Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Sciences, Beijing, China.
Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Front Endocrinol (Lausanne). 2023 Feb 22;14:1110845. doi: 10.3389/fendo.2023.1110845. eCollection 2023.
Intermittently scanned continuous glucose monitoring (isCGM) is used for unblinded or blinded monitoring of interstitial glucose. We aimed to compare the efficacy of blinded and unblinded isCGM with the FreeStyle Libre system for glycemic control in adults with type 1 diabetes (T1D).
This randomized clinical trial conducted between October 2018 and September 2019 across four endocrinology practices in China included 273 adults aged ≥18 years with T1D, who were randomly divided in a 2:1 ratio into the unblinded (n = 199) or blinded isCGM group (n = 78). In the blinded group, the clinician used FreeStyle Libre Pro system for monitoring, but self-monitoring was also performed by the patients.
Two hundred sixteen (78%) participants completed the study (152 [75%] in the unblinded and 64 [82%] in the blinded group). At 12 weeks, a significant increase in TIR (3.9-10.0 mmol/L) was only observed in the unblinded group, along with a significant decrease in hyperglycemia (>13.9 mmol/L), hypoglycemia (<3.0 mmol/L), glycemic variability. Further, the mean HbA1c reduction from baseline to 12 weeks was 0.5% in the unblinded isCGM group and 0.4% in the blinded isCGM group respectively (P < 0.001), but the significance did not remain after adjustment for between-group differences. Finally, 99.5% of the blinded isCGM values and 93.8% the of unblinded isCGM values were obtained at the final visit.
The unblinded isCGM system was associated with benefits for glucose management, but nearly 100% of the attempted profiles were obtained successfully with the blinded isCGM system. Thus, combining real-time and retrospective data with isCGM might be the most impactful way to utilize flash glycemic monitoring devices.
间歇性扫描连续血糖监测（isCGM）用于间质葡萄糖的非盲或盲监测。我们旨在比较自由式利柏血糖仪的盲法和非盲法 isCGM 对 1 型糖尿病（T1D）成人血糖控制的疗效。
这项于 2018 年 10 月至 2019 年 9 月在中国 4 家内分泌科诊所进行的随机临床试验纳入了 273 名年龄≥18 岁的 T1D 成年患者，他们按 2:1 的比例随机分为非盲（n = 199）或盲法 isCGM 组（n = 78）。在盲法组中，临床医生使用 FreeStyle Libre Pro 系统进行监测，但患者也进行自我监测。
206 名（78%）参与者完成了研究（非盲组 152 名[75%]，盲法组 64 名[82%]）。12 周时，仅在非盲组观察到 TIR（3.9-10.0mmol/L）显著增加，同时高血糖（>13.9mmol/L）、低血糖（<3.0mmol/L）、血糖变异性显著降低。此外，从基线到 12 周，非盲法 isCGM 组的平均 HbA1c 降低了 0.5%，盲法 isCGM 组降低了 0.4%（均<0.001），但在调整组间差异后，这种差异不再具有统计学意义。最后，在最后一次就诊时，99.5%的盲法 isCGM 值和 93.8%的非盲法 isCGM 值获得。
非盲法 isCGM 系统与改善血糖管理相关，但盲法 isCGM 系统几乎成功获得了 100%的尝试性图谱。因此，将实时和回顾性数据与 isCGM 相结合可能是利用闪测血糖仪最有意义的方式。
