应用持续血糖监测技术评估德谷胰岛素治疗1型糖尿病的优势

Application of continuous glucose monitoring technology to evaluate the advantages of insulin degludec in the treatment of type 1 diabetes mellitus

目的应用持续血糖监测(CGM)技术评估德谷胰岛素(IDeg)作为基础胰岛素的方案与甘精胰岛素(IGlar)相比治疗成人1型糖尿病(T1DM)的优势。方法筛选2019年9月至2020年12月长治医学院附属和济医院收治的T1DM成年患者30例,按随机数字表法以1∶1的比例分为两组(德谷组和甘精组),分别以IDeg、IGLar为基础胰岛素联合门冬胰岛素治疗12周。主要观察指标是血糖变异系数(CV)、平均血糖波动幅度(MAGE)、血糖在目标范围内时间(TIR)、高于目标血糖范围内时间(TAR)、低于目标血糖范围内时间(TBR)。次要观察指标为平均血糖(MBG)、血糖标准差(SD),空腹血糖(FPG)、餐后2 h血糖(2 h BG)、糖化血红蛋白(HbA_(1c))、日间血糖平均绝对差(MODD)及低血糖事件的发生频率。结果治疗12周时,德谷组HbA_(1c)、FPG、2 h BG、MBG、SD、CV、MAGE均小于甘精组,且差异具有统计学意义(均P<0.05)。德谷组患者的TIR显著高于甘精组[73(63,75)%vs 43(28,63)%,P<0.001],且TAR低于甘精组[25(17,23)%vs 35(33,64)%,P=0.003]。从两组的血糖水平曲线谱来看,德谷组的血糖稳定性优于甘精组。经过12周的治疗,德谷组HbA_(1c)<7.0%的有8例(8/15),甘精组有4例(4/15)HbA_(1c)达到目标值,差异无统计学意义(P=0.264)。德谷组有7例(7/15)实现高质量血糖控制达标,甘精组有1例(1/15)实现高质量血糖控制达标,差异有统计学意义(P=0.035)。在第12周门诊随访时德谷组夜间低血糖事件发生率显著低于甘精组(4/15 vs 11/15,P=0.027)。结论与甘精胰岛素相比,德谷胰岛素治疗T1DM能实现更高的血糖达标率,降低血糖水平,减少血糖波动。

Objective Continuous glucose monitoring(CGM)technology is used to compare the advantages of insulin degludec(IDeg)as a basal insulin regimen compared with insulin glargine(IGlar)in the treatment of adult type 1 diabetes mellitus.Methods 30 adult patients with T1DM admitted to Heji Hospital Affiliated to Changzhi Medical College from September 2019 to December 2020 were screened.According to the random number table method,the patients were randomly divided into two groups(insulin degludec group and insulin glargine group)at a ratio of 1∶1,respectively treated with IDeg,IGlar and aspartate insulin for 12 weeks.The main outcome measures were the coefficient of variation of blood glucose(CV),mean amplitude of glycemic excursions(MAGE),time in range(TIR),time above range(TAR)and time below range(TBR).The secondary outcome measures were mean blood glucose(MBG),standard deviation of blood glucose(SD),fasting blood glucose(FPG),2 h postprandial blood glucose(2 h BG),hemoglobin A_(1c)(HbA_(1c)),means of daily differences(MOOD),and the frequency of hypoglycemic events.Results At 12 weeks of treatment,the HbA_(1c),FPG,2 h BG,MBG,SD,CV and MAGE of insulin degludec group were lower than those of insulin glargine group,with statistically significant difference(all P<0.05).The TIR in the insulin degludec group was significantly higher than that in the insulin glargine group[73(63,75)%vs 43(28,63)%,P<0.001],and the TAR was lower than that in the glycerine group[25(17,23)%vs 35(33,64)%,P=0.003].From the curve spectrum of blood glucose level of the two groups,the stability of blood glucose in the insulin degludec group was better than that in the insulin glargine group.After 12 weeks of treatment,8 cases(8/15)in insulin degludec group had HbA_(1c)<7.0%,and 4 cases(4/15)in insulin glargine group had HbA_(1c)<7.0%,without statistically significant difference(P=0.264).There were 7 cases(7/15)in the insulin degludec group and 1 case(1/15)in the insulin glargine group who achieved high quality blood glucose control,with statistically significant difference(P=0.035).At the 12th week of outpatient follow-up,the incidence of nocturnal hypoglycemic events in insulin degludec group was significantly lower than that in insulin glargine group(4/15 vs 11/15,P=0.027).Conclusions Compared with insulin glargine,insulin degludec can achieve higher blood glucose compliance rate,lower blood glucose level and reduce blood glucose fluctuations in patients with type 1 diabetes.