## Background
Diabetes mellitus is a major global public health issue, with projections of 700 million affected worldwide by 2045. Approximately 10% have type 1 diabetes (T1D), which requires continuous 24/7 self-management, including blood glucose monitoring, insulin correction, and metabolic balance. This persistent burden reduces quality of life (QoL) and poses challenges to health systems. While numerous diabetes apps exist, they fail to adequately address user needs, lack integration of physical activity, education, and health feedback, and have inconsistent interoperability and data security. In Germany, where approximately 341,000 T1D cases exist, no diabetes app was registered in the Digitale Gesundheitsanwendungen (DiGA) directory at the time of study, and the fast-track approval procedure does not sufficiently evaluate medical benefit for users.
## Methods
The study employed an exploratory qualitative design grounded in the Responsible Research and Innovation framework, using vision assessment to explore user perspectives before technology development. Between February and March 2021, 24 semistructured interviews were conducted with T1D patients recruited via a diabetologist using purposive sampling. Of participants, 10/24 (42%) currently used an app, 7/24 (29%) wanted to use an app but were prevented by external circumstances, and 7/24 (29%) did not want or consider using an app. Half (12/24, 50%) were female; ages ranged from 23 to 81 years. Interviews lasted 45 minutes to 1 hour, with 62% (15/24) conducted face-to-face at a diabetologist practice and 38% (9/24) via videoconference due to COVID-19 restrictions. Data were analyzed inductively and deductively using ATLAS.ti, following Creswell's qualitative analysis approach. Four subquestions operationalized the four elements of the vision assessment (Arentshorst et al).
## Key Results
The analysis identified one guiding vision: diabetes apps should improve QoL and enable living as normally as possible without anticipated stigma, achieved through (1) personalized self-management options and (2) technological fixes for anticipated stigmatization.
Six main topics emerged regarding desired app features:
1. **Alarm tone**: 9/10 users (90%) wanted customizable alarm sounds and time slots, as alarms attracted unwanted attention in work, restaurant, and sports settings. 17/24 interviewees (71%) wanted smartwatch installation with vibrating alerts to minimize stigmatization.
2. **Sensor and app connection**: All 10/10 users (100%) reported that delayed value transmission hampered self-management. 3/24 (13%) avoided apps entirely because of value delay. 17/24 (71%) preferred smartwatch installation to reduce signal loss.
3. **AI features**: 7/10 users (70%) felt they adapted to apps rather than vice versa. 8/24 (33%) forgot insulin doses during work due to phone restrictions or attention concerns. 5/24 (21%) avoided new sports due to self-management fears. 8/10 users (80%) wanted personalized AI-based predictions for sports, nutrition, and insulin dosing. 17/24 (71%) wanted a photo AI to calculate bread units discreetly at restaurants.
4. **Information and communication features**: 17/24 (71%) wanted reliable, individualized in-app information. 11/24 (46%) valued peer exchange at diagnosis. 13/24 (54%) preferred direct chat with their physician over a chatbot, while 12/24 (50%) considered forums suitable for daily peer exchange. 5/24 (21%) recognized challenges ensuring medically accurate forum content.
5. **Contextual aspects**: 18/24 (75%) cited fast technological innovation and digitalization as supporting factors, while 10/24 (42%) identified data security measures and lack of inter-company collaboration as barriers. Notably, 17/24 (71%) did not prioritize data security if it hindered useful features.
6. **Desirable states**: The combination of personalized features (AI predictions, tailored information, communication options) and stigma-reducing features (discreet smartwatch alerts, photo AI for bread units) was considered necessary to improve QoL.
## Clinical Implications
This vision assessment provides the patient perspective needed to inform diabetes app development and DiGA evaluation criteria in Germany. The findings suggest that current app approval processes should incorporate assessment of patient benefit beyond safety and conformity certification. Healthcare professionals and policymakers should recognize that people with T1D prioritize features that enable normalization of life and reduction of anticipated stigma over data security concerns, highlighting the need for patient education on cybersecurity risks. Developers should focus on AI-driven personalization, smartwatch-compatible designs, transparent value-delay indicators, and integrated physician communication channels. The authors call for vision assessments with other stakeholders, including patient organizations, healthcare professionals, insurers, policymakers, device manufacturers, app developers, researchers, ethicists, and data security experts, to create a shared vision guiding responsible innovation in diabetes apps, ultimately aiming to reduce acute metabolic complications, hospitalizations, and long-term comorbidities.