Botelho Mayra Souza, Galendi Julia Simões Correa, Novo Mariana Andrades Fiorini Monteiro, Nunes-Nogueira Vania Dos Santos
Department of Internal Medicine, Medical School, São Paulo State University (UNESP), Botucatu, São Paulo, Brazil.
Diabetol Metab Syndr. 2025 Aug 31;17(1):366. doi: 10.1186/s13098-025-01935-x.
Monitoring glucose levels is crucial for managing glycemic control. Methods include self-monitored blood glucose (SMBG), continuous glucose monitoring (CGM), and intermittently scanned continuous glucose monitoring (isCGM).
To assess the efficacy of isCGM versus SMBG in individuals with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) on insulin therapy.
We conducted a systematic review including randomized controlled trials involving patients over 4 years old with T1DM or T2DM on multiple daily insulin regimens, comparing isCGM to SMBG. The outcomes analyzed were HbA1c (%), time below the target glucose range (TBR), patient satisfaction (DTSQ), device-related adverse events, time in range (TIR), and hypoglycemic events. Searches were performed in MEDLINE, EMBASE, and CENTRAL. Two independent reviewers screened studies, assessed the risk of bias, and extracted data. The meta-analyses employed a random-effects model, and the certainty of evidence was evaluated via the GRADE system.
Seventeen studies with 1,860 participants were included. The isCGM demonstrated a moderate certainty of evidence for reducing HbA1c (Mean difference [MD]: -0.25%, 95% confidence interval [95% CI]: -0.39- -0.10%; I²: 82.6% 13 studies; 1,482 patients) and enhancing patient satisfaction (MD: 4.5, 95% CI: 2.18- 6.82; I²: 92.9%; 10 studies; 1,150 patients). Meta-regression revealed that intervention duration was a significant moderator of HbA1c reduction. isCGM also favored a reduction in TBR, with an MD of -0.15% (95% CI: -0.23- -0.07%; I²: 96.7% 8 studies; 1,094 patients; low certainty). Mild device-related adverse events were more common in the isCGM group (Relative risk: 2.69, 95% CI: 1.5- 4.81; I²: 0%; 7 studies; 991 participants; moderate certainty). The overall frequency of participants who discontinued isCGM due to cutaneous adverse events was 1% (95% CI: 0-6%; 7 studies; 533 participants). No clear effects were observed for TIR (MD: 0.02%, 95% CI: -0.05- 0.1%; I²: 79.6%; 11 studies; 1,318 patients; very low certainty) or hypoglycemic episodes.
Compared with SMBG, isCGM reduces HbA1c, enhances patient satisfaction, and reduces TBR. However, it may increase the incidence of mild device-related adverse events. No definitive effects were observed on the TIR or hypoglycemia frequency.
CRD42024562805.
监测血糖水平对于控制血糖至关重要。方法包括自我监测血糖(SMBG)、持续葡萄糖监测(CGM)和间歇性扫描持续葡萄糖监测(isCGM)。
评估isCGM与SMBG在接受胰岛素治疗的1型糖尿病(T1DM)或2型糖尿病(T2DM)患者中的疗效。
我们进行了一项系统评价,纳入了涉及4岁以上接受每日多次胰岛素治疗方案的T1DM或T2DM患者的随机对照试验,比较isCGM与SMBG。分析的结局指标包括糖化血红蛋白(HbA1c,%)、低于目标血糖范围的时间(TBR)、患者满意度(糖尿病治疗满意度问卷,DTSQ)、与设备相关的不良事件、血糖达标时间(TIR)和低血糖事件。检索了MEDLINE、EMBASE和CENTRAL数据库。两名独立的评审员筛选研究、评估偏倚风险并提取数据。荟萃分析采用随机效应模型,并通过GRADE系统评估证据的确定性。
纳入了17项研究,共1860名参与者。isCGM在降低HbA1c方面显示出中等确定性的证据(平均差[MD]:-0.25%,95%置信区间[95%CI]:-0.39至-0.10%;I²:82.6%,13项研究;1482名患者),并提高了患者满意度(MD:4.5,95%CI:2.18至6.82;I²:92.9%;10项研究;1150名患者)。荟萃回归显示,干预持续时间是HbA1c降低的显著调节因素。isCGM也有利于降低TBR,MD为-0.15%(95%CI:-0.23至-0.07%;I²:96.7%,8项研究;1094名患者;低确定性)。轻度与设备相关的不良事件在isCGM组中更常见(相对风险:2.69,95%CI:1.5至4.81;I²:0%;7项研究;991名参与者;中等确定性)。因皮肤不良事件而停用isCGM的参与者的总体频率为1%(95%CI:0至6%;7项研究;533名参与者)。未观察到TIR(MD:0.02%,95%CI:-0.05至0.1%;I²:79.6%;11项研究;1318名患者;极低确定性)或低血糖发作的明确影响。
与SMBG相比,isCGM降低了HbA1c,提高了患者满意度,并降低了TBR。然而,它可能会增加轻度与设备相关的不良事件的发生率。未观察到对TIR或低血糖频率的明确影响。
PROSPERO注册号:CRD42024562805。