Registry for Observational Studies Assessing the Impact of Diabetes DiGA on Type 2 Diabetes Patients in a Real-world Care Setting - OSAKA

Registry for Observational Studies Assessing the Impact of Diabetes DiGA on Type 2 Diabetes Patients in a Real-world Care Setting - OSAKA - OSAKA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035790

Enrollment

100000

Registered

2025-01-02

Start date

2025-01-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E11

Interventions

Group 1: Users of DiGAs (according to BfArM list) in the field of diabetes

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient with prescription of the Apps

Exclusion criteria

Exclusion criteria: - Patient not eligible for the Apps prescription - Patients with impairments – including mental or psychic impairments – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study

Design outcomes

Primary

Measure	Time frame
Quality of Life (WHO-5) (every three months up to one year during usage of DiGA)	—

Secondary

Measure	Time frame
Change in the following endpoints during the usage of DiGA every three months up to one year 1. self-management (SDSCA-G) 2. diabetes-related emotional stress in connection with in connection with diabetes and treatment requirements (PAID) 3. HbA1c	—

Countries

Germany

Contacts

Public ContactPeter Schwarz

Universitätsklinikum Carl Gustav Carus

peter.schwarz@ukdd.de+493514582715

Outcome results

None listed

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