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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions. A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels). The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes. The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Diabetes Center Mergentheim
RECRUITING
Bad Mergentheim
Diabetes Practice Mergentheim
RECRUITING
Bad Mergentheim
Contact Information
Primary
Norbert Hermanns, Prof, PhD
hermanns@fidam.de
+49 7931 9619253
Backup
Andreas Schmitt, PhD
schmitt@diabetes-zentrum.de
+49 7931 594411
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1500
Sponsors
Leads: Forschungsinstitut der Diabetes Akademie Mergentheim

This content was sourced from clinicaltrials.gov