Zhang Xiaodan, Yan Dewen, Du Tao, Zhao Yunjuan, Zhang Jiangong, Zhang Tong, Lin Mingrun, Li Yanli, Li Wangen
Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Endocrinology, The First Affiliated Hospital of Shenzhen University, Shenzhen, China.
Diabetol Metab Syndr. 2023 Nov 27;15(1):243. doi: 10.1186/s13098-023-01193-9.
Most studies initiated basal-bolus insulin in a ratio of 1:1 and titrated based on glucose. This study aimed to investigate the effectiveness and safety of a weight-based and ratio of 1:1.5 basal-bolus insulin using an algorithm for both initiation and titration in hospitalized patients with type 2 diabetes (T2D).
Hospitalized patients with T2D were randomly assigned to two groups in equal numbers to receive 1:1.5 and 1:1 ratios of basal-bolus insulin using a weight-based algorithm for both initiation and titration. The primary outcome was the time taken to reach the fasting blood glucose (FBG) target and 2-h postprandial blood glucose (2hBG) targets after three meals. The secondary outcome included insulin dosage to achieve glycemic control and the incidence of hypoglycemia during hospitalization.
250 patients were screened between October 2021 and June 2022, 220 were randomly grouped, and 182 completed the trial (89 in the 1:1.5 and 93 in the 1:1 groups). The time taken to reach FBG targets was comparable between the two groups (3.4 ± 1.7 vs. 3.0 ± 1.3 days, p = 0.137) within about 3 days. The 2hBG after three meals was shorter in the 1:1.5 group than in the 1:1group (2.9 ± 1.5 vs. 3.4 ± 1.4 days, p = 0.015 for breakfast, 3.0 ± 1.6 vs. 3.6 ± 1.4 days, p = 0.005 for lunch, and 3.1 ± 2.1 vs. 4.0 ± 1.5 days, p = 0.002 for dinner). No significant difference in insulin dosages was found between the two groups at the end of the study. The incidence of hypoglycemia was similar in both groups.
We demonstrated that fixed dose-ratio basal-bolus insulin at 1:1.5 calculated using a weight-based initiation and titration algorithm was simple, as effective, and safe as ratio at 1:1 in managing T2D in hospitalized patients. Trial Registration ChiCTR 2,100,050,963. Date of registration: September 8, 2021.
大多数研究起始基础胰岛素与餐时胰岛素的比例为1:1，并根据血糖水平进行调整。本研究旨在探讨在住院2型糖尿病（T2D）患者中，使用基于体重的算法起始和调整剂量的基础胰岛素与餐时胰岛素比例为1:1.5的有效性和安全性。
将住院T2D患者随机等分为两组，使用基于体重的算法起始和调整剂量，分别接受基础胰岛素与餐时胰岛素比例为1:1.5和1:1的治疗。主要结局是达到空腹血糖（FBG）目标和三餐后2小时血糖（2hBG）目标所需的时间。次要结局包括实现血糖控制所需的胰岛素剂量以及住院期间低血糖的发生率。
2021年10月至2022年6月期间筛选了250例患者，220例被随机分组，182例完成试验（1:1.5组89例，1:1组93例）。两组达到FBG目标的时间相当（3.4±1.7天 vs. 3.0±1.3天，p = 0.137），约在3天内。1:1.5组三餐后的2hBG短于1:1组（早餐：2.9±1.5天 vs. 3.4±1.4天，p = 0.015；午餐：3.0±1.6天 vs. 3.6±1.4天，p = 0.005；晚餐：3.1±2.1天 vs. 4.0±1.5天，p = 0.002）。研究结束时，两组胰岛素剂量无显著差异。两组低血糖发生率相似。
我们证明，在住院T2D患者中，使用基于体重的起始和调整剂量算法计算的固定剂量比1:1.5的基础胰岛素与餐时胰岛素，在管理T2D方面与1:1的比例一样简单、有效且安全。试验注册号：ChiCTR 2,100,050,963。注册日期：2021年9月8日。
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