National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Front Public Health. 2022 Aug 25;10:990281. doi: 10.3389/fpubh.2022.990281. eCollection 2022.
Regarding the effects and practical application of insulin pumps on patients with type 1 diabetes mellitus (T1DM), the real-world evidence is limited especially concerning the incidence of hypoglycemia. This study aimed to compare the efficacy of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy on glycemic metrics evaluated by retrospective continuous glucose monitoring (CGM) in Chinese patients with T1DM.
In total, 362 T1DM Chinese patients from the outpatient department of the Second Xiangya Hospital, Central South University, who underwent intensive insulin therapy and used a retrospective CGM system were included in this retrospective cross-sectional study. Comprehensive analysis of clinical and biological features and retrospective CGM derived-metrics was performed on the 362 enrolled T1DM patients who underwent CSII ( = 61) or MDI ( = 301) therapy (defined as 4 or more insulin injections per day).
Our findings demonstrated that patients who underwent CSII therapy, compared with those who received MDI therapy, had lower levels of hemoglobin A1c (HbA1c) and fasting blood glucose; moreover, CSII therapy was associated with better glycemic outcomes in terms of increasing time in range (TIR), decreasing time above range (TAR), and achieving CGM-associated targets of TIR ≥70% and TAR <25%. However, patients who underwent CSII therapy did not experience decreasing time below range (TBR), achieving CGM-associated targets of TBR <4%, and reduction of the risk of hypoglycemia as evidenced by comparing TBR and low blood glucose index (LBGI) between the two treatment regimens. The parameters of glycemic variability, such as standard deviation of glucose (SD), mean amplitude glycemic excursion (MAGE), and large amplitude glycemic excursion (LAGE) in T1DM patients who underwent CSII therapy outperformed.
Our results provided further evidence that CSII therapy is safe and effective for management of Chinese T1DM patients, which was confirmed by a lower HbA1c level and better CGM-derived metrics but no demonstration of improvment in the risk of hypoglycemia. To achieve more satisfactory glycemic outcomes through the utilization of CSII therapy for Chinese T1DM patients, a strong physician-patient relationship is essential.
关于胰岛素泵对 1 型糖尿病（T1DM）患者的作用和实际应用，真实世界的证据有限，尤其是关于低血糖的发生率。本研究旨在比较连续皮下胰岛素输注（CSII）与多次皮下注射（MDI）疗法对中国 T1DM 患者通过回顾性连续血糖监测（CGM）评估的血糖指标的疗效。
本回顾性横断面研究共纳入了 362 例来自中南大学湘雅二医院门诊的接受强化胰岛素治疗并使用回顾性 CGM 系统的 T1DM 中国患者。对 362 例接受 CSII（=61）或 MDI（=301）治疗的 T1DM 患者（定义为每天注射 4 次或更多胰岛素）进行了临床和生物学特征的综合分析以及回顾性 CGM 衍生指标的分析。
我们的研究结果表明，与接受 MDI 治疗的患者相比，接受 CSII 治疗的患者的糖化血红蛋白（HbA1c）和空腹血糖水平更低；此外，CSII 治疗在增加时间在目标范围内（TIR）、降低时间超过目标范围（TAR）以及实现 CGM 相关目标 TIR≥70%和 TAR<25%方面与更好的血糖控制结果相关。然而，接受 CSII 治疗的患者并没有经历时间低于目标范围（TBR）的减少，也没有达到 CGM 相关目标 TBR<4%和低血糖风险降低的目标，通过比较两种治疗方案的 TBR 和低血糖指数（LBGI）可以证明这一点。CSII 治疗的 T1DM 患者的血糖变异性参数，如血糖标准差（SD）、平均血糖波动幅度（MAGE）和大幅血糖波动幅度（LAGE）等，均表现出更好的效果。
我们的研究结果进一步证明，CSII 治疗对中国 T1DM 患者的管理是安全有效的，这一点从较低的 HbA1c 水平和更好的 CGM 衍生指标得到了证实，但没有证明低血糖风险的改善。为了通过 CSII 治疗为中国 T1DM 患者获得更满意的血糖控制结果，需要建立良好的医患关系。
