Blood Glucose Monitoring Systems: Discounter Versus Brand

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Diagnostic Test: blood glucose measurement: POCT

Diagnostic Test: blood glucose measurement: reference

Study type

Interventional

Funder types

Other

Identifiers

NCT05031000

IDK_ISO_2021_002

Details and patient eligibility

About

This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, with clinical indication for blood glucose measurement
Signed informed consent form
Minimum age of 18 years
Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion criteria

Pregnancy or lactation period
Severe acute disease (at the study physician's discretion)
Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
Being unable to give informed consent
< 18 years
Legally incompetent