Digital twins to classify mental health patterns in adults with diabetes
Official title: Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
Run by Forschungsinstitut der Diabetes Akademie Mergentheim · NCT07212075 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1809 (estimated) |
| Sponsor | Forschungsinstitut der Diabetes Akademie Mergentheim Academic / other |
| Locations | 3 sites (Bad Mergentheim, Baden-Wurttemberg and 2 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07212075 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.