Glycemic Reduction Approaches in Diabetes: A Comparative Effectiveness Study

我们网站的目标是招募150名主要是印第安人的参与者加入GRADE。参与者将主要通过凤凰城印第安医疗中心从凤凰城的城市人口中招募。潜在的志愿者将接受筛选检查，随后是磨合期，参与者将被滴定到二甲双胍的最大耐受剂量。在磨合期结束时，血红蛋白a1c为6.8-8.5%的参与者将有资格继续研究，并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、认知测试和健康保健问卷调查。每6个月收集一次尿液白蛋白。所有参与者的糖尿病将由GRADE工作人员管理。反复测量血红蛋白a1c高于7.5%的参与者将增加甘精胰岛素的治疗，或者对于已经使用甘精胰岛素的参与者，在餐中使用速效胰岛素。招聘于2013年6月开始，并于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.