Abstract：
The effectiveness of a hybrid closed-loop (HCL) system in improving glycemic control is unclear in Japanese individuals. Therefore, we assessed the effect impact of the MiniMed 770G HCL system on glycemic control in this population. This prospective, single-center, 24-week observational study (registration number: UMIN000047394) enrolled 23 individuals with type 1 diabetes mellitus using the Medtronic MiniMed 640G system. The primary endpoint was the improvement in time in the range of 70-180 mg/dL after transitioning to the MiniMed 770G HCL system. We observed an increase in time in range (from 64.1 [55.8-69.5] to 70.9 [67.1-74.4] %, interquartile range 25-75%, p < 0.001) and a decrease in glycated hemoglobin level (from 7.4 [7.0-7.9] to 7.1 [6.8-7.4] %, p = 0.003). There was a significant reduction in time above the range (181-250 mg/dL: 25.8 [20.9-28.6] to 19.5 [17.1-22.1] %, p < 0.001; >251 mg/dL: 8.7 [4.0-13.0] to 4.7 [3.6-9.1] %, p < 0.001). Time below the range remained unchanged (54-69 mg/dL: 1.8 [0.4-2.4] to 2.1 [0.4-3.9] %, p = 0.24; <54 mg/dL: 0.2 [0.0-1.0] to 0.5 [0.1-1.3] %, p = 0.14). In a subgroup of 12 patients with a high HCL implementation rate, the basal insulin infusion decreased immediately after mealtime insulin administration and increased after approximately 120 minutes. The ratings from questionnaires assessing treatment burden, satisfaction, and quality of life remained unchanged. The MiniMed 770G HCL system improved glycemic control and optimized insulin delivery, particularly in patients with high implementation rates.
摘要：
在日本人中，混合闭环（HCL）系统在改善血糖控制方面的有效性尚不清楚。因此,我们评估了MiniMed770GHCL系统对该人群血糖控制的影响.这个未来,单中心,24周的观察性研究（注册号：UMIN000047394）使用MedtronicMiniMed640G系统纳入了23名1型糖尿病患者。主要终点是过渡到MiniMed770GHCL系统后在70-180mg/dL范围内的时间改善。我们观察到时间范围增加（从64.1[55.8-69.5]到70.9[67.1-74.4]％，四分位数间距25-75%，p<0.001）和糖化血红蛋白水平降低（从7.4[7.0-7.9]降至7.1[6.8-7.4]％，p=0.003)。超过该范围的时间显着减少（181-250mg/dL：25.8[20.9-28.6]至19.5[17.1-22.1]％，p<0.001;>251mg/dL：8.7[4.0-13.0]至4.7[3.6-9.1]%，p<0.001)。低于该范围的时间保持不变（54-69mg/dL：1.8[0.4-2.4]至2.1[0.4-3.9]％，p=0.24;<54mg/dL:0.2[0.0-1.0]至0.5[0.1-1.3]%,p=0.14）。在HCL执行率高的12例患者的亚组中，基础胰岛素输注在进餐时间胰岛素给药后立即减少,约120分钟后增加.来自评估治疗负担的问卷的评级，满意,生活质量保持不变。MiniMed770GHCL系统改善了血糖控制并优化了胰岛素输送，尤其是执行率高的患者。
