Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.
Cambridge University Hospitals NHS Foundation Trust, Wolfson Diabetes and Endocrine Clinic, Cambridge, United Kingdom.
Diabetes Technol Ther. 2024 Apr;26(4):211-221. doi: 10.1089/dia.2023.0394. Epub 2024 Feb 28.
The Closing the Loop in Adults With Type 1 Diabetes (CLEAR) randomized crossover study compared a novel fully closed-loop insulin delivery system with no carbohydrate entry or mealtime bolusing (CamAPS HX), with standard insulin pump therapy and glucose sensor in adults with type 1 diabetes and suboptimal glycemic outcomes. This qualitative substudy aimed to understand the psychosocial impact of using the fully automated system. Adults participating in the CLEAR study were invited to take part in a virtual semistructured interview after they had completed 8 weeks using the fully closed-loop system. Recruitment continued until there was adequate representation and data saturation occurred. Interviews were anonymized and transcribed for in-depth thematic analysis using an inductive-deductive approach. Study participants were also asked to complete questionnaires assessing diabetes distress, hypoglycemia confidence, and closed-loop treatment satisfaction. Eleven participants (eight male and three female; age range 26-66 years) were interviewed. After an initial adjustment period, interviewees reported enjoying a reduction in diabetes burden, freed-up mental capacity, and improved mood. All were happy with overnight glycemic outcomes, with the majority reporting benefits on sleep. Although experiences of postprandial glucose outcomes varied, all found mealtimes easier and less stressful, particularly when eating out. Negatives raised by participants predominantly related to the insulin pump hardware, but some also reported increased snacking and challenges around resuming carbohydrate counting at trial closeout. In adults with type 1 diabetes, use of a fully closed-loop insulin delivery system had significant quality-of-life benefits and provided a welcome break from the day-to-day demands of living with diabetes. NCT04977908.
成人 1 型糖尿病闭环（CLEAR）随机交叉研究比较了一种新型的完全闭环胰岛素输送系统，该系统无需输入碳水化合物或进餐时推注（CamAPS HX），与使用标准胰岛素泵治疗和葡萄糖传感器的 1 型糖尿病和血糖控制不佳的成年人。这项定性子研究旨在了解使用全自动系统的心理社会影响。参与 CLEAR 研究的成年人在使用完全闭环系统 8 周后，被邀请参加虚拟半结构化访谈。招募继续进行，直到有足够的代表性和数据达到饱和。访谈被匿名化并转录，使用归纳演绎方法进行深入的主题分析。研究参与者还被要求完成评估糖尿病困扰、低血糖信心和闭环治疗满意度的问卷。11 名参与者（8 名男性和 3 名女性；年龄范围 26-66 岁）接受了采访。在最初的调整期后，受访者报告说糖尿病负担减轻了，精神压力减轻了，情绪也改善了。所有人都对夜间血糖结果感到满意，大多数人报告说睡眠质量得到了改善。尽管餐后血糖结果的体验各不相同，但所有人都发现用餐时间更容易且压力更小，尤其是外出就餐时。参与者提出的负面影响主要与胰岛素泵硬件有关，但也有一些人报告说，在试验结束时，增加了吃零食的次数，并且在重新开始计算碳水化合物摄入量方面存在挑战。在 1 型糖尿病成年人中，使用完全闭环胰岛素输送系统具有显著的生活质量益处，并为日常应对糖尿病需求提供了一个受欢迎的休息。NCT04977908。
