胰岛素滴定临床决策支持系统的开发及其有效性和安全性验证

Development of clinical decision support system for insulin titration and validation of its effectiveness and safety

目的胰岛素滴定临床决策支持系统(CDSS)的开发及其有效性和安全性验证。方法选择新乡医学院第一附属医院内分泌科2021年1月至2023年7月收治的80例在生活方式干预及口服降糖药物治疗的基础上血糖难以控制达标的2型糖尿病患者为研究对象,采用随机数字表法将患者分为观察组和对照组,每组40例。2组患者均口服二甲双胍缓释片、睡前皮下注射德谷胰岛素、三餐前皮下注射门冬胰岛素控制血糖,观察组患者采用CDSS决策意见进行胰岛素滴定,对照组患者进行常规胰岛素滴定。采用回顾式动态血糖监测系统监测葡萄糖在目标范围内时间(TIR)、平均血糖波动幅度(MAGE)、平均血糖(MBG)、血糖标准差(SDBG)、血糖变异系数(CV);记录2组患者治疗前后空腹血糖、餐后2 h血糖及住院时间、血糖控制达标所需时间、低血糖发生率。结果治疗前2组患者空腹血糖、餐后2 h血糖比较差异无统计学意义(P>0.05)。2组患者治疗后的空腹血糖、餐后2 h血糖均显著低于治疗前(P<0.05)。治疗后,观察组患者的空腹血糖、餐后2 h血糖显著低于对照组(P<0.05)。治疗后,观察组患者的TIR显著高于对照组,MAGE、MBG、SDBG、CV显著低于对照组(P<0.05)。观察组和对照组患者住院时间分别为9.0(7.3,10.0)、11.0(8.3,12.0)d,对照组患者住院时间显著长于观察组(Z=-2.408,P<0.05)。观察组和对照组患者血糖控制达标所需时间分别为6.5(5.0,8.8)d、7.5(6.0,10.0)d,对照组患者血糖控制达标所需时间显著长于观察组(Z=-2.019,P<0.05)。观察组和对照组患者低血糖发生率分别为20.0%(8/40)、12.5%(5/40),2组患者低血糖发生率比较差异无统计学意义(χ^(2)=0.827,P>0.05)。结论与常规胰岛素滴定相比,应用CDSS可以在基础-餐时胰岛素方案的实施过程中提供决策支持,可以更加有效地控制血糖,提高葡萄糖TIR,减少血糖波动,缩短患者血糖控制达标所需时间,缩短住院时间,且不增加低血糖风险。

Objective To develope a clinical decision support system(CDSS)on insulin titration and validate its effectiveness and safety.Methods Eighty patients with type 2 diabetes mellitus treated at the Department of Endocrinology of the First Affiliated Hospital of Xinxiang Medical University from January 2021 to July 2023,who had difficulty in achieving glycemic control on the basis of lifestyle interventions and oral hypoglycemic drug treatments,were selected for the study.The patients were divided into the observation group and the control group using a random number table,with 40 cases in each group.Patients in both groups received oral metformin extended-release tablets,subcutaneous insulin degludec before bedtime,and subcutaneous aspartate insulin injection before three meals for glycemic control.Patients in the observation group were given insulin titration using the CDSS,and patients in the control group were given insulin titration using the conventional method.The retrospective continuous glucose monitoring system was used to monitor time in range(TIR)for glucose,mean amplitude of glycemic excursion(MAGE),mean blood glucose(MBG),standard deviation of blood glucose(SDBG),and the coefficient of variation(CV)of blood glucose.Fasting blood glucose(FBG),2-hour postprandial glucose(2hPG),length of hospitalization,time to achieve standard blood glucose control,and incidence of hypoglycemia of patients were recorded before and after treatment in the two groups.Results There was no significant difference in FBG and 2hPG of patients between the two groups before treatment(P>0.05).The FBG and 2hPG levels of patients in the two groups were significantly lower than those before treatment(P<0.05).The FBG and 2hPG levels of patients in the observation group were significantly lower than those in the control group after treatment(P<0.05).TIR of patients in the observation group was significantly higher than that in the control group,while MAGE,MBG,SDBG,and CV were significantly lower than those in the control group after treatment(P<0.05).The length of hospitalization was 9.0(7.3,10.0)days and 11.0(8.3,12.0)days of patients in the observation group and control group,respectively;and the length of hospitalization of patients in the control group was significantly longer than that in the observation group(Z=-2.408,P<0.05).The time required to achieve glycemic control was 6.5(5.0,8.8)days and 7.5(6.0,10.0)days of patients in the observation group and control group,respectively;and the time required to achieve glycemic control of patients in the control group was significantly longer than that in the observation group(Z=-2.019,P<0.05).The incidence of hypoglycemia of patients in the observation group and control group was 20.0%(8/40),12.5%(5/40),respectively;there was no significant difference in the incidence of hypoglycemia between the observation group and the control group(χ^(2)=0.827,P>0.05).Conclusion Compared with the conventional titration of insulin,the application of CDSS can provide decision support during the implementation of a basal-meal insulin regimen,which can lead to more effective glycemic control,improved glucose TIR,reduced glycemic fluctuations,shorter time required for patients to achieve glycemic control,and shorter hospital stays without increasing the risk of hypoglycemia.