METHODS: De-identified data were obtained between 2014 and 2021 from patients using FLASH uninterrupted for a 24-week period. Glycemic parameters during first and last sensor use were examined in four identifiable groups: type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) on basal-bolus insulin, T2DM on basal insulin, and T2DM without insulin treatment. Within each group, subgroup analyses were performed in persons with initial suboptimal glycemic regulation (time in range (TIR; 3.9-10 mmol/L) < 70%, time above range (TAR; >10 mmol/L) > 25%, or time below range (TBR; <3.9 mmol/L) > 4%).
RESULTS: Data were obtained from 1,909 persons with T1DM and 1,813 persons with T2DM (1,499 basal-bolus insulin, 189 basal insulin, and 125 non-insulin users). In most of the performed analyses, both overall and in the various subgroups, significant improvements were observed in virtually all predefined primary (TIR) and secondary endpoints (eHbA1c, TAR, TBR and glucose variability).
CONCLUSIONS: 24-weeks FLASH use in real life by persons with T1DM and T2DM with suboptimal glycemic regulation is associated with improvement of glycemic parameters, irrespective of pre-use regulation or treatment modality.
方法:在2014年至2021年期间,从使用FLASH的患者中获得了24周不间断的去识别数据。在四个可识别的组中检查了第一次和最后一次传感器使用期间的血糖参数:1型糖尿病(T1DM),2型糖尿病(T2DM)基础推注胰岛素,T2DM对基础胰岛素,2型糖尿病不使用胰岛素治疗。在每一组中,亚组分析是在血糖调节初始次优(时间范围(TIR;3.9-10mmol/L)<70%,超过时间范围(TAR;>10mmol/L)>25%,或时间低于范围(TBR;<3.9mmol/L)>4%)。
结果:数据来自1,909名T1DM患者和1,813名T2DM患者(1,499基础推注胰岛素,189基础胰岛素,和125个非胰岛素使用者)。在大多数执行的分析中,在总体上和各个子组中,在几乎所有预定义的主要终点(TIR)和次要终点(eHbA1c,TAR,TBR和葡萄糖变异性)。
结论:血糖调节欠佳的T1DM和T2DM患者在现实生活中使用24周FLASH与血糖参数的改善有关。无论使用前的规定或治疗方式如何。