Department of Endocrinology, Liaocheng People's Hospital, Liaocheng, 252000, China.
Cadre Health Care Department, Liaocheng People's Hospital, Liaocheng, 252000, China.
Sci Rep. 2021 Dec 14;11(1):23950. doi: 10.1038/s41598-021-03480-9.
Flash glucose monitoring (FGM) was introduced in China in 2016, and it might improve HbA1c measurements and reduce glycaemic variability during T1DM therapy. A total of 146 patients were recruited from October 2018 to September 2019 in Liaocheng. The patients were randomly divided into the FGM group or self-monitoring blood glucose (SMBG) group. Both groups wore the FGM device for multiple 2-week periods, beginning with the 1st, 24th, and 48th weeks for gathering data, while blood samples were also collected for HbA1c measurement. Dietary guidance and insulin dose adjustments were provided to the FGM group patients according to their Ambulatory Glucose Profile (AGP) and to the SMBG group patients according to their SMBG measurements taken 3-4 times daily. All of the participants underwent SMBG measurements on the days when not wearing the FGM device. At the final visit, HbA1c, time in range (TIR), duration of hypoglycaemia and the number of diabetic ketoacidosis (DKA) events were taken as the main endpoints. There were no significant difference in the baseline characteristics of the two groups. At 24 weeks, the HbA1c level of the FGM group was 8.16 ± 1.03%, which was much lower than that of the SMBG group (8.68 ± 1.01%) (p = 0.003). The interquartile range (IQR), mean blood glucose (MBG), and the duration of hypoglycaemia in the FGM group also showed significant declines, compared with the SMBG group (p < 0.05), while the TIR increased in the FGM group [(49.39 ± 17.54)% vs (42.44 ± 15.49)%] (p = 0.012). At 48 weeks, the differences were more pronounced (p < 0.01). There were no observed changes in the number of episodes of DKA by the end of the study [(0.25 ± 0.50) vs (0.28 ± 0.51), p = 0.75]. Intermittent use of FGM by T1DM patients can improve their HbA1c and glycaemic control without increasing the hypoglycaemic exposure in insulin-treated individuals with type 1 diabetes in an developing country.
在中国,2016 年引入了即时血糖监测(FGM),它可能改善 1 型糖尿病(T1DM)治疗期间的 HbA1c 测量值并降低血糖变异性。2018 年 10 月至 2019 年 9 月,共有 146 名患者在聊城招募。这些患者被随机分为 FGM 组或自我监测血糖(SMBG)组。两组均佩戴 FGM 设备进行多次为期 2 周的测量,第 1、24 和 48 周收集数据,同时采集血样测量 HbA1c。根据患者的动态血糖图谱(AGP)为 FGM 组患者提供饮食指导和胰岛素剂量调整,根据 SMBG 组患者的每日 3-4 次 SMBG 测量值提供饮食指导和胰岛素剂量调整。所有参与者在不佩戴 FGM 设备的日子里进行 SMBG 测量。在最后一次就诊时,HbA1c、血糖达标时间(TIR)、低血糖持续时间和糖尿病酮症酸中毒(DKA)事件发生次数作为主要终点。两组患者的基线特征无显著差异。24 周时,FGM 组的 HbA1c 水平为 8.16±1.03%,明显低于 SMBG 组的 8.68±1.01%(p=0.003)。与 SMBG 组相比,FGM 组的四分位间距(IQR)、平均血糖(MBG)和低血糖持续时间也显著下降(p<0.05),而 TIR 升高(FGM 组:49.39±17.54%vs SMBG 组:42.44±15.49%)(p=0.012)。48 周时,差异更加显著(p<0.01)。研究结束时,DKA 发作次数无明显变化[(0.25±0.50)vs(0.28±0.51),p=0.75]。在发展中国家,1 型糖尿病患者间歇性使用 FGM 可以改善 HbA1c 和血糖控制,而不会增加胰岛素治疗的 1 型糖尿病患者的低血糖暴露。