Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.
The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.
Diabetes Technol Ther. 2019 Dec;21(12):682-690. doi: 10.1089/dia.2019.0202. Epub 2019 Sep 4.
The lycemia eduction pproaches in iabetes: A Comparative ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.
一项比较有效性（GRADE）研究纳入了具有 2 型糖尿病的不同种族和民族的人群，进行了广泛的表型分析，并将参与者随机分配到四种二线糖尿病药物之一。连续血糖监测（CGM）子研究已添加，以确定平均血糖（AG）和糖化血红蛋白（HbA1c）之间的关系是否存在种族/民族差异。CGM 还将用于比较各组之间的目标范围内时间、血糖变异性以及低血糖的频率和持续时间。观察性 CGM 子研究将从四个治疗组中招募最多 1800 名 GRADE 研究参与者，包括每个种族/少数民族组的多达 450 名参与者，要比较的组包括：西班牙裔白人、非西班牙裔白人、非西班牙裔非裔美国人和非西班牙裔其他族裔。CGM 将在 GRADE 年度就诊附近进行两周，在此期间将进行口服葡萄糖耐量试验，并测量 HbA1c 和糖化白蛋白。还将测量基于特殊红细胞测量的红细胞周转率个体间变异的指标，以探索个体间 HbA1c 变异的潜在原因。GRADE CGM 子研究将提供新的见解，即不同种族/民族群体之间 HbA1c 和 AG 之间的关系是否存在差异，以及常用糖尿病药物及其潜在临床意义之间的血糖谱是否存在差异。了解这些差异对于不同种族或民族的患者的临床护理和糖尿病药物的调整非常重要。
