NCT07212075 Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
| NCT ID | NCT07212075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Forschungsinstitut der Diabetes Akademie Mergentheim |
| Condition | Diabetes (DM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,809 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,809 participants in total. It began in 2025-01-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * Informed consent Exclusion Criteria: * 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 * Being bedridden
Frequently Asked Questions
Who can join the NCT07212075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetes (DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07212075 currently recruiting?
Yes, NCT07212075 is actively recruiting participants. Visit ClinicalTrials.gov or contact Forschungsinstitut der Diabetes Akademie Mergentheim to inquire about joining.
Where is the NCT07212075 trial being conducted?
This trial is being conducted at Bad Mergentheim, Germany, Bad Mergentheim, Germany, Würzburg, Germany.
Who is sponsoring the NCT07212075 clinical trial?
NCT07212075 is sponsored by Forschungsinstitut der Diabetes Akademie Mergentheim. The trial plans to enroll 1,809 participants.
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