Glycemic Reduction Approaches in Diabetes: A Comparative Effectiveness Study

我们网站的目标是招募150名主要是美洲原住民的参与者进入年级。参与者将从凤凰城的城市人口中招募，主要通过凤凰城印第安人医疗中心进行。潜在的志愿者将接受筛查检查，然后是磨合期，在此期间，参与者被滴定到最大耐受量的二甲双胍。在磨合期结束时，血红蛋白A1C6.8-8.5%的参与者将有资格继续研究，并被随机分配到上述附加药物中的一种。参与者将接受基线和年度口服葡萄糖耐量测试、神经病变筛查、认知测试和健康护理问卷。尿白蛋白将每6个月收集一次。所有参与者的糖尿病都将由年级工作人员管理。重复测量Hb A1Cs高于7.5%的参与者将通过添加甘精胰岛素来加强治疗，或者对于那些已经服用甘精胰岛素并在用餐时快速作用的胰岛素的参与者来说。招聘于2013年6月开始，2017年7月完成。我们有142名随机参与者，这项研究将持续到2021年。

The goal of our site was to recruit 150 primarily Native American participants into GRADE. Participants will be recruited from the urban population in Phoenix mostly via the Phoenix Indian Medical Center. Potential volunteers will undergo screening examinations, followed by run-in period in which participants are titrated to maximal tolerated dose of metformin. At the completion of the run-in period, participants with hemoglobin A1Cs 6.8-8.5% will be eligible to continue in the study and be randomized to one of the additional medications noted above. Participants will undergo baseline and yearly oral glucose tolerance tests, neuropathy screens, cognitive testing, and health care questionnaires. Urine for albumin will be collected every 6 months. All participants will have their diabetes managed by GRADE staff. Participants whose hemoglobin A1Cs rise above 7.5% on repeated measurements will have their therapy intensified with the addition of insulin glargine or for those already on glargine with the rapid acting insulin aspart at meals. The recruitment began in June, 2013 and was completed in July 2017. We have 142 randomized participants, the study will continue through 2021.