Trust at First Click? User Acceptance of Digital Consent Interfaces Among Diabetes Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038318

Enrollment

Registered

2025-10-30

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study involves adult participants with type 1 or type 2 diabetes receiving care at the Department of Diabetology, University Hospital Carl Gustav Carus Dresden. The focus is not on therapeutic intervention but on assessing the acceptance and understanding of a digital consent management system (Standard Health Consent, SHC) in the context of health data use and sharing. Additionally, the study collects information on emotional well-being and diabetes-related distress using the validated DDS-

Interventions

Group 1: Patients with diabetes who will use the web-based GlucoMind App for four weeks. The app includes short weekly questionnaires assessing emotional well-being and diabetes-related distress (DDS-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients over the age of 18 at the Medical Clinic and Polyclinic III of Dresden University Hospital with type 1 or type 2 diabetes. - Declaration of consent to participate in the study - Sufficient knowledge of German - Access to a smartphone, tablet, or computer

Exclusion criteria

Exclusion criteria: - Inability to give informed consent - Acute illness that would prevent safe and meaningful use of the app - Vulnerable groups (children, individuals who cannot give consent, emergency patients, pregnant women/nursing mothers)

Design outcomes

Primary

Measure	Time frame
- Perceived benefits of sharing health data from apps and wearables - Level of understanding of SHC content - Perceived ease of use and user engagement with the SHC - Perceived level of trust in the SHC - Percentage of consent to share personal app-generated health data	—

Secondary

Measure	Time frame
no secondary outcomes	—

Countries

Germany

Contacts

Public ContactCindy Welzel

Else Kröner Fresenius Zentrum für Digitale Gesundheit, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden

cindy.welzel@ukdd.de+49 (0)351 458-15840

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026