Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorForschungsinstitut der Diabetes Akademie Mergentheim

About this trial

Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health.

Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups.

Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person.

The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions.

To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews.

The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 80 years of age

Diagnosis of type 1 diabetes or type 2 diabetes or other specific type of diabetes

Diabetes duration ≥ 1 year

Sufficient German language skills

Disqualifiers

Inability to consent

Significant cognitive impairment (e.g. dementia)

Severe disorder or condition impacting the person's ability to participate in the study or likely to confound results (e.g. treated cancer, heart disease ≥ NYHA III, schizophrenia/psychotic disorder)

Terminal illness

Trial population

The study participants are enrolled from the population of people with diabetes treated at several specialised diabetes centres in South Germany. Including the Diabetes Clinic Mergentheim (DCM), Diabetes Practice Mergentheim, DiaMedicum Center Würzburg.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,809 Participants
are grouped into 1 trial group
Group A: Patients with Diabetes

Trial outcomes

Primary outcomes

1

Incidence of affective disorders from baseline to follow-up (per structured diagnostic interview)

Diagnoses of affective disorders were assessed at baseline (as part of the PRO-MENTAL study) using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS OA, improved version). The PRO-MENTAL cohort is followed up in the TwinPeaks study including a re-assessment of affective disorders using the Mini-DIPS OA at 2-year follow-up. Primary outcome is the 2-year incidence of affective disorders as per structured diagnostic interview.

Time frame
Baseline, 2-year Follow-up
2

Incidence of anxiety disorders from baseline to follow-up (per structured diagnostic interview)

Diagnoses of anxiety disorders were assessed at baseline (as part of the PRO-MENTAL study) using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS OA, improved version). The PRO-MENTAL cohort is followed up in the TwinPeaks study including a re-assessment of anxiety disorders using the Mini-DIPS OA at 2-year follow-up. Primary outcome is the 2-year incidence of anxiety disorders as per structured diagnostic interview.

Time frame
Baseline, 2-year Follow-up
3

Incidence of eating disorders at from baseline to follow-up (per structured diagnostic interview)

Diagnoses of eating disorders were assessed at baseline (as part of the PRO-MENTAL study) using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS OA, improved version). The PRO-MENTAL cohort is followed up in the TwinPeaks study including a re-assessment of eating disorders using the Mini-DIPS OA at 2-year follow-up. Primary outcome is the 2-year incidence of eating disorders as per structured diagnostic interview.

Time frame
Baseline, 2-year Follow-up
4

Depressive symptoms: Incidence at 2-year Follow-up

Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 12 months, and 24 months. PHQ-9 sum score range: 0 - 27; higher scores indicate higher depressive symptoms; scores of 10 and above are considered as elevated depressive symptoms. The incidence of depressive symptoms at 2-year follow-up compared to baseline (for persons without depressive symptoms at baseline) is a secondary outcome.

Time frame
Baseline, 2-year Follow-up

Secondary outcomes

1

Subjective health state 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 2-year Follow-up. EQ-5D VAS score range: 0 - 100; higher scores indicate better health states.

Time frame
Baseline, 2-year Follow-up
2

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. WHO-5 sum score range: 0 - 25; higher scores indicate better well-being.

Time frame
Baseline, 2-year Follow-up
3

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 selected items of the Pittsburgh Sleep Quality Index (PSQI) to detect changes in sleep quality from baseline to 2-year FU. A total score range is 0 - 4 each for sleep quality as well as for frequency of sleep problems, whereby higher scores indicate better sleep.

Time frame
Baseline, 2-year Follow-up
4

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 (EMA) 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 2-year Follow-up. EMA sleep items are scored on an 11-point scale from 0 - 10 with higher values indicating better sleep quality.

Time frame
Baseline, 2-year Follow-up

Other outcomes

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