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。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。潜在志愿者将接受筛选检查，然后进入导入期，在导入期内，将受试者滴定至二甲双胍的最大耐受剂量。导入期结束时，血红蛋白A1 C 6.8-8.5%的受试者将有资格继续参加研究，并随机接受上述其他药物之一。参与者将接受基线和年度口服葡萄糖耐量试验、神经病变筛查、认知测试和健康护理问卷调查。将每6个月采集一次尿液进行白蛋白检测。所有参与者将由GRADE工作人员管理他们的糖尿病。 重复测量血红蛋白A1 C升高超过7.5%的受试者将通过添加甘精胰岛素或餐时速效门冬胰岛素强化治疗。招募于2013年6月开始，于2017年7月完成。我们目前正在随访146名随机化受试者（142名在我们的研究中心随机化，4名从其他研究中心转移），该研究将持续到2021年4月。 本研究还包括几项重要的辅助和子研究。我们参与了一项研究，该研究调查了自身免疫在2型糖尿病中的作用，以及这是否会影响对治疗的反应。我们还收集了粪便用于肠道微生物组测量，将分析肠道微生物组对治疗的反应以及这些变化是否影响肠道菌群。我们还邀请参与者佩戴连续葡萄糖监测仪（CGM）2周，以使我们能够在种族和种族多样化的队列中将平均葡萄糖与血红蛋白A1 C相关联，并分析葡萄糖变异性如何受到治疗的影响，以及它是否预测长期糖尿病相关结局。

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.