Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE 68198, USA.
Velocity Clinical Research at Medical City, Dallas, TX 75230, USA.
J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.
CONTEXT: Intermediate-term glycemic control metrics may represent a viable alternative to continuous glucose monitoring (CGM) in patients without access to CGM. OBJECTIVE: This work aimed to compare the relationship between CGM parameters and glycated albumin (GA), glycated hemoglobin A1c (HbA1c), and fructosamine for 24 weeks. METHODS: We conducted exploratory comparative analyses of CGM subgroup data from a previously published 24-week prospective study of assay performance in 8 US clinics. Participants included 34 individuals with type 1 (n = 18) and type 2 diabetes (n = 16) undergoing changes to improve glycemic control (n = 22; group 1) or with stable diabetes therapy (n = 12; group 2). Main outcome measures included Pearson correlations between CGM and glycemic indices and receiver operating characteristic (ROC) analysis of glycemic index values predictive of time in range (TIR) greater than 70%. RESULTS: At weeks 4 and 8, GA correlations with TIR were higher than HbA1c correlations in group 1. In group 2, GA correlations with TIR were statistically significant, whereas HbA1c correlations were not. In both groups over the first 12 weeks, GA correlations with TIR were higher than fructosamine-TIR correlations. In the ROC analysis, GA predicted a TIR greater than 70% during weeks 2 to 24 (area under the curve >0.80); HbA1c was predictive during weeks 12 to 24. Cutoff values for TIR greater than 70% were 17.5% (sensitivity and specificity, 0.88) for GA and 7.3% (0.86) for HbA1c. CONCLUSION: GA is the most accurate predictor of TIR over 8 weeks compared with other glycemic indices, which may assist in clinical evaluation of changes in treatment where CGM is not possible and it is too early to use HbA1c (NCT02489773).
背景:对于无法进行连续血糖监测(CGM)的患者,中期血糖控制指标可能是 CGM 的一种可行替代方法。
目的:本研究旨在比较 CGM 参数与糖化白蛋白(GA)、糖化血红蛋白 A1c(HbA1c)和果糖胺在 24 周时的相关性。
方法:我们对之前发表的一项为期 24 周的美国 8 家临床研究中关于检测性能的前瞻性研究的 CGM 亚组数据进行了探索性比较分析。参与者包括 34 名 1 型(n=18)和 2 型糖尿病(n=16)患者,他们正在改变治疗方案以改善血糖控制(n=22;第 1 组)或使用稳定的糖尿病治疗(n=12;第 2 组)。主要观察指标包括 CGM 与血糖指数之间的 Pearson 相关性和血糖指数预测时间在范围内(TIR)大于 70%的受试者工作特征(ROC)分析。
结果:在第 4 周和第 8 周,第 1 组中 GA 与 TIR 的相关性高于 HbA1c,具有统计学意义。在第 2 组中,GA 与 TIR 的相关性具有统计学意义,而 HbA1c 则没有。在最初的 12 周内,GA 与 TIR 的相关性在两组中均高于果糖胺-TIR 的相关性。在 ROC 分析中,GA 在第 2 周到第 24 周预测 TIR 大于 70%(曲线下面积>0.80);HbA1c 在第 12 周到第 24 周预测。TIR 大于 70%的截断值为 GA 为 17.5%(灵敏度和特异性为 0.88),HbA1c 为 7.3%(0.86)。
结论:与其他血糖指数相比,GA 在 8 周内是 TIR 最准确的预测指标,这可能有助于在无法进行 CGM 且使用 HbA1c 还为时过早的情况下对治疗变化进行临床评估(NCT02489773)。
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