Fundación Canaria de Investigación Sanitaria (FUNCANIS), Las Palmas de Gran Canaria, Spain.
Universitat Internacional de Catalunya (UIC), Barcelona, Spain.
J Eval Clin Pract. 2018 Aug;24(4):772-781. doi: 10.1111/jep.12987. Epub 2018 Jul 3.
RATIONALE, AIMS AND OBJECTIVES: Self-monitoring of blood glucose (SMBG) is recommended to monitor glycaemic levels. The recent development of real-time continuous glucose monitoring (RT-CGM) enables continuous display of glucose concentration alerting patients in the event of relevant glucose fluctuations, potentially avoiding hypoglycaemic events and reducing long-term complications related to glycosylated haemoglobin (HbA1c) levels. This paper aims to evaluate the cost-effectiveness of RT-CGM compared to SMBG in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which should support decision-making on public funding of RT-CGM in Spain.
We performed a systematic review and meta-analyses on the effectiveness of RT-CGM in the reduction of HbA1c levels and severe hypoglycaemic events. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals treated under these alternatives for a lifetime horizon from the perspective of the Spanish Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.
Real-time continuous glucose monitoring provides a significant reduction of HbA1c for T1DM (13 studies; weighted mean difference (WMD) = -0.23%, 95% CI: -0.35, -0.11) and T2DM (5 studies; WMD = -0.48%, 95% CI: -0.79, -0.17). There were no statistically significant differences in the rate of severe hypoglycaemic events in T1DM (9 studies; OR = 1.16, 95% CI: 0.78, 1.72) or T2DM (no severe hypoglycaemic events were reported in any study). In the base case analysis, RT-CGM led to higher QALYs and health care costs with an estimated incremental cost-effectiveness ratio of €2 554 723 and €180 553 per QALY for T1DM and T2DM patients respectively. Sensitivity analyses revealed that the study results were robust.
Real-time continuous glucose monitoring is not a cost-effective technology when compared to SMBG in Spain.
背景、目的和目标：自我血糖监测（SMBG）被推荐用于监测血糖水平。实时连续血糖监测（RT-CGM）的最新发展能够连续显示血糖浓度，在出现相关血糖波动时提醒患者，有可能避免低血糖事件，并降低与糖化血红蛋白（HbA1c）水平相关的长期并发症。本文旨在评估 RT-CGM 相对于 1 型糖尿病（T1DM）和 2 型糖尿病（T2DM）患者的 SMBG 的成本效益，以支持在西班牙对 RT-CGM 进行公共资金决策。
我们对 RT-CGM 在降低 HbA1c 水平和严重低血糖事件方面的有效性进行了系统评价和荟萃分析。使用 Markov 模型进行成本效益分析，该模型模拟了在终生范围内，根据这些替代方案治疗的个体的成本和健康结果，从西班牙卫生服务的角度出发。有效性测量指标是质量调整生命年（QALYs）。我们进行了广泛的敏感性分析，包括概率敏感性分析。
实时连续血糖监测为 T1DM（13 项研究；加权均数差（WMD）=-0.23%，95%置信区间：-0.35，-0.11）和 T2DM（5 项研究；WMD=-0.48%，95%置信区间：-0.79，-0.17）提供了 HbA1c 的显著降低。在 T1DM（9 项研究；OR=1.16，95%置信区间：0.78，1.72）或 T2DM（任何研究均未报告严重低血糖事件）中，严重低血糖事件的发生率无统计学差异。在基本案例分析中，RT-CGM 导致更高的 QALYs 和医疗保健成本，估计 T1DM 和 T2DM 患者的增量成本效益比分别为 2554723 欧元和 180553 欧元/QALY。敏感性分析表明，研究结果是稳健的。
在西班牙，与 SMBG 相比，实时连续血糖监测不是一种具有成本效益的技术。
