System Accuracy of 12 Bloog Glucose Monitoring Systems

Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05219526

Enrollment

700

Registered

2022-02-02

Start date

2022-01-03

Completion date

2022-12-31

Last updated

2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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.

Interventions

DIAGNOSTIC_TESTblood glucose measurement: BGM

measurement of blood glucose concentration using different BGM

DIAGNOSTIC_TESTblood glucose measurement: reference method

measurement of blood glucose concentration using reference Method

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Measurement performance: System accuracy	4-6 hours	Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026