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Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

NCT05548699 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1290

Last updated 2025-12-04

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Forschungsinstitut der Diabetes Akademie Mergentheim

    lead OTHER

Principal Investigators

  • Norbert Hermanns, Prof, PhD · Research Institute Diabetes Academy Mergentheim (FIDAM)

  • Bernhard Kulzer, Prof, PhD · Research Institute Diabetes Academy Mergentheim (FIDAM)

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548699 on ClinicalTrials.gov