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。我们目前正在跟踪146名随机参与者(142名在我们的站点随机进行，4名从其他站点转移)，这项研究将持续到2021年4月。 这项研究还包括几项重要的辅助研究和分研究。我们参与了一项研究，调查自身免疫在2型糖尿病中的作用，以及这是否会影响治疗反应。我们还收集了用于肠道微生物组测量的粪便，将分析肠道微生物组在治疗后的变化以及这些变化是否影响血糖。我们还邀请参与者佩戴连续血糖监测仪(CGM)两周，以使我们能够将不同种族和民族的队列中的平均血糖与血红蛋白A1C相关联，并分析血糖变异性如何受到治疗的影响，以及它是否预测与糖尿病相关的长期结果。

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 are currently following 146 randomized participants (142 randomized at our site and 4 who have transferred from other sites), the study will continue through April, 2021. This study has also included several important ancillary and sub-studies. We have participated in a study which investigates the role of auto-immunity in type 2 diabetes, and whether this affects response to treatment. We have also collected stool for gut microbiome measurements which will be analyzed for changes in gut microbiome in response to treatment and if these changes affect glycemia. We have also invited participants to wear a continuous glucose monitor (CGM) for 2 weeks to allow us to correlated average glucose to hemoglobin A1C in a racially and ethnically diverse cohort and to analyze how glucose variability is affected by treatment and whether it predicts longer term diabetes related outcomes.