Digital twins to classify mental health patterns in adults with diabetes
Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
This project will try to create 'digital twin' profiles that combine glucose, mood, and behavior data to track mental health patterns in adults with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1809 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Forschungsinstitut der Diabetes Akademie Mergentheim Academic / other |
| Locations | 3 sites (Bad Mergentheim, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT07212075 on ClinicalTrials.gov |
What this trial studies
This observational project will collect continuous glucose monitoring (CGM), ecological momentary assessment (EMA) of mood and behavior, and clinical data from adults with type 1 or type 2 diabetes to identify distinct mental health subgroups. Investigators will analyze longitudinal trajectories of glycaemia and psychological symptoms to understand how glucose patterns, physiological, and behavioral factors interact. The work aims to build individualized 'digital twin' profiles that predict who is at higher risk of diabetes distress, depression, anxiety, or disordered eating. Findings are intended to inform more personalized mental health and diabetes care strategies.
Who should consider this trial
Good fit: Adults aged 18–80 with type 1, type 2, or other specified diabetes for at least one year who speak German and can give informed consent are ideal candidates.
Not a fit: People who are unable to consent, have significant cognitive impairment or severe comorbid conditions (for example advanced heart disease, active cancer treatment, psychotic disorders), are bedridden, terminally ill, or who do not speak sufficient German are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could help clinicians tailor psychological and diabetes care to individual risk patterns, improving mental well‑being and glycaemic outcomes.
How similar studies have performed: Previous projects (DIA-LINK and PRO-MENTAL) combined CGM and EMA to inform precision mental health, but using 'digital twins' for formal subgroup classification remains a relatively novel and exploratory approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bad Mergentheim, Baden-Wurttemberg and 2 other locations
- Diabetes Clinic Mergentheim (DCM) — Bad Mergentheim, Baden-Wurttemberg, Germany (Recruiting)
- MVZ Diabetespraxis Mergentheim — Bad Mergentheim, Baden-Wurttemberg, Germany (Completed)
- MVZ DiaMedicum Würzburg — Würzburg, Baden-Wurttemberg, Germany (Completed)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.