ECRI, Plymouth Meeting, PA 19462, USA.
University of Arizona College of Medicine, Tucson, AZ 85724, USA.
J Clin Endocrinol Metab. 2024 Mar 15;109(4):1119-1131. doi: 10.1210/clinem/dgad652.
To provide a systematic review and meta-analysis synthesizing the findings of randomized controlled trials (RCTs) of continuous glucose monitors (CGMs) in the management of adults with type 2 diabetes mellitus (T2DM) on glucose control and clinical outcomes.
MEDLINE, Embase, and Cochrane were searched for RCTs that assessed the effectiveness of real-time CGM (rt-CGM) or flash CGM (FGM) in adults (≥18 years) with T2DM that reported on at least 1 of the following outcomes: hemoglobin A1c (HbA1c), time in range, time in hyperglycemia, or time in hypoglycemia. The GRADE approach was used to assess certainty of evidence for primary outcomes.
Fourteen RCTs assessing CGM were included, with 825 patients in 9 RCTs using rt-CGM and 822 in 5 RCTs using FGM. Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%. Our analyses of each device type separately showed similar reductions in HbA1c (0.34% and 0.33%, respectively, for rt-CGM and FGM), with trends for improvement in other glucose metrics favoring rt-CGM over self-monitored blood glucose.
Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results. However, the duration of the included RCTs was relatively short and few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes.
系统评价和荟萃分析综合了随机对照试验（RCTs）的研究结果，这些试验评估了实时连续血糖监测（rt-CGM）或瞬态血糖监测（FGM）在 2 型糖尿病（T2DM）成人患者血糖控制和临床结局中的作用。
检索 MEDLINE、Embase 和 Cochrane 数据库，以评估在 T2DM 成人（≥18 岁）中使用实时 CGM（rt-CGM）或闪光 CGM（FGM）的 RCTs，这些 RCT 至少报告了以下结果之一：糖化血红蛋白（HbA1c）、达标时间、高血糖时间或低血糖时间。采用 GRADE 方法评估主要结局的证据确定性。
共纳入 14 项 CGM 评估 RCT，其中 9 项 RCT 中 825 例患者使用 rt-CGM，5 项 RCT 中 822 例患者使用 FGM。中等确定性的证据表明，CGM 的使用使 HbA1c 水平降低了约 0.32%，但幅度较小，且具有统计学意义。我们对每种设备类型分别进行分析，发现 HbA1c 水平降低幅度相似（rt-CGM 和 FGM 分别为 0.34%和 0.33%），其他血糖指标也有改善趋势，表明 rt-CGM 优于自我监测血糖。
rt-CGM 和 FGM 均能使 T2DM 患者的 HbA1c 水平适度但具有统计学意义地降低，结果的异质性较小。然而，纳入的 RCT 持续时间相对较短，且很少有研究报告重要的临床结局，如不良事件、急诊就诊或住院。需要进行更长期的研究，以确定短期血糖控制的改善是否能导致临床上重要结局的改善。
