Clinical trial NCT05548699: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
Official title: PRO-MENTAL: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Depressive Disorder
Depressive Symptoms
Anxiety Disorders
Anxiety and Fear
Eating Disorders
Eating Disorder Symptom
Eating Behavior
Hyperglycemia
Emotional Distress
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Type 1 Diabetes or Type 2 Diabetes

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 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

Primary outcomes:
measure: Prevalence of affective disorders at baseline (per diagnostic interview)
timeFrame: Baseline
measure: Prevalence of anxiety disorders at baseline (per diagnostic interview)
timeFrame: Baseline
measure: Prevalence of eating disorders at baseline (per diagnostic interview)
timeFrame: Baseline
measure: Depressive symptoms: incidence at 24-month FU
timeFrame: Baseline, 24-month FU
measure: Depressive symptoms: recovery at 24-month FU
timeFrame: Baseline, 24-month FU
measure: Anxiety symptoms: incidence at 24-month FU
timeFrame: Baseline, 24-month FU
measure: Anxiety symptoms: recovery
timeFrame: Baseline, 24-month FU
measure: Diabetes distress over time
timeFrame: Baseline, 24-month FU
measure: Daily diabetes burdens over time
timeFrame: Baseline, 24-month FU
measure: Eating problems: incidence
timeFrame: Baseline, 24-month FU
measure: Glycated hemoglobin (HbA1c) over time
timeFrame: Baseline, 24-month FU
measure: Glycemic levels (CGM glucose) over time
timeFrame: Baseline, 24-month FU
measure: Daily stress levels over time
timeFrame: Baseline, 24-month FU
Secondary outcomes:
measure: General health state over time
timeFrame: Baseline, 24-month FU
measure: Subjective health over time
timeFrame: Baseline, 24-month FU
measure: Wellbeing over time
timeFrame: Baseline, 24-month FU
measure: General sleep quality over time
timeFrame: Baseline, 24-month FU
measure: Daily sleep quality over time
timeFrame: Baseline, 24-month FU
measure: Fear of diabetes complications over time
timeFrame: Baseline, 24-month FU
measure: Fear of hypoglycemia over time
timeFrame: Baseline, 24-month FU
measure: Diabetes acceptance over time
timeFrame: Baseline, 24-month FU
measure: Daily eating problems over time
timeFrame: Baseline, 24-month FU
measure: Diabetes self-management over time
timeFrame: Baseline, 24-month FU
measure: Alcohol misuse over time
timeFrame: Baseline, 24-month FU
Other outcomes:
measure: COVID-19-related burden
timeFrame: Baseline, 24-month FU
measure: Psychological resilience
timeFrame: Baseline
measure: Social support
timeFrame: Baseline, 24-month FU
measure: Night eating
timeFrame: Baseline, 24-month FU
measure: Stressful life events
timeFrame: Baseline, 24-month FU
Locations:
city: Bad Mergentheim
country: Germany
facility: Diabetes Center Mergentheim
state: Baden-Württemberg
city: Bad Mergentheim
country: Germany
facility: Diabetes Practice Mergentheim
state: Baden-Württemberg
Study officials:
affiliation: Research Institute Diabetes Academy Mergentheim (FIDAM)
name: Norbert Hermanns, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute Diabetes Academy Mergentheim (FIDAM)
name: Bernhard Kulzer, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References: