Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control A Randomized Clinical Trial
Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control A Randomized Clinical Trial
复制标题
DOI：
10.1001/jamaophthalmol.2015.1312
复制
发表时间：
2015-08-01
影响因子：
8.1
通讯作者：
Wolpert, Howard A.
中科院分区：
文献类型：
--
作者：
Aiello, Lloyd Paul;Ayala, Allison R.;Wolpert, Howard A.
血糖控制的优化对于减少糖尿病相关并发症的数量至关重要，但长期成功具有挑战性。虽然视力丧失是糖尿病患者最大的恐惧之一，但全面的个性化糖尿病教育和风险评估并不一致地用于眼科settings. ObjectiveTo确定是否点的护理测量血红蛋白A（1c）（HbA（1c））和个性化的糖尿病风险评估进行视网膜眼科访问期间改善血糖控制评估HbA 1c水平。设计、设置和参与者：基于眼科医生办公室的随机、多中心临床试验，其中来自42个研究中心的研究者被随机分配，提供研究规定的增强糖尿病评估和教育或常规护理。1型或2型糖尿病成年患者分为两个队列：随访频率高于每年的队列（502名对照参与者和488名干预参与者）和每年随访的队列（368名对照参与者和388名干预参与者）。干预措施：对HbA 1c、血压和视网膜病变严重程度进行床旁测量;根据眼科访视结果对视网膜病变进展风险进行个体化评估;对过去和当前临床结果进行结构化比较和回顾;对参与者的理解进行结构化教育，并立即评估和反馈。这些干预措施进行了登记，并在常规眼科随访访视安排至少12 wheels.Main结果和措施平均变化HbA 1c水平从基线到1年的后续行动。次要结果包括体重指数、血压和对糖尿病自我管理实践和态度调查的反应。结果在随访频率高于每年的队列中，1年时HbA 1c水平的平均（SD）变化为-0.1%（1.5%），干预组为-0.3%（1.4%）（校正平均差异，-0.09% [95% CI，-0.29%至0.12%]; P = 0.35）。在每年随访的队列中，对照组HbA 1c水平的平均（SD）变化为0.0%（1.1%），干预组为-0.1%（1.6%）（平均差异，-0.05%（95%CI，-0.27%至0.18%）; P = 0.63）。结果是相似的所有次要outcome.CONCLUSIONS和相关性长期优化血糖控制是没有实现的大多数糖尿病患者。与常规护理相比，在视网膜眼科就诊期间增加个性化教育和风险评估并没有导致1年内HbA 1c水平降低。这些数据表明，优化血糖控制仍然是一个实质性的挑战，需要干预范式以外的其他研究。
IMPORTANCE Optimization of glycemic control is critical to reduce the number of diabetes mellitus-related complications, but long-term success is challenging. Although vision loss is among the greatest fears of individuals with diabetes, comprehensive personalized diabetes education and risk assessments are not consistently used in ophthalmologic settings.OBJECTIVE To determine whether the point-of-care measurement of hemoglobin A(1c) (HbA(1c)) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA1c level. DESIGN, SETTING, AND PARTICIPANTS Ophthalmologist office-based randomized, multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care. Adults with type 1 or 2 diabetes enrolled into 2 cohorts: those with a more-frequent-than-annual follow-up (502 control participants and 488 intervention participants) and those with an annual follow-up (368 control participants and 388 intervention participants). Enrollment was from April 2011 through January 2013.INTERVENTIONS Point-of-care measurements of HbA1c, blood pressure, and retinopathy severity; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant's understanding. These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart.MAIN OUTCOMES AND MEASURES Mean change in HbA1c level from baseline to 1-year follow-up. Secondary outcomes included body mass index, blood pressure, and responses to diabetes self-management practices and attitudes surveys.RESULTS In the cohort with more-frequent-than-annual follow-ups, the mean (SD) change in HbA1c level at 1 year was -0.1% (1.5%) in the control group and -0.3%(1.4%) in the intervention group (adjusted mean difference, -0.09% [95% CI, -0.29% to 0.12%]; P = .35). In the cohort with annual follow-ups, the mean (SD) change in HbA1c level was 0.0% (1.1%) in the control group and -0.1%(1.6%) in the intervention group (mean difference, -0.05% [95% CI, -0.27% to 0.18%]; P = .63). Results were similar for all secondary outcomes.CONCLUSIONS AND RELEVANCE Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes. The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA1c level compared with usual care over 1 year. These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in our study.