University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.
Department of Pediatrics, Psychiatry, & Behavioral Sciences, Stanford University School of Medicine, Stanford Diabetes Research Center, Stanford, California, USA.
Diabetes Obes Metab. 2024 Dec;26(12):5569-5579. doi: 10.1111/dom.15906. Epub 2024 Sep 20.
Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children.
This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0-5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes-diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well-being (World Health Organization 5 Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use.
Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes-related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001).
Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management.
自动化胰岛素输送（AID）系统已证明可改善 1 型糖尿病（T1D）患者的血糖控制结果，但关于这些系统在非常年幼的儿童中的应用及其对护理人员的影响的数据有限。我们评估了在非常年幼的儿童中使用无管 Omnipod® 5 AID 系统后护理人员的心理社会结果。
这是一项为期 3 个月的单臂、多中心、关键临床试验，招募了 80 名年龄在 2.0-5.9 岁的 T1D 儿童使用 Omnipod 5 AID 系统。护理人员在基线时和使用 AID 3 个月后使用问卷评估心理社会结果-糖尿病困扰（糖尿病问题领域）、低血糖信心（低血糖信心量表）、幸福感（世界卫生组织 5 项幸福感指数）、睡眠质量（匹兹堡睡眠质量指数）、胰岛素输送满意度（胰岛素输送满意度调查）和系统可用性（系统可用性量表）。
在使用 Omnipod 5 3 个月后，护理人员在所有测量指标上都有显著改善，包括与糖尿病相关的心理社会结果（糖尿病问题领域；p<0.0001，低血糖信心量表；p<0.01）、幸福感（世界卫生组织 5 项幸福感指数；p<0.0001）和感知系统可用性（系统可用性量表；p<0.0001）。匹兹堡睡眠质量指数总分和整体睡眠质量、睡眠持续时间和效率子量表的评分均有显著改善（均 p<0.05）。胰岛素输送满意度调查的所有子量表评分均有改善（更高的满意度、更低的负担和更少的不便；均 p<0.0001）。
在非常年幼的儿童中管理 T1D 时，护理人员面临独特的挑战。虽然血糖指标无疑非常重要，但这些评估心理社会结果的结果揭示了额外的有意义的益处，并表明 Omnipod 5 AID 系统减轻了护理人员在糖尿病管理方面面临的一些负担。
