血糖变异性对1型糖尿病患者葡萄糖目标范围内时间与血糖管理指标关系的影响

Impacts of glycemic variability on the relationship between time in range and estimated glycated hemoglobin in patients with type 1 diabetes mellitus

目的:研究1型糖尿病(T1DM)患者葡萄糖目标范围内时间(TIR)和血糖管理指标(GMI)之间的关系以及血糖变异性(GV)对其关系的影响。方法:动态血糖监测(CGM)数据来自2017年11月至2021年6月一项在成年T1DM患者(≥18岁)中开展的多中心随机对照研究,共入组了83例T1DM患者,分别来自中山大学附属第三医院(72例)、南京大学医学院附属鼓楼医院(2例)、中国科学技术大学附属第一医院(9例)。使用回顾性CGM系统在基线(0~2周)、3个月(12~14周)和6个月(24~26周)随访时获得了患者连续2周的CGM数据,计算TIR、GMI及GV[包括变异系数(CV)、标准差(SD)]等CGM参数。根据CV的达标情况(<36%)和分布范围进行分组,探讨TIR和GMI之间的关系以及通过线性回归方程计算相同GMI值所对应的TIR预测值。结果:共收集CGM数据集233个,其中83个来自基线、80个来自3个月随访以及70个来自6个月随访。基线时患者年龄及病程[M(Q1,Q3)]分别为30.69(25.22,38.43)岁、10.05(4.46,13.92)年,男性27例。CGM平均佩戴时长及有效佩戴时间百分比[M(Q1,Q3)]分别为13.92(3.02,14.00)d、91.61%(84.96%,95.94%),TIR、GMI以及CV分别为60.34%±13.03%、7.14%±0.61%和41.01%±7.64%。TIR与GMI呈高度逆线性相关(r=-0.822,P<0.001)。多重线性回归分析显示,CV达标时(<36%),通过给定GMI计算的TIR预测值比CV不达标时高8.352%。在CV的四分位分组中,当GMI值为7%时,CV越大,TIR预测值越小,分别为69.98%(CV≤35.91%)、64.57%(35.91%<CV≤40.08%)、60.96%(40.08%<CV≤45.86%)以及56.44%(CV>45.86%)。结论:T1DM患者TIR和GMI呈高度逆线性相关,且CV影响两者的关系。

Objective This study is to investigate the relationship between time in range(TIR)and glucose management indicator(GMI),and the impact of glycemic variability(GV)on their relationship in patients with type 1 diabetes mellitus(T1DM).Methods The CGM data were collected from a multicenter randomized clinical trial of adults(≥18 years old)with T1DM,including 83 T1DM patients,respectively from the Third Affiliated Hospital of Sun Yat-sen University(72 cases),Drum Tower Hospital Affiliated to Nanjing University School of Medicine(2 cases),and the First Affiliated Hospital of University of Science and Technology of China(9 cases).All subjects wore the iProTM2 system for 14 days at baseline(0-2 weeks),3 months(12-14 weeks),and 6 months(24-26 weeks).Data derived from iProTM2 sensor was used to calculate CGM parameters.Correlation between TIR and GMI was explored according to different stratification of glycemic variability assessed by glucose coefficient of variation(CV).Predicted TIR in the fixed GMI value was calculated via the linear regression equations performed in the respective interquartile group of CV.Results From November 2017 to June 2021,a total of 233 CGM data were collected with 83 collected from baseline,80 from the 3-month follow-up,70 from the 6-month follow-up.Patients including 27 males had a median(Q1,Q3)age of 30.69(25.22,38.43)years,with a diabetes duration of 10.05(4.46,13.92)years.The median(Q1,Q3)and effective wearing time of available CGM data was 13.92(13.02,14.00)days and 91.61%(84.96%,95.94%),and the value of TIR,GMI and CV was 60.34%±13.03%,7.14%±0.61%and 41.01%±7.64%,respectively.There was a strong negative correlation between TIR and GMI(r=-0.822,P<0.001).Multiple linear regression analysis showed that the predictive value of TIR calculated from a given GMI was 8.352%higher when CV was up to standard(36%)than that when CV was down to standard.Based on the multiple linear regression equations generated from quartiles of CV,the predicted TIR value was decreased across the ascending quartiles with 69.98%in the lowest quartile of CV(≤35.91%),64.57%in 25th-50th quartile of CV(35.91%<CV≤40.08%),60.96%in 50th-75th quartile of CV(40.08%<CV≤45.86%)and 56.44%in the highest quartile of CV(>75th quartile,CV>45.86%)when GMI was set as 7%.Conclusions There is a strong correlation between TIR and GMI in adult patients with T1DM in patients with type 1 diabetes mellitus.CV influenced the relationship between TIR and GMI.