Diabetes MellitusPRO-MENTALNCT05548699
Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
An observational study of Diabetes Mellitus and Depressive Disorder, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Depressive Disorder, Depressive Symptoms
- How many people
- 1,290 participants
- Where
- 2 sitesGermany
- Study dates
- 2 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Type 1 Diabetes or Type 2 Diabetes
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
Diabetes Practice Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
About this study
Official title: PRO-MENTAL: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
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).
Read more
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.
Read the 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
- Medical subject headings
- Diabetes Mellitus, Depressive Disorder, Depression, Anxiety Disorders, Feeding and Eating Disorders, Feeding Behavior, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of affective disorders at baseline (per diagnostic interview)
Diagnoses of affective disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Measured: Baseline
Prevalence of anxiety disorders at baseline (per diagnostic interview)
Diagnoses of anxiety disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Measured: Baseline
Prevalence of eating disorders at baseline (per diagnostic interview)
Diagnoses of eating disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Measured: Baseline
Depressive symptoms: incidence at 24-month FU
Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of depressive symptoms at 24-month FU compared to baseline.
Measured: Baseline, 24-month FU
Depressive symptoms: recovery at 24-month FU
Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from depressive symptoms at 24-month FU compared to baseline.
Measured: Baseline, 24-month FU
Anxiety symptoms: incidence at 24-month FU
Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month. Primary outcome is the incidence of anxiety symptoms at 24-month FU compared to baseline.
Measured: Baseline, 24-month FU
Anxiety symptoms: recovery
Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from anxiety symptoms at 24-month FU compared to baseline.
Measured: Baseline, 24-month FU
Diabetes distress over time
Diabetes distress is assessed with the Problem Areas in Diabetes Scale (PAID) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU to detect changes in diabetes distress from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Daily diabetes burdens over time
Daily diabetes burdens (daily diabetes distress) are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with selected items of the Problem Areas in Diabetes Scale (PAID) adapted for daily assessment (rated on an 11-point scale from 0 - 10) to detect changes in daily burdens from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Eating problems: incidence
Eating problems (=disordered eating behavior/eating disorder symptoms) are assessed with the Diabetes Eating Problems Survey-Revised (DEPS-R; a validated, self-report measure for eating problems of people with diabetes where generic eating disorder questionnaires yield significant false-positive rates due to specific eating behaviors and dietary requirements for diabetes) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of eating problems at 24-month FU compared to baseline.
Measured: Baseline, 24-month FU
Glycated hemoglobin (HbA1c) over time
HbA1c (glycated hemoglobin), a laboratory measure of average blood glucose over the past 8 to 12 weeks, is estimated/collected at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU from the participants to detect changes for glycated hemoglobin from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Glycemic levels (CGM glucose) over time
In addition to the global parameter HbA1c, automatically recorded daily glucose values are obtained from participants where continuous glucose monitoring (CGM) devices are used. Available glucose data are extracted at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU for each over 14 consecutive days of CGM measurement - parallel to the daily EMA - to detect changes in glucose levels from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Daily stress levels over time
Daily stress levels are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with items from the previous DIA-LINK study (requesting the current stress level and specific stressors, rated on an 11-point scale from 0 - 10) to detect changes in daily stress levels from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Secondary outcomes (11)
General health state over time
The self-evaluated general self-rated health state is assessed at baseline, 12-month FU, and 24-month FU using the 8-item Short Form Health Survey (SF-8) to detect changes in the health state from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Subjective health over time
The subjective health state is assessed at baseline, 12-month FU, and 24-month FU using the visual analogue scale (VAS) of the EuroQol Five Dimensions Questionnaire (EQ-5D) to detect changes in subjective health from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Wellbeing over time
Wellbeing is assessed at baseline, 12-month FU, and 24-month FU using the WHO-Five Well-being Index (WHO-5) to detect changes in wellbeing from baseline to 24-month FU.
Measured: Baseline, 24-month FU
General sleep quality over time
General sleep quality assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU using items of the Pittsburgh Sleep Quality Index (PSQI) to detect changes in sleep quality from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Daily sleep quality over time
Daily sleep quality assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 days using smartphone-based ecological momentary assessment with selected PSQI items adapted for daily assessment (rated on an 11-point scale from 0 - 10) to detect changes in daily sleep quality from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Fear of diabetes complications over time
Fear of diabetes complications is assessed at baseline, 12-month FU, and 24-month FU with the short form of the Fear of Diabetes Complications Questionnaire (FDCQ; requesting frequencies of worries and fears regarding long-term complications of diabetes) to detect changes in fear levels from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Fear of hypoglycemia over time
Fear of hypoglycemia is assessed at baseline, 12-month FU, and 24-month FU with the short form of the Hypoglycemia Fear Survey II (HFS-II-SF; requesting hypoglycemia-related worries and avoidance behaviors) to detect changes in fear levels from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Diabetes acceptance over time
Diabetes acceptance is assessed at baseline, 12-month FU, and 24-month FU with a short form of the Diabetes Acceptance Scale (DAS) to detect changes in diabetes acceptance from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Daily eating problems over time
Eating problems in daily life are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with items requesting specific problematic eating behaviors (rated on an 11-point scale from 0 - 10) to detect changes in daily eating problems from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Diabetes self-management over time
Diabetes self-management behaviors are assessed at baseline, 12-month FU, and 24-month FU with the revised Diabetes Self-Management Questionnaire-Revised (DSMQ-R) to detect changes in diabetes self-management from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Alcohol misuse over time
Alcohol abuse/misuse is assessed at baseline, 12-month FU, and 24-month FU using the 5-item alcohol module of the Patient Health Questionnaire (PHQ-D) to detect changes in alcohol use from baseline to 24-month FU.
Measured: Baseline, 24-month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start2 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Norbert Hermanns, Prof, PhD, Principal investigator, Research Institute Diabetes Academy Mergentheim (FIDAM)Bernhard Kulzer, Prof, PhD, Principal investigator, Research Institute Diabetes Academy Mergentheim (FIDAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548699
- Sponsor's protocol ID
- HermannsNorbert2022-07-14VADM
- Acronym
- PRO-MENTAL
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ehrmann D, Hermanns N, Schmitt A, Klinker LY, Bergis D, Kulzer B. Temporal dynamics of daily diabetes-specific burdens using intensive longitudinal data: the central role of feelings of guilt within a multilevel network analysis. Diabetologia. 2026 Sep 21. doi: 10.1007/s00125-026-06869-1. Online ahead of print.
PubMed 42766003
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-MENTAL: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
- ClinicalTrials.gov ID
- NCT05548699
- Acronym / sponsor ID
- PRO-MENTAL / HermannsNorbert2022-07-14VADM
- Conditions
- Diabetes Mellitus, Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety and Fear, Eating Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Type 1 Diabetes or Type 2 Diabetes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of affective disorders at baseline (per diagnostic interview)
Time frame: Baseline
Diagnoses of affective disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Prevalence of anxiety disorders at baseline (per diagnostic interview)
Time frame: Baseline
Diagnoses of anxiety disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Prevalence of eating disorders at baseline (per diagnostic interview)
Time frame: Baseline
Diagnoses of eating disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).
Depressive symptoms: incidence at 24-month FU
Time frame: Baseline, 24-month FU
Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of depressive symptoms at 24-month FU compared to baseline.
Depressive symptoms: recovery at 24-month FU
Time frame: Baseline, 24-month FU
Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from depressive symptoms at 24-month FU compared to baseline.
Anxiety symptoms: incidence at 24-month FU
Time frame: Baseline, 24-month FU
Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month. Primary outcome is the incidence of anxiety symptoms at 24-month FU compared to baseline.
Anxiety symptoms: recovery
Time frame: Baseline, 24-month FU
Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from anxiety symptoms at 24-month FU compared to baseline.
Diabetes distress over time
Time frame: Baseline, 24-month FU
Diabetes distress is assessed with the Problem Areas in Diabetes Scale (PAID) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU to detect changes in diabetes distress from baseline to 24-month FU.
Daily diabetes burdens over time
Time frame: Baseline, 24-month FU
Daily diabetes burdens (daily diabetes distress) are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with selected items of the Problem Areas in Diabetes Scale (PAID) adapted for daily assessment (rated on an 11-point scale from 0 - 10) to detect changes in daily burdens from baseline to 24-month FU.
Eating problems: incidence
Time frame: Baseline, 24-month FU
Eating problems (=disordered eating behavior/eating disorder symptoms) are assessed with the Diabetes Eating Problems Survey-Revised (DEPS-R; a validated, self-report measure for eating problems of people with diabetes where generic eating disorder questionnaires yield significant false-positive rates due to specific eating behaviors and dietary requirements for diabetes) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of eating problems at 24-month FU compared to baseline.
Glycated hemoglobin (HbA1c) over time
Time frame: Baseline, 24-month FU
HbA1c (glycated hemoglobin), a laboratory measure of average blood glucose over the past 8 to 12 weeks, is estimated/collected at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU from the participants to detect changes for glycated hemoglobin from baseline to 24-month FU.
Glycemic levels (CGM glucose) over time
Time frame: Baseline, 24-month FU
In addition to the global parameter HbA1c, automatically recorded daily glucose values are obtained from participants where continuous glucose monitoring (CGM) devices are used. Available glucose data are extracted at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU for each over 14 consecutive days of CGM measurement - parallel to the daily EMA - to detect changes in glucose levels from baseline to 24-month FU.
Daily stress levels over time
Time frame: Baseline, 24-month FU
Daily stress levels are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with items from the previous DIA-LINK study (requesting the current stress level and specific stressors, rated on an 11-point scale from 0 - 10) to detect changes in daily stress levels from baseline to 24-month FU.
11 secondary outcomes
General health state over time
Time frame: Baseline, 24-month FU
Subjective health over time
Time frame: Baseline, 24-month FU
Wellbeing over time
Time frame: Baseline, 24-month FU
General sleep quality over time
Time frame: Baseline, 24-month FU
Daily sleep quality over time
Time frame: Baseline, 24-month FU
Fear of diabetes complications over time
Time frame: Baseline, 24-month FU
Fear of hypoglycemia over time
Time frame: Baseline, 24-month FU
Diabetes acceptance over time
Time frame: Baseline, 24-month FU
Daily eating problems over time
Time frame: Baseline, 24-month FU
Diabetes self-management over time
Time frame: Baseline, 24-month FU
Alcohol misuse over time
Time frame: Baseline, 24-month FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 42766003Ehrmann D, Hermanns N, Schmitt A, Klinker LY, Bergis D, Kulzer B. Temporal dynamics of daily diabetes-specific burdens using intensive longitudinal data: the central role of feelings of guilt within a multilevel network analysis. Diabetologia. 2026 Sep 21. doi: 10.1007/s00125-026-06869-1. Online ahead of print.
- ClinicalTrials entry of the "TwinPeaks" study that has continued the recruitment and follow-up of the PRO-MENTAL cohort since 2025.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Hermanns, Prof, PhD principal investigator
Research Institute Diabetes Academy Mergentheim (FIDAM)
Bernhard Kulzer, Prof, PhD principal investigator
Research Institute Diabetes Academy Mergentheim (FIDAM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Depressive Disorder, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of affective disorders at baseline (per diagnostic interview) (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.