Diabetes Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Front Endocrinol (Lausanne). 2023 Aug 31;14:1228153. doi: 10.3389/fendo.2023.1228153. eCollection 2023.
Cystic fibrosis (CF)-related diabetes (CFRD) resulting from partial-to-complete insulin deficiency occurs in 40-50% of adults with CF. In people with CFRD, poor glycemic control leads to a catabolic state that may aggravate CF-induced nutritional impairment and loss of muscle mass. Sensor augmented pump (SAP) therapy may improve glycemic control as compared to multiple daily injection (MDI) therapy.
This non-randomized clinical trial was aimed at evaluating the effects of insulin therapy optimization with SAP therapy, combined with a structured educational program, on glycemic control and body composition in individuals with insulin-requiring CFRD. Of 46 participants who were offered to switch from MDI to SAP therapy, 20 accepted and 26 continued the MDI therapy. Baseline demographic and clinical characteristics were balanced between groups using a propensity score-based overlap weighting procedure and weighted mixed-effects regression models were used to estimate changes in study outcomes.
After 24 months changes in HbA1c were: -1.1% (-12.1 mmol/mol) (95% CI: -1.5; -0.8) and -0.1% (-1 mmol/mol) (95% CI: -0.5; 0.3) in the SAP and MDI therapy group, respectively, with a between-group difference of -1.0 (-10 mmol/mol) (-1.5; -0.5). SAP therapy was also associated with a decrease in mean glucose (between group difference: -32 mg/dL; 95% CI: -44; -20) and an increase in TIR (between group difference: 19.3%; 95% CI 13.9; 24.7) and in fat-free mass (between group difference: +5.5 Kg, 95% CI: 3.2; 7.8).
Therapy optimization with SAP led to a significant improvement in glycemic control, which was associated with an increase in fat-free mass.
囊性纤维化（CF）相关糖尿病（CFRD）是由部分至完全胰岛素缺乏引起的，发生在 40-50%的 CF 成人中。在 CFRD 患者中，血糖控制不佳会导致分解代谢状态，从而可能加重 CF 引起的营养损害和肌肉质量损失。与多次皮下注射（MDI）治疗相比，传感器增强型泵（SAP）治疗可能改善血糖控制。
本非随机临床试验旨在评估 SAP 治疗联合结构化教育计划优化胰岛素治疗对胰岛素依赖型 CFRD 个体血糖控制和身体成分的影响。在 46 名被提议从 MDI 转为 SAP 治疗的参与者中，有 20 人接受了治疗，26 人继续接受 MDI 治疗。使用倾向评分重叠加权程序平衡组间的基线人口统计学和临床特征，并使用加权混合效应回归模型估计研究结果的变化。
24 个月后，HbA1c 的变化为：SAP 治疗组为-1.1%（-12.1mmol/mol）（95%CI：-1.5；-0.8）和-0.1%（-1mmol/mol）（95%CI：-0.5；0.3），MDI 治疗组分别为-0.1%（-1mmol/mol）（95%CI：-0.5；0.3），组间差异为-1.0（-10mmol/mol）（-1.5；-0.5）。SAP 治疗还与平均血糖降低（组间差异：-32mg/dL；95%CI：-44；-20）和 TIR 增加（组间差异：19.3%；95%CI 13.9；24.7）以及去脂体重增加（组间差异：+5.5kg，95%CI：3.2；7.8）相关。
SAP 治疗的优化导致血糖控制显著改善，这与去脂体重增加有关。
