JMIR Publications

ABSTRACT

Background:

Type 2 diabetes 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 healthcare 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:

To test the clinical feasibility and efficacy of DiaFocus, a mobile health (mHealth) system recently developed for adults with type 2 diabetes.

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 HCPs. The system is designed to collect 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 between the HCP and the person with diabetes. Participants were eligible if they were ≥18 years old, diagnosed with type 2 diabetes ≥12 months, spoke Danish, and had a smartphone (iOS 13+ or Android 8.0+). For each participant, three visits and one telephone call were scheduled during the 6-month study period. The primary outcome of the study was the change in Diabetes Distress Scale (DDS) scores from baseline to 6 months. Secondary outcomes included changes in Perceived Competence for Diabetes (PCDS), Diabetes Treatment Satisfaction (DTSQs+c), HbA1c levels, and body weight. The DiaFocus system's acceptability and feasibility were assessed through retention rates, app usage, participant feedback and by the CUMACF questionnaire.

Results:

A total of 17 participants with type 2 diabetes were included in the study, 15 completed the study, and data were analyzed on an intention-to-treat basis. The median age was 68 years, 70.6% were males, the median diabetes duration was 18 years, and the median HbA1c was 59 mmol/mol. Participants found the DiaFocus system feasible to support diabetes management despite technical problems concerning the app. They valued the ability to set focus areas and discuss these with the HCP, expressing a desire for a broader health focus beyond diet, exercise, medication, and smoking. The CUMACF questionnaire showed that the participants found the DiaFocus system useful and easy to understand. Feedback was generally positive, indicating participants would use a refined version without the technical problems that the participants experienced during the pilot study. Despite these findings, no statistically significant clinical changes in primary or secondary 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 type 2 diabetes, although there is a need for optimization of app functionality and stability.