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Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

Launched by FORSCHUNGSINSTITUT DER DIABETES AKADEMIE MERGENTHEIM · Sep 19, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The PRO-MENTAL trial is a research study looking at how mental health affects people with diabetes, specifically focusing on those with type 1 and type 2 diabetes. The goal is to understand the different types of mental health challenges, like depression and anxiety, and how these issues relate to managing blood sugar levels (glycemic control) over time. By studying 1,500 participants over two years, researchers hope to find patterns in mental health and diabetes care that can lead to personalized treatments and better support for individuals facing these challenges.

To participate, you need to be between 18 and 75 years old and have been diagnosed with type 1 or type 2 diabetes for at least a year. If you join, you'll complete a series of questionnaires and assessments every six months, which include questions about your mental well-being, daily mood, and stress, as well as monitoring your blood sugar levels. This study aims to create a better understanding of how mental health and diabetes interact, ultimately helping to develop tailored interventions that suit the specific needs of different people with diabetes.

Gender

ALL

Eligibility 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

About Forschungsinstitut Der Diabetes Akademie Mergentheim

The Forschungsinstitut der Diabetes Akademie Mergentheim is a leading clinical research organization dedicated to advancing diabetes care through innovative research and development. With a focus on conducting high-quality clinical trials, the institute collaborates with academic institutions, healthcare providers, and pharmaceutical companies to explore new therapeutic approaches and enhance patient outcomes. Committed to excellence in research and ethical standards, the institute plays a pivotal role in shaping the future of diabetes treatment and management.

Locations

Bad Mergentheim, Baden Württemberg, Germany

Bad Mergentheim, Baden Württemberg, Germany

Bad Mergentheim, , Germany

Bad Mergentheim, , Germany

Patients applied

0 patients applied

Trial Officials

Norbert Hermanns, Prof, PhD

Principal Investigator

Research Institute Diabetes Academy Mergentheim (FIDAM)

Bernhard Kulzer, Prof, PhD

Principal Investigator

Research Institute Diabetes Academy Mergentheim (FIDAM)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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