基于女性外阴残割术的远程干预用于治疗 1 型糖尿病成人患者：FRIEND 随机临床试验。
FGM-based remote intervention for adults with type 1 diabetes: The FRIEND randomized clinical trial.
机构信息
Department of Biomedical Science, Graduate School, CHA University, Seongnam, South Korea.
Institute for Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam, South Korea.
出版信息
Front Endocrinol (Lausanne). 2022 Nov 25;13:1054697. doi: 10.3389/fendo.2022.1054697. eCollection 2022.
BACKGROUND
The use of flash glucose monitoring (FGM) in conjunction with proper education has been reported to improve glycemic control in people with diabetes on insulin therapy. However, there are still few randomized controlled trials on the educational effect, and an ideal educational model has not been established. This study aimed to estimate the efficacy of remote intervention for glycemic control in adults with type 1 diabetes using FGM.
METHODS
In this single-center, randomized controlled trial, we enrolled adults with type 1 diabetes (HbA1c ≥7.0%). The participants were randomly assigned (1:1) to either FGM use with remote intervention (intervention group) or FGM use only (control group). Changes in glycemic outcomes such as HbA1c levels and continuous glucose monitoring metrics were evaluated at 12 weeks.
RESULTS
Among 36 randomized participants (mean age, 44.3 years; mean baseline HbA1c, 8.9%), 34 completed the study. The remote intervention did not significantly reduce HbA1c levels. FGM use significantly improved HbA1c levels by -1.4% and -0.8% in both groups with and without remote intervention, respectively (=0.003 and =0.004, respectively). However, the intervention group showed significant increases in time with glucose in the range of 70-180 mg/dL (TIR; from 49.8% to 60.9%, =0.001) and significant decreases in time with hyperglycemia (=0.002) and mean glucose (=0.017), but the control group did not. Moreover, the TIR (=0.019), time with hyperglycemia >250 mg/dL (=0.019), and coefficient of variation (=0.018) were significantly improved in the intervention group compared to the control group. In particular, the CGM metrics improved gradually as the remote intervention was repeated. Furthermore, the intervention group reported higher treatment satisfaction (=0.016).
CONCLUSIONS
Ongoing, personalized education during FGM use may lead to amelioration of glycemic control in adults with type 1 diabetes, even remotely.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT04936633, identifier NCT04936633.
背景
已有研究报道，在接受胰岛素治疗的糖尿病患者中，使用瞬感血糖监测（FGM）并辅以适当的教育可改善血糖控制。然而，关于教育效果的随机对照试验仍然较少，并且尚未建立理想的教育模式。本研究旨在评估使用 FGM 对 1 型糖尿病成人进行远程干预以控制血糖的疗效。
方法
这是一项单中心、随机对照试验，纳入了糖化血红蛋白（HbA1c）≥7.0%的 1 型糖尿病成人患者。将参与者随机分为 FGM 联合远程干预（干预组）或仅使用 FGM（对照组）。在 12 周时评估血糖结局（如 HbA1c 水平和连续血糖监测指标）的变化。
结果
在 36 名随机参与者（平均年龄 44.3 岁；平均基线 HbA1c 8.9%）中，有 34 名完成了研究。远程干预并未显著降低 HbA1c 水平。FGM 的使用分别使两组患者的 HbA1c 水平分别降低了-1.4%和-0.8%（均 P=0.003 和 P=0.004）。然而，干预组的葡萄糖在 70-180mg/dL 范围内的时间（TIR；从 49.8%增加至 60.9%，P=0.001）显著增加，且高血糖时间（P=0.002）和平均血糖（P=0.017）显著降低，而对照组则没有。此外，与对照组相比，干预组的 TIR（P=0.019）、血糖>250mg/dL 的时间（P=0.019）和变异系数（P=0.018）也显著改善。特别是，随着远程干预的重复，CGM 指标逐渐改善。此外，干预组的治疗满意度较高（P=0.016）。
结论
在使用 FGM 期间进行持续的、个性化的教育可能会改善 1 型糖尿病成人的血糖控制，即使是远程进行。
临床试验注册
https://clinicaltrials.gov/ct2/show/NCT04936633，标识符 NCT04936633。
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