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

NCT ID: NCT05548699

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Comorbid mental disorders as well as mental symptoms are common in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). Depression, anxiety, and eating problems are particularly prevalent, and diabetes-related distress may contribute to or interact with mental disorders. Furthermore, while the management of diabetes aims to achieve near-normal glucose levels to prevent health decline and complications, glycemic outcomes may be impaired in people with significant mental comorbidity.

The objective of the PRO-MENTAL study is to use precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcomes, to determine typical patterns and derive patient trajectories for informing a precision medicine approach offering personalized interventions for people with T1D and T2D. Precision monitoring uses continuous glucose monitoring (CGM) and ecological momentary assessment (EMA) methods as well as patient-reported outcomes (PRO) according to self-report scales and interviews.

Another aim is to answer epidemiological questions regarding depressive, anxiety and eating disorders in people with T1D and T2D (including assessment of bipolar disorders for differential diagnosis). In addition to clinical disorders, subclinical (=elevated) mental symptoms (e.g., depressive symptoms) and diabetes-related distress will be investigated as adverse factors in diabetes.

The findings of the study will serve as the basis for developing a precision medicine approach with personalized interventions for specific subgroups of people with T1D and T2D and mental comorbidity.

The primary research question refers to prospective associations of psychological disturbances/problems, especially depressive symptoms, anxiety symptoms, diabetes distress, and eating disorder symptoms, with self-management/health behaviors and glycemic outcomes. Using diagnostic interviews assessing affective, anxiety, and eating disorders and the collection of behavioral, somatic and psychological variables using questionnaires and surveys, subgroups and trajectories will be identified. In longitudinal analyses, the prognostic and moderating contribution of these parameters to the prediction of glycemic and mental health outcomes will be investigated.

Secondary objectives of the study are to identify predictors and/or moderators that may explain the incidence and persistence as well as associations between the above mental health variables and diabetes outcomes. For this purpose, measures of health-related quality of life, well-being, sleep quality, hypoglycemic anxiety, fear of sequelae, problems of diabetes treatment, diabetes acceptance, stressful life events, alcohol misuse, social support, COVID-19-related burden, and psychological resilience are also collected.

Conditions

Diabetes Mellitus; Depressive Disorder; Depressive Symptoms; Anxiety Disorders; Anxiety and Fear; Eating Disorders; Eating Disorder Symptom; Eating Behavior; Hyperglycemia; Emotional Distress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years
• Diagnosis of type 1 diabetes (T1D) or type 2 diabetes (T2D)
• Diabetes duration ≥ 1 year
• Sufficient German language skills
• Written informed consent

Exclusion Criteria

• Inability to consent,
• Significant cognitive impairment (e.g., cognitive disorder, dementia)
• Severe somatic disease or mental disorder likely to impede study participation or confound results (e.g., severe heart failure ≥ NYHA III; cancer requiring treatment; dialysis-dependent nephropathy; schizophrenia/psychotic disorder)
• Terminal illness
• Being bedridden

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forschungsinstitut der Diabetes Akademie Mergentheim

OTHER

Sponsor Role: lead

Responsible Party

Norbert Hermanns

Prof. Dr. phil.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norbert Hermanns, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute Diabetes Academy Mergentheim (FIDAM)

Bernhard Kulzer, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute Diabetes Academy Mergentheim (FIDAM)

Locations

Diabetes Center Mergentheim

Bad Mergentheim, Baden-Wurttemberg, Germany

Diabetes Practice Mergentheim

Bad Mergentheim, Baden-Wurttemberg, Germany

Countries

Germany

Related Links

https://clinicaltrials.gov/study/NCT07212075

ClinicalTrials entry of the "TwinPeaks" study that has continued the recruitment and follow-up of the PRO-MENTAL cohort since 2025.

Other Identifiers

HermannsNorbert2022-07-14VADM

Identifier Type: -

Identifier Source: org_study_id