Assessing the Clinical Feasibility of the DiaFocus System for Integrated Personalized Management of Type 2 Diabetes: 6-Month Pilot Cohort Study.

Background: 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. Objective: This study aims to test the clinical feasibility of DiaFocus, a mobile health system developed for adults with T2D. Methods: 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. Results: 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. Conclusions: 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.