糖尿病成年患者随机分配（1:1），接受基于rtCGM的血糖监测和管理方案或即时检验（POC）标准护理（每天8次），同时进行盲法CGM。主要结局指标是血糖目标范围3.9 - 10 mmol/L内的时间百分比差异（TIR，%）。本研究已在www.chictr.org.cn注册（ChiCTR2300068933）。
在475名随机参与者中（rtCGM组237名，POC组238名），平均年龄为60±13岁，平均基线糖化血红蛋白水平为9.4±1.8%。rtCGM组CGM记录的平均TIR为71.1±15.8%，POC组为62.9±18.9%，平均差异为8.2%（95%置信区间[CI]：5.1 - 11.4%，P<0.001）。rtCGM组高于范围>10 mmol/L的平均时间显著低于POC组（28.3±15.8%对36.6±19.0%，P<0.001），而低于范围<3.9 mmol/L的时间在组间无显著差异（P = 0.11）。此外，rtCGM组达到目标血糖的时间显著短于POC组（2.0[1.0 - 4.0]天对4.0[2.0 - 5.0]天，P<0.001）。两组均未发生严重不良事件。
在住院期间接受短期CSII治疗的糖尿病患者中，rtCGM方案比POC标准护理能更好地控制血糖，且不增加低血糖风险。
上海市学术研究领军人才计划（22XD1402300）、上海东方英才计划（青年项目）（编号NA）、上海市“医苑新星”青年医学人才培养计划 - 优秀青年医学人才（SHWSRS(2021)_099）以及上海市内分泌代谢病研究所（2022ZZ01002）。
