Understanding mental health and diabetes management
PRO-MENTAL: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
This study looks at how mental health and feelings about diabetes affect blood sugar control in people with type 1 and type 2 diabetes to find better ways to help them manage both their diabetes and mental health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Forschungsinstitut der Diabetes Akademie Mergentheim Academic / other |
| Locations | 2 sites (Bad Mergentheim, Baden-Württemberg and 1 other locations) |
| Trial ID | NCT05548699 on ClinicalTrials.gov |
What this trial studies
The PRO-MENTAL study is an observational research project that investigates the relationships between diabetes distress, mental health disorders, and glycemic control in individuals with type 1 and type 2 diabetes. Over a 24-month period, 1500 participants will undergo a baseline assessment followed by four additional evaluations every six months, utilizing continuous glucose monitoring and ecological momentary assessment methods. The study aims to identify mental health subtypes and trajectories to inform personalized interventions for improving mental health outcomes in diabetes care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of type 1 or type 2 diabetes and a diabetes duration of at least one year.
Not a fit: Patients with significant cognitive impairments or severe mental disorders that could interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored mental health interventions that improve overall diabetes management and patient well-being.
How similar studies have performed: While there is ongoing research in this area, the precision monitoring approach used in this study is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bad Mergentheim, Baden-Württemberg and 1 other locations
- Diabetes Center Mergentheim — Bad Mergentheim, Baden-Württemberg, Germany (Recruiting)
- Diabetes Practice Mergentheim — Bad Mergentheim, Baden-Württemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Norbert Hermanns, Prof, PhD — Research Institute Diabetes Academy Mergentheim (FIDAM)
- Study coordinator: Norbert Hermanns, Prof, PhD
- Email: hermanns@fidam.de
- Phone: +49 7931 9619253
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.