Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Endocrinology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
BMJ Open Diabetes Res Care. 2020 Sep;8(1). doi: 10.1136/bmjdrc-2020-001261.
Subcutaneous administration of insulin is the preferred method for achieving glucose control in non-critically ill patients with diabetes. Glucose-based titration protocols were widely applied in clinical practice. However, most of these algorithms are experience-based and there is considerable variability and complexity. This study aimed to compare the effectiveness and safety of a weight-based insulin titration algorithm versus glucose-based algorithm in hospitalized patients with type 2 diabetes mellitus (T2DM).
This randomized clinical trial was carried out at four centers in the South, Central and North China. Inpatients with T2DM were randomly assigned (1:1) to receive weight-based and glucose-based insulin titration algorithms. The primary outcome was the length of time for reaching blood glucose (BG) targets (fasting BG (FBG) and 2-hour postprandial BG (2hBG) after three meals). The secondary outcome included insulin dose for achieving glycemic control and the incidence of hypoglycemia during hospitalization.
Between January 2016 and June 2019, 780 patients were screened, and 575 completed the trial (283 in the weight-based group and 292 in the glucose-based group). The lengths of time for reaching BG targets at four time points were comparable between two groups. FBG reached targets within 3 days and 2hBG after three meals within 4 days. There is no significant difference in insulin doses between two groups at the end of the study. The total daily dosage was about 1 unit/kg/day, and the ratio of basal-to-bolus was about 2:3 in both groups. The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
Weight-based insulin titration algorithm is equally effective and safe in hospitalized patients with T2DM compared with glucose-based algorithm.
NCT03220919.
在非危重症糖尿病患者中，皮下注射胰岛素是控制血糖的首选方法。基于血糖的滴定方案在临床实践中得到了广泛应用。然而，这些算法大多是基于经验的，存在相当大的变异性和复杂性。本研究旨在比较基于体重的胰岛素滴定算法与基于血糖的算法在住院 2 型糖尿病（T2DM）患者中的有效性和安全性。
这项随机临床试验在中国南方、中部和北部的四个中心进行。将 T2DM 住院患者按 1:1 随机分为接受基于体重和基于血糖的胰岛素滴定算法的两组。主要结局是达到血糖（BG）目标的时间（空腹 BG（FBG）和三餐后 2 小时 BG（2hBG））。次要结局包括达到血糖控制的胰岛素剂量和住院期间低血糖的发生率。
2016 年 1 月至 2019 年 6 月，共筛选出 780 例患者，其中 575 例完成了试验（体重组 283 例，血糖组 292 例）。两组在四个时间点达到 BG 目标的时间无显著差异。FBG 在 3 天内达到目标，三餐后 2hBG 在 4 天内达到目标。两组在研究结束时胰岛素剂量无显著差异。总的日剂量约为 1 单位/kg/天，两组基础-餐时胰岛素比例约为 2:3。两组低血糖发生率相似，均未发现严重低血糖。
与基于血糖的算法相比，基于体重的胰岛素滴定算法在住院 T2DM 患者中同样有效且安全。
NCT03220919。
