System Accuracy of BGM GL60

Institut fur Diabetes Karlsburg GmbH101 enrolled

Overview

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

101

Conditions

Diabetes Mellitus

Interventions

Glucometer TestDIAGNOSTIC_TEST

measurement of the blood glucose concentration using the blood glucose monitor for personal use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

Analysis of system accuracy based on DIN EN ISO 15197

Assessment of the analytical measurement performance of the blood glucose monitor

Time frame: Day 1

Data from ClinicalTrials.gov

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