Lind Nanna, Bækgaard Per, Bardram Jakob E, Cramer-Petersen Claus, Nørgaard Kirsten, Christensen Merete B
Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Borgmester Ib Juuls vej 83, Herlev, 2730, Denmark, 45 28711435.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
JMIR Diabetes. 2025 Aug 25;10:e63894. doi: 10.2196/63894.
Type 2 diabetes (T2D) is a complex, chronic condition that requires ongoing management. An important aspect of effective diabetes management is shared decision-making between the person with diabetes and the health care professionals (HCPs) to tailor individual treatment plans. Personal health technologies can play a crucial role in this collaborative effort by providing tools for monitoring, communication, and education.
This study aims to test the clinical feasibility of DiaFocus, a mobile health system developed for adults with T2D.
This was a single-arm, prospective, 6-month pilot study in a clinical outpatient setting at Steno Diabetes Center Copenhagen, Denmark. The DiaFocus system includes an app for the participants and a web portal for the HCPs. The system collects diabetes-related data, including participant-reported lifestyle surveys, sensor-based measures on physical activity, and participant-selected focus areas, aiming to support communication and shared decision-making at clinical visits. Participants were eligible if they were ≥18 years old, diagnosed with T2D≥12 months, spoke Danish, and had a smartphone (iOS 13+ or Android 8.0+). For each participant, 3 visits and 1 telephone call were scheduled during the 6-month study period. The DiaFocus system's acceptability and feasibility were assessed through retention rates, app usage, participant feedback, and by the CACHET Unified Method for Assessment of Clinical Feasibility (CUMACF) questionnaire. The clinical outcomes were assessed by the following questionnaires: Diabetes Distress Scale (DDS), Perceived Competence for Diabetes (PCDS), Diabetes Treatment Satisfaction Questionnaire (DTSQs+c), hemoglobin A1c levels, and body weight.
A total of 17 participants with T2D were included in the study, 15 completed the study, and data were analyzed on an intention-to-treat basis. The median age was 68 (IQR 56-72) years, 12 (71%) were males, the median diabetes duration was 18 (IQR 11-21) years, and the median hemoglobin A1c was 59 (IQR 49-68) mmol/mol. Participants found the DiaFocus system feasible to support diabetes management despite technical problems, and they valued the ability to set focus areas. The most common focus areas were "blood glucose" (n=10, 59%) and "exercise" (n=9, 53%), but areas such as "sleep" and "mood" were also used. The CUMACF questionnaire showed that 90% (9/10) of the participants had very favorable views of how easy the system is to understand, learn, and use, and 80% (8/10) of the participants agreed or strongly agreed that the system was useful. Feedback was generally positive, indicating participants would use a refined version. Despite these findings, no statistically significant changes in clinical outcomes were observed throughout the study period using the DiaFocus system.
This pilot study demonstrated that the DiaFocus system is clinically feasible and acceptable for users with T2D, although there is a need for optimization of app functionality and stability.
2型糖尿病（T2D）是一种复杂的慢性疾病，需要持续管理。有效糖尿病管理的一个重要方面是糖尿病患者与医护人员（HCPs）之间的共同决策，以制定个性化治疗方案。个人健康技术可以通过提供监测、沟通和教育工具，在这项协作努力中发挥关键作用。
本研究旨在测试为成年T2D患者开发的移动健康系统DiaFocus的临床可行性。
这是一项在丹麦哥本哈根斯滕诺糖尿病中心临床门诊进行的单臂、前瞻性、为期6个月的试点研究。DiaFocus系统包括一个供参与者使用的应用程序和一个供HCPs使用的门户网站。该系统收集与糖尿病相关的数据，包括参与者报告的生活方式调查、基于传感器的身体活动测量以及参与者选择的关注领域，旨在支持临床就诊时的沟通和共同决策。符合条件的参与者需年满18岁，确诊T2D≥12个月，会说丹麦语，且拥有智能手机（iOS 13+或安卓8.0+）。在为期6个月的研究期间，为每位参与者安排了3次就诊和1次电话随访。通过留存率、应用程序使用情况、参与者反馈以及CACHET临床可行性统一评估方法（CUMACF）问卷对DiaFocus系统的可接受性和可行性进行评估。通过以下问卷评估临床结果：糖尿病痛苦量表（DDS）、糖尿病自我效能感量表（PCDS）、糖尿病治疗满意度问卷（DTSQs+c）、糖化血红蛋白水平和体重。
共有17名T2D参与者纳入研究，15名完成研究，数据按意向性分析原则进行分析。中位年龄为68（四分位间距56 - 72）岁，12名（71%）为男性，中位糖尿病病程为18（四分位间距11 - 21）年，中位糖化血红蛋白为59（四分位间距49 - 68）mmol/mol。尽管存在技术问题，参与者认为DiaFocus系统在支持糖尿病管理方面是可行的，并且他们重视设置关注领域的能力。最常见的关注领域是“血糖”（n = 10，59%）和“运动”（n = 9，53%），但“睡眠”和“情绪”等领域也被使用。CUMACF问卷显示，90%（9/10）的参与者对系统的易理解性、易学习性和易用性给予了非常积极的评价，80%（8/10）的参与者同意或强烈同意该系统有用。反馈总体上是积极的，表明参与者会使用优化后的版本。尽管有这些发现，但在整个研究期间，使用DiaFocus系统未观察到临床结果有统计学意义的变化。
这项试点研究表明，DiaFocus系统对于T2D用户在临床方面是可行且可接受的，尽管需要优化应用程序功能和稳定性。
