Prevalence of HCV infections among diabetes patients within German Diabetes Centers

Prevalence of HCV infections among diabetes patients within German Diabetes Centers - Pioneer (HCV Screening Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017810

Enrollment

1774

Registered

2019-09-03

Start date

2019-08-13

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

B17.1 B18.2

Interventions

Group 1: Diabetes mellitus type 2 patients who meet the inclusion criteria are screened during a baseline visit: Baseline data and general risk factors of an HCV infection are recorded via the patient

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. =18 years old 2. Diagnosed type 2 diabetes 3. Scheduled check-up for routine venous blood sample 4. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients previously documented within this study 2. Investigator considers patient's information on demographic or sociomedical information as unreliable

Design outcomes

Primary

Measure	Time frame
Prevalence of HCV infection in type 2 diabetes patients in Germany, as defined by a positive anti HCV result, confirmed by a positive PCR test for HCV RNA. Calculation: Point estimates and 95% confidence intervals for the prevalence of HCV infection will be calculated. Moreover, a one-sided exact binomial test will be used for testing the increased prevalence of HCV infections in patients with diabetes vs. the published population mean (0.3%16 at the time the study is planned). For the difference vs. the population mean a 95% confidence interval will be provided. Patients are understood as HCV infected, if they show a positive anti HCV result, confirmed by a positive PCR test for HCV RNA.	—

Measure

Time frame

Prevalence of HCV infection in type 2 diabetes patients in Germany, as defined by a positive anti HCV result, confirmed by a positive PCR test for HCV RNA. Calculation: Point estimates and 95% confidence intervals for the prevalence of HCV infection will be calculated. Moreover, a one-sided exact binomial test will be used for testing the increased prevalence of HCV infections in patients with diabetes vs. the published population mean (0.3%16 at the time the study is planned). For the difference vs. the population mean a 95% confidence interval will be provided. Patients are understood as HCV infected, if they show a positive anti HCV result, confirmed by a positive PCR test for HCV RNA.

—

Secondary

Measure	Time frame
An exploratory objective of this observational study is to investigate differences in demographic information, sociomedical history, and laboratory parameters between HCV positive and HCV negative patients.	—

Countries

Germany

Contacts

Public ContactMarkus Christian Becker-Camps

MSD Sharp & Dohme GmbH

markus.christian.becker@msd.de+49 1728519493

Outcome results

None listed

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