PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions. A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels). The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes. The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes. Note/Update 27.11.2025: The recruitment resulted in a total of 1290 participants enrolled until 31.12.2024 (= study completion date). Yet the recruitment and follow-up of participants is being continued within the ongoing TwinPeaks study (NCT07212075) from 2025-2027.
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Prevalence of affective disorders at baseline (per diagnostic interview)
Timeframe: Baseline
Prevalence of anxiety disorders at baseline (per diagnostic interview)
Timeframe: Baseline
Prevalence of eating disorders at baseline (per diagnostic interview)
Timeframe: Baseline
Depressive symptoms: incidence at 24-month FU
Timeframe: Baseline, 24-month FU
Depressive symptoms: recovery at 24-month FU
Timeframe: Baseline, 24-month FU
Anxiety symptoms: incidence at 24-month FU
Timeframe: Baseline, 24-month FU
Anxiety symptoms: recovery
Timeframe: Baseline, 24-month FU
Diabetes distress over time
Timeframe: Baseline, 24-month FU
Daily diabetes burdens over time
Timeframe: Baseline, 24-month FU
Eating problems: incidence
Timeframe: Baseline, 24-month FU
Glycated hemoglobin (HbA1c) over time
Timeframe: Baseline, 24-month FU
Glycemic levels (CGM glucose) over time
Timeframe: Baseline, 24-month FU
Daily stress levels over time
Timeframe: Baseline, 24-month FU