Evaluation of the digital treatment program diaxilo for people with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035128

Enrollment

Registered

2024-10-04

Start date

2024-09-18

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 E14

Interventions

Group 1: Usual care (DMP for type 2 diabetes mellitus, Germany) + diaxilo App Group 2: Usual care (DMP for type 2 diabetes mellitus, Germany)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Diagnosis of type 2 diabetes mellitus (ICD-10 code E11.- and E14.-) ? Treatment according to the National Disease Management Guidelines (NVL) in the Diabetes Disease Management Program (DMP) (“care as usual”) for at least 6 months ? Physical and mental ability to independently implement behavioral changes and physical activity ? Ability to speak, understand and write German fluently ? Ability to give informed consent to the study ? Ability to operate a smartphone or tablet ? Availability of the current HbA1c value (+/- 2 weeks) and the HbA1c value recorded 3 months previously (+/- 2 weeks) ? Availability of a current (not older than 4 weeks) (nationally standardized) medication plan

Exclusion criteria

Exclusion criteria: ? HbA1c value > 11.0 % ? Pregnancy or full breastfeeding ? Existing treatment with insulin, glinides or sulfonylureas ? Persons whose physical or mental condition requires priority treatment at the time of the start of the study, e.g. acute suicidal tendencies, parasuicidal behavior, presence of self-harming behavior, eating disorder ? Use of another prescription-only digital health application (DiGA) for the treatment of diabetes or obesity ? Serious changes in therapy (within 6 months before the start of the study or during the study period) ? Participation in other clinical trials (current and in the last 6 months) ? Employees of Sidekick Health Germany GmbH

Design outcomes

Primary

Measure	Time frame
Long-term blood glucose value (HbA1c) after 3 (6) months	—

Secondary

Measure	Time frame
Quality of life (questionnaire: Problem Areas in Diabetes, PAID), Self-management (questionnaire: Summary of Diabetes Self-Care Activities Measure, SDSCA-G), Depression (questionnaire: Beck Depression Inventory, BDI II), Body weight	—

Countries

Germany

Contacts

Public ContactPeter Schwarz

Studienleitung

prof.dr.med.peter.schwarz@gmail.com01733723177

Outcome results

None listed

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