Department of Diabetology, Careggi Hospital, Florence, Italy.
Department Mario Serio, University of Florence, Florence, Italy.
Diabetes Obes Metab. 2019 Dec;21(12):2619-2625. doi: 10.1111/dom.13845. Epub 2019 Sep 13.
To conduct a meta-analysis to assess the effect of continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and the combination of the two, on glycaemic control in type 2 diabetes.
The analysis included randomized clinical trials comparing CSII with multiple daily injections (MDI) in people with type 2 diabetes, as well as studies comparing CGM or flash glucose monitoring (FGM) with self-monitoring of blood glucose (SMBG), with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was glycated haemoglobin (HbA1c) at the end of the trial. Mean and 95% confidence intervals (CIs) for HbA1c and Mantel-Haenzel odds ratios for severe hypoglycaemia were calculated, using random-effect models.
The retrieved trials showed a significant heterogeneity (I = 90%). The difference in HbA1c between CSII and MDI was not statistically significant (-0.26% [95% CI -0.74;0.22]; P = .29). The difference in endpoint HbA1c between CGM and SMBG was marginally significant (-0.24 [95% CI -0.49;0.00]; P = .05), and CGM was possibly associated with a lower hypoglycaemic risk. Only one trial explored the effect of FGM, as compared with SMBG, on HbA1c in type 2 diabetes, finding no difference across groups (at study end: 8.4% ± 0.8% vs 8.3% ± 1.1% with FGM and SMBG, respectively). Conversely, FGM was associated with an improvement in quality of life and with a lower incidence of hypoglycaemic events. The small number of retrieved trials indicates that the results should be interpreted with caution.
The analysis showed that CSII, CGM and FGM provide only small benefits compared with MDI (on either HbA1c, hypoglycaemic risk or quality of life) in insulin-treated people with type 2 diabetes.
进行荟萃分析以评估持续皮下胰岛素输注(CSII)、连续血糖监测(CGM)以及两者联合应用对 2 型糖尿病患者血糖控制的影响。
该分析包括比较 CSII 与 2 型糖尿病患者多次皮下注射(MDI)的随机临床试验,以及比较 CGM 或闪光血糖监测(FGM)与自我血糖监测(SMBG)的研究,研究持续时间至少为 12 周,在 Medline 或 clinicaltrials.gov 中确定。主要终点是试验结束时糖化血红蛋白(HbA1c)。使用随机效应模型计算 HbA1c 的平均值和 95%置信区间(CI)以及严重低血糖的 Mantel-Haenzel 比值比。
检索到的试验显示存在显著的异质性(I = 90%)。CSII 与 MDI 之间 HbA1c 的差异无统计学意义(-0.26%[95%CI-0.74;0.22];P =.29)。CGM 与 SMBG 之间终点 HbA1c 的差异具有边缘统计学意义(-0.24[95%CI-0.49;0.00];P =.05),并且 CGM 可能与较低的低血糖风险相关。只有一项试验比较了 FGM 与 SMBG 对 2 型糖尿病患者 HbA1c 的影响,发现两组之间没有差异(研究结束时:FGM 和 SMBG 组分别为 8.4%±0.8%和 8.3%±1.1%)。相反,FGM 与生活质量的改善和低血糖事件发生率的降低相关。检索到的试验数量较少表明结果应谨慎解释。
该分析表明,与 MDI 相比,CSII、CGM 和 FGM 在接受胰岛素治疗的 2 型糖尿病患者中仅提供较小的益处(无论是 HbA1c、低血糖风险还是生活质量)。