Objectives:

We will generate real-world evidence regarding new digital forms of prevention in the German health care system. We do this by assessing whether an app-based lifestyle intervention has a positive health impact.

Background:

App-based interventions offer high potential for supporting recommended behavioral changes for diabetes prevention (glycemic control, physical activity, dietary changes, weight loss etc.) in people with prediabetes. However, the effectiveness and cost-effectiveness of those interventions in the German health care system and under routine care conditions are unknown.

Methods:

We plan a three-arm multicenter individually randomized pragmatic trial. In this trial we will investigate whether an app-based lifestyle intervention with or without a continuous glucose monitor has an impact on HbA1c in people with increased type 2 diabetes risk. Recruitment will occur through Checkup-35 examinations in primary care practices and diabetology practices in five regions in Germany. In addition, next to clinical and quality of life data, we will assess process parameters regarding feasibility, acceptance, and retention.

Impact:

Through this study we will generate evidence for the first time regarding an app intervention in combination with a continuous glucose monitoring device for the prevention of diabetes in several regions in Germany. By embedding the study in routine care, we will also contribute valuable real-world evidence on the feasibility and the effectiveness of app-based interventions in routine care setting.

Contact: Laura Suhlrie