Inzucchi Silvio E, Umpierrez Guillermo, DiGenio Andres, Zhou Rong, Kovatchev Boris
Yale School of Medicine, New Haven, CT, USA.
Emory University School of Medicine, Atlanta, GA, USA.
Diabetes Res Clin Pract. 2015 Apr;108(1):179-86. doi: 10.1016/j.diabres.2014.12.020. Epub 2015 Jan 21.
Despite links to clinical outcomes in patients with type 2 diabetes mellitus (T2DM), the clinical utility of glycaemic variability (GV) measures is unknown. We evaluated the correlation between baseline GV, and glycated haemoglobin (HbA1c) attainment and hypoglycaemic events during treatment intensification in a large group of patients.
Patient-level data from six 24-week clinical trials of T2DM patients undergoing treatment intensification with basal insulin or comparators (N=1699) were pooled. Baseline GV measures included standard deviation (SD), mean amplitude of glycaemic excursions (MAGE), mean absolute glucose (MAG), coefficient of variation (CV), high blood glucose index (HBGI), and low blood glucose index (LBGI) were correlated with HbA1c change and hypoglycaemic events.
All mean GV measures, excluding CV which worsened, improved significantly from baseline to Week 24, with the largest proportional reduction obtained for HBGI (-65.5%). When assessed as mean individual percentage changes only HBGI improved significantly. Baseline GV correlated positively with Week 24 HbA1c for SD, MAGE, and HBGI. Baseline HBGI and CV correlated negatively and positively, respectively, with Week 24 HbA1c change. Correlations also existed between most baseline GV measures and age, body mass index, Week 24 fasting plasma glucose, Week 24 postprandial plasma glucose, and hypoglycaemic events; statistical significance depended on the specific measure.
Pre-treatment GV is associated with glycaemic outcomes in T2DM patients undergoing treatment intensification over 24 weeks. HBGI might be the most robust predictor, warranting validation in dedicated prospective studies or randomized trials to assess the predictive value of measuring GV.
尽管血糖变异性(GV)指标与2型糖尿病(T2DM)患者的临床结局相关,但其临床实用性尚不清楚。我们评估了一大组患者强化治疗期间基线GV与糖化血红蛋白(HbA1c)达标情况及低血糖事件之间的相关性。
汇总了六项针对接受基础胰岛素或对照药物强化治疗的T2DM患者进行的24周临床试验的患者水平数据(N = 1699)。基线GV指标包括标准差(SD)、血糖波动幅度均值(MAGE)、平均绝对血糖(MAG)、变异系数(CV)、高血糖指数(HBGI)和低血糖指数(LBGI),并将其与HbA1c变化及低血糖事件进行相关性分析。
除CV恶化外,所有平均GV指标从基线到第24周均有显著改善,其中HBGI的降幅最大(-65.5%)。仅将其评估为平均个体百分比变化时,HBGI有显著改善。对于SD、MAGE和HBGI,基线GV与第24周HbA1c呈正相关。基线HBGI和CV分别与第24周HbA1c变化呈负相关和正相关。大多数基线GV指标与年龄、体重指数、第24周空腹血糖、第24周餐后血糖及低血糖事件之间也存在相关性;统计学显著性取决于具体指标。
在接受24周强化治疗的T2DM患者中,治疗前GV与血糖结局相关。HBGI可能是最可靠的预测指标,需要在专门的前瞻性研究或随机试验中进行验证,以评估测量GV的预测价值。