International Diabetes Center, HealthPartners Institute, 3800 Park Nicollet Blvd, Minneapolis, Minnesota, USA.
Clinical Drug Development, Novo Nordisk A/S, Søborg, Denmark.
Diabetes Technol Ther. 2023 Jun;25(6):378-383. doi: 10.1089/dia.2022.0447. Epub 2023 May 8.
Time spent in glycemic target range (time in range [TIR]; plasma glucose 70-180 mg/dL [3.9-10.0 mmol/L]) as a surrogate endpoint for long-term diabetes-related outcomes requires validation. This post hoc analysis investigated the association between TIR, derived from 8-point glucose profiles (derived TIR [dTIR]) at 12 months, and time to cardiovascular or severe hypoglycemic episodes in people with type 2 diabetes in the DEVOTE trial. At 12 months, dTIR was significantly negatively associated with time to first major adverse cardiovascular event ( = 0.0087), severe hypoglycemic episode ( < 0.0001), or microvascular event ( = 0.024). A nonsignificant trend was seen toward association between 12-month hemoglobin A1c (HbA1c) and these outcomes, but this was no longer seen after addition of dTIR to the model. The results support targeting TIR >70% and suggest dTIR could be used in addition to, or in some instances in place of, HbA1c as a clinical biomarker. ClinicalTrials.gov, NCT01959529.
时间在血糖目标范围内（时间范围 [TIR]；血浆葡萄糖 70-180mg/dL [3.9-10.0mmol/L]）作为长期糖尿病相关结局的替代终点需要验证。本事后分析研究了 12 个月时 8 点血糖谱（衍生 TIR [dTIR]）得出的 TIR 与 2 型糖尿病患者心血管或严重低血糖事件时间之间的关联在 DEVOTE 试验中。在 12 个月时，dTIR 与首次主要不良心血管事件（ = 0.0087）、严重低血糖事件（ < 0.0001）或微血管事件（ = 0.024）的时间呈显著负相关。HbA1c（HbA1c）与这些结局之间存在非显著趋势，但在向模型中添加 dTIR 后，这种趋势不再存在。结果支持将 TIR >70%作为目标，并表明 dTIR 可作为临床生物标志物，单独使用或替代 HbA1c 用于某些情况。ClinicalTrials.gov，NCT01959529。
