Southern District Health Board, 201 Great King Street, Dunedin, 9016, New Zealand.
Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, 201 Great King Street, Dunedin, 9016, New Zealand.
Acta Diabetol. 2022 Jan;59(1):31-37. doi: 10.1007/s00592-021-01789-5. Epub 2021 Aug 27.
Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes.
We present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers.
59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n = 28) vs SAP + PLGM (n = 29) (30.9 ± 0.7 vs 27.9 ± 0.7, p = 0.004) and DTSQc AHCL (n = 29) vs SAP + PLGM (n = 30) (11.7 ± 0.9 vs 9.2 ± 0.8, p = 0.032). Adolescents (aged 13-17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 ± 0.7 vs 12.1 ± 0.8, p = 0.024). The DTQ "change" score (n = 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0, p < 0.001). PSQI was completed in those > 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3, p = 0.048) with a total score > 5 indicating poor quality sleep.
These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.
自动化胰岛素输送旨在降低治疗负担,改善生活质量和血糖控制效果。
我们展示了一项在自动化胰岛素输送新手使用者中进行的双中心、随机、开放标签、两序列交叉研究的亚组研究数据,比较了美敦力 MiniMed® 高级混合闭环 (AHCL) 与传感器增强型泵治疗加预测性低血糖管理 (SAP+PLGM)。在每 4 周的干预结束时,使用 7 种适合年龄的经过验证的问卷比较生活质量、睡眠和治疗满意度的影响,这些问卷提供给患者或护理人员。
60 人中有 59 人完成了研究(平均年龄 23.3±14.4 岁)。多项研究结果表明 AHCL 具有统计学优势。在成年人(≥18 岁)中,DTSQs 显示 AHCL 的技术满意度优于 PLGM,AHCL(n=28)的 DTSQs 评分高于 SAP+PLGM(n=29)(30.9±0.7 vs 27.9±0.7,p=0.004)和 DTSQc AHCL(n=29)的评分高于 SAP+PLGM(n=30)(11.7±0.9 vs 9.2±0.8,p=0.032)。青少年(13-17 岁)在 AHCL(n=16)期间的 DTSQc 评分也高于 SAP+PLGM(n=15)(14.8±0.7 vs 12.1±0.8,p=0.024)。DTQ“变化”评分(n=59)也显示 AHCL 优于 SAP+PLGM(3.5±0.0 vs 3.3±0.0,p<0.001)。PSQI 在年龄大于 16 岁的人群中完成(n=36),表明 AHCL 与 SAP+PLGM 相比睡眠质量有所改善(4.8±0.3 vs 5.7±0.3,p=0.048),总得分>5 表示睡眠质量差。
这些数据表明,与 SAP+PLGM 模式相比,AHCL 有可能提高青少年和成年人 1 型糖尿病患者的治疗满意度并改善主观睡眠质量。