Improved glycemic control and diabetes distress after using an m-health application: a preparation analysis for the digital health care act in Germany

Background and Aims: The German Digital Health Care Act allows healthcare professionals to prescribe mHealth applications. However, apps must show efficacy on medical outcomes as well as patient‐reported outcomes (PRO). To create evidence, we analyzed the changes in estimated HbA1c (eHbA1c) of mySugr users as well as their current state of diabetes distress. Methods: We performed a retrospective analysis of glucose metrics from 5920 German app users' with BG‐meters with automatic importing. This enabled the collection of values generated before app usage to perform a pre/post comparison. The cohort was divided into tertiles based on their initial eHbA1c. In a cross‐sectional analysis, the PAID‐5 questionnaire assessing diabetes distress was completed by 1099 users with T1D or T2D, and tested against a comparative sample from literature. Results: The glycemic parameters showed substantial differences between the tertiles. The largest user group (n = 3836, initial eHbA1c<7.5%) showed a stable eHbA1c around 6.4% over three and six months. The subgroup with initial eHbA1c> 9% decreased by 1.5% after 3 months and 1.7% after 6 months. The PAID‐5 score (5.1 ± 4.2) of app users was significantly lower than the comparative sample without using the app (6.3 ± 4.4; p < .001). Conclusions: Substantial improvements of eHbA1c were visible after 3 months of using the mySugr app for users with suboptimal glycemic control. Furthermore, the results indicate a positive effect on diabetes distress of app users. As the next step, a randomized controlled trial evaluating the mySugr app is planned.