University of Melbourne Department of Medicine, St. Vincent's Hospital, Fitzroy, Australia.
Diabetes Technol Ther. 2011 Feb;13(2):105-9. doi: 10.1089/dia.2010.0139.
This study evaluated the impact on quality of life (QoL) of an algorithm guiding the responses of continuous subcutaneous insulin infusion (CSII)-treated type 1 diabetes (T1D) patients using real-time (RT)-continuous glucose monitoring (CGM).
Sixty CSII-treated T1D participants (13-70 years old, glycosylated hemoglobin [HbA1c] ≤ 9.5%), including adult and adolescent subgroups, were randomized in age-, gender-, and HbA1c-matched pairs. Phase 1 was an open 16-week multicenter randomized controlled trial; Group A received CSII/RT-CGM with the algorithm, and Group B received CSII/RT-CGM without algorithm. Phase 2 was the 16-32-week follow-up study; Group A returned to usual care (CSII without RT-CGM), and Group B was provided with algorithm at 16 weeks. QoL was assessed by DQOL (adults) and DQOLY (adolescents) questionnaires at baseline, 16 weeks, and 32 weeks. Higher scores (range 1-5) indicate poorer QoL. Analysis was by analysis of variance (between group for baseline-16 weeks) and paired two-tailed t tests (within group for baseline and 32 weeks) with significance at P < 0.05.
Withdrawals left 28 of 30 patients in Group A and 27 of 30 patients in Group B at 32 weeks. In Phase 1, QoL in Group A (2.16 [0.44] baseline to 1.86 [0.40] at 16 weeks) improved compared with Group B (2.03 [0.47] to 2.03 [0.50]) (P = 0.002). Change in QoL correlated with changes in HbA1c (R = 0.36; P = 0.007). In Phase 2, Group A QoL was better at 32 weeks compared with baseline (2.16 [0.44] vs. 2.02 [0.43]) (P = 0.04) but was not in Group B (2.03 [0.47] vs. 1.99 [0.51]) (P = not significant).
An algorithm guiding CSII-treated T1D responses to RT-CGM improved QoL, which persisted post-RT-CGM withdrawal. Algorithm provision at RT-CGM initiation was required to benefit QoL.
本研究评估了实时（RT）-连续血糖监测（CGM）指导使用连续皮下胰岛素输注（CSII）治疗的 1 型糖尿病（T1D）患者的反应的算法对生活质量（QoL）的影响。
60 名接受 CSII 治疗的 T1D 参与者（13-70 岁，糖化血红蛋白[HbA1c]≤9.5%），包括成人和青少年亚组，按年龄、性别和 HbA1c 匹配进行随机分组。第 1 阶段是一项为期 16 周的开放多中心随机对照试验；A 组接受 CSII/RT-CGM 加算法，B 组接受 CSII/RT-CGM 无算法。第 2 阶段是 16-32 周的随访研究；A 组恢复常规治疗（无 RT-CGM 的 CSII），B 组在 16 周时使用算法。基线、16 周和 32 周时使用 DQOL（成人）和 DQOLY（青少年）问卷评估 QoL。得分越高（范围 1-5）表示 QoL 越差。分析采用方差分析（组间基线-16 周）和配对双侧 t 检验（组内基线和 32 周），P<0.05 为差异有统计学意义。
32 周时，A 组有 28 名患者（30 名中的 28 名）和 B 组有 27 名患者（30 名中的 27 名）退出。第 1 阶段，A 组的 QoL 从基线的 2.16（0.44）改善至 16 周的 1.86（0.40）（P=0.002），而 B 组从 2.03（0.47）到 2.03（0.50）没有变化（P=0.002）。QoL 的变化与 HbA1c 的变化相关（R=0.36；P=0.007）。第 2 阶段，A 组的 QoL 在 32 周时与基线相比更好（2.16（0.44）比 2.02（0.43））（P=0.04），而 B 组则没有变化（2.03（0.47）比 1.99（0.51））（P=无显著差异）。
指导 CSII 治疗的 T1D 对 RT-CGM 反应的算法改善了 QoL，且在 RT-CGM 退出后仍保持。在 RT-CGM 启动时提供算法是提高 QoL 的必要条件。
