Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.
Clin Ther. 2018 Jun;40(6):862-871. doi: 10.1016/j.clinthera.2018.02.004. Epub 2018 Mar 1.
Automated bolus calculation may benefit patients with poorly controlled type 1 diabetes who are relatively new to continuous subcutaneous insulin infusion (CSII). This study investigated the effect of automated bolus calculation on glucose variability, glucose control, and diabetes-related quality of life in patients with reasonably well-controlled type 1 diabetes, accustomed to treatment with CSII for several years.
This open-label, single-center study included 32 patients (mean age, 45.9 [15.1] years; 34% male; disease duration, 27.3 [12.9] years; glycosylated hemoglobin [HbA] level, 64.6 [12.5] mmol/mol [8.1% (1.1%)]; CSII treatment, 9.0 [7.8] years) who were randomly assigned to receive 4 months' treatment with a bolus calculator (n = 14) or continuation of standard care without a bolus calculator (n = 18). All participants received dietary counseling on carbohydrate counting. Primary outcome was glucose variability, as assessed by the SD of 7-point glucose profiles. Secondary outcomes included HbA, rate of (severe) hypoglycemia, and diabetes-related quality of life.
After 4 months of follow-up, glucose variability had improved in the bolus calculator group compared with the control group (change, -0.8 [0.9] vs 0.1 [0.9] mmol/L; P = 0.030). Mean glucose levels did not change in either group (0.4 [1.1] vs 0.3 [0.9] mmol/L; P = 0.95). There were also no differences in change in hypoglycemia rate (-0.6 [1.6] vs -0.4 [1.6] event per patient per week; P = 0.67), HbA value (-0.5 [6.6] vs -4.9 [10.6] mmol/mol; P = 0.21), or diabetes-related quality of life between the bolus calculator group and the control group.
Use of a bolus calculator modestly improved glucose variability in this relatively small group of patients with longstanding type 1 diabetes on CSII but did not affect other parameters of glycemic control or diabetes-related quality of life.
自动化推注计算可能有益于刚接受持续皮下胰岛素输注（CSII）治疗、血糖控制不佳的 1 型糖尿病患者。本研究旨在探究自动化推注计算对血糖变异性、血糖控制及糖尿病相关生活质量的影响，纳入血糖控制尚可、使用 CSII 治疗多年的 1 型糖尿病患者。
这是一项开放标签、单中心研究，共纳入 32 名患者（平均年龄 45.9 [15.1] 岁；34%为男性；病程 27.3 [12.9] 年；糖化血红蛋白 [HbA] 水平 64.6 [12.5] mmol/mol [8.1%（1.1%）]；CSII 治疗 9.0 [7.8] 年），随机分配至接受 4 个月的推注计算器治疗（n = 14）或继续接受无推注计算器的标准治疗（n = 18）。所有患者均接受基于碳水化合物计数的饮食咨询。主要结局是通过 7 点血糖谱的标准差评估血糖变异性。次要结局包括 HbA、低血糖（严重程度）发生率及糖尿病相关生活质量。
在 4 个月的随访后，推注计算器组的血糖变异性较对照组改善（变化值 -0.8 [0.9] 与 0.1 [0.9] mmol/L；P = 0.030）。两组患者的平均血糖水平均无变化（0.4 [1.1] 与 0.3 [0.9] mmol/L；P = 0.95）。低血糖发生率的变化也无差异（-0.6 [1.6] 与 -0.4 [1.6] 事件/患者/周；P = 0.67），HbA 值（-0.5 [6.6] 与 -4.9 [10.6] mmol/mol；P = 0.21）或糖尿病相关生活质量在推注计算器组和对照组之间也无差异。
在使用 CSII 的病程较长的 1 型糖尿病患者中，使用推注计算器可适度改善血糖变异性，但对其他血糖控制参数或糖尿病相关生活质量无影响。
