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Advanced pharmaceutical care intervention to prevent adverse effects and drug-related problems as well as improving adherence in a follow-up home-visit: multicenter randomized controlled trial in patients with type 2 diabetes mellitus

Advanced pharmaceutical care intervention to prevent adverse effects and drug-related problems as well as improving adherence in a follow-up home-visit: multicenter randomized controlled trial in patients with type 2 diabetes mellitus - BayPharmCare-Diabetes Trail

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036258
Enrollment
66
Registered
2025-02-27
Start date
2024-01-15
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: In the control group, at the beginning of the enrollment, a status-quo home-visit (t0) is performed to identify predefined adverse effects, drug-related problems, and adherence. 4-6 weeks aft

Sponsors

Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients are enrolled if they had a diagnosis of type 2 diabetes mellitus (ICD-10 E11) and are prescribed at least one (or more) antidiabetic medication (e.g., insulin, peroral and injectable antidiabetic agents) prior to study enrollment. In addition, patients have to be of legal age (=18 years), live at home, take responsibility for the administration of their medicines, and having given their written informed consent to participate in advance.

Exclusion criteria

Exclusion criteria: Patients are not enrolled if they have not a diagnosis of type 2 diabetes mellitus (ICD-10 E11) and are not prescribed at least one (or more) antidiabetic medication (e.g., insulin, peroral and injectable antidiabetic agents) prior to study enrollment. Patients not being of legal age (=18 years), not living at home, not taking responsibility for the administration of their medicines, and not having given their written informed consent to participate in advance are excluded.

Design outcomes

Primary

MeasureTime frame
- Gastrointestinal adverse effects (primary outcome)

Secondary

MeasureTime frame
- Hypoglycemic adverse effects (secondary outcome) - Dermatological adverse effects (secondary outcome) - Drug-related problems (secondary outcome) - Adherence (secondary outcome)

Countries

Germany

Contacts

Public ContactThilo Bertsche

Universität Leipzig

klinische.pharmazie@uni-leipzig.de+49 341 97 11800

Outcome results

None listed

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