在糖尿病控制和并发症试验中，毛细血管葡萄糖时间范围内估计值与 HbA1c 与微血管并发症进展的相关性。
Association of Estimated Time-in-Range Capillary Glucose Levels Versus HbA1c With Progression of Microvascular Complications in the Diabetes Control and Complications Trial.
机构信息
The Biostatistics Center, George Washington University, Rockville, MD.
Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, MA.
出版信息
Diabetes Care. 2022 Oct 1;45(10):2445-2448. doi: 10.2337/dc21-2298.
OBJECTIVE
Estimated time in range (eTIR) obtained from DCCT glucose profiles (pre- and postprandial and bedtime) was recently reported to be associated with microvascular outcomes and was recommended as a clinical trial outcome, but without consideration of HbA1c.
RESEARCH DESIGN AND METHODS
The associations of eTIR with diabetic retinopathy and microalbuminuria were assessed without and with adjustment for HbA1c and baseline covariates.
RESULTS
Adjusted for HbA1c and covariates, eTIR was marginally significantly associated with retinopathy in the full cohort (hazard ratio [HR] 1.12 per 10% lower eTIR [95% CI 1.0, 1.26], P = 0.042). Conversely, HbA1c was significantly associated with both outcomes (HR ≥1.19 per 0.5% higher HbA1c, P ≤ 0.0002) in five of six adjusted analyses.
CONCLUSIONS
The association of eTIR with complications is largely explained by its correlation with HbA1c. HbA1c, not eTIR or continuous glucose monitoring TIR, remains the preferred outcome in clinical studies of type 1 diabetes complications.
目的
最近有研究报告称，来自 DCCT 血糖谱（餐前、餐后和睡前）的估计时间在目标范围内（eTIR）与微血管结局相关，并被推荐作为临床试验的结局，但未考虑糖化血红蛋白（HbA1c）。
研究设计和方法
在不考虑 HbA1c 和基线协变量以及考虑 HbA1c 和基线协变量的情况下，评估 eTIR 与糖尿病视网膜病变和微量白蛋白尿的关系。
结果
调整 HbA1c 和协变量后，eTIR 与全队列的视网膜病变呈边缘显著相关（每降低 10% eTIR，风险比 [HR] 为 1.12[95%CI 1.0，1.26]，P = 0.042）。相反，在六项调整分析中的五项中，HbA1c 与这两种结局均显著相关（每升高 0.5% HbA1c，HR≥1.19，P≤0.0002）。
结论
eTIR 与并发症的关联在很大程度上与其与 HbA1c 的相关性有关。在 1 型糖尿病并发症的临床研究中，HbA1c 而不是 eTIR 或连续血糖监测 TIR，仍然是首选的结局。
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