System Accuracy of 14 Blood Glucose Monitoring Systems

Leistungsbewertungsprüfung Der Systemgenauigkeit, Von 14 Blutglukose Monitoring Systemen in Anlehnung an ISO 15197:2015

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06037499

Enrollment

500

Registered

2023-09-14

Start date

2023-03-03

Completion date

2025-01-01

Last updated

2025-04-25

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

Conditions

Diabetes

Brief summary

The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months

Interventions

DIAGNOSTIC_TESTGlucometer Test

measurement of blood glucose concentration using different BGM and 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 patients with hypo-, eu- or hyperglycaemia * The written informed consent had to be signed * The volunteers must be older than 18 years * The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria

* Pregnancy or lactation * Acute or chronic diseases with the risk of aggravation by the measure * A current constitution that does not allow participating in the study * Participation in another study or activity with the blood glucose measuring system evaluated in the present study * Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Design outcomes

Primary

Measure	Time frame
Blood glucose measurement using BGMS	Day 1

Countries

Germany

Outcome results

None listed

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