System Accuracy of 12 Bloog Glucose Monitoring Systems

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Diagnostic Test: blood glucose measurement: reference method

Diagnostic Test: blood glucose measurement: BGM

Study type

Interventional

Funder types

Other

Identifiers

NCT05219526

IDK_2021_006

Details and patient eligibility

About

The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No 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