Yu Huijie, Zhang Lingfang, Xu Songao, Xu Jun, Sun Hui, Zhu Xiangyun, Xu Xiaoqin, Cao Weizhong
Department of Emergency Intensive Care Unit, the First Hospital of Jiaxing, Jiaxing 314000, Zhejiang, China. Corresponding author: Cao Weizhong, Email:
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Aug;30(8):771-776. doi: 10.3760/cma.j.issn.2095-4352.2018.08.012.
To observe the effects of insulin caliper for blood glucose control on glycemic central tendency, fluctuation and incidence of hypoglycemia, etc., in emergent and critical patients to evaluate its application value.
A prospective single-blinded randomized parallel controlled intervention study was conducted. One hundred patients with severe hyperglycemia requiring treatment with insulin infusion admitted to emergency department and intensive care unit (ICU) of the First Hospital of Jiaxing from November 2015 to November 2017 were enrolled, and they were divided into the caliper group (used patented product insulin calipers for blood glucose control to adjust insulin dose for blood glucose control) and the conventional group (used paper-based insulin dose modification scheme to adjust insulin dose for blood glucose control) on average by random number table, 50 in each group. The gender, age, acute physiology and chronic health evaluation II (APACHE II), sequential organ failure assessment (SOFA), the principal diseases, main factors affecting blood glucose (hepatic and renal insufficiency, hypoglycemic drugs, glucocorticoids, mechanical ventilation, enteral nutrition, parenteral nutrition, intravenous glucose use, etc.), blood glucose levels at each time node (once every 2 hours after insulin use and once every 4 hours after 16-72 hours), glycemic coefficient of variance (CV), glycemic lability index (GLU) and mean amplitude of glycemic excursion (GLU), insulin dose, incidence of hypoglycemia, proportion of achieving the glucose control target at each time point, the length of ICU stay and hospitalization cost per patient were recorded and compared between the two groups.
After excluding those with incomplete data and withdraw in the midway, 92 patients were enrolled in the analysis finally, 47 in caliper group and 45 in conventional group. There were no significant differences in the incidence of the gender, age, APACHE II, SOFA, presence of infection at admission, previous diabetes history, glycosylated hemoglobin level, blood glucose at admission, proportion of patients after surgery, major diseases at admission and major factors affecting blood glucose between the two groups. A total of 1 379 blood glucose measurements were obtained in the caliper group and 1 332 blood glucose measurements were obtained in the conventional group. The glycemic measurements in caliper group were significantly lower than that in conventional group at each time point from 6-72 hours. Compared with conventional group, GLU and GLU were significantly decreased in the caliper group [GLU: 12.96 (8.73, 19.58) vs. 23.27 (13.07, 44.61), GLU (mmol/L): 0.66±0.22 vs. 0.87±0.28, both P < 0.01]; there was a tendency towards decreasing incidence of hypoglycemia in the caliper group [8.51% (4/47) vs. 15.56% (7/45)], but no statistical difference was found (P > 0.05); the proportion of achieving the glucose control target was significantly increased in the caliper group [41.99% (579/1 379) vs. 27.18% (362/1 332), P < 0.01]. There were no significant differences in glycemic CV, insulin dose, proportion of hypoglycemic measurements in total measurements, and the length of ICU stay, the length of hospital stay, incidence of nosocomial infection, patient prognosis and cost between the two groups.
For emergent and critical patients, insulin caliper for blood glucose control presents favorable application value for achieving glucose control target, reducing glycemic fluctuation, and lowering the incidence of hypoglycemia.
China clinical trial registration center, ChiCTR1800015024.
观察胰岛素卡尺血糖控制法对急危重症患者血糖控制中心趋势、波动及低血糖发生率等的影响，评估其应用价值。
进行一项前瞻性单盲随机平行对照干预研究。选取2015年11月至2017年11月在嘉兴市第一医院急诊科及重症监护病房（ICU）收治的100例需胰岛素静脉输注治疗的严重高血糖患者，采用随机数字表法平均分为卡尺组（使用专利产品胰岛素卡尺进行血糖控制以调整胰岛素剂量）和传统组（使用纸质胰岛素剂量调整方案调整胰岛素剂量进行血糖控制），每组50例。记录并比较两组患者的性别、年龄、急性生理与慢性健康状况评分系统II（APACHE II）、序贯器官衰竭评估（SOFA）、主要疾病、影响血糖的主要因素（肝肾功能不全、降糖药物、糖皮质激素、机械通气、肠内营养、肠外营养、静脉使用葡萄糖等）、各时间节点血糖水平（胰岛素使用后每2小时1次，16 - 72小时后每4小时1次）、血糖变异系数（CV）、血糖波动指数（GLU）、血糖平均波动幅度（MAGE）、胰岛素剂量、低血糖发生率、各时间点血糖控制达标比例、ICU住院时间及患者住院费用。
剔除中途数据不全及退出者后，最终纳入分析92例患者，卡尺组47例，传统组45例。两组患者性别、年龄、APACHE II、SOFA、入院时感染情况、既往糖尿病史、糖化血红蛋白水平、入院血糖、术后患者比例、入院主要疾病及影响血糖的主要因素等发生率比较，差异均无统计学意义。卡尺组共获得1379次血糖测量值，传统组共获得1332次血糖测量值。卡尺组6 - 72小时各时间点血糖测量值均显著低于传统组。与传统组比较，卡尺组GLU及MAGE显著降低[GLU：12.96（8.73，19.58）比23.27（13.07，44.61），MAGE（mmol/L）：0.66±0.22比0.87±0.28，均P<0.01]；卡尺组低血糖发生率有降低趋势[8.51%（4/47）比15.56%（7/45）]，但差异无统计学意义（P>0.05）；卡尺组血糖控制达标比例显著升高[41.99%（579/1379）比27.18%（362/1332），P<0.01]。两组血糖CV、胰岛素剂量、总测量次数中低血糖测量比例、ICU住院时间、住院时间、医院感染发生率、患者预后及费用比较，差异均无统计学意义。
对于急危重症患者，胰岛素卡尺血糖控制法在实现血糖控制目标、降低血糖波动及降低低血糖发生率方面具有良好的应用价值。
中国临床试验注册中心，ChiCTR1800015024。
