Timeline for data collection, intervention, and outcome evaluation

A randomized, controlled, double-blind study has been designed for completion at Lianyungang Oriental Hospital, China. Sixty patients with hyperglycemia after severe closed traumatic brain injury will be randomized into an intensive insulin therapy group and a nonintensive insulin therapy group. The intensive insulin therapy group will then be divided into three subgroups based on the following targetblood glucose levels: 4.4–7.0 mM (strict control group), 7.1–10.0 mM (moderate control group), and 10.1– 3.0 mM (slight control group). Inthe intensive insulin therapy group, the blood glucose levels will be monitored and controlled using the Yale Insulin Infusion Protocol, and amicropump will be used for intravenous injection of insulin. The nonintensive insulin therapy group will be given subcutaneous insulin injections. The primary endpoint will be the blood glucose levels, and the secondary endpoints will be mortality, activities of daily living, and prognosis.

本研究设计为一项随机对照双盲试验，将在中国连云港东方医院开展。共计60例重型闭合性颅脑损伤后高血糖患者将被随机分配至强化胰岛素治疗组与非强化胰岛素治疗组。其中强化胰岛素治疗组将根据以下目标血糖水平划分为三个亚组：4.4–7.0 mM（严格控制组）、7.1–10.0 mM（中度控制组）以及10.1–3.0 mM（轻度控制组）。在强化胰岛素治疗组中，将采用耶鲁胰岛素输注方案（Yale Insulin Infusion Protocol）监测并调控血糖水平，并使用微量泵进行胰岛素静脉输注。非强化胰岛素治疗组将接受皮下胰岛素注射。本研究的主要终点为血糖水平，次要终点包括死亡率、日常生活活动能力及预后情况。