目的:本研究旨在评估1型糖尿病(T1D)患者在启动第二代FreestyleLibre2(FSL2)系统后患者报告的满意度和代谢结果。
方法:这项非随机单臂观察研究是对居住在沙特阿拉伯的86例T1D患者进行的,他们被要求佩戴FSL212周。人口统计数据是在基线时收集的,在收集连续血糖监测(CGM)指标的同时,即,葡萄糖变异性(GV)(%),平均时间范围(TIR),超限时间(TAR),低于范围的时间(TBR),在基线时收集低血糖事件的平均持续时间,第6周和12周。Further,随访结束时收集连续血糖监测满意度(CGM-SAT).
结果:与第6周相比,在低葡萄糖事件中观察到显着差异(p=0.037),%TIR(p=0.045),和%在12周时低于70mg/dL(p=0.047)。其他血糖变量有所改善,但无明显变化(p>0.05)。学习完成后,动态血糖谱(AGP)指标显示,FSL2低血糖警报阈值为74.3±5.01(mg/dL),高血糖警报阈值为213±38.1(mg/dL).大多数患者表示CGM-SAT有益处(平均得分>3.58),尽管他们认为FSL2有额外的好处。关于使用FSL2的问题,大多数患者表示FSL2具有最小的不适。
结论:在T1D患者中使用第二代FSL2与患者报告的满意度和代谢结果呈正相关。
OBJECTIVE: This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D).
METHODS: This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the continuous glucose monitoring (CGM) metrics were gathered, i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up.
RESULTS: Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had \'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort.
CONCLUSIONS: Using second-generation FSL2 in patients with T1D is positively associated with patient- reported satisfaction and metabolic outcomes.